Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-03-08 @ 1:26 AM
Study NCT ID:
NCT05525520
Status:
COMPLETED
Last Update Posted:
2025-07-31
First Post:
2022-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011537', 'term': 'Pruritus'}, {'id': 'D008105', 'term': 'Liver Cirrhosis, Biliary'}, {'id': 'D015209', 'term': 'Cholangitis, Sclerosing'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002780', 'term': 'Cholestasis, Intrahepatic'}, {'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D002761', 'term': 'Cholangitis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@incyte.com', 'phone': '1-855-463-3463', 'title': 'Study Director', 'organization': 'Incyte Corporation'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'For participants who received placebo up to Week 6 and then switched to EP547, adverse events are presented by the treatment they were on at onset of the event.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive oral placebo 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind (DB) Treatment Period.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 7, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'EP547', 'description': 'Participants were randomized to receive oral EP547 100 mg QD for 6 weeks in the DB Treatment Period and for 6 weeks in the Open-Label Extension Period. Participants who were randomized to receive oral placebo 100 mg QD for 6 weeks during the DB Treatment Period received EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 24, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 15, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'seriousEvents': [{'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gun shot wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Worst Itch Numeric Rating Scale (WI-NRS) Score up to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.'}, {'id': 'OG001', 'title': 'EP547 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.20', 'spread': '0.445', 'groupId': 'OG000'}, {'value': '-1.75', 'spread': '0.430', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4577', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square mean difference (LSMD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.46', 'ciLowerLimit': '-0.77', 'ciUpperLimit': '1.68', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.609', 'estimateComment': 'LSMD=EP547 minus placebo', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Treatment, type of cholestatic disease, week, and treatment-by-week interaction were fixed effects, and Baseline WI-NRS score was a covariate.', 'nonInferiorityComment': 'two-sided equivalence test'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; up to Week 6', 'description': 'Participants were asked to rate the severity of their worst level of itching in the past 24 hours using the daily WI-NRS, an 11-point scale ranging from 0 (no itching) to 10 (worst itching imaginable). Itching severity scores collected via the WI-NRS have been categorized in the as mild (\\<4), moderate (≥4 to \\<7), or severe (≥7). The average WI-NRS score using the daily values from the week before the first dose of study drug (including the WI-NRS score captured on Study Day 1 of dosing) served as the Baseline score. A weekly score was determined based on the average of all available daily scores of the week. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all participants who were randomized and took at least 1 dose of randomized study drug. Participants were analyzed according to randomized treatment assignment. Only participants with available data were analyzed. MMRM=mixed effects model for repeated measures.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the 5-D Itch Scale Total Score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.'}, {'id': 'OG001', 'title': 'EP547 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.7', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 6', 'description': 'The 5-D Itch Scale is a multidimensional (degree, duration, direction, disability, and distribution) questionnaire measuring changes in pruritis. The duration, degree, and direction domain scores range from 1 (no pruritus) to 5 (most severe pruritus). The disability domain includes 4 items assessing itching impact on daily activities: sleep, leisure/social activities, housework/errands, and work/school. Disability domain score=highest score on any of the 4 categories (1 \\[no pruritis\\] to 5 \\[most severe pruritis\\]). For the distribution domain, 16 body parts are listed to determine the distribution of itching over the last 2 weeks; the number of affected body parts is tallied (potential sum=0-16); the sum is sorted into 5 thresholds: 0-2 is assigned a score of 1; 3-5, a score of 2; 6-10, a score of 3; 11-13, a score of 4; 14-16, a score of 5. Higher scores indicate more severe pruritis. The 5 domain scores are summed to get a total 5-D score: 5 (no pruritus) to 25 (most severe pruritus).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with available data were analyzed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement in Pruritus as Defined by Patient Global Impression of Change (PGI-C) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.'}, {'id': 'OG001', 'title': 'EP547 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000', 'lowerLimit': '35.3', 'upperLimit': '74.5'}, {'value': '60.7', 'groupId': 'OG001', 'lowerLimit': '40.6', 'upperLimit': '78.