A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3, induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn’s Disease

Immune system disseases

Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving clinical remission per Crohn’s Disease Activity Index (CDAI) at Week 12, Sub-Study 2: Co-primary endpoints US/FDA: Proportion of participants achieving endoscopic response (Simple Endoscopic Score for Crohn's Disease [SES-CD]) at Week 12, Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving clinical remission per 2-item patient-reported outcome (PRO-2) at Week 12, Sub-Study 2: Co-primary endpoints EU/EMA: Proportion of participants achieving endoscopic response (SES-CD) at Week 12

Sub-Study 2: Proportion of participants achieving CDAI clinical response at Week 12, Sub-study 2: Proportion of participants achieving CDAI clinical response and endoscopic response (SES-CD) at Week 12, Sub-study 2: Proportion of participants achieving endoscopic SES- CD remission at Week 12, Sub-study 2: US/FDA: Proportion of participants achieving clinical remission per PRO-2 at Week 12, Sub-study 2: EU/EMA: Proportion of participants achieving clinical remission per CDAI at Week 12, Sub-study 2: Proportion of participants achieving ulcer-free endoscopy (in the subset of participants with ulcers at baseline) at Week 12, Sub-study 2: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form 7a T-score at Week 12, Sub-study 2: Proportion of participants achieving CDAI clinical response at Week 4, Sub-study 2: US/FDA: Proportion of participants achieving corticosteroid free remission (in the subset of participants with corticosteroids at baseline) per CDAI at Week 12, Sub-study 2: EU/EMA: Proportion of participants achieving corticosteroid free remission per PRO-2 (in the subset of participants with corticosteroids at baseline) at Week 12, Sub-study 2: Proportion of participants achieving CDAI clinical remission and endoscopic remission (SES-CD) at Week 12, Sub-study 2: Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 12, Sub-study 2: Proportion of participants with no bowel urgency by Numeric Rating Scale (NRS) at Week 12, Sub-study 2: Proportion of participants with CD-related hospitalizations by Week 12, Sub-study 2: Number of participants with any Treatment Emergent Adverse Events (TEAEs), treatment-emergent adverse event of special interest (TEAESIs), treatment-emergent serious adverse event (TESAEs), and TEAEs leading to permanent study intervention discontinuation, Sub-study 2: Serum concentrations of duvakitug, Sub-study 2: Incidence of treatment-emergent Anti-drug Antibodies (ADA) against duvakitug

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