The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis
- Conditions
- Ulcerative Colitis
- Interventions
- Registration Number
- NCT04985968
- Lead Sponsor
- InDex Pharmaceuticals
- Brief 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.
- Detailed Description
This phase III study protocol includes an induction study for 6 weeks and a maintenance study for an additional 45 weeks.
In the induction study there will be an initial phase to explore the best dose, between cobitolimod 250 mg and cobitolimod 500 mg using adaptive design.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 171
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cobitolimod 250 mg Cobitolimod 250 mg Dose of 250 mg cobitolimod 2 treatments during induction study and subsequently every third week Placebo Placebo Dose of Placebo 2 treatments during induction study and subsequently every third week Cobitolimod 500 mg Cobitolimod 500 mg Dose of 500 mg cobitolimod 2 treatments during induction study and subsequently every third week
- Primary Outcome Measures
Name Time Method Induction - Proportion of participants with clinical remission. Week 6 Clinical remission defined by the 3-component Mayo score.
Maintenance - Proportion of participants with clinical remission. Week 52 Clinical remission defined by the 3-component Mayo score.
- Secondary Outcome Measures
Name Time Method Induction - Proportion of participants with symptomatic remission. Week 6 Symptomatic remission defined by the 2-component Mayo score.
Induction - Mean stool frequency. Week 6 Mean stool frequency defined by the Mayo score for Stool Frequency.
Induction - Proportion of participants with histologic remission. Week 6 Histologic remission defined by the Robarts Histologic Index.
Induction - Proportion of participants with mucosal healing. Week 6 Mucosal healing defined by the Mayo Endoscopic score and Robarts Histologic Index.
Induction - Mean IBDQ total score. Week 6 Defined by the Inflammatory Bowel Disease Questionnaire (IBDQ).
Maintenance - Proportion of participants with clinical remission and steroid-free. Week 52 Defined by the 3-component Mayo score and use of glucocorticosteroids.
Induction - Proportion of participants with endoscopic improvement. Week 6 Endoscopic improvement defined by the Mayo Endoscopic score.
Induction - Proportion of participants with normalisation of stool frequency. Week 6 Stool frequency defined by the Mayo score for Stool Frequency.
Induction - Proportion of participants with absence of rectal bleeding. Week 6 Rectal bleeding defined by the Mayo score for Rectal Bleeding.
Induction - Proportion of participants with clinical response. Week 6 Clinical remission defined by the 3-component Mayo score.
Induction - Proportion of participants with histologic improvement. Week 6 Defined by the Robarts Histologic Index.
Maintenance - Proportion of participants with histologic improvement. Week 52 Histologic improvement defined by the Robarts Histologic Index.
Maintenance - Proportion of participants with clinical response. Week 52 Clinical response defined by the 3-component Mayo score.
Maintenance - Proportion of participants with absence of rectal bleeding. Week 52 Rectal bleeding defined by the Mayo score for Rectal Bleeding.
Maintenance - Mean 3-component and 4-component Mayo scores. Week 52 Defined by 3-component and 4-component Mayo scores.
Induction - Mean ln-transformed faecal calprotectin. Week 6 Mean ln-transformed faecal calprotectin defined by faecal calprotectin values.
Induction - Mean 3-component and 4-component Mayo scores. Week 6 Defined by 3-component and 4-component Mayo scores.
Induction - Proportion of participants with an improvement in IBDQ total score. Week 6 Defined by the IBDQ.
Maintenance - Proportion of participants with endoscopic improvement. Week 52 Endoscopic improvement defined by the Mayo Endoscopic score.
Maintenance - Proportion of participants with clinical remission among those who achieved clinical remission Week 52 Defined by the 3-component Mayo score.
Maintenance - Proportion of participants with symptomatic remission. Week 52 Symptomatic remission defined by the 2-component Mayo score.
Maintenance - Proportion of participants with histologic remission. Week 52 Histologic remission defined by the Robarts Histologic Index.
Maintenance - Proportion of participants with mucosal healing. Week 52 Mucosal healing defined by the Mayo Endoscopic score and Robarts Histologic Index.
Maintenance - Proportion of participants with normalisation of stool frequency. Week 52 Stool frequency defined by the Mayo score for Stool Frequency.
Maintenance - Mean stool frequency. Week 52 Mean stool frequency defined by the Mayo score for Stool Frequency.
Maintenance - Mean ln-transformed faecal calprotectin. Week 52 Mean ln-transformed faecal calprotectin.
Maintenance - Proportion of participants with an improvement in IBDQ total score. Week 52 Defined by the IBDQ.
Maintenance - Mean IBDQ total score. Week 52 Defined by the use of the Inflammatory Bowel Disease Questionnaire (IBDQ).
Trial Locations
- Locations (202)
Amicis Research Center
🇺🇸Granada Hills, California, United States
Allameh Medical Corporation
🇺🇸Mission Viejo, California, United States
Prospective Research Innovations Inc.
🇺🇸Rancho Cucamonga, California, United States
Valiance Clinical Research
🇺🇸Tarzana, California, United States
RecioMed Clinical Research Network, Inc.
🇺🇸Boynton Beach, Florida, United States
MB & V Medical Research
🇺🇸Doral, Florida, United States
A+ Research, Inc.
🇺🇸Miami, Florida, United States
SouthCoast Research Center, Inc
🇺🇸Miami, Florida, United States
I.V.A.M. Clinical & Investigational Center LLC
🇺🇸Miami, Florida, United States
D&H National Research Centers, Inc.
🇺🇸Miami, Florida, United States
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