SHP647 as induction therapy in moderate to severe Ulcerative Colitis
Research type
Research Study
Full title
A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)
IRAS ID
235509
Contact name
Jeffrey Butterworth
Contact email
Sponsor organisation
Shire Human Genetic Therapies, Inc.
Eudract number
2017-000599-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 7 days
Research summary
Ulcerative colitis (UC) is a long lasting disease that causes swelling and ulcers on the inner lining of the large intestine. The common symptoms are diarrhea with blood/pus and abdominal (belly) discomfort. Standard treatments for UC include aminosalicylates, glucocorticoids, immunosuppressants and biologics.
SHP647 binds to certain proteins in the gut to lessen swelling in the bowel. The aim of this study is to see if SHP647 can lessen UC symptoms and is safe for participants.
To take part in this study, participants must be between 16 and 80 years old, have moderate to severe active UC and have not responded well to standard treatments.
Participants will get 1 of 3 treatments by chance (like rolling dice). Participants will get injections under the skin of one of the following:
• SHP647 at a dose of 25 mg in 1 ml of liquid
• SHP647 at a dose of 75 mg in 1 ml of liquid
• placebo (looks like SHP647 but with no medicine in it).
UC disease activity will be checked by looking at UC symptoms and bowel endoscopy results. Participants will be in remission if the UC symptoms and bowel endoscopy results together improve up to a certain amount.
Safety will be checked by looking at side effects of SHP647 and placebo.
One blood sample from each participant will be banked. This may be tested if the participant shows signs of certain symptoms.
About 825 participants are planned to enrol in this study, with 31 of them being in the UK.
Each participant will make at least 8 visits to the clinic. Each participant will be in the study for ~4 ½ months if they switch to SHP647-303 or SHP647-304, or ~8 ½ months if they go into follow-up.
Shire is the sponsor of this study.REC name
South Central - Oxford B Research Ethics Committee
REC reference
17/SC/0650
Date of REC Opinion
7 Mar 2018
REC opinion
Further Information Favourable Opinion