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

• Status: Not yet recruiting
• Trial end date: 2023-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InDex Pharmaceuticals

Criteria

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 of latent or active tuberculosis.

• Gastrointestinal infections including positive Clostridium difficile stool assay.

• Females who are lactating or have a positive serum pregnancy test.

• Women of childbearing potential not using highly effective contraceptive methods.

• Concurrent participation in another clinical study.

• Previous exposure to cobitolimod.

Inclusion Criteria Maintenance:

• Participants are eligible to be included in the maintenance study if they have achieved clinical response at week 6 and have adhered to the protocol procedures of the induction study.

Exclusion Criteria Maintenance:

• Participants will not be eligible for the maintenance study if they are not willing to comply with all further study requirements.