SHP647 as an maintenance therapy for moderate-severe Crohn's disease
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 Crohn’s Disease (CARMEN CD 307)
IRAS ID
243674
Contact name
Matthew Brookes
Contact email
Sponsor organisation
Shire Human Genetic Therapies, Inc.
Eudract number
2017-000617-23
Duration of Study in the UK
4 years, 2 months, 2 days
Research summary
Summary of Research
Crohn’s Disease (CD) is a chronic, reoccurring disease that causes inflammation of the gut (gastrointestinal (GI) tract). The most common symptoms are abdominal (stomach) pain, diarrhoea and rectal bleeding. Standard treatments for CD include aminosalicylates, glucocorticoids, immunosuppressants, opiates and biologics.SHP647 binds to certain proteins in the gut to lessen inflammation. The aim of this study is to see if SHP647 is safe and can lessen CD symptoms.
To take part in this study, participants must be between 16 and 80 years old, have moderate to severe CD and have completed the 4 month induction treatment period from SHP647-305.
SHP647 will be given by injection under the skin.
Participants will get 1 of 3 treatments by chance (like rolling dice) of one of the following:
• SHP647 dose of 25 mg in 1 ml of liquid
• SHP647 dose of 75 mg in 1 ml of liquid
• Placebo (looks like SHP647 but with no medicine in it).
CD disease activity will be checked using the ‘Crohn’s disease activity index’ and with biopsy results. Participants will be in remission if both the CD symptoms and endoscopy results 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, related to brain function.
About 983 participants are planned to enrol in this study, with 15 of them enrolling in the UK.Each participant will make at least 14 study visits to the clinic over ~ 12 months. Each participant will continue into a 4 month safety follow-up period if they either discontinue treatment early or complete the treatment period and do not enter the long-term safety extension study.
Shire is the sponsor of this study.
Summary of Results
40 participants were treated in this study. This study helped researchers find out if ontamalimab could treat participants with Crohn's disease.
The participants were put into 1 of 3 study groups and received the below treatment for 52 weeks.
10 participants received Ontamalimab 25 mg
10 participants received Ontamalimab 75 mg
10 participants received Placebo (product that looks like the study medication but does not have any active medicine in it).Researchers wanted to see if participants with Crohn’s disease were in clinical remission (An average worst daily stomach pain of 3 or less and average of 2 or less bowel movements each day with a stool consistency of type 6 or 7) and if they had an endoscopic response at Week 52.
Below shows how many participants showed clinical remission at week 52:
3 participants (on the Ontamalimab 25 mg treatment arm) out of 10
5 participants out of 11 (on the Ontamalimab 25 mg treatment arm)
2 participants out of 19 (on placebo arm) showed clinical remission at week 52.In this study, endoscopic response meant that the SES-CD score decreased by at least 50% from the start of the previous study.
Below shows how many participants in each group had an endoscopic response at Week 52.
4 participants out of 10 (on the Ontamalimab 25 mg treatment arm)
6 participants out of 11 (on the Ontamalimab 25 mg treatment arm)
2 participants out of 19 (on placebo arm)REC name
South Central - Oxford B Research Ethics Committee
REC reference
18/SC/0430
Date of REC Opinion
28 Feb 2019
REC opinion
Further Information Favourable Opinion