An Interventional Study to Evaluate Treating to a Target of Transmural Healing in Patients with Moderately to Severely Active Crohn’s Disease (VECTORS)

Moderately to Severely Active Crohn’s Disease

Corticosteroid-free endoscopic remission at Week 48

Corticosteroid-free TMH + endoscopic remission + clinical remission at Week 48; Corticosteroid-free IUS response + endoscopic remission + clinical remission at Week 48; Corticosteroid-free endoscopic remission + clinical remission at Week 48; Corticosteroid-free endoscopic response + clinical response at Week 48, Corticosteroid-free clinical remission at Weeks 14, 22, and 48; Corticosteroid-free clinical response at Weeks 14, 22, and 48; CDAI total score and corresponding change from baseline during follow-up (Weeks 6, 14, 22, 30, 38, and 48), Corticosteroid-free endoscopic response at Week 48; SES-CD total score and corresponding change from baseline to Week 48, TMH at Week 48; IUS response at Week 48; BWT and corresponding change from baseline at Week 48; CDS and corresponding change from baseline at Week 48; International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) (per segment as well as total) and corresponding change from baseline at Week 48, TMH at Weeks 14, 22, 30, 38, and 48; IUS response at Weeks 14, 22, 30, 38, and 48; BWT and corresponding change from baseline at Weeks 14, 22, 30, 38, and 48; CDS and corresponding change from baseline at Weeks 14, 22, 30, 38, and 48; IBUS-SAS and corresponding change from baseline at Weeks 14, 22, 30, 38, and 48, Histologic remission at Week 48; Histologic response at Week 48, Biomarker remission at Week 48; Biomarker response at Week 48; CRP response during follow-up (Weeks 6, 14, 22, 30, 38, and 48); FCal response during follow-up (Weeks 6, 14, 22, 30, 38, and 48); CRP and FCal and their corresponding changes from baseline during follow-up (Weeks 6, 14, 22, 30, 38, and 48), 2-item Patient-Reported Outcome (PRO 2) score, Symptoms and Impacts Questionnaire for CD (SIQ-CD) score, and Urgency Numerical Rating Score (NRS) and their corresponding changes from baseline during follow-up (Weeks 6, 14, 22, 30, 38, and 48); Inflammatory Bowel Disease Questionnaire (IBDQ) score and corresponding changes from baseline during follow-up (Weeks 30 and 48), Time to CD-related complication from randomization through Week 96.; Time to each component of CD-related complication; Switched to an alternate biologic (yes/no) by Week 48 and Week 96; Endpoints related to CDAI, CRP, FCal, and patient-reported measures (as specified above) at Weeks 64, 80, and 96., Exposure-adjusted incidence rates of serious adverse events (SAEs), all adverse events (AEs), and AEs of special interest (AESIs)

Belgium, Denmark, France, Germany, Italy, Netherlands, Poland