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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03178669
• Date of registration: 05/06/2017
• Prospective Registration: Yes
• Primary sponsor: InDex Pharmaceuticals
• Public title: The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis CONDUCT
• Scientific title: A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients
• Date of first enrolment: June 21, 2017
• Target sample size: 213
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03178669
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Czechia, France, Germany, Hungary, Poland, Russian Federation, Serbia, Spain, Sweden, Ukraine

Contacts

• Name: Raja Atreya
• Affiliation: Friedrich-Alexander University Erlangen-Nuremberg

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age = 18 years old

- Established diagnosis of UC

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

- Current oral 5-ASA/SP use or a history of oral 5-ASA/SP use

- Current 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

- TNF-a 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-a 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: cobitolimod

Drug: Placebo

Primary Outcome(s)

Clinical Remission [Time Frame: 6 weeks after first treatment]

Secondary Outcome(s)

Modified Clinical Remission [Time Frame: Week 6]

Normal or enhanced stool frequency [Time Frame: Week 4 and Week 6]

Histological Response [Time Frame: Week 6]

Change in the inflammatory bowel disease questionnaire (IBDQ) [Time Frame: Week 6]

Endoscopic Remission [Time Frame: Week 6]

Abscence of rectal bleeding [Time Frame: Week 4 and Week 6]

Symptomatic Remission [Time Frame: Week 4 and Week 6]

Change in faecal calprotectin [Time Frame: Week 1,2, 3 and 6]

Clinical Response [Time Frame: Week 6]

Histological Remission [Time Frame: Week 6]

Secondary ID(s)

CSUC-01/16

2016-004217-26

Source(s) of Monetary Support

Please refer to primary and secondary sponsors