The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis

• Status: Completed
• Trial end date: 2019-08-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to evaluate efficacy of cobitolimod treatment at different dose levels and frequencies compared to placebo in patients with moderate to severe left-sided ulcerative colitis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InDex Pharmaceuticals

Criteria

Inclusion Criteria:

• Age ≥ 18 years old

• Established diagnosis of Ulcerative Colitis (UC)

• Moderately to severely active left sided UC assessed by central reading

• Current oral 5-Aminosalicylic Acid (5-ASA)/ Sulphasalazine (SP) use or a history of oral 5-ASA/SP use

• Current Glucocorticosteroids (GCS) use or history of GCS dependency, refractory, or intolerance

• Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following agents:

• Immunomodulators

• Tumor Necrosis Factor alpha (TNF-α) inhibitors and/or anti-integrins

Exclusion Criteria:

• Suspicion of differential diagnosis

• Acute fulminant UC and/or signs of systemic toxicity

• UC limited to the rectum (disease which extend <15 cm above the anal verge)

• History of malignancy

• History or presence of any clinically significant disorder

• Concomitant treatment with cyclosporine, methotrexate, tacrolimus, TNF-α inhibitors, anti-integrins or similar immunosuppressants and immunomodulators

• Treatment with rectal GCS, 5-ASA/SP or tacrolimus

• Long term treatment with antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs)

• Serious active infection

• Gastrointestinal infections

• Currently receiving parenteral nutrition or blood transfusions

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

• Women of childbearing potential not using reliable contraceptive methods

• Concurrent participation in another clinical study

• Previous exposure to cobitolimod