NCT02503644

Proof-of-concept Trial of IVA337 in Diffuse Cutaneous Systemic Sclerosis

A Randomized, Double-blind, Placebo-controlled, Multicentre Proof-of-concept Trial of IVA337 in the Treatment of Diffuse Cutaneous Systemic Sclerosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Inventiva Pharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study design: randomized, double-blind, placebo-controlled, multicentre phase 2 proof-of-concept trial of IVA337 for the treatment DcSSc. The treatments are randomly assigned. The randomisation is stratified for background therapy to ensure even distribution of background therapies among treatment groups. There are 3 parallel treatment groups: placebo, IVA337 400mg bid and IVA337 600mg bid (identical capsules of 200mg IVA337 or placebo). Both, patient and investigator are blinded. The treatment lasts 48 weeks. A follow-up assessment takes place 4 weeks after the last dose.

Conditions

• Scleroderma, Diffuse
• Diffuse Cutaneous Systemic Sclerosis

Interventions

Type	Name	Description
DRUG	IVA337	Capsules of 200mg IVA337
DRUG	Placebo	Identical capsules without active substance

Timeline

• Start date: 2015-10-29
• Primary completion: 2018-10-01
• Completion: 2018-10-12
• First posted: 2015-07-21
• Last updated: 2019-03-04

Locations

49 sites across 10 countries: Bulgaria, France, Germany, Italy, Netherlands, Poland, Slovenia, Spain, Switzerland, United Kingdom