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Week 6', 'description': 'Participants were asked to rate their impression of overall change in pruritus in the past 7 days compared to before they started taking study drug using the PGI-C, a 7-point scale ranging from "much improved" to "much worse," with higher scores indicating less improvement in pruritus. Participants that reported a change in their itch of "minimally improved" or better were considered to be responders in terms of "improvement in pruritus."', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with available data were analyzed. Exact binomial (Clopper-Pearson) confidence intervals have been reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement in Pruritus Severity From Baseline as Defined by Change in Patient Global Impress of Severity (PGI-S) at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.'}, {'id': 'OG001', 'title': 'EP547 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.0', 'groupId': 'OG000', 'lowerLimit': '34.9', 'upperLimit': '75.6'}, {'value': '52.0', 'groupId': 'OG001', 'lowerLimit': '31.3', 'upperLimit': '72.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Week 6', 'description': 'Participants were asked to rate the severity of their pruritus in the past 7 days using the PGI-S, a 4-point scale ranging from "none" to "severe." Participants that reported a positive shift in their categorical assessment of itch compared to their Baseline level (e.g., "severe" at Visit 2 \\[Day 1\\] with a shift to "moderate" at Visit 6 \\[Week 6\\]) were considered to be responders in terms of "improvement in pruritus."', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with available data were analyzed. Exact binomial (Clopper-Pearson) confidence intervals have been reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Reduction in WI-NRS Score ≥2 From Baseline at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.'}, {'id': 'OG001', 'title': 'EP547 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000', 'lowerLimit': '25.5', 'upperLimit': '64.7'}, {'value': '35.7', 'groupId': 'OG001', 'lowerLimit': '18.6', 'upperLimit': '55.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Week 6', 'description': 'Participants were asked to rate the severity of their worst level of itching in the past 24 hours using the daily WI-NRS, an 11-point scale ranging from 0 (no itching) to 10 (worst itching imaginable). Itching severity scores collected via the WI-NRS have been categorized in the as mild (\\<4), moderate (≥4 to \\<7), or severe (≥7). The average WI-NRS score using the daily values from the week before the first dose of study drug (including the WI-NRS score captured on Study Day 1 of dosing) served as the Baseline score. A weekly score was determined based on the average of all available daily scores of the week.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with available data were analyzed. Exact binomial (Clopper-Pearson) confidence intervals have been reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Reduction in WI-NRS Score ≥3 From Baseline at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.'}, {'id': 'OG001', 'title': 'EP547 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.0', 'groupId': 'OG000', 'lowerLimit': '19.4', 'upperLimit': '57.6'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '44.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Week 6', 'description': 'Participants were asked to rate the severity of their worst level of itching in the past 24 hours using the daily WI-NRS, an 11-point scale ranging from 0 (no itching) to 10 (worst itching imaginable). Itching severity scores collected via the WI-NRS have been categorized in the as mild (\\<4), moderate (≥4 to \\<7), or severe (≥7). The average WI-NRS score using the daily values from the week before the first dose of study drug (including the WI-NRS score captured on Study Day 1 of dosing) served as the Baseline score. A weekly score was determined based on the average of all available daily scores of the week.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with available data were analyzed. Exact binomial (Clopper-Pearson) confidence intervals have been reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Reduction in WI-NRS Score ≥4 From Baseline at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.'}, {'id': 'OG001', 'title': 'EP547 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.0', 'groupId': 'OG000', 'lowerLimit': '19.4', 'upperLimit': '57.6'}, {'value': '17.9', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '36.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Week 6', 'description': 'Participants were asked to rate the severity of their worst level of itching in the past 24 hours using the daily WI-NRS, an 11-point scale ranging from 0 (no itching) to 10 (worst itching imaginable). Itching severity scores collected via the WI-NRS have been categorized in the as mild (\\<4), moderate (≥4 to \\<7), or severe (≥7). The average WI-NRS score using the daily values from the week before the first dose of study drug (including the WI-NRS score captured on Study Day 1 of dosing) served as the Baseline score. A weekly score was determined based on the average of all available daily scores of the week.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with available data were analyzed. Exact binomial (Clopper-Pearson) confidence intervals have been reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a WI-NRS Score <4 at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.'