Proof-of-concept Trial of IVA337 in Diffuse Cutaneous Systemic Sclerosis
Status:
Completed
Trial end date:
2018-10-12
Target enrollment:
Participant gender:
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 , either IVA337 400mg
bid, IVA337 600mg bid or placebo bid. 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.