NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease

This is a randomized, double-blind, placebo-controlled, dose-ranging, multicenter Phase 2b trial to assess the efficacy and safety of ontunisertib in participants diagnosed with FSCD. The trial population will include adults 18 years of age and older with symptomatic FSCD based on clinical, endoscopic, and radiological criteria. This trial consists of 3 periods (a screening period, a placebo-controlled, double-blind treatment period, and safety follow-up). After signing informed consent, eligibility will be assessed during a 6-week screening period. The presence of qualifying intestinal strictures will be assessed by ileocolonoscopy and magnetic resonance enterography (MRE). The presence of obstructive symptoms will also be evaluated. Eligible participants will be randomized 1:1:1:1 to receive AGMB-129 (Ontunisertib) high dose, medium dose, low dose or placebo for 52 weeks. During Screening and Weeks 24 and 52 visits, participants will undergo ileocolonoscopy with biopsy collection for exploring pharmacodynamics. Participants will have blood sample collection at Weeks 6, 12, 18, 24, 30, 36, 44 and 52 to assess safety, pharmacokinetics, and pharmacodynamics. Throughout the study, participants will undergo routine safety assessments at study visits, which will include physical examination, vital signs, clinical laboratory assessment, electrocardiogram (ECG), and recording of AEs.