GS-US-419-4015 Filgotinib in treatment of Small Bowel Crohn’s Disease

• Research type

  Research Study

• Full title

  A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease SBCD)

• IRAS ID

  220647

• Contact name

  John Paul Seenan

• Contact email

  johnpaul.seenan@nhs.net

• Sponsor organisation

  Gilead Sciences, Inc.

• Eudract number

  2016-003179-23

• Duration of Study in the UK

  0 years, 11 months, 21 days

• Research summary

  This is a A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD). Crohn's disease is an ongoing condition that causes inflammation of the digestive tract
  This study focuses on the involvement of Crohn’s Disease in the small bowel. The small bowel is part of the upper digestive tract that consists of sections called the duodenum, jejunum, and ileum. The purpose of this study is to see if filgotinib is effective and safe in treating people with small bowel Crohn’s disease. In this study, images obtained using Magnetic Resonance Enterography (MRE) will be used to score the severity of Crohn’s disease in the small intestine. Severity scores will be checked at the beginning and the end of the study. There will be no endoscopy (camera into the rectum or the mouth to look at the digestive tract) required for participation this study.

  It is open to men and women with Crohn’s disease who are between 18 to 75 years of age and meet the study requirements and it will take place in approximately 80 centres in North America and Europe. The study will last about 24 weeks,30 days screening visit, 24 weeks treatment period and 30 days post treatment visit and remove text regarding.

  The participants will be assigned to one of three treatment groups as described below. The participant and the doctor will not know what treatment group you are in:

  • Treatment 1: filgotinib 200 mg daily
  • Treatment 2: filgotinib 100mg daily
  • Treatment 3: placebo daily

  Crohn’s disease is a progressive and potentially life-threatening disease with few treatment options, many of which result in primary or secondary nonresponse. Inflammatory bowel disease may lead to increased risk of gastrointestinal malignancies, impairment in quality of life, and ultimate need for life-altering surgery.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  17/SC/0165

• Date of REC Opinion

  25 Apr 2017

• REC opinion

  Favourable Opinion