MedTrace Logo

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

NCT02503644 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2019-03-04

No results posted yet for this study

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.

Conditions

  • Scleroderma, Diffuse
  • Diffuse Cutaneous Systemic Sclerosis

Interventions

DRUG

IVA337

Capsules of 200mg IVA337

DRUG

Placebo

Identical capsules without active substance

Sponsors & Collaborators

  • Inventiva Pharma

    lead INDUSTRY

Principal Investigators

  • Yannick Allanore, Professor · Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM, Paris, France,

  • Christopher Denton, Professor · Royal Free Hospital NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-29
Primary Completion
2018-10-31
Completion
2018-10-12

Countries

  • Bulgaria
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Slovenia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02503644 on ClinicalTrials.gov