The Efficacy and Safety of Cobitolimod (Kappaproct®) in Chronic Active Treatment Refractory Ulcerative Colitis Patients (COLLECT)
|ClinicalTrials.gov Identifier: NCT01493960|
Recruitment Status : Completed
First Posted : December 16, 2011
Results First Posted : January 24, 2018
Last Update Posted : January 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colitis, Ulcerative||Drug: Cobitolimod Drug: Placebo||Phase 3|
The study is a placebo-controlled, double-blind, randomised study to assess the efficacy and safety of cobitolimod as an add-on to current practice in treatment refractory ulcerative colitis patients. The study population will be chronic active ulcerative colitis patients who are no longer responding adequately to standard therapies and who are potential candidates for colectomy. Cobitolimod/placebo will be add-on treatment allowing all included patients to be on concomitant medication, as well as mandatory steroids at inclusion, throughout the study.
Cobitolimod (DIMS0150) is a modified single strand DNA-based synthetic oligodeoxyribonucleotide of 19 bases in length. The drug functions as an immunomodulatory agent by targeting the Toll-like receptor 9 (TLR9) present in immune cells (i.e., B-cells and pDCs) residing in high abundance on mucosal surfaces, such as colonic and nasal mucosa. The mucosa of the colon and rectum of patients with ulcerative colitis contains active immune cells, which produce damage to the tissue. The activation of these cells by cobitolimod results in the systemic release of specific cytokines (e.g., IL-10 and type I interferons) and chemokines which are believed to be important factors for the clinical effect cobitolimod of cobitolimod. 131 eligible patients was randomly assigned in a 2:1 allocation to receive two single rectal doses of cobitolimod at 30 mg each, or placebo, at week 0 and 4.
The primary endpoint is the induction of clinical remission at week 12 and patients will be continuously followed for efficacy and safety until 12 months after the first dose. Secondary endpoints include the induction of symptomatic remission (number of stools and blood in stools), induction of registration remission (clinical and endoscopic remission) and rate of colectomy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||131 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Placebo-controlled, Double-blind, Randomised Study to Assess the Efficacy and Safety of Cobitolimod as an add-on to Current Practice in Chronic Active Treatment Refractory Ulcerative Colitis Patients|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||March 2014|
2 doses 4 weeks apart
30 mg rectal dose at week 0 and 4
Other Name: DIMS0150, Kappaproct
Placebo Comparator: Placebo
2 doses 4 weeks apart
Rectal dose at week 0 and 4
- Induction of Clinical Remission [ Time Frame: Week 12 ]The induction of clinical remission at week 12, defined as a CAI score of ≤4.(Full Analysis Set)
- The Time to Colectomy [ Time Frame: Within 12 months ]Median time to colectomy after 1st dose.
- The Rate of Colectomy [ Time Frame: at 12 months ]Percentage of participants undergoing colectomy at 12 months after 1st dose.
- Steroid Free Remission at 12 Months [ Time Frame: at 12 months ]Percentage of participants with steroid free remission at 12 months after 1st dose.
- The Induction of Mucosal Healing [ Time Frame: Week 4 and 12 ]Percentage of participants with induction of mucosal healing, defined as an endoscopic score of 0 or 1, at week 4 and 12.
- The Induction of Symptomatic Remission [ Time Frame: Week 4, 12 ]Percentage of participants with induction of symptomatic remission, defined as subscores of blood in stool and number of stools weekly not exceeding 0 and 0 or 1, respectively, at week 4 and 12.
- The Induction of Registration Remission [ Time Frame: Week 4 and 12 ]Percentage of participants with induction of registration remission, defined as a CAI score of ≤4 and an endoscopic score of 0 or 1, at week 4 and 12.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493960
Show 37 Study Locations
|Principal Investigator:||Christopher Hawkey, MD||Nottingham Digestive Diseases Centre, Queens Campus University Hospitals, Nottingham, UK|