Galarisso
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered GLPG3667 once daily for 24 weeks in adult subjects with dermatomyositis
IRAS ID
1006552
Contact name
Ann Fieuw
Contact email
Sponsor organisation
Galapagos
Research summary
An inflammatory disease called dermatomyositis affects the skin and muscles, and sometimes other organs. This research study is testing whether an experimental (not yet approved) drug called GLPG3667 (study drug) helps to treat dermatomyositis and is safe to use.
Adult subjects with dermatomyositis who demonstrate failure to, or intolerance of first-line treatment for dermatomyositis will be eligible to participate if they meet the inclusion criteria and none of the exclusion criteria as listed in the study protocol. Approximately 62 participants will be included in the study, which will last for approximately 32 weeks.
For participants on the study, there is a one in two chance participants will receive study drug or placebo. The study drug is taken orally with food. The study drug will be provided in the form of capsules. Each capsules will contain 75 mg GLPG3667 in it. Two capsules will be taken daily to provide 150 mg study drug for 24 weeks of treatment.
The study consists of three periods: screening (4 weeks), treatment (24 weeks with 8 visits) and safety follow-up (4 weeks after final study drug administration). After screening, visits begin on day 1 of treatment and, with the exception of visits 2 and 3 which are 2 weeks apart, will occur every 4 weeks. Visits during treatment will last approximately 2-2.5 hours with the exception of the week 4 visit where more blood samples are required. In total, approximately 375 mL of blood will be taken over the entire study. For reference, when donating blood, approximately 450 mL is taken at one time.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0458
Date of REC Opinion
29 Jun 2023
REC opinion
Further Information Favourable Opinion