255NP101: Phase 1b study of BIIB095 and BIIB074
Research type
Research Study
Full title
A Phase 1b, Randomized, Double-Blind, Parallel, Placebo- and Active-Controlled, Pharmacodynamic Study of BIIB095 and BIIB074 in Healthy Participants and Participants With Painful Diabetic Polyneuropathy
IRAS ID
272590
Contact name
Dr Jorg Taubel
Contact email
Sponsor organisation
Biogen Idec Research Limited
Eudract number
2019-001900-39
Duration of Study in the UK
1 years, 2 months, 14 days
Research summary
This is a phase 1b clinical trial of 175 adults aged 18 to 65 years who are either healthy volunteers or volunteers with painful diabetic polyneuropathy. Diabetic polyneuropathy is a type of pain from nerve damage that is caused by uncontrolled high blood sugar in people who have diabetes. The study is being run at two UK sites.
The study drug, BIIB095 being tested in part A of the study has been designed to block pain signals in the body. It is hoped that this can help to reduce the pain in people with painful diabetic polyneuropathy.
BIIB095 will be compared with a placebo and an active control called lidocaine. A placebo looks the same as the study drug but does not contain any active ingredients. Lidocaine is an approved pain medication that blocks pain by numbing an area.
Healthy participants or participants with painful diabetic polyneuropathy, will be randomly assigned (by chance) to one of the following groups:
• Groups 1 and 6: 50 mg study drug twice a day
• Groups 2 and 7: 150 mg study drug twice a day
• Groups 3 and 8: 300 mg study drug twice a day
• Groups 4 and 9: placebo twice a day
• Groups 5 and 10: lidocaine (given once)This study is ‘double-blinded’, which means that neither the participant or the study doctor will know who is receiving the study drug or placebo. Lidocaine will be given as an injection and without blinding.
If a participant is randomised to either study drug or placebo, they will take the study medication as capsules by mouth for 8 days.
Study duration will be approximately 43 days which consists of a screening period (up to 21 days), study treatment period (up to 8 days) and follow-up period (up to 14 days).
REC name
North East - York Research Ethics Committee
REC reference
19/NE/0333
Date of REC Opinion
5 Dec 2019
REC opinion
Further Information Favourable Opinion