}, {'id': 'OG001', 'title': 'EP547 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000', 'lowerLimit': '24.5', 'upperLimit': '62.8'}, {'value': '35.7', 'groupId': 'OG001', 'lowerLimit': '18.6', 'upperLimit': '55.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Week 6', 'description': 'Participants were asked to rate the severity of their worst level of itching in the past 24 hours using the daily WI-NRS, an 11-point scale ranging from 0 (no itching) to 10 (worst itching imaginable). Itching severity scores collected via the WI-NRS have been categorized in the as mild (\\<4), moderate (≥4 to \\<7), or severe (≥7). The average WI-NRS score using the daily values from the week before the first dose of study drug (including the WI-NRS score captured on Study Day 1 of dosing) served as the Baseline score. A weekly score was determined based on the average of all available daily scores of the week.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with available data were analyzed. Exact binomial (Clopper-Pearson) confidence intervals have been reported.'}, {'type': 'SECONDARY', 'title': 'Double-blind Treatment Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any ≥Grade 3 TEAE, Any Related TEAE, and Any TEAE That Led to Discontinuation of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.'}, {'id': 'OG001', 'title': 'EP547 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Any ≥Grade 3 TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any related TEAE', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Any TEAE that led to discontinuation of study drug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to the end of Week 6', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. TEAEs are AEs with an onset after the first dose of study drug or existing events that worsened after the first dose during the study. TEAEs were graded for severity (mild \\[Grade 1\\], moderate \\[Grade 2\\], severe \\[Grade 3\\], life threatening \\[Grade 4\\], death \\[Grade 5\\]) using Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. The investigator assessed whether the TEAEs were related or unrelated to the study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: All participants who were randomized and took at least 1 dose of randomized study drug. Analysis was based on the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Open-label Extension Period: Number of Participants With Any TEAE, Any ≥Grade 3 TEAE, Any Related TEAE, and Any TEAE That Led to Discontinuation of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.'}, {'id': 'OG001', 'title': 'EP547 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Any ≥Grade 3 TEAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any related TEAE', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any TEAE that led to discontinuation of study drug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from the beginning of Week 7 up to Week 12', 'description': 'An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. TEAEs are AEs with an onset after the first dose of study drug or existing events that worsened after the first dose during the study. TEAEs were graded for severity (mild \\[Grade 1\\], moderate \\[Grade 2\\], severe \\[Grade 3\\], life threatening \\[Grade 4\\], death \\[Grade 5\\]) using CTCAE, version 5.0. The investigator assessed whether the TEAEs were related or unrelated to the study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Open-label Extension Analysis Set: all participants who completed the Double-Blind Treatment Period and received at least 1 dose of study drug in the Open-Label Extension Period'}, {'type': 'SECONDARY', 'title': 'Double-blind Treatment Period: Number of Participants With Any Serious TEAE, Any ≥Grade 3 Serious TEAE, Any Related Serious TEAE, and Any Serious TEAE That Led to Discontinuation of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.'}, {'id': 'OG001', 'title': 'EP547 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.'}], 'classes': [{'title': 'Any serious TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any ≥Grade 3 serious TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any related serious TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any serious TEAE that led to discontinuation of study drug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to the end of Week 6', 'description': 'TEAEs are AEs with an onset after the first dose of study drug or existing events that worsened after the first dose during the study. A serious TEAE is any untoward medical occurrence, that at any dose: results in death; is life threatening; requires hospital admission or prolongs hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly/birth defect; or is a medically significant event that, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent one of the previously listed outcomes. Serious TEAEs were graded for severity (mild \\[Grade 1\\], moderate \\[Grade 2\\], severe \\[Grade 3\\], life threatening \\[Grade 4\\], death \\[Grade 5\\]) using CTCAE, version 5.0. The investigator assessed whether the serious TEAEs were related or unrelated to the study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Open-label Extension Period: Number of Participants With Any Serious TEAE, Any ≥Grade 3 Serious TEAE, Any Related Serious TEAE, and Any Serious TEAE That Led to Discontinuation of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.'}, {'id': 'OG001', 'title': 'EP547 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.'