APD334003_ OASIS_Version 1
Research type
Research Study
Full title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis
IRAS ID
184353
Contact name
James Lindsay
Contact email
Sponsor organisation
Arena Pharmaceuticals, Inc.
Eudract number
2015-001942-28
Duration of Study in the UK
0 years, 10 months, 14 days
Research summary
The purpose of this study is to find out about the safety and efficacy of APD334 for the treatment of moderately to severely active ulcerative colitis. APD334 is an experimental drug which has not yet been approved by Health Authorities including the MHRA (Medicines and Healthcare Products Regulatory Agency) for the treatment of moderately or severely active ulcerative colitis.
APD334 is being investigated to treat so-called autoimmune diseases, specifically inflammatory bowel diseases such as ulcerative colitis. APD334 is an oral drug (tablet or capsule) aimed to reduce the inflammation in the gut in patients with moderately to severely active ulcerative colitis.REC name
London - South East Research Ethics Committee
REC reference
15/LO/1876
Date of REC Opinion
12 Jan 2016
REC opinion
Further Information Favourable Opinion