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Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Back to all Current clinical trials
A clinical trial to assess the efficacy and safety of ontunisertib compared to placebo in patients with Fibrostenosing Crohn’s Disease
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.
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.
What you need to know
Who can take part?
Inclusion Criteria:- Aged 18 or older
- 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 colitis not consistent with CD
- CD-related complications (protocol specific)
- Endoscopic balloon dilation or surgical treatment of the index small bowel stricture within the last 6 months prior to screening.
- Current or history of heart condition.
- 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.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
What is involved for me?
- Regular study visits on site at Mater Hospital Brisbane (South Brisbane).
- Daily eDiary entries
- Blood, stool & urine tests at regular timepoints
- Colonoscopy at specified timepoints
- Injected study medication.