}], 'classes': [{'title': 'Any serious TEAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any ≥Grade 3 serious TEAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any related serious TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any serious TEAE that led to discontinuation of study drug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from the beginning of Week 7 up to Week 12', 'description': 'TEAEs are AEs with an onset after the first dose of study drug or existing events that worsened after the first dose during the study. A serious TEAE is any untoward medical occurrence, that at any dose: results in death; is life threatening; requires hospital admission or prolongs hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly/birth defect; or is a medically significant event that, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent one of the previously listed outcomes. Serious TEAEs were graded for severity (mild \\[Grade 1\\], moderate \\[Grade 2\\], severe \\[Grade 3\\], life threatening \\[Grade 4\\], death \\[Grade 5\\]) using CTCAE, version 5.0. The investigator assessed whether the serious TEAEs were related or unrelated to the study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Open-label Extension Analysis Set'}, {'type': 'SECONDARY', 'title': 'Double-blind Treatment Period: Number of Participants With Any Treatment-emergent (TE) Adverse Event of Special Interest (AESI), Any ≥Grade 3 TE AESI, Any Related TE AESI, and Any TE AESI That Led to Discontinuation of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.'}, {'id': 'OG001', 'title': 'EP547 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.'}], 'classes': [{'title': 'Any treatment-emergent (TE) AESI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any ≥Grade 3 TE AESI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any related TE AESI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any TE AESI that led to discontinuation of study drug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to the end of Week 6', 'description': 'An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are AEs with an onset after the first dose of study drug or existing events that worsened after the first dose during the study. AESI were considered to be any clinically meaningful new, worsening from Baseline, or abnormal laboratory findings or symptoms suggestive of acute kidney injury (AKI) (e.g., "blood urea increased" or "protein urine present" AEs as identified by the Standardized Medical Dictionary for Regulatory Activities \\[MedDRA\\] Query \\[SMQ\\] "Acute renal failure"). TE AESIs were graded for severity (mild \\[Grade 1\\], moderate \\[Grade 2\\], severe \\[Grade 3\\], life threatening \\[Grade 4\\], death \\[Grade 5\\]) using CTCAE, version 5.0. The investigator assessed whether the AE AESIs were related or unrelated to the study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Open-label Extension Period: Number of Participants With Any Treatment-emergent (TE) AESI, Any ≥Grade 3 TE AESI, Any Related TE AESI, and Any TE AESI That Led to Discontinuation of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.'}, {'id': 'OG001', 'title': 'EP547 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.'}], 'classes': [{'title': 'Any TE AESI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any ≥Grade 3 TE AESI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any related TE AESI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any TE AESI that led to discontinuation of study drug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from the beginning of Week 7 up to Week 12', 'description': 'An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are AEs with an onset after the first dose of study drug or existing events that worsened after the first dose during the study. AESI were considered to be any clinically meaningful new, worsening from Baseline, or abnormal laboratory findings or symptoms suggestive of acute kidney injury (AKI) (e.g., "blood urea increased" or "protein urine present" AEs as identified by the Standardized Medical Dictionary for Regulatory Activities \\[MedDRA\\] Query \\[SMQ\\] "Acute renal failure"). TE AESIs were graded for severity (mild \\[Grade 1\\], moderate \\[Grade 2\\], severe \\[Grade 3\\], life threatening \\[Grade 4\\], death \\[Grade 5\\]) using CTCAE, version 5.0. The investigator assessed whether the AE AESIs were related or unrelated to the study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Open-label Extension Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Clinically Meaningful Changes From Baseline in Clinically Meaningful in Clinical Laboratory Test Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.'}, {'id': 'OG001', 'title': 'EP547 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to the end of Week 12', 'description': 'Clinical laboratory test results included results for clinical hematology, chemistry, coagulation, and thyroid function parameters . The investigator determined if changes were clinically meaningful.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Clinically Meaningful Changes From Baseline in Vital Sign Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.'}, {'id': 'OG001', 'title': 'EP547 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to the end of Week 12', 'description': 'Vital sign measurements included measurements for blood pressure, pulse rate, oxygen saturation, body temperature, and respiratory rate. The investigator determined if changes were clinically meaningful.