New drug could unblock Crohn's-Related bowel narrowing without surgery

NCT ID NCT07683325

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 06, 2026 · Last updated Aug 25, 2026 · Updated 3 times

Summary

This trial tests an experimental drug called ontunisertib in people with Crohn's disease who have developed scarred, narrowed sections in their bowel that cause pain and blockages. The goal is to see if the drug can reopen these narrowed areas, potentially reducing symptoms and the need for surgery. Participants will take the drug or a placebo for up to a year, with regular check-ups to monitor changes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ontunisertib (AGMB-129)
What this could lead to
If successful, this drug could offer a non-surgical option to open narrowed sections of the bowel, reducing pain and the need for surgery in people with fibrostenosing Crohn's disease.
What could go wrong
This is a mid-stage trial, so the drug may not prove effective or safe enough. Side effects are possible, and results may not apply to all patients with Crohn's strictures.

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

About 320 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

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: * Diagnosis of ileal or ileocolonic CD based on clinical and endoscopic or radiological evidence established at least 12 weeks prior to signing the ICF. * Presence of at least 1 endoscopically non-passable ileal stricture. * Present stricture(s) can be naïve or anastomotic, and will be confirmed by centrally read MRE. * Presence of (sub)obstructive symptoms AND/OR dietary restrictions like limiting the amount or type of food, and/or food processing methods. * Participants should be on stable anti-inflammatory background therapy for CD and agree to maintain stable background therapy for the duration of the trial. * Participants should have a body mass index ≥18 kg/m2 and \<35 kg/m2. * Not expected in the investigator's opinion to require hospitalization, endoscopic balloon dilation, surgical resection, or optimized anti-inflammatory therapy during the first 4 weeks of the trial. Exclusion Criteria: * History or current diagnosis of ulcerative colitis, indeterminate colitis, ischemic colitis, nonsteroidal anti-inflammatory drug-induced colitis, idiopathic colitis (i.e., colitis not consistent with CD), radiation colitis, microscopic colitis, colonic mucosal dysplasia, untreated bile acid malabsorption, or infectious colitis. * CD-related complications: 1. Short bowel syndrome (\<200 cm small bowel remaining). 2. Ileostomy (diverting or end), colostomy, small bowel stoma, or ileoanal pouch. 3. Internal fistulae and sinus tracts deriving from the area of stenosis. Participants with perianal fistulae could be included if not septic. 4. Anal and perianal stricture. 5. Suspected or diagnosed active intra-abdominal or perianal abscess that has not been appropriately treated and abscess in relation to the stricture. 6. Toxic megacolon. 7. Blind-ending sinus could be included. * Endoscopic balloon dilation or surgical treatment of the index small bowel stricture within the last 6 months prior to screening. * Current or history of valvulopathy, or moderate or severe heart valve function defect, including moderate or severe valve stenosis or regurgitation OR left ventricular ejection fraction \<50% as assessed locally through echocardiography. * Any other severe acute or chronic medical condition, psychiatric disorder, laboratory abnormality, or systemic or opportunistic infection that may increase the risk associated with trial participation or trial treatment administration, or may interfere with the interpretation of trial results, as determined by the investigator. * Clinically significant abnormal vital signs, physical examination, or abnormalities at 12-lead ECG at screening or baseline.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Synergy Healthcare, LLC

    RECRUITING

    Bradenton, Florida, 34209, United States

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