CULTIVATE
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease
IRAS ID
1003607
Contact name
Tracy Angelly
Contact email
Sponsor organisation
Arena Pharmaceuticals Inc.
Eudract number
2020-004775-40
Research summary
Crohn's Disease (CD) is a life-long condition, which causes widespread inflammation of the digestive system caused by an over-reaction of the immune system. The most common symptoms are diarrhoea, abdominal cramps, blood in the stool, weight loss, and tiredness. Current treatments aim to relieve symptoms, improve inflammation and quality of life, and prevent complications that require hospitalisation. Current treatments may help improve CD symptoms for some, but not for others. CD is not considered curable and there remains a need to develop and find new safe and effective treatments.
The purpose of this study is to assess a potential new treatment for CD, etrasimod. Etrasimod is designed to block the movement of a type of white blood cell in the body (part of the immune system called “lymphocytes”) to areas of inflammation in the digestive system. It is hoped that etrasimod may reduce inflammation in the digestive system, thereby improving the symptoms of CD.
This study is contains five "sub-studies":
Sub-study A (Phase 2) will investigate the safety, tolerability, and efficacy of two different doses of etrasimod in participants with moderate to severe CD.
Sub-study 1 (Phase 2B) will investigate how the two different doses of etrasimod compare to a placebo in participants with moderate to severe CD. This sub-study will also allow the researchers to select the dose of etrasimod for future sub-studies ("chosen dose").
Sub-study 2 (Phase 3) will investigate how the "chosen dose" of etrasimod performs compared to a placebo over a 14-week induction period. It is anticipated that 14-weeks is the duration of time required for etrasimod to show improvements in patients with CD.
Sub-study 3 (Phase 3) will investigate how the "chosen dose" of etrasimod performs compared to a placebo over a 38-week "maintenance" period.
Sub-study 4 (Phase 3) will investigate the long-term safety and efficacy of etrasimod.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
21/LO/0422
Date of REC Opinion
12 Aug 2021
REC opinion
Further Information Favourable Opinion