This is a randomized, placebo-controlled, double-blind, parallel, multicenter, phase 2a study in participants with fibrostenotic CD.~This study 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 5-week screening period. Magnetic resonance enterography (MRE) will be performed at screening to assess eligibility.~Eligible participants will be randomized 1:1:1 to receive AGMB-129 high dose, low dose or placebo for 12 weeks.~During Screening and Week 12 visits, participants will undergo ileocolonoscopy with biopsy collection for exploring pharmacodynamics. Participants will have blood sample collection at Weeks 2, 4, 8, and 12 to assess safety, PK, and PD.~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.
The goal of this clinical trial is to learn about the safety, pharmacokinetics and pharmacodynamics of AGMB-129 in patients with Crohn's disease. The main questions it aims to answer are:~is AGMB-129 safe and well tolerated in these patients?~what does the body do to the drug (pharmacokinetics)?~what does the drug do to the body (pharmacodynamics)?~The participants will be in the study for a total duration of up to 19 weeks, including a 5-week screening period, a 12-week double-blind, placebo-controlled treatment period where they will receive either a high or low dose or placebo (1:1:1), and 2-week safety follow-up period