Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-01-01 @ 6:36 AM
Study NCT ID:
NCT05013905
Status:
COMPLETED
Last Update Posted:
2025-07-04
First Post:
2021-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Ukraine'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mm@prometheusbiosciences.com', 'phone': '858-422-4300', 'title': 'Study Director', 'organization': 'Prometheus Biosciences, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '14 weeks', 'description': 'Adverse event assessment occurred at every scheduled visit. An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.', 'eventGroups': [{'id': 'EG000', 'title': 'PRA023', 'description': 'Participants received PRA023 administered by intravenous (IV) infusion as directed by the protocol.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 20, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': "Crohn's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19 Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRA023', 'description': 'Participants received PRA023 administered by intravenous (IV) infusion as directed by the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'Number of participants who experienced treatment-emergent adverse events (AEs)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRA023', 'description': 'Participants received PRA023 administered by intravenous (IV) infusion as directed by the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'Number of participants who experienced serious adverse events (SAEs)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Adverse Events Leading to Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRA023', 'description': 'Participants received PRA023 administered by intravenous (IV) infusion as directed by the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'Number of participants who experienced AEs leading to discontinuation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Endoscopic Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRA023', 'description': 'Participants received PRA023 administered by intravenous (IV) infusion as directed by the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': "Number of participants achieving induction of endoscopic improvement (decrease in simple endoscopy score for Crohn's disease \\[SES-CD\\] ≥ 50% from Baseline)", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who have been treated with PRA023 with Baseline CDAI and SES-CD scores with no important protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Clinical Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRA023', 'description': 'Participants received PRA023 administered by intravenous (IV) infusion as directed by the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': "Number of participants achieving clinical remission, as defined by Crohn's disease activity index \\[CDAI\\] score \\< 150", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who have been treated with PRA023 with Baseline CDAI and SES-CD scores.'}, {'type': 'SECONDARY', 'title': 'Endoscopic and Clinical Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRA023', 'description': 'Participants received PRA023 administered by intravenous (IV) infusion as directed by the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'Number of participants who achieved a decrease in SES-CD ≥ 50% AND reduction in CDAI ≥ 100 points from Baseline or CDAI\\<150', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who have been treated with PRA023 with Baseline CDAI and SES-CD scores.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving a Composite Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRA023', 'description': 'Participants received PRA023 administered by intravenous (IV) infusion as directed by the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'Composite response is defined as a decrease by at least 50% in hsCRP or fecal calprotectin from baseline and a reduction of either CDAI ≥ 100 points from Baseline or CDAI\\<150 in subjects with at least one elevated biomarker at baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who have been treated with PRA023 with Baseline CDAI and SES-CD scores with at least one elevated biomarker at Baseline.'}, {'type': 'SECONDARY', 'title': 'Normalization of C-reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRA023', 'description': 'Participants received PRA023 administered by intravenous (IV) infusion as directed by the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'Number of participants with normalization of hsCRP (as defined by hsCRP \\< 5 mg/L), among subjects with elevated concentrations at Baseline, at Week 12', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who have been treated with PRA023 with Baseline CDAI and SES-CD scores who have elevated hsCRP values at Baseline.'}, {'type': 'SECONDARY', 'title': 'Normalization of Fecal Calprotectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRA023', 'description': 'Participants received PRA023 administered by intravenous (IV) infusion as directed by the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'Number of participants with normalization of fecal calprotectin (fecal calprotectin \\< 250 ug/g), among subjects with elevated concentrations at Baseline, at Week 12', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who have been treated with PRA023 with Baseline CDAI and SES-CD scores with elevated fecal calprotectin at Baseline.'}, {'type': 'SECONDARY', 'title': 'Clinical Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRA023', 'description': 'Participants received PRA023 administered by intravenous (IV) infusion as directed by the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'Clinical response is defined as either a reduction of either CDAI ≥ 100 points from Baseline or CDAI\\<150.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who have been treated with PRA023 with Baseline CDAI and SES-CD scores.'}, {'type': 'SECONDARY', 'title': 'Two Component Patient-reported Outcome (PRO-2) Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRA023', 'description': 'Participants received PRA023 administered by intravenous (IV) infusion as directed by the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'Number of subjects with PRO-2 remission (defined as average daily abdominal pain score ≤ 1 point and average daily stool frequency ≤ 3 points with abdominal pain and stool frequency no worse than Baseline) at Week 12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who have been treated with PRA023 with Baseline CDAI and SES-CD scores.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Simple Endoscopy Score for Crohn's Disease (SES-CD)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRA023', 'description': 'Participants received PRA023 administered by intravenous (IV) infusion as directed by the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.6', 'spread': '4.32', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': "Assessment of change in simple endoscopy score for Crohn's Disease (SES-CD) from Baseline. Measure Description: The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who have been treated with PRA023 with Baseline CDAI and SES-CD scores, who have SES-CD scores at Baseline and Week 12.'}, {'type': 'SECONDARY', 'title': 'Serum Concentration of PRA023 (MK-7240)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRA023', 'description': 'Participants received PRA023 administered by intravenous (IV) infusion as directed by the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '88199.1', 'spread': '43811.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Blood samples were obtained for PK analysis of the serum concentration of PRA023 at week 12.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were treated with PRA023 with Baseline CDAI and SES-CD scores, and had blood samples drawn for serum concentration of PRA023'}, {'type': 'SECONDARY', 'title': 'Number of Participants Positive for Anti-drug Antibody (ADA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRA023', 'description': 'Participants received PRA023 administered by intravenous (IV) infusion as directed by the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 12 weeks', 'description': 'Blood samples were collected for the determination of anti-PR023 antibodies based on confirmatory assay. The number of participants with confirmed positive anti-PR023 antibodies results at any visit during the study is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were treated with PRA023 with Baseline CDAI and SES-CD scores and had blood samples collected for ADA determination'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Neutralizing Anti-Bodies (NAB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PRA023', 'description': 'Participants received PRA023 administered by intravenous (IV) infusion as directed by the protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 12 weeks', 'description': 'Blood samples were collected for the determination of NAB. The number of participants with positive NAB results at any visit during the study is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were treated with PRA023 with Baseline CDAI and SES-CD scores and who were ADA positive post-baseline'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PRA023', 'description': 'Participants received PRA023 administered by intravenous (IV) infusion as directed by the protocol.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed Induction Period', 'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PRA023', 'description': 'Participants received PRA023 administered by intravenous (IV) infusion as directed by the protocol.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age (years)', 'categories': [{'title': '18-44 years', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': '45-64 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': '65+ years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '77.6', 'spread': '20.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Disease (years)', 'classes': [{'categories': [{'measurements': [{'value': '10.29', 'spread': '9.27', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Baseline Crohn's disease activity index (CDAI) Score", 'classes': [{'categories': [{'measurements': [{'value': '317.9', 'spread': '67.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'CDAI includes abdominal pain, stool frequency, general well-being, presence of complications (arthritis/arthralgia, uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI score is the sum of the 8 weighted scores and approximately ranges from 0 to 600; higher scores indicate more severe disease.', 'unitOfMeasure': 'score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Prior Exposure to Biologic Therapy', 'classes': [{'categories': [{'title': 'Biologic Naive', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': '1 Prior Biologic', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '2 Prior Biologics', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=3 Prior Biologics', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "Baseline Simple Endoscopic Score for Crohn's Disease (SES-CD)", 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'spread': '6.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "Assessment of change in Simple Endoscopy Score for Crohn's Disease (SES-CD) from Baseline. Measure Description: The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.", 'unitOfMeasure': 'score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Concomitant Immunomodulator Use', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Concomitant Oral Corticosteroid Use', 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-28', 'size': 1545089, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-09-11T15:45', 'hasProtocol': True}, {'date': '2022-04-19', 'size': 2123746, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-09-11T15:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2021-08-13', 'resultsFirstSubmitDate': '2023-09-11', 'studyFirstSubmitQcDate': '2021-08-13', 'lastUpdatePostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-30', 'studyFirstPostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'Week 12', 'description': 'Number of participants who experienced treatment-emergent adverse events (AEs)'}, {'measure': 'Serious Adverse Events', 'timeFrame': 'Week 12', 'description': 'Number of participants who experienced serious adverse events (SAEs)'}, {'measure': 'Adverse Events Leading to Discontinuation', 'timeFrame': 'Week 12', 'description': 'Number of participants who experienced AEs leading to discontinuation'}, {'measure': 'Endoscopic Improvement', 'timeFrame': 'Week 12', 'description': "Number of participants achieving induction of endoscopic improvement (decrease in simple endoscopy score for Crohn's disease \\[SES-CD\\] ≥ 50% from Baseline)"}], 'secondaryOutcomes': [{'measure': 'Clinical Remission', 'timeFrame': 'Week 12', 'description': "Number of participants achieving clinical remission, as defined by Crohn's disease activity index \\[CDAI\\] score \\< 150"}, {'measure': 'Endoscopic and Clinical Improvement', 'timeFrame': 'Week 12', 'description': 'Number of participants who achieved a decrease in SES-CD ≥ 50% AND reduction in CDAI ≥ 100 points from Baseline or CDAI\\<150'}, {'measure': 'Number of Participants Achieving a Composite Response', 'timeFrame': 'Week 12', 'description': 'Composite response is defined as a decrease by at least 50% in hsCRP or fecal calprotectin from baseline and a reduction of either CDAI ≥ 100 points from Baseline or CDAI\\<150 in subjects with at least one elevated biomarker at baseline.'}, {'measure': 'Normalization of C-reactive Protein', 'timeFrame': 'Week 12', 'description': 'Number of participants with normalization of hsCRP (as defined by hsCRP \\< 5 mg/L), among subjects with elevated concentrations at Baseline, at Week 12'}, {'measure': 'Normalization of Fecal Calprotectin', 'timeFrame': 'Week 12', 'description': 'Number of participants with normalization of fecal calprotectin (fecal calprotectin \\< 250 ug/g), among subjects with elevated concentrations at Baseline, at Week 12'}, {'measure': 'Clinical Response', 'timeFrame': 'Week 12', 'description': 'Clinical response is defined as either a reduction of either CDAI ≥ 100 points from Baseline or CDAI\\<150.'}, {'measure': 'Two Component Patient-reported Outcome (PRO-2) Remission', 'timeFrame': 'Week 12', 'description': 'Number of subjects with PRO-2 remission (defined as average daily abdominal pain score ≤ 1 point and average daily stool frequency ≤ 3 points with abdominal pain and stool frequency no worse than Baseline) at Week 12.'}, {'measure': "Change From Baseline in Simple Endoscopy Score for Crohn's Disease (SES-CD)", 'timeFrame': 'Baseline and Week 12', 'description': "Assessment of change in simple endoscopy score for Crohn's Disease (SES-CD) from Baseline. Measure Description: The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease."}, {'measure': 'Serum Concentration of PRA023 (MK-7240)', 'timeFrame': 'Week 12', 'description': 'Blood samples were obtained for PK analysis of the serum concentration of PRA023 at week 12.'}, {'measure': 'Number of Participants Positive for Anti-drug Antibody (ADA)', 'timeFrame': 'Up to approximately 12 weeks', 'description': 'Blood samples were collected for the determination of anti-PR023 antibodies based on confirmatory assay. The number of participants with confirmed positive anti-PR023 antibodies results at any visit during the study is presented.'}, {'measure': 'Number of Participants With Positive Neutralizing Anti-Bodies (NAB)', 'timeFrame': 'Up to approximately 12 weeks', 'description': 'Blood samples were collected for the determination of NAB. The number of participants with positive NAB results at any visit during the study is presented.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['APOLLO-CD', 'APOLLO', "Crohn's Disease"], 'conditions': ['Crohn Disease']}, 'referencesModule': {'references': [{'pmid': '40456235', 'type': 'DERIVED', 'citation': "Feagan BG, Sands BE, Siegel CA, Dubinsky MC, Longman RS, Sabino J, Laurent O, Luo A, Lu J, Nguyen DD, Munoz-Elias EJ, Llewellyn H, Wang Y, Jang I, Bilsborough J, Marchelletta R, Towfic F, Yen M, Anderson JK, DuVall A, Kierkus J, Woynarowski M, Al Kharrat H, Targan SR, McGovern DPB. Safety and efficacy of the anti-TL1A monoclonal antibody tulisokibart for Crohn's disease: a phase 2a induction trial. Lancet Gastroenterol Hepatol. 2025 Aug;10(8):715-725. doi: 10.1016/S2468-1253(25)00071-8. Epub 2025 May 30."}], 'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}, {'url': 'https://msd.trialsummaries.com/Study/StudyDetails?id=26174&tenant=MT_MSD_9011', 'label': 'Plain Language Summary'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess the safety and efficacy of PRA023 in participants with moderately to severely active Crohn's Disease.\n\nAfter the completion of the 12-week induction period, all participants have the option to continue in the open-label extension for another 38 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed diagnosis of Crohn's disease\n* Moderately to severely active CD as defined by Crohn's disease activity index (CDAI) score and centrally read endoscopy\n* Must have corticosteroid dependence or have had no response, insufficient response, loss of response and/or intolerance to at least one of the following therapies: corticosteroid, immunosuppressants, or an approved anti-tumor necrosis factor (TNF), anti-integrin, or anti-interleukin (IL)12/23\n* Able to provide written informed consent and understand and comply with the requirements of the study\n\nExclusion Criteria:\n\n* Women of child bearing potential (WOCBP) and men with female partner of childbearing potential who are unwilling to use two highly effective methods of contraception to avoid pregnancy for the entire study period and up to 12 weeks after the last dose of study drug\n* Diagnosis of ulcerative colitis (UC) or indeterminate colitis\n* CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or illeal involvement\n* Suspected or diagnosed intra-abdominal or perianal abscess at screening\n* Current stoma or need for colostomy or ileostomy\n* Previous small bowel resection with a combined resected length of \\>100 cm or previous colonic resection of \\> 2 segments\n* Surgical bowel resection within 3 months before screening\n* Past or current evidence of definite low-grade or high-grade colonic dysplasia not completely removed\n* Subjects in the opinion of the investigator are at an unacceptable risk for participation in the study\n* Subjects who meet the protocol criteria for important laboratory exclusion criteria"}, 'identificationModule': {'nctId': 'NCT05013905', 'acronym': 'APOLLO-CD', 'briefTitle': "A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. 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