RightFit
RecruitingPhase 2

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

A Phase 2b, Randomized, Placebo-controlled, Double-blind, Dose-ranging Trial to Assess the Efficacy and Safety of Ontunisertib in Patients With Fibrostenosing Crohn's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 2 visits, 24 visits
  • Time periods mentioned: 60 weeks, 52 weeks
  • Procedures mentioned: MRI scans, Biopsies, Blood draws, Heart tracing (ECG), Physical exams

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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 presence of qualifying intestinal strictures will be assessed by ileocolonoscopy and magnetic resonance enterography (MRE)."
  • "Eligible participants will be randomized 1:1:1:1 to receive AGMB-129 (Ontunisertib) high dose, medium dose, low dose or placebo for 52 weeks."
  • "During Screening and Weeks 24 and 52 visits, participants will undergo ileocolonoscopy with biopsy collection for exploring pharmacodynamics."
  • "Participants will have blood sample collection at Weeks 6, 12, 18, 24, 30, 36, 44 and 52 to assess safety, pharmacokinetics, and pharmacodynamics."
  • "Throughout the study, participants will undergo routine safety assessments at study visits, which will include physical examination, vital signs, clinical laboratory assessment, electrocardiogram (ECG), and recording of AEs."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ontunisertib against a placebo in people with Crohn’s disease whose bowel has narrowed from scarring. It checks how well the drug works, how safe it is, and how different doses work. The study lasts up to 60 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have Crohn’s disease in the last part of the small bowel, with or without large bowel disease, confirmed at least 12 weeks before signing the consent form.
  • Have at least one narrow area in the last part of the small bowel that a viewing tube cannot pass through.
  • Have the narrowing confirmed by a special MRI scan. It may be in an area with no prior surgery or where bowel ends were joined after surgery.
  • Have symptoms of a bowel blockage, need to limit food amounts or types, or need to change how food is prepared.
  • Be on a steady dose of medicine for Crohn’s inflammation and agree to keep this treatment steady during the study.
  • Have a body mass index (BMI), a measure based on height and weight, of at least 18 but less than 35.
  • The study doctor must not expect you to need hospital care, a procedure to widen the bowel, bowel surgery, or stronger treatment for inflammation during the first 4 weeks.

Who can't join

  • Have or have had certain bowel conditions other than Crohn’s, including other types of colon inflammation, abnormal cells in the colon lining, or an untreated problem absorbing bile acids.
  • Have less than 200 cm of small bowel left, a bowel opening through the belly for waste, or an internal pouch connected to the anus.
  • Have abnormal tunnels from the narrowed area, or narrowing in or around the anus. A tunnel that ends blindly may be allowed. Tunnels near the anus may be allowed if they are not causing sepsis, a dangerous response to infection.
  • Have an active pocket of infection in the belly or near the anus that has not been properly treated, a pocket of infection linked to the narrowing, or a dangerously swollen colon.
  • Had balloon widening or surgery on the small bowel narrowing being studied within 6 months before screening.
  • Have or have had heart valve disease, have a moderate or severe heart valve problem, or have a heart scan showing that the main pumping chamber pumps out less than 50% of its blood per beat.
  • Have another serious illness, mental health condition, abnormal lab result, or infection that the study doctor thinks could make participation unsafe or affect the results.
  • Have important abnormal findings in vital signs, a physical exam, or an ECG, a test of the heart’s electrical activity, at screening or the start of the study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (5)

FL

NY

RI

TX