A Study to Evaluate Safety, Tolerability, PK and PD of AGMB-129 in Patients With Fibrostenotic Crohn's Disease

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Agomab Spain S.L.

Criteria

Inclusion Criteria:

1. Diagnosis of ileal or ileocolonic CD based on supporting guideline criteria (eg, clinical, endoscopic, and histologic evidence) established at least 3 months prior to screening.

2. Presence of up to 2 ileal stricture(s) which should be noncritical naive or anastomotic stricture(s), caused by CD and with at least 1 stricture located in the (neo)terminal ileum within reach of an endoscope and confirmed centrally by MRE according to the following criteria:

• localized luminal narrowing (luminal diameter ≤50% relative to normal adjacent bowel); AND

• bowel wall thickening (≥25% relative to adjacent bowel).

3. Presence of tolerable obstructive symptoms (such as abdominal pain, abdominal pain after eating, limitations in amount or types of food, etc.), and not expected to require hospitalization, endoscopic balloon dilation, surgical resection, or additional therapy during the study. Participants should have sufficient food intake, even with diet modification.

4. Stable background therapy for CD and agree to maintain background therapy for the study duration

Exclusion criteria:

1. History or current diagnosis of ulcerative colitis, indeterminate colitis, ischemic colitis, nonsteroidal anti-inflammatory drug-induced colitis, idiopathic colitis (ie, colitis not consistent with CD), radiation colitis, microscopic colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption.

2. CD-related complications (previous extensive small bowel resection, ileorectal anastomosis, proctocolectomy, short bowel syndrome, ileostomy [diverting or end], colostomy, small bowel stoma, ileoanal pouch, inactive fistulae in or adjacent to an ileal stricture, colonic stricture, anal and perianal stricture, active intra-abdominal or perianal abscess that has not been appropriately treated, abscess in relation to the stricture, toxic megacolon, very severe inflammation, or presence of deep ulceration in the colon or terminal ileum).

3. Ileitis not associated with CD (eg, ileitis associated with infections, spondyloarthropathies, ischemia, etc.).

4. Endoscopic balloon dilation or surgical treatment of the same small bowel stricture within the last 6 months prior to screening

5. Receiving cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks of screening or Janus kinase inhibitor therapy within 4 weeks of screening.

6. Requiring continued treatment with systemically administered medications that are sensitive CYP3A4/5 substrates with a narrow therapeutic index or strong inhibitors of aldehyde oxidase or xanthine oxidase.

7. Current or history of vasculitis, valvulopathy or large vessel disorder or major abnormalities documented by cardiac echocardiography with Doppler