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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2024
• Main ID: NCT04985968
• Date of registration: 22/07/2021
• Prospective Registration: Yes
• Primary sponsor: InDex Pharmaceuticals
• Public title: The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis CONCLUDE
• Scientific title: A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis
• Date of first enrolment: November 24, 2021
• Target sample size: 171
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT04985968
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Canada, Croatia, Denmark, France, Georgia, Germany, Hungary, Israel, Italy, Korea, Democratic People's Republic of, Korea, Republic of, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Sweden, Turkey, United Kingdom, United States

Contacts

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

Key inclusion & exclusion 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.



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

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Cobitolimod 250 mg

Drug: Placebo

Drug: Cobitolimod 500 mg

Primary Outcome(s)

Maintenance - Proportion of participants with clinical remission. [Time Frame: Week 52]

Induction - Proportion of participants with clinical remission. [Time Frame: Week 6]

Secondary Outcome(s)

Induction - Proportion of participants with symptomatic remission. [Time Frame: Week 6]

Maintenance - Mean stool frequency. [Time Frame: Week 52]

Maintenance - Proportion of participants with clinical response. [Time Frame: Week 52]

Maintenance - Proportion of participants with endoscopic improvement. [Time Frame: Week 52]

Maintenance - Proportion of participants with histologic improvement. [Time Frame: Week 52]

Maintenance - Proportion of participants with normalisation of stool frequency. [Time Frame: Week 52]

Induction - Mean 3-component and 4-component Mayo scores. [Time Frame: Week 6]

Maintenance - Mean ln-transformed faecal calprotectin. [Time Frame: Week 52]

Induction - Mean stool frequency. [Time Frame: Week 6]

Induction - Proportion of participants with absence of rectal bleeding. [Time Frame: Week 6]

Maintenance - Proportion of participants with an improvement in IBDQ total score. [Time Frame: Week 52]

Maintenance - Mean 3-component and 4-component Mayo scores. [Time Frame: Week 52]

Induction - Mean IBDQ total score. [Time Frame: Week 6]

Induction - Proportion of participants with endoscopic improvement. [Time Frame: Week 6]

Induction - Proportion of participants with clinical response. [Time Frame: Week 6]

Induction - Proportion of participants with normalisation of stool frequency. [Time Frame: Week 6]

Induction - Proportion of participants with histologic improvement. [Time Frame: Week 6]

Induction - Proportion of participants with histologic remission. [Time Frame: Week 6]

Maintenance - Mean IBDQ total score. [Time Frame: Week 52]

Maintenance - Proportion of participants with histologic remission. [Time Frame: Week 52]

Induction - Proportion of participants with mucosal healing. [Time Frame: Week 6]

Maintenance - Proportion of participants with absence of rectal bleeding. [Time Frame: Week 52]

Maintenance - Proportion of participants with clinical remission among those who achieved clinical remission [Time Frame: Week 52]

Maintenance - Proportion of participants with symptomatic remission. [Time Frame: Week 52]

Induction - Mean ln-transformed faecal calprotectin. [Time Frame: Week 6]

Induction - Proportion of participants with an improvement in IBDQ total score. [Time Frame: Week 6]

Maintenance - Proportion of participants with mucosal healing. [Time Frame: Week 52]

Maintenance - Proportion of participants with clinical remission and steroid-free. [Time Frame: Week 52]

Secondary ID(s)

CSUC-01/21

Source(s) of Monetary Support

Please refer to primary and secondary sponsors