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Clinically Significant Changes From Baseline in Electrocardiogram (ECG) Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.'}, {'id': 'OG001', 'title': 'EP547 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to the end of Week 12', 'description': 'ECG parameters included heart rate, RR interval, PR interval, QRS duration, or QT interval. The investigator determined if changes were clinically significant.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of EP547 and Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.'}, {'id': 'OG001', 'title': 'EP547 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.'}], 'classes': [{'title': 'EP547: Day 1, 1 hour postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2661.0', 'spread': '159.42', 'groupId': 'OG001'}]}]}, {'title': 'EP547: Day 1, 2 hours postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5197.7', 'spread': '93.75', 'groupId': 'OG001'}]}]}, {'title': 'EP547: Day 1, 3 hours postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5698.4', 'spread': '75.27', 'groupId': 'OG001'}]}]}, {'title': 'EP547: Week 1, predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6267.9', 'spread': '51.54', 'groupId': 'OG001'}]}]}, {'title': 'EP547: Week 2, predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5786.5', 'spread': '56.27', 'groupId': 'OG001'}]}]}, {'title': 'EP547: Week 3, predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6617.4', 'spread': '49.06', 'groupId': 'OG001'}]}]}, {'title': 'EP547: Week 3, 1 hour postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11709.4', 'spread': '39.25', 'groupId': 'OG001'}]}]}, {'title': 'EP547: Week 3, 2 hours postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12012.7', 'spread': '30.98', 'groupId': 'OG001'}]}]}, {'title': 'EP547: Week 3, 3 hours postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11909.4', 'spread': '49.76', 'groupId': 'OG001'}]}]}, {'title': 'EP547: Week 6, predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4947.6', 'spread': '91.61', 'groupId': 'OG001'}]}]}, {'title': 'EP3583: Day 1, 1 hour postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '308.5', 'spread': '160.23', 'groupId': 'OG001'}]}]}, {'title': 'EP3583: : Day 1, 2 hours postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '796.1', 'spread': '104.08', 'groupId': 'OG001'}]}]}, {'title': 'EP3583: : Day 1, 3 hours postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '910.6', 'spread': '90.22', 'groupId': 'OG001'}]}]}, {'title': 'EP3583: Week 1, predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '952.1', 'spread': '56.10', 'groupId': 'OG001'}]}]}, {'title': 'EP3583: Week 2, predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '948.2', 'spread': '61.73', 'groupId': 'OG001'}]}]}, {'title': 'EP3583: Week 3, predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1028.9', 'spread': '64.53', 'groupId': 'OG001'}]}]}, {'title': 'EP3583: Week 3, 1 hour postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1625.4', 'spread': '54.57', 'groupId': 'OG001'}]}]}, {'title': 'EP3583: Week 3, 2 hours postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1898.0', 'spread': '47.98', 'groupId': 'OG001'}]}]}, {'title': 'EP3583: Week 3, 3 hours postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1836.0', 'spread': '62.20', 'groupId': 'OG001'}]}]}, {'title': 'EP3583: Week 6, predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '801.8', 'spread': '103.25', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1, 2, and 3 hours postdose on Day 1 and Week 3; predose on Weeks 1, 2, and 6', 'description': 'The lower level of quantitation = 0.01 micrograms per milliliter (µg/mL) for EP547 and 0.005 μg/mL for EP3583.', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmokinetic Set: all participants who received at least 1 dose of EP547 and provided adequate blood samples for bioanalysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.'}, {'id': 'FG001', 'title': 'EP547 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.'}], 'periods': [{'title': 'DB Treatment Period (Weeks 1-6)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Open-label Extension Period (Weeks 7-12)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants were enrolled at 29 study sites across the United States, United Kingdom, France, Spain, Canada, Israel, Belgium, and the Netherlands.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral placebo 100 mg QD for 6 weeks in the Double-Blind (DB) Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug switched to oral EP547 100 mg QD for 6 weeks in the Open-Label Extension Period.'}, {'id': 'BG001', 'title': 'EP547 100 mg QD; EP547 100 mg QD', 'description': 'Participants were randomized to receive oral EP547 100 milligrams (mg) once daily (QD) for 6 weeks in the Double-Blind Treatment Period. Participants who completed the Double-Blind Treatment Period and were still receiving study drug received oral EP547 100 mg QD for an additional 6 weeks in the Open-Label Extension Period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.6', 'spread': '12.99', 'groupId': 'BG000'}, {'value': '51.6', 'spread': '12.88', 'groupId': 'BG001'}, {'value': '51.1', 'spread': '12.83', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': 'Asian/White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native/White', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'North African (Morocco)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Data are reported for the Full Analysis Set, comprised of all participants who were randomized and took at least 1 dose of randomized