Recruiting
Phase 2

Ontunisertib

Sponsor:

Agomab Spain S.L.U.

Code:

NCT07683325

Conditions

Fibrostenotic Crohn's Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ontunisertib

Ontunisertib

Ontunisertib

Placebo

Study Details

Brief summary:

Many patients with Crohn's disease (CD) 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 efficacy, safety, and dose-response relationship of ontunisertib in participants with CD and symptomatic strictures, and contribute to the validation of novel endpoints to assess potential treatment benefit in patients with fibrostenosing Crohn's disease (FSCD).

The participants will be in the trial for a duration of up to 60 weeks, consisting of a 6-week screening period (with 2 screening visits), a 52-week treatment period, and a 2-week follow-up period. The visit frequency in the treatment period will be every 6 to 8 weeks.

Conditions

Fibrostenotic Crohn's Disease

Study ID

NCT07683325

Start date

Oct 30, 2026

Status verified date

Oct, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

320 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ontunisertib High

Ontunisertib high dose

experimental: Ontunisertib Medium

Ontunisertib medium dose

experimental: Ontunisertib Low

Ontunisertib low dose

experimental: Placebo

Matching placebo

Interventions

Ontunisertib

Oral capsule

Ontunisertib

Oral capsule

Ontunisertib

Oral capsule

Placebo

Matching oral capsule

Primary outcome measure

  • Proportion of participants achieving endoscopic passability of the ileal index stricture [ Time Frame: At week 24 ]

Central Contacts and Locations

Central contacts

Agomab Clinical Operations

0032 3318 91 70clinicalstudies@agomab.com

Locations

Synergy Healthcare, LLC

Recruiting

Bradenton, Florida, United States, 34209

Albany Gastroenterology Consultants

Recruiting

Albany, New York, United States, 12206

University Gastroenterology

Recruiting

Providence, Rhode Island, United States, 02905

GI Alliance - Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Amel Med LLC

Recruiting

Georgetown, Texas, United States, 78628

More Information

Sponsor

Agomab Spain S.L.U.

Last update posted

Oct 19, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Agomab Spain S.L.U. on 2026-10-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.