IVA337 SSc POC
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis (DcSSc)
IRAS ID
183669
Contact name
Christopher Denton
Contact email
Sponsor organisation
Inventiva SAS
Eudract number
2015-001617-27
Duration of Study in the UK
2 years, 2 months, 0 days
Research summary
Systemic sclerosis (SSc), or scleroderma is a connective tissue disease of autoimmune origin. It is a life-threatening orphan disease with severe physical and psychosocial consequences. IVA337 has a novel mechanism of action and this study is designed to compare IVA337 at two dose levels with a placebo control treatment. Patients will be unaware of the treatment they are receiving and will be randomized to one of three treatment arms, twice daily intake of either IVA337 400mg, IVA600mg or placebo. They will receive drug for 48 weeks and during that time assessments will be made to monitor both the efficacy and safety of the treatment.
REC name
London - Harrow Research Ethics Committee
REC reference
15/LO/1244
Date of REC Opinion
16 Sep 2015
REC opinion
Further Information Favourable Opinion