NCT07683325 NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease
| NCT ID | NCT07683325 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Agomab Spain S.L.U. |
| Condition | Fibrostenotic Crohn's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 320 participants |
| Start Date | 2026-10-30 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 320 participants in total. It began in 2026-10-30 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Silke Hüttner, MD
STUDY DIRECTOR
Agomab Therapeutics
Frequently Asked Questions
Who can join the NCT07683325 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fibrostenotic Crohn's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07683325 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07683325 currently recruiting?
Yes, NCT07683325 is actively recruiting participants. Contact the research team at clinicalstudies@agomab.com for enrollment information.
Where is the NCT07683325 trial being conducted?
This trial is being conducted at Sun City, United States, Bradenton, United States, Albany, United States, Providence, United States and 7 additional locations.
Who is sponsoring the NCT07683325 clinical trial?
NCT07683325 is sponsored by Agomab Spain S.L.U.. The principal investigator is Silke Hüttner, MD at Agomab Therapeutics. The trial plans to enroll 320 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.