NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease

NCT07683325 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: AGMB129-01-CL-201
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving endoscopic passability of the ileal index stricture

  To evaluate the efficacy and dose-response relationship of multiple doses of ontunisertib

  At week 24

Secondary Outcomes (12)

• Proportion of participants achieving endoscopic passability of the ileal index stricture

  At week 52

• Change in reliable MRE imaging features (stricture length, bowel wall thickness, prestenotic dilatation diameter) of the index stricture

  At week 52 compared to baseline (week 1)

• Change in total SES-CD (range, 0-56 points) (Reference: https://www.giejournal.org/article/S0016-5107(04)01878-4/abstract)

  At week 52 compared to baseline

• Proportion of participants with an endoscopic response (≥50% decrease in total SES-CD) and remission (SES-CD ≤4 with no item >1)

  At week 52 compared to baseline

• Change in S-PRO severity score

  At week 52 compared to baseline

Study Arms (4)

Ontunisertib High

EXPERIMENTAL

Ontunisertib high dose

Drug: Ontunisertib

Ontunisertib Medium

EXPERIMENTAL

Ontunisertib medium dose

Drug: Ontunisertib

Ontunisertib Low

EXPERIMENTAL

Ontunisertib low dose

Drug: Ontunisertib

Placebo

EXPERIMENTAL

Matching placebo

Drug: Placebo

Interventions

Ontunisertib DRUG

Oral capsule

Also known as: AGMB-129

Ontunisertib High

Placebo DRUG

Matching oral capsule

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Short bowel syndrome (\<200 cm small bowel remaining).
• Ileostomy (diverting or end), colostomy, small bowel stoma, or ileoanal pouch.
• Internal fistulae and sinus tracts deriving from the area of stenosis. Participants with perianal fistulae could be included if not septic.
• Anal and perianal stricture.
• Suspected or diagnosed active intra-abdominal or perianal abscess that has not been appropriately treated and abscess in relation to the stricture.
• Toxic megacolon.
• 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.

Sponsors & Collaborators

• Agomab Spain S.L.U.: lead

Study Officials

• Silke Hüttner, MD

  Agomab Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Agomab Clinical Operations

CONTACT

0032 3318 91 70; clinicalstudies@agomab.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, placebo-controlled, double-blind, parallel, multicenter, phase 2b study

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 6, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share