The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided … (NCT04985968) | Clinical Trial Compass
TerminatedPhase 3
The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis
Stopped: Due to futility
United States171 participantsStarted 2021-11-24
Plain-language summary
The purpose of the study is to evaluate the efficacy of cobitolimod treatment compared to placebo in inducing clinical remission, in participants with moderate to severe active left-sided UC and to evaluate the efficacy of cobitolimod maintenance treatment compared to placebo in inducing or maintaining clinical remission at week 52, in participants with clinical response at week 6 after induction treatment with cobitolimod.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria Induction:
* Male or female ≥ 18 years of age.
* Established diagnosis of UC.
* Moderate to severe active left-sided UC assessed by central reading.
* Have inadequate response, loss of response or be intolerant of at least one of the following treatments: Oral GCS, AZA/6-MP, Biologics, JAK-inhibitors, or other approved advanced therapies for UC.
* Allowed to receive a therapeutic dose of the following UC drugs during the study: Oral GCS therapy (≤20 mg prednisone or equivalent/day) , Oral 5-ASA/SP compounds, AZA/6-MP.
* Ability to understand the treatment, willingness to comply with all study requirements, and ability to provide informed consent.
Exclusion Criteria Induction:
* Suspicion of differential diagnosis.
* Acute fulminant UC and/or signs of systemic toxicity.
* UC limited to the rectum or extending beyond the splenic flexure.
* Have failed treatment with more than three advanced therapies of two different therapeutic classes.
* Have had surgery for treatment of UC.
* History of malignancy, unless treated with no relapse of the disease and ≥ 5 years since last treatment (cured).
* History or presence of any clinically significant disorder.
* Concomitant treatment with cyclosporine, methotrexate, tacrolimus, or advanced therapies or similar immunosuppressants and immunomodulators.
* Treatment with rectal GCS, 5-ASA/SP or tacrolimus.
* Long-term treatment (\>14 days) with antibiotics or NSAIDs .
* Serious known active infection including history o…
What they're measuring
1
Induction - Proportion of participants with clinical remission.
Timeframe: Week 6
2
Maintenance - Proportion of participants with clinical remission.