Scleroderma Research Foundation (SRF) Launches Conquest Trial Platform

The Scleroderma Research Foundation (SRF) has announced that Sanofi will contribute the first experimental agent to CONQUEST, a clinical trial platform created by the SRF. The platform is designed to advance treatments for scleroderma and to identify those agents that should progress from Phase IIb to Phase II clinical trials.

In its initial iteration, CONQUEST will focus on Interstitial Lung Disease secondary to Scleroderma (SSc-ILD). In the future, the CONQUEST platform will be expanded to address other manifestations of scleroderma.

This effort, conceived and led by the SRF, will enroll patients across more than 130 centers in more than 22 countries. CONQUEST offers advantages to all stakeholders—patients, physician, and drug innovators—and provides for a transition to a global Phase III trial, investigation of a drug’s activity in a wide range of genetic backgrounds, as well as patient enrollment.

CONQUEST uses a master protocol that provides a regulatory framework to study multiple potential treatments for scleroderma. Some of its features include:

• New agents may enter and leave the platform without halting patient enrollment or resubmitting the entire clinical trial protocol for regulatory review.
• The trial infrastructure is built once but remains open with efficiencies for each cycle.
• A common control group is enrolled that serves multiple experimental arms.

The CONQUEST Therapy Evaluation Committee, comprised of expert scleroderma clinicians and scientists, selected from a range of possible treatments for the inaugural run of the CONQUEST platform. The SRF anticipates that treatments will be added to the CONQUEST Platform Trial and is in active discussions with academic and industry partners for the next round of CONQUEST. Nominations of therapies for inclusion in the platform trial will continue on an ongoing, rolling basis.

The first iteration of CONQUEST is designed to include two innovative drugs including one from Sanofi. CONQUEST represents the first time this drug will be evaluated in scleroderma patients, but it has been evaluated in related diseases in early-stage clinical trials. The initial run of CONQUEST is expected to enroll approximately 400 patients and trial initiation is targeted for Q4 2023. The primary endpoint as measured at 52 weeks is forced vital capacity (FVC), the total volume of air that can be exhaled during a maximal forced expiration effort.

Reference

The Scleroderma Research Foundation (SRF) Launches Conquest Trial Platform to Address Critical Issues in Clinical Development and Enable Advances in Scleroderma Therapeutics. (2023, August 1). Business Wire.