study drug. Participants were analyzed according to randomized treatment assignment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-02', 'size': 13805018, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-15T09:09', 'hasProtocol': True}, {'date': '2024-05-01', 'size': 694918, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-15T09:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2022-08-30', 'resultsFirstSubmitDate': '2025-07-15', 'studyFirstSubmitQcDate': '2022-08-30', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-15', 'studyFirstPostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Worst Itch Numeric Rating Scale (WI-NRS) Score up to Week 6', 'timeFrame': 'Baseline; up to Week 6', 'description': 'Participants were asked to rate the severity of their worst level of itching in the past 24 hours using the daily WI-NRS, an 11-point scale ranging from 0 (no itching) to 10 (worst itching imaginable). Itching severity scores collected via the WI-NRS have been categorized in the as mild (\\<4), moderate (≥4 to \\<7), or severe (≥7). The average WI-NRS score using the daily values from the week before the first dose of study drug (including the WI-NRS score captured on Study Day 1 of dosing) served as the Baseline score. A weekly score was determined based on the average of all available daily scores of the week. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the 5-D Itch Scale Total Score at Week 6', 'timeFrame': 'Baseline; Week 6', 'description': 'The 5-D Itch Scale is a multidimensional (degree, duration, direction, disability, and distribution) questionnaire measuring changes in pruritis. The duration, degree, and direction domain scores range from 1 (no pruritus) to 5 (most severe pruritus). The disability domain includes 4 items assessing itching impact on daily activities: sleep, leisure/social activities, housework/errands, and work/school. Disability domain score=highest score on any of the 4 categories (1 \\[no pruritis\\] to 5 \\[most severe pruritis\\]). For the distribution domain, 16 body parts are listed to determine the distribution of itching over the last 2 weeks; the number of affected body parts is tallied (potential sum=0-16); the sum is sorted into 5 thresholds: 0-2 is assigned a score of 1; 3-5, a score of 2; 6-10, a score of 3; 11-13, a score of 4; 14-16, a score of 5. Higher scores indicate more severe pruritis. The 5 domain scores are summed to get a total 5-D score: 5 (no pruritus) to 25 (most severe pruritus).'}, {'measure': 'Percentage of Participants With Improvement in Pruritus as Defined by Patient Global Impression of Change (PGI-C) at Week 6', 'timeFrame': 'Baseline; Week 6', 'description': 'Participants were asked to rate their impression of overall change in pruritus in the past 7 days compared to before they started taking study drug using the PGI-C, a 7-point scale ranging from "much improved" to "much worse," with higher scores indicating less improvement in pruritus. Participants that reported a change in their itch of "minimally improved" or better were considered to be responders in terms of "improvement in pruritus."'}, {'measure': 'Percentage of Participants With Improvement in Pruritus Severity From Baseline as Defined by Change in Patient Global Impress of Severity (PGI-S) at Week 6', 'timeFrame': 'Baseline; Week 6', 'description': 'Participants were asked to rate the severity of their pruritus in the past 7 days using the PGI-S, a 4-point scale ranging from "none" to "severe." Participants that reported a positive shift in their categorical assessment of itch compared to their Baseline level (e.g., "severe" at Visit 2 \\[Day 1\\] with a shift to "moderate" at Visit 6 \\[Week 6\\]) were considered to be responders in terms of "improvement in pruritus."'}, {'measure': 'Percentage of Participants With a Reduction in WI-NRS Score ≥2 From Baseline at Week 6', 'timeFrame': 'Baseline; Week 6', 'description': 'Participants were asked to rate the severity of their worst level of itching in the past 24 hours using the daily WI-NRS, an 11-point scale ranging from 0 (no itching) to 10 (worst itching imaginable). Itching severity scores collected via the WI-NRS have been categorized in the as mild (\\<4), moderate (≥4 to \\<7), or severe (≥7). The average WI-NRS score using the daily values from the week before the first dose of study drug (including the WI-NRS score captured on Study Day 1 of dosing) served as the Baseline score. A weekly score was determined based on the average of all available daily scores of the week.'}, {'measure': 'Percentage of Participants With a Reduction in WI-NRS Score ≥3 From Baseline at Week 6', 'timeFrame': 'Baseline; Week 6', 'description': 'Participants were asked to rate the severity of their worst level of itching in the past 24 hours using the daily WI-NRS, an 11-point scale ranging from 0 (no itching) to 10 (worst itching imaginable). Itching severity scores collected via the WI-NRS have been categorized in the as mild (\\<4), moderate (≥4 to \\<7), or severe (≥7). The average WI-NRS score using the daily values from the week before the first dose of study drug (including the WI-NRS score captured on Study Day 1 of dosing) served as the Baseline score. A weekly score was determined based on the average of all available daily scores of the week.'}, {'measure': 'Percentage of Participants With a Reduction in WI-NRS Score ≥4 From Baseline at Week 6', 'timeFrame': 'Baseline; Week 6', 'description': 'Participants were asked to rate the severity of their worst level of itching in the past 24 hours using the daily WI-NRS, an 11-point scale ranging from 0 (no itching) to 10 (worst itching imaginable). Itching severity scores collected via the WI-NRS have been categorized in the as mild (\\<4), moderate (≥4 to \\<7), or severe (≥7). The average WI-NRS score using the daily values from the week before the first dose of study drug (including the WI-NRS score captured on Study Day 1 of dosing) served as the Baseline score. A weekly score was determined based on the average of all available daily scores of the week.'}, {'measure': 'Percentage of Participants With a WI-NRS Score <4 at Week 6', 'timeFrame': 'Baseline; Week 6', 'description': 'Participants were asked to rate the severity of their worst level of itching in the past 24 hours using the daily WI-NRS, an 11-point scale ranging from 0 (no itching) to 10 (worst itching imaginable). Itching severity scores collected via the WI-NRS have been categorized in the as mild (\\<4), moderate (≥4 to \\<7), or severe (≥7). The average WI-NRS score using the daily values from the week before the first dose of study drug (including the WI-NRS score captured on Study Day 1 of dosing) served as the Baseline score. A weekly score was determined based on the average of all available daily scores of the week.'}, {'measure': 'Double-blind Treatment Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any ≥Grade 3 TEAE, Any Related TEAE, and Any TEAE That Led to Discontinuation of Study Drug', 'timeFrame': 'up to the end of Week 6', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. TEAEs are AEs with an onset after the first dose of study drug or existing events that worsened after the first dose during the study. TEAEs were graded for severity (mild \\[Grade 1\\], moderate \\[Grade 2\\], severe \\[Grade 3\\], life threatening \\[Grade 4\\], death \\[Grade 5\\]) using Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. The investigator assessed whether the TEAEs were related or unrelated to the study drug.'}, {'measure': 'Open-label Extension Period: Number of Participants With Any TEAE, Any ≥Grade 3 TEAE, Any Related TEAE, and Any TEAE That Led to Discontinuation of Study Drug', 'timeFrame': 'from the beginning of Week 7 up to Week 12', 'description': 'An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. TEAEs are AEs with an onset after the first dose of study drug or existing events that worsened after the first dose during the study. TEAEs were graded for severity (mild \\[Grade 1\\], moderate \\[Grade 2\\], severe \\[Grade 3\\], life threatening \\[Grade 4\\], death \\[Grade 5\\]) using CTCAE, version 5.0. The investigator assessed whether the TEAEs were related or unrelated to the study drug.'}, {'measure': 'Double-blind Treatment Period: Number of Participants With Any Serious TEAE, Any ≥Grade 3 Serious TEAE, Any Related Serious TEAE, and Any Serious TEAE That Led to Discontinuation of Study Drug', 'timeFrame': 'up to the end of Week 6', 'description': 'TEAEs are AEs with an onset after the first dose of study drug or existing events that worsened after the first dose during the study. A serious TEAE is any untoward medical occurrence, that at any dose: results in death; is life threatening; requires hospital admission or prolongs hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly/birth defect; or is a medically significant event that, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent one of the previously listed outcomes. Serious TEAEs were graded for severity (mild \\[Grade 1\\], moderate \\[Grade 2\\], severe \\[Grade 3\\], life threatening \\[Grade 4\\], death \\[Grade 5\\]) using CTCAE, version 5.0. The investigator assessed whether the serious TEAEs were related or unrelated to the study drug.'}, {'measure': 'Open-label Extension Period: Number of Participants With Any Serious TEAE, Any ≥Grade 3 Serious TEAE, Any Related Serious TEAE, and Any Serious TEAE That Led to Discontinuation of Study Drug', 'timeFrame': 'from the beginning of Week 7 up to Week 12', 'description': 'TEAEs are AEs with an onset after the first dose of study drug or existing events that worsened after the first dose during the study. A serious TEAE is any untoward medical occurrence, that at any dose: results in death; is life threatening; requires hospital admission or prolongs hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly/birth defect; or is a medically significant event that, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent one of the previously listed outcomes. Serious TEAEs were graded for severity (mild \\[Grade 1\\], moderate \\[Grade 2\\], severe \\[Grade 3\\], life threatening \\[Grade 4\\], death \\[Grade 5\\]) using CTCAE, version 5.0. The investigator assessed whether the serious TEAEs were related or unrelated to the study drug.'}, {'measure': 'Double-blind Treatment Period: Number of Participants With Any Treatment-emergent (TE) Adverse Event of Special Interest (AESI), Any ≥Grade 3 TE AESI, Any Related TE AESI, and Any TE AESI That Led to Discontinuation of Study Drug', 'timeFrame': 'up to the end of Week 6', 'description': 'An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are AEs with an onset after the first dose of study drug or existing events that worsened after the first dose during the study. AESI were considered to be any clinically meaningful new, worsening from Baseline, or abnormal laboratory findings or symptoms suggestive of acute kidney injury (AKI) (e.g., "blood urea increased" or "protein urine present" AEs as identified by the Standardized Medical Dictionary for Regulatory Activities \\[MedDRA\\] Query \\[SMQ\\] "Acute renal failure"). TE AESIs were graded for severity (mild \\[Grade 1\\], moderate \\[Grade 2\\], severe \\[Grade 3\\], life threatening \\[Grade 4\\], death \\[Grade 5\\]) using CTCAE, version 5.0. The investigator assessed whether the AE AESIs were related or unrelated to the study drug.'}, {'measure': 'Open-label Extension Period: Number of Participants With Any Treatment-emergent (TE) AESI, Any ≥Grade 3 TE AESI, Any Related TE AESI, and Any TE AESI That Led to Discontinuation of Study Drug', 'timeFrame': 'from the beginning of Week 7 up to Week 12', 'description': 'An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are AEs with an onset after the first dose of study drug or existing events that worsened after the first dose during the study. AESI were considered to be any clinically meaningful new, worsening from Baseline, or abnormal laboratory findings or symptoms suggestive of acute kidney injury (AKI) (e.g., "blood urea increased" or "protein urine present" AEs as identified by the Standardized Medical Dictionary for Regulatory Activities \\[MedDRA\\] Query \\[SMQ\\] "Acute renal failure"). TE AESIs were graded for severity (mild \\[Grade 1\\], moderate \\[Grade 2\\], severe \\[Grade 3\\], life threatening \\[Grade 4\\], death \\[Grade 5\\]) using CTCAE, version 5.0. The investigator assessed whether the AE AESIs were related or unrelated to the study drug.'}, {'measure': 'Number of Participants With Any Clinically Meaningful Changes From Baseline in Clinically Meaningful in Clinical Laboratory Test Results', 'timeFrame': 'up to the end of Week 12', 'description': 'Clinical laboratory test results included results for clinical hematology, chemistry, coagulation, and thyroid function parameters . The investigator determined if changes were clinically meaningful.'}, {'measure': 'Number of Participants With Any Clinically Meaningful Changes From Baseline in Vital Sign Measurements', 'timeFrame': 'up to the end of Week 12', 'description': 'Vital sign measurements included measurements for blood pressure, pulse rate, oxygen saturation, body temperature, and respiratory rate. The investigator determined if changes were clinically meaningful.'}, {'measure': 'Number of Participants With Any Clinically Significant Changes From Baseline in Electrocardiogram (ECG) Parameters', 'timeFrame': 'up to the end of Week 12', 'description': 'ECG parameters included heart rate, RR interval, PR interval, QRS duration, or QT interval. The investigator determined if changes were clinically significant.'}, {'measure': 'Plasma Concentration of EP547 and Metabolites', 'timeFrame': '1, 2, and 3 hours postdose on Day 1 and Week 3; predose on Weeks 1, 2, and 6', 'description': 'The lower level of quantitation = 0.01 micrograms per milliliter (µg/mL) for EP547 and 0.005 μg/mL for EP3583.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pruritus', 'Itch', 'Primary Biliary Cholangitis', 'Primary Sclerosing Cholangitis', 'PACIFIC', 'EP547'], 'conditions': ['Pruritus']}, 'descriptionModule': {'briefSummary': 'This phase 2 trial will evaluate the effects of EP547 in subjects with cholestatic pruritus due to Primary Biliary Cholangitis (PBC) or Primary Sclerosing Cholangitis (PSC)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 80 years\n* Documented primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC)\n* Presence of consistent moderate to severe pruritus\n* Use of anti-pruritic and anti-cholestatic (including UDCA and obeticholic acid) medication allowed if meeting additional criteria\n* Individuals with concomitant inflammatory bowel disease must meet additional relevant criteria\n\nExclusion Criteria:\n\n* Pruritus associated with an etiology other than PBC or PSC\n* Prior or planned liver transplantation\n* Evidence of compensated or decompensated cirrhosis\n* Alternative causes of liver disease\n* Presence of documented secondary sclerosing cholangitis\n* Current evidence of clinically significant high-grade strictures or presence of biliary stent\n* History of significant small bowel resection or short bowel syndrome\n* Has exclusionary laboratory or biochemical results at Screening'}, 'identificationModule': {'nctId': 'NCT05525520', 'acronym': 'PACIFIC', 'briefTitle': 'Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Escient Pharmaceuticals, Inc'}, 'officialTitle': 'Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis', 'orgStudyIdInfo': {'id': 'EP-547-201'}, 'secondaryIdInfos': [{'id': '2021-002526-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EP547 100 mg', 'interventionNames': ['Drug: EP547']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'EP547', 'type': 'DRUG', 'description': 'Once daily', 'armGroupLabels': ['EP547 100 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama Birmingham Hospital', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Dignity Health Center for Clinical Research at St. Joseph Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92118', 'city': 'Coronado', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Research Center', 'geoPoint': {'lat': 32.68589, 'lon': -117.18309}}, {'zip': '90230', 'city': 'Culver City', 'state': 'California', 'country': 'United States', 'facility': 'Science 37', 'geoPoint': {'lat': 34.02112, 'lon': -118.39647}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'California Liver Research Institute', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami - 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