TerminatedPhase 3

The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis

Stopped: Due to futility

United States, Australia, Austria171 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 range

18 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Induction - Proportion of participants with clinical remission.

Timeframe: Week 6

Maintenance - Proportion of participants with clinical remission.

Timeframe: Week 52

Trial details

NCT IDNCT04985968

SponsorInDex Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-20

View on ClinicalTrials.gov More Ulcerative Colitis trials