Groundbreaking clinical study recently launched to accelerate clinical development of new treatments for scleroderma
Journal of Scleroderma and Related Disorders outlines protocol and rationale for two initial investigational drugs
San Francisco, CA (November 7, 2024)— The Scleroderma Research Foundation (SRF) today announced the publication of a peer-reviewed article detailing the design of CONQUEST, a highly innovative platform clinical study aimed at accelerating the development of new therapies for systemic sclerosis, also known as scleroderma. The article, which outlines the innovative trial design and methodology, appears in the latest issue of the Journal of Scleroderma and Related Disorders.
CONQUEST represents the first platform trial in rheumatology, adapting an approach pioneered in oncology to test multiple investigational drugs simultaneously. