APD334-202: Etrasimod Efficacy & Safety in Crohn's Disease
Research type
Research Study
Full title
A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease
IRAS ID
277777
Contact name
Dr Christian Selinger
Contact email
Sponsor organisation
Arena Pharmaceuticals, Inc.
Eudract number
2019-002895-14
Duration of Study in the UK
2 years, 5 months, 13 days
Research summary
Crohn's Disease is a life-long condition, which causes widespread inflammation (pain, swelling, and redness) of the digestive system (mouth, stomach, and intestines) caused by an over-reaction of the immune system (the body’s defence system, which fights infection). 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 include anti-inflammatory medication and biologic medications, these may help improve CD symptoms for some, but not for others. For some patients, existing treatments may help at first, but the symptoms may return. CD is not considered to be curable. There remains a need to develop and find new safe and effective treatments for patients with CD.
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 cells 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 CD symptoms.
In this study there are 2 treatment periods, a 14-week induction period, in which etrasimod or placebo will be given to participants aged 18-80 years old with moderately to severely active CD who have not responded to CD therapy, responded to CD therapy at first but are no longer responding, or could not tolerate available CD therapies. After the induction period participants may enter the 52-week extension period where they will receive either 2 mg or 3 mg etrasimod. During the study neither the doctor nor the participant will know whether they are receiving etrasimod or placebo. Participants will be assigned to receive etrasimod by chance.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
20/SC/0123
Date of REC Opinion
5 Aug 2020
REC opinion
Further Information Favourable Opinion