Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2026-03-02 @ 8:50 AM
Study NCT ID:
NCT02975206
Status:
COMPLETED
Last Update Posted:
2021-05-20
First Post:
2016-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011537', 'term': 'Pruritus'}, {'id': 'D003876', 'term': 'Dermatitis, Atopic'}], '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': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C551592', 'term': 'serlopitant'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'agururajan@menlotx.com', 'phone': '(650) 486-1416', 'title': 'Anna Gururajan', 'organization': 'Menlo Therapeutics Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first study drug administration through the follow-up visit at Week 10. After the Week 10 visit, SAEs that are believed to be drug related will be reported, without a specific end time.', 'description': 'The at risk safety population is a subset of participants who received at least one dose of study medication. This population is analyzed based upon the actual treatment received, at the highest dose received.', 'eventGroups': [{'id': 'EG000', 'title': 'Serlopitant 5 mg', 'description': 'Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks', 'otherNumAtRisk': 161, 'deathsNumAtRisk': 161, 'otherNumAffected': 27, 'seriousNumAtRisk': 161, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Serlopitant 1 mg', 'description': 'Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks', 'otherNumAtRisk': 160, 'deathsNumAtRisk': 160, 'otherNumAffected': 22, 'seriousNumAtRisk': 160, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo Oral Tablet', 'description': 'Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral Placebo tablet taken once daily by mouth for 6 weeks', 'otherNumAtRisk': 158, 'deathsNumAtRisk': 158, 'otherNumAffected': 32, 'seriousNumAtRisk': 158, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 158, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 158, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 158, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 158, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 158, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 158, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Abscess jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colon cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 158, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 158, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in WI-NRS From Baseline to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '158', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Serlopitant 5 mg', 'description': 'Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks'}, {'id': 'OG001', 'title': 'Serlopitant 1 mg', 'description': 'Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks'}, {'id': 'OG002', 'title': 'Placebo Oral Tablet', 'description': 'Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral Placebo taken once daily by mouth for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.25', 'spread': '2.198', 'groupId': 'OG000'}, {'value': '-2.32', 'spread': '2.418', 'groupId': 'OG001'}, {'value': '-2.01', 'spread': '2.212', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 6 compared to Baseline', 'description': 'Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. The primary outcome is the change in WI-NRS score between the visit and Baseline.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'These figures represent full analysis set.'}, {'type': 'SECONDARY', 'title': 'WI-NRS 4-point Responder Rate at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '158', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Serlopitant 5 mg', 'description': 'Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks'}, {'id': 'OG001', 'title': 'Serlopitant 1 mg', 'description': 'Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks'}, {'id': 'OG002', 'title': 'Placebo Oral Tablet', 'description': 'Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral Placebo taken once daily by mouth for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 6 compared to Baseline', 'description': 'Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. A 4-point responder is a subject who had at least a 4-point reduction in score between Week 6 and baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'These figures represent full analysis set.'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life (ItchyQoL) From Baseline to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Serlopitant 5 mg', 'description': 'Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks'}, {'id': 'OG001', 'title': 'Serlopitant 1 mg', 'description': 'Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks'}, {'id': 'OG002', 'title': 'Placebo Oral Tablet', 'description': 'Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral Placebo taken once daily by mouth for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.57', 'spread': '0.749', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '0.779', 'groupId': 'OG001'}, {'value': '-0.53', 'spread': '0.683', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 6 compared to Baseline', 'description': 'ItchyQoL is a 22-item pruritus-specific instrument that measures the degree to which pruritus affects quality-of-life. The responses to the items are Never (1), Rarely (2), Sometimes (3), Often (4) and All the Time (5). A higher score corresponds to a more adverse impact. The overall score is the average of the 22 items ranging from 1 to 5.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'These figures represent all participants in the full analysis set who completed the ItchyQol assessment at both Baseline and Week 6.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Serlopitant 5 mg', 'description': 'Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks'}, {'id': 'FG001', 'title': 'Serlopitant 1 mg', 'description': 'Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks'}, {'id': 'FG002', 'title': 'Placebo Oral Tablet', 'description': 'Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral Placebo tablet taken once daily by mouth for 6 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '161'}, {'groupId': 'FG001', 'numSubjects': '161'}, {'groupId': 'FG002', 'numSubjects': '162'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '134'}, {'groupId': 'FG001', 'numSubjects': '144'}, {'groupId': 'FG002', 'numSubjects': '145'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Other (e.g., lost to follow up)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}, {'value': '484', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Serlopitant 5 mg', 'description': 'Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 5 mg dose of Serlopitant taken once daily by mouth for 6 weeks'}, {'id': 'BG001', 'title': 'Serlopitant 1 mg', 'description': 'Subjects received a 3-tablet oral loading dose on the first day of the treatment period followed by an oral 1 mg dose of Serlopitant taken once daily by mouth for 6 weeks'}, {'id': 'BG002', 'title': 'Placebo Oral Tablet', 'description': 'Subjects received a 3-tablet Placebo oral loading dose on the first day of the treatment period followed by an oral Placebo tablet taken once daily by mouth for 6 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}, {'value': '484', 'groupId': 'BG003'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '418', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}, {'value': '484', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '35.9', 'spread': '16.62', 'groupId': 'BG000'}, {'value': '38.1', 'spread': '15.16', 'groupId': 'BG001'}, {'value': '37.5', 'spread': '13.04', 'groupId': 'BG002'}, {'value': '37.1', 'spread': '15.01', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}, {'value': '484', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '325', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '159', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}, {'value': '484', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '200', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '207', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}, {'value': '484', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}, {'value': '484', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'WI-NRS', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}, {'value': '479', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '8.38', 'spread': '0.993', 'groupId': 'BG000'}, {'value': '8.23', 'spread': '1.039', 'groupId': 'BG001'}, {'value': '8.26', 'spread': '1.057', 'groupId': 'BG002'}, {'value': '8.29', 'spread': '1.029', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Subject-reported score from reflection on past 24 hours. The baseline was established by averaging 7 daily scores leading up to randomization.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The row populations here represent the Full Analysis Set, not all subjects randomized.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-21', 'size': 1710026, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-01-14T10:17', 'hasProtocol': True}, {'date': '2018-02-07', 'size': 505455, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-01-14T10:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 484}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-18', 'studyFirstSubmitDate': '2016-11-22', 'resultsFirstSubmitDate': '2019-01-14', 'studyFirstSubmitQcDate': '2016-11-23', 'lastUpdatePostDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-13', 'studyFirstPostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in WI-NRS From Baseline to Week 6', 'timeFrame': 'Week 6 compared to Baseline', 'description': 'Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. The primary outcome is the change in WI-NRS score between the visit and Baseline.'}], 'secondaryOutcomes': [{'measure': 'WI-NRS 4-point Responder Rate at Week 6', 'timeFrame': 'Week 6 compared to Baseline', 'description': 'Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. A 4-point responder is a subject who had at least a 4-point reduction in score between Week 6 and baseline.'}, {'measure': 'Change in Quality of Life (ItchyQoL) From Baseline to Week 6', 'timeFrame': 'Week 6 compared to Baseline', 'description': 'ItchyQoL is a 22-item pruritus-specific instrument that measures the degree to which pruritus affects quality-of-life. The responses to the items are Never (1), Rarely (2), Sometimes (3), Often (4) and All the Time (5). A higher score corresponds to a more adverse impact. The overall score is the average of the 22 items ranging from 1 to 5.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pruritus', 'Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis', 'detailedDescription': 'This is a double-blind, randomized, placebo-controlled study. Approximately 450 subjects will be randomized in a 1:1:1 ratio to receive daily oral doses of serlopitant 1 mg, 5 mg, or placebo for 6 weeks. During the screening period, subjects will be provided with an electronic device for recording electronic diary (eDiary) assessments throughout the study. This eDiary will be used to capture efficacy endpoint data and treatment information. At the Baseline visit, eligible subjects will be randomized, and study drug dispensed beginning with a loading dose of 3 tablets to be taken at bedtime that same day. Starting on Study Day 2, subjects will take one tablet per day at bedtime. Treatment will continue for 6 weeks. The primary efficacy endpoint will be assessed during Week 6. After completion of the 6-week treatment period, all subjects will enter a 4-week follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, age 13 years or older\n* Pruritus prior to and during the initial screening period\n* Diagnosis of atopic dermatitis\n* Judged to be in good health in the investigator's opinion\n\nExclusion Criteria:\n\n* Prior treatment with study drug or similar drug\n* Pruritus due to another reason besides atopic dermatitis\n* Presence of any medical condition or disability that could interfere with study\n* History of hypersensitivity to serlopitant or any of its components\n* Currently pregnant or male partner of pregnant female\n* Females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding"}, 'identificationModule': {'nctId': 'NCT02975206', 'acronym': 'ATOMIK', 'briefTitle': 'Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vyne Therapeutics Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo Controlled Study Of The Efficacy, Safety, And Tolerability Of Serlopitant For The Treatment Of Pruritus In Adults And Adolescents With A History Of Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'MTI-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Serlopitant High Dose', 'description': 'serlopitant tablets - high dose', 'interventionNames': ['Drug: Serlopitant High Dose']}, {'type': 'EXPERIMENTAL', 'label': 'Serlopitant Low Dose', 'description': 'serlopitant tablets - low dose', 'interventionNames': ['Drug: Serlopitant Low Dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Oral Tablet', 'description': 'matching placebo tablets', 'interventionNames': ['Drug: Placebo Oral Tablet']}], 'interventions': [{'name': 'Serlopitant High Dose', 'type': 'DRUG', 'description': 'serlopitant tablets - high dose', 'armGroupLabels': ['Serlopitant High Dose']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'description': 'placebo tablet', 'armGroupLabels': ['Placebo Oral Tablet']}, {'name': 'Serlopitant Low Dose', 'type': 'DRUG', 'description': 'serlopitant tablets - low dose', 'armGroupLabels': ['Serlopitant Low Dose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Study Site 332', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Study Site 363', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Hoover', 'state': 'Alabama', 'country': 'United States', 'facility': 'Study Site 340', 'geoPoint': {'lat': 33.40539, 'lon': -86.81138}}, {'city': 'Glendale', 'state': 'Arizona', 'country': 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'geoPoint': {'lat': 42.49044, 'lon': -83.01304}}, {'city': 'Saint Joseph', 'state': 'Missouri', 'country': 'United States', 'facility': 'Study Site 371', 'geoPoint': {'lat': 39.76861, 'lon': -94.84663}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Study Site 387', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'Berlin', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Study Site 352', 'geoPoint': {'lat': 39.79123, 'lon': -74.92905}}, {'city': 'Forest Hills', 'state': 'New York', 'country': 'United States', 'facility': 'Study Site 375', 'geoPoint': {'lat': 40.71621, 'lon': -73.85014}}, {'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Study Site 373', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Study Site 341', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'city': 'Shelby', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Study Site 355', 'geoPoint': {'lat': 35.29235, 'lon': -81.53565}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Study Site 337', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Johnston', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Study Site 345', 'geoPoint': {'lat': 41.82186, 'lon': -71.50675}}, {'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Study Site 362', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Study Site 382', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Study Site 343', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Study 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States', 'facility': 'Study Site 342', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Study Site 336', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Study Site 367', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Mary Spellman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vyne Therapeutics Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vyne Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}