CONQUEST
Research type
Research Study
Full title
Platform Clinical Study for Conquering Scleroderma: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2b Platform Clinical Study to Evaluate the Safety and Efficacy of Investigational Products in Participants with Interstitial Lung Disease Secondary to Systemic Sclerosis (CONQUEST)
IRAS ID
1008913
Contact name
Melanie Milde
Contact email
Sponsor organisation
Scleroderma Research Foundation
Eudract number
2023-507129-40
Clinicaltrials.gov Identifier
Research summary
Systemic sclerosis (or SSc) is a rare autoimmune disorder causing the tightening and hardening of the skin and internal organs. Interstitial lung disease (ILD) is characterised by inflammation and progressive fibrosis in the lung tissue. ILD is a common manifestation of SSc that tends to occur early in the disease process and is the leading cause of death in SSc.
Currently, patients with SSc-ILD have a poor prognosis and there is a lack of meaningful effective therapies available that improve how the patient feels, functions and lives. Recent research has resulted in several IPs with potential use in SSc-ILD to meet this need.
This is a Phase 2b, double blind, multicentre, randomised, placebo-controlled platform study to evaluate the safety and efficacy of investigational products (IP) in participants with SSc-ILD. This study will investigate multiple IPs in parallel with the capability to adapt over time. The IPs will be tested under the same general study design with participants randomly assigned to different “treatment regimens” for the different IPs.
Currently, there are two treatment regimens available:
• Amlitelimab – an investigational monoclonal antibody being developed for immune-mediated diseases. It works by binding to a protein involved in the function of certain cells in the immune system. By interrupting how these cells works, it is hoped that it will stop the process causing ILD in these participants.
• BI 1015550 – an investigational drug being developed for the treatment of various inflammatory disorders. It works by inhibiting a protein involved in the growth of cells that cause fibrosis.Approximately 430 eligible participants will be enrolled globally. The total duration for participation is approximately 60 weeks (including screening and follow-up period).
The study is sponsored by Scleroderma Research Foundation Inc.
REC name
London - Brent Research Ethics Committee
REC reference
24/LO/0408
Date of REC Opinion
17 Jun 2024
REC opinion
Further Information Favourable Opinion