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

Immune system diseases

Co-primary endpoints US/FDA: Pivotal Maintenance Sub-Study Cohort 1 • Proportion of participants achieving clinical remission (CDAI) at Week 40, Co-primary endpoints US/FDA: Pivotal Maintenance Sub-Study Cohort 1 • Proportion of participants achieving Endoscopic Response (SES-CD) at Week 40, Co-primary endpoints EU/EMA: Pivotal Maintenance Sub-Study Cohort 1 • Proportion of participants achieving clinical remission per PRO-2 at Week 40, Co-primary endpoints EU/EMA: Pivotal Maintenance Sub-Study Cohort 1 • Proportion of participants achieving Endoscopic Response (SES-CD) at Week 40

Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical response Week 40, Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving SES-CD endoscopic remission at Week 40, US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical remission and endoscopic remission at Week 40, EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving PRO-2 clinical remission and endoscopic remission at Week 40, US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving PRO-2 clinical remission at Week 40, EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical remission at Week 40, US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving corticosteroids free CDAI clinical remission at Week 40, EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving corticosteroids free PRO-2 remission at Week 40, Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving ulcer-free endoscopy (in the subset of participants with ulcers at Baseline) at Week 40, US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission per CDAI at Week 40 in the subset of participants with clinical remission per CDAI at Week 0 (maintenance of clinical remission per CDAI), EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission per PRO-2 at Week 40 in the subset of participants with clinical remission per PRO-2 at Week 0 (maintenance of clinical remission per PRO-2), Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in PROMIS-Fatigue Short Form 7a T-score at Week 40, Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in IBDQ total score at Week 40, Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with no bowel urgency by NRS at Week 40, Pivotal Maintenance Sub-Study Cohort 1: Incidence of CD related hospitalization by Week 40, Pivotal Maintenance Sub-Study Cohort 1: Serum concentrations of duvakitug measured over time, Pivotal Maintenance Sub-Study Cohort 1: Incidence of treatment- emergent antidrug antibody (ADA) against duvakitug, Pivotal Maintenance Sub-Study Cohort 1: Incidence of treatment- emergent adverse events (TEAEs), treatment-emergent adverse events of special interest (TEAESIs), treatment-emergent serious adverse events (TESAEs) and TEAEs leading to permanent study intervention discontinuation, Open-Label Extension Sub-Study: Incidence of TEAEs, TEAESIs, TESAEs, and TEAEs leading to permanent study intervention discontinuation

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