CONCLUDE
Research type
Research Study
Full 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
IRAS ID
1004395
Contact name
Karin Arnesson
Contact email
Sponsor organisation
InDex Pharmaceuticals
Eudract number
2021-002549-13
Research summary
The CONCLUDE study.
Ulcerative Colitis (UC) is a disease characterised by chronic inflammation of the rectal and colonic lining. The disease is recurrent, with both active and inactive stages. The underlying cause of UC is not understood, nor is it known what triggers the disease to recur between its inactive and active forms.
Current therapy for UC includes the treatment of active disease and the maintenance of remission. Treatment of patients with active UC aims to reduce inflammation, promote colonic healing and mucosal recovery. In many cases the disease can be controlled with conventional drugs.
UC is often treated with 5-ASA and GCS. Maintenance treatment with GCS is not advised due to the risks associated with long-term use. In patients for whom GCS isn’t effective and who suffer from severe or moderately severe attacks of UC, drugs such as AZA/6-MP are sometimes used. However, these are slow-acting and induction of remission in these patients is often temporary. These treatments are now used less frequently than in the past due to their side-effects.
In the past few years, the number of drugs used to treat UC has increased. However, a significant proportion of patients do not respond to these treatments or lose response over time.
For patients with UC that has become refractory to medical management surgery might be the last option.
There is an ongoing unmet need for alternative safe and effective treatments.
Cobitolimod, is believed to modify or control the body’s own mucosal immune system and decrease the inflammation in the colon. It will be administered rectally using an enema.
The induction study will include 440 participants worldwide. Patients that respond to Cobitlimod during the induction study will continue for long term follow up, in total for 52 weeks.
The study is being sponsored by InDex Pharmaceuticals.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
22/NE/0015
Date of REC Opinion
10 Mar 2022
REC opinion
Further Information Unfavourable Opinion