A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn’s Disease

Condition studied

Crohn’s Disease

Investigational medicinal product(s)

Eligibility

Primary endpoint

Study 2: [US/FDA Only] Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12, Study 2: [EU/EMA Only] Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12, Study 2: Percentage of Participants Achieving Endoscopic Response at Week 12

Endpoint detail

Study 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Clinical Remission per CDAI at Week 12, Study 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Endoscopic Response at Week 12, Study 2: Number of Participants Who Experienced an Adverse Event (AE), Study 2: Number of Participants who Discontinue Study Intervention due to an AE, Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12, Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12, Study 2: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 12, Study 2: Mean Change from Baseline in FACIT-Fatigue Score at Week 12, Study 2: Percentage of Participants Achieving Endoscopic Remission at Week 12, Study 2: Mean Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12, Study 2: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 6, Study 2: Percentage of Participants with Ulcer-Free Endoscopy at Week 12