Open-Label Extension Trial of RPC1063 in Relapsing Multiple Sclerosis
Research type
Research Study
Full title
A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis
IRAS ID
187983
Contact name
Basil Sharrack
Contact email
Sponsor organisation
Receptos, Inc.
Eudract number
2015-002500-91
Duration of Study in the UK
4 years, 1 months, 30 days
Research summary
This is an open-label extension trial of oral RPC1063 1mg. The study drug will be administered once daily to patients with relapsing multiple sclerosis (RMS) who have completed either of the randomised controlled trials RPC01-201 or RPC01-301 (the “parent trials”) and are eligible according to the enrolment criteria. The purpose of this study is to characterise whether RPC1063 is safe and tolerable and effective in patients with RMS in the long-term.
RPC1063 is an oral capsule medication that acts on the immune system by making certain types of white blood cells (lymphocytes including T cells) stay in the lymph nodes and other places in the body, keeping them away from sites of inflammation.Regardless of treatment assignment in the parent trial, patients will receive RPC1063 1 mg daily in the extension trial after a 7-day dose adjustment (0.25 mg on Days 1 to 4, 0.5 mg on Days 5 to 7, and 1 mg from Day 8 onward). Patients from the blinded extension of the RPC01-201 Part A trial will not require initial dose adjustment.
It is anticipated that approximately 2350 patients from North America, Europe,
South Africa, New Zealand, and Latin America may be eligible for enrolment in the trial depending on the completion of one of the parent trials. The study is being sponsored by Receptos, Inc.
Patients will receive RPC1063 at 1 mg/day until the end of trial, or until the Sponsor discontinues the development program.summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3Du001.QwnS5iG-2B4nwcunWxC03fkEPHC0LbJlX4PhbXmW-2Fy42RiFSMU1si2MAY-2Bdyv-2FUC5MPON29J9y-2FXnfonIYJcdQ6ElCuaPTxv954T9n6dWHgKzleKUyWD6KeYfCb0-2Bw8-2FCSoZQW_a04dWCHmDh7gi4hRuvmsd-2FMEDkPNm6D0IRdq0o1v81f-2FKhS9R8n0pYrJIZdQb5H3Syw1LQBOSsZdJUFblP2SOw8cUyy9346HmkW8A2DdF7zD98pthUGbXSW2R0Xq3OeCdi7ZXRmitcqkmAkTKkVLZM835Sk1xAAwSb6hEZHt7rA0u7adgsDs4XMIwhaeizOH82cIPhE9EySqeYTgd2zAdg-3D-3D&data=05%7C02%7Cleicestercentral.rec%40hra.nhs.uk%7Ca708da86ce8748d1a24f08dc391d102e%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638448044188703780%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=rmxKYaCBF6%2BxgGoKO1UlYWTYBzg2XpRNPLNqN54JzBg%3D&reserved=0
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
15/EM/0443
Date of REC Opinion
10 Nov 2015
REC opinion
Further Information Favourable Opinion