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New hope for Crohn's patients: drug may prevent bowel surgery

NCT ID NCT05843578

Disease control Sponsor: Agomab Spain S.L.U. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study tests an experimental drug called AGMB-129 in about 100 people with Crohn's disease who have painful bowel narrowing (strictures). The goal is to see if the drug is safe and can help reduce the narrowing, potentially avoiding the need for surgery. Participants receive either the drug or a placebo for 12 weeks, with an option to continue treatment for up to 48 more weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

103 people

The number who actually took part.

Started

Aug 2023

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria (Part A): 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 at least 1 stricture in the terminal ileum within reach of an endoscope (passable or nonpassable).Strictures should be noncritical, naïve or anastomotic stricture(s), caused by CD 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; AND * Either prestenotic dilation (defined as a luminal diameter ≥3 cm) or nonpassable with adult colonoscope 3. Presence of tolerable obstructive symptoms, as defined by a screening S-PRO severity score ≥2, and not expected to require hospitalization, endoscopic balloon dilation, surgical resection, or additional therapy during the study. Participant 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 (Part A): 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, 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 Inclusion Criteria (Part B): 1. Completion of the 12-week treatment period (Part A) and participant is willing and able to continue treatment. 2. Per investigator judgment, participant is able to continue or resume treatment following completion of the Week 12 visit in Part A. Exclusion criteria (Part B): 1. More than 24 weeks since completion of the Week 12 visit in Part A. 2. Experienced any AE leading to permanent treatment discontinuation during treatment with study drug in the double blind treatment period (Part A). 3. Have undergone endoscopic balloon dilation or bowel surgery (resection surgery or strictureplasty) for any intestinal stricture since the Week 12 visit in Part A. 4. Developed any condition which meets the Part A exclusion criteria, as per investigator judgment. 5. Any condition which in the opinion of the investigator affects the safety or ability to participate in Part B. 6. Participation in any other clinical trial since the completion of the Week 12 visit in Part A.

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fibrostenotic Crohn's disease

Contacts and locations

Locations

  • (G.I.R.I) GI Research Institute

    Vancouver, BC V6Z 2K5, Canada

  • Aarhus University Hospital, Department of Hepatology and Gastroenterology

    Aarhus, Denmark

  • Azienda Ospedaliera San Camillo Forlanini

    Rome, 00152, Italy

  • Azienda Ospedaliero Universitaria di Modena - Struttura Complessa di Gastroenterologia

    Modena, 41124, Italy

  • BSF Studiengesellschaft UG (Unternehmergesellschaft, haftungsbeschränkt)

    Halle, 06108, Germany

  • Bispebjerg Hospital

    Copenhagen, 2400, Denmark

  • Charite Universitatsmedizin Berlin KöR Campus Benjamin Franklin Medizinische

    Berlin, 12203/12200, Germany

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Digestive and Liver Center of Florida

    Orlando, Florida, 32825, United States

  • ETG Zamość

    Zamość, 22-400, Poland

  • Endoskopia Sp. z o.o.

    Sopot, Poland

  • Gastro One

    Cordova, Tennessee, 38018, United States

  • Gastroenterology Health Partners

    New Albany, Indiana, 47150, United States

  • Gastroenterology Health Partners

    Louisville, Kentucky, 40218, United States

  • Gastroenterology and Internal Medicine Research Institute (GIRI)

    Edmonton, T5R1W2, Canada

  • Gemeinnutzige Salzburger Landeskliniken Betriebsgesellschaft mbH (Landeskrankenhaus Salzburg/Regional Hospital Salzburg)

    Salzburg, 5020, Austria

  • H-T. Medical Center

    Tychy, Poland

  • Herlev Hospital (University of Copenhagen)

    Herlev, 2730, Denmark

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Landstrasse, Department of Internal Medicine IV

    Vienna, Austria

  • Hospital San Raffaele

    Milan, Italy

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital Universitario de Gran Canaria

    Las Palmas de Gran Canaria, 35010, Spain

  • Humanitas Research Hospital IRCCS Istituto Clinico Humanitas

    Milan, 20089, Italy

  • Louisiana Research Center

    Shreveport, Louisiana, 71105, United States

  • MEDRISE Sp. z o.o.

    Lublin, 20-582, Poland

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut, 06518, United States

  • Medical University Of Vienna (AKH Wien)

    Vienna, 1090, Austria

  • Medical University of Graz

    Graz, 8036, Austria

  • Nova Scotia Health Authority

    Halifax, Canada

  • Odense University Hospital

    Odense, 5000, Denmark

  • Ottawa Hospital Research Institute

    Ottawa, Canada

  • Planetmed Sp. z o.o.

    Wroclaw, 52210, Poland

  • Rigshospitalet - University Hospital Copenhagen

    Copenhagen, Denmark

  • SOLUMED Medical Center

    Poznan, Poland

  • Sacred Heart Don Calabria

    Negrar, Italy

  • Servicegesellschaft Krankenhaus Waldfriede mbH Krankenhaus Waldfriede e.V Akademisches Lehrkrankenhaus der Charite

    Berlin, 14163, Germany

  • South Edmonton Gastroenterology Research Clinic

    Edmonton, T6K 4B2, Canada

  • Specialist Gastrology Centre GASTROMED

    Bialystok, Poland

  • TIDHI Innovation Inc.

    North York, ON M6A 3B4, Canada

  • Universitatsklinikum Ulm AöR (University of Ulm)

    Ulm, 89081, Germany

  • University Polyclinic Foundation "Agostino Gemelli"

    Rome, Italy

  • University Polyclinic Hospital "G. Martino"

    Messina, Italy

  • University of Calgary

    Calgary, AB T2N 4Z6, Canada

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • VISTAMED

    Wroclaw, Poland

  • Vita Longa Sp. z.o.o.

    Katowice, 40-748, Poland

  • WIP Warsaw IBD Point

    Warsaw, 00-728, Poland

  • WSD Medi Clinical Sp. z o.o.

    Warsaw, Poland

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.