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

Phase 2

Active, not recruiting

• Conditions: Fibrostenotic Crohn's Disease
• Interventions: Drug: AGMB-129; Drug: Placebo

• Registration Number: NCT05843578
• Lead Sponsor: Agomab Spain S.L.

Brief Summary

Many patients with Crohn's disease develop fibrotic narrowing (strictures) in their bowel, causing obstructive symptoms such as abdominal pain, cramping, or vomiting after meals. Because of these symptoms, patients often require bowel resection surgery. The objective of this clinical trial is to evaluate the safety, pharmacokinetics, and pharmacodynamics of AGMB-129 in patients with Crohn's disease and symptomatic strictures, and whether it can have a beneficial effect on intestinal strictures.

The participants will be in the Part A for a duration of up to 19 weeks including a 5 week screening period, a 12-week double-blind, placebo-controlled treatment period, and 2 week safety follow up period. Participants who continue to Part B can receive treatment for up to an additional 48 weeks, with a safety follow-up visit 2 weeks after the last dose of treatment.

Detailed Description

Part A is a randomized, placebo-controlled, double-blind, parallel, multicenter, phase 2a study in participants with Crohn's disease and symptomatic intestinal strictures.

Part A 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. The presence of qualifying intestinal strictures will be assessed by ileocolonoscopy and magnetic resonance enterography (MRE). The presence of obstructive symptoms will be also evaluated.

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, 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.

Part B is an open-label treatment extension for participants who have completed the double-blind treatment period in Part A.

Study Timeline

• Study First Submitted: 2023-04-25
• Study First Submitted QC: 2023-04-25
• Study First Posted: 2023-05-06
• Study Start: 2023-08-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AGMB-129 Low	AGMB-129	AGMB-129 low dose
AGMB-129 High	AGMB-129	AGMB-129 high dose
Placebo	Placebo	Matching placebo

Primary Outcome Measures

Name	Time	Method
Number of participants with abnormal clinical laboratory values (Part A and B)	From Screening to Week 48	To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of abnormal laboratory parameters at every visit
Number of participants with abnormal ECG parameters (Part A and B)	From Screening to Week 48	To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of abnormal ECG parameters at every visit
Number of participants with abnormal vital signs (Part A and B)	From Screening to Week 48	To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of vital signs at every visit
Number of participants with abnormal physical exams (Part A and B)	From Screening to Week 48	To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of physical exams at every visit
Number of participants with abnormal 2D-echocardiography (Part A and B)	From Screening to Week 48	To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of echocardiography at week 12
Number of participants with adverse events (Part A and B)	From Screening to Week 48	To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of adverse events at every visit

Secondary Outcome Measures

Name	Time	Method
Plasma levels of AGMB-129 and its metabolites (Part A and B)	From Baseline to Week 48	To characterize the pharmacokinetics (PK) of AGMB-129 and its metabolites by measuring the amount in plasma
Changes in mRNA gene expression in ileal biopsies ((Part A)	From Baseline to Week 48	To characterize the pharmacodynamics of AGMB-129 by determining the gene expression in ileal biopsies

Trial Locations

Locations (51)

Medical Research Center of Connecticut, LLC; 🇺🇸 Hamden, Connecticut, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Digestive and Liver Center of Florida; 🇺🇸 Orlando, Florida, United States

Gastroenterology Health Partners; 🇺🇸 Louisville, Kentucky, United States

Louisiana Research Center; 🇺🇸 Shreveport, Louisiana, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Gastro One; 🇺🇸 Cordova, Tennessee, United States

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