Fibrostenotic Crohn's Disease study: Ontunisertib
Official title NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease
ClinicalTrials.gov ID: NCT07683325
What this study is testing
What is Ontunisertib?
An investigational oral capsule being studied for fibrostenotic Crohn's disease.
Also referred to as AGMB-129.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see if ontunisertib is safe and helps reduce bowel narrowing and related symptoms in Crohn’s disease patients.
- Who it's for
- Adults with Crohn’s disease who have painful, obstructive bowel strictures.
- What's involved
- Participants will receive either ontunisertib or a placebo, have regular clinic visits every 6‑8 weeks, and undergo tests to monitor safety and bowel changes.
- Time commitment
- The study lasts up to 60 weeks, including a 6‑week screening, 52‑week treatment, and 2‑week follow‑up, with visits every 6‑8 weeks during treatment.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join if
- History or current diagnosis of ulcerative colitis, indeterminate colitis, ischemic colitis, nonsteroidal anti-inflammatory drug-induced colitis...
- 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.
See the full eligibility 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.
- 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...
- 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...
- 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...
- Clinically significant abnormal vital signs, physical examination, or abnormalities at 12-lead ECG at screening or baseline.
The study team makes the final eligibility decision.
Where it is enrolling
- Sun City, Arizona, United States
- Bradenton, Florida, United States
- Albany, New York, United States
- Providence, Rhode Island, United States
- Cedar Park, Texas, United States
- Fort Worth, Texas, United States
- Georgetown, Texas, United States
- Belgrade, Serbia
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Sun City, Arizona, United States; Bradenton, Florida, United States; Albany, New York, United States; Providence, Rhode Island, United States; Cedar Park, Texas, United States; Fort Worth, Texas, United States and 3 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.