SHP647 as maintenance therapy for moderate-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 Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)
IRAS ID
235510
Contact name
Jeffrey Butterworth
Contact email
Sponsor organisation
Shire Human Genetic Therapies, Inc.
Eudract number
2017-000573-37
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 4 months, 17 days
Research summary
Summary of Research
Ulcerative colitis (UC) is a long lasting disease that causes swelling and ulcers on the inner lining of the large intestine (bowel). 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 keep UC symptoms under control and is safe for participants.
To take part in this study, participants must have shown a clinical response in either SHP647-301 or SHP647-302.
In this study, the treatment given will depend on which treatment participants had in the previous study.
The study treatment will be decided by chance (like rolling dice) as follows:
• Participants previously given 25 mg of SHP647 will get 25 mg SHP647 or placebo
• Participants previously given 75 mg of SHP647 will get 75 mg SHP647 or placebo
• Participants previously given placebo will get 1 of 3 treatments: 25 mg of SHP647, 75 mg of SHP647 or placebo.
Participants will get injections every 4 weeks for 52 weeks (13 injections). UC disease activity will be checked before, during and after treatment. Participants will stay in remission if the UC symptoms and bowel endoscopy results together improve to a certain amount.
Safety will be checked by looking at side effects of SHP647 and placebo.
After treatment, participants may enrol into a safety study (SHP647-304) or continue in this study for a 16-week follow-up.
About 772 participants are planned to be invited to take part in this study, with 14 of them being in the UK. Each participant will make at least 14 visits to the clinic.
Each participant will be in the study for up to 16 months.
Shire is the sponsor of this study.Summary of Results
"Ulcerative colitis, also called UC, is often a long-term condition where the large bowel, also called the colon, becomes inflamed. Doctors usually treat these patients by controlling their symptoms through changes in their diet or with medicine for loose stools. Sometimes, patients are also given medicine to reduce the inflammation. Currently, there are no medicines available that can fully control the symptoms of UC.
The medicine ontamalimab is an antibody that reduces the sticking of lymphocytes to the inflamed colon. Antibodies are your body’s way of fighting infection. A lymphocyte is a type of white blood cell that is part of your immune system.
In this study, researchers wanted to learn if ontamalimab could continue to control the symptoms of moderate to severe UC. The main aim of the study was to find out if ontamalimab could continue to control the symptoms of moderate to severe Ulcerative colitis. There were a total of 366 participants enrolled onto this study.To find the percentage of patients who had controlled symptoms, the researchers checked the symptoms of UC from the patient’s daily diaries and the colonoscopy results after 52 weeks of treatment.
The main study result for each patient was a number, also called a score. Each patient’s score combined information on their symptoms and their colonoscopy results. The lower the combined score, the better the control of inflammation of the colon and related symptoms of UC. In terms of results, the researchers looked at the results from the 312 patients who were given ontamalimab in the previous study or in this study (see results below). (Not include the 54 patients who were given placebo in the previous study).Below is shown percentage of patients with controlled symptoms:
The patients given ontamalimab 25 mg in the previous study and placebo in this study: 8% The patients given ontamalimab 25 mg in both studies: 54 % The patients given ontamalimab 75 mg in the previous study and placebo in this study: 13 %
The patients given ontamalimab 75 mg in both studies: 40%
Overall, after 52 weeks of treatment, the patients who were given ontamalimab had lower scores than the patients who were given placebo. This means that ontamalimab helped to control the inflammation of the colon and related symptoms of UC."REC name
South Central - Oxford B Research Ethics Committee
REC reference
17/SC/0651
Date of REC Opinion
7 Mar 2018
REC opinion
Further Information Favourable Opinion