SHP647 long term extension for moderate to severe Ulcerative Colitis
Research type
Research Study
Full title
A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis (AIDA)
IRAS ID
235511
Contact name
Jeffrey Butterworth
Contact email
Sponsor organisation
Shire Human Genetic Therapies, Inc.
Eudract number
2017-000574-11
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 9 months, 30 days
Research summary
Research Summary:
Ulcerative colitis (UC) is a long lasting disease that causes swelling and ulcers on the inner lining of the large intestine. The most common symptoms are diarrhea with blood/ pus and abdominal 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. This study aims to see if SHP647 can keep UC symptoms under control and is safe for participants.
To take part in this study, participants must have been enrolled in one or more of these studies: SHP647-301, SHP647-302 or SHP647-303.
Treatment will depend on which treatment the participants had in their last study.
Participants will get one of the following treatments:
• Participants who completed the SHP647-303 study and were treated with SHP647 will stay on the same dose of SHP647 in this study (25 mg or 75 mg of SHP647).
• All other participants (who did not respond well in the SHP647-301, SHP647-302, or SHP647-303 studies or who completed the SHP647-303 study and were treated with placebo) will be treated with SHP647 in this study. The dose they get (25 mg or 75 mg) will be decided by chance (like rolling dice).
Participants will be given a diary to record their daily symptoms. Participants will get injections of SHP647 every 4 weeks. If they tolerate the study drug and respond well, they can stay in this study until one of the following happens: SHP647 becomes available commercially, the participant decides to withdraw, the study doctor/sponsor decides that it is in the best interest of the participant to withdraw, or the sponsor decides to close the study.
About 1114 participants are planned to be invited to take part in this study, with 20 being in the UK. Shire is the sponsor of this study.Summary of Results:
Efficacy Results:
For severe ulcerative colitis (UC) and Crohn’s disease (CD) subjects, when comparing the ontamalimab 25–75 mg treatment group and the 75 mg treatment group, there was little difference between study completion, mean duration, and treatment response. Overall, for any dose of ontamalimab, subjects with UC and CD were still exhibiting high treatment response at the end of the study and it would be expected that subjects would continue to respond at a high rate if treatment was continued.
Safety Results:
Overall, ontamalimab was found to be safe and well tolerated when administered at doses of
25 mg and 75 mg in subjects with moderate to severe UC or CD.
For subjects with UC, 3 deaths occurred during the study (coronavirus infection, bronchiectasis, and death [cause unknown]) and 82 (15.9%) subjects receiving any dose of ontamalimab reported treatment-emergent serious adverse events (SAEs).
For subjects with CD, 1 death occurred (death [cause unknown]) and 8 (19.5%) subjects receiving any dose of ontamalimab reported treatment-emergent SAEs
CONCLUSIONS:
Although efficacy was not formally evaluated in this study under Protocol Amendment 4, subjects with both UC and CD exhibited a treatment response during the course of the study.
In general, there was little difference between study completion, mean duration, and treatment response when comparing the ontamalimab 25–75 mg treatment group and the 75 mg treatment group. Overall, ontamalimab was found to be safe and well tolerated when administered at doses of 25 mg and 75 mg for both UC and CD subjects.REC name
South Central - Oxford B Research Ethics Committee
REC reference
17/SC/0652
Date of REC Opinion
6 Mar 2018
REC opinion
Further Information Favourable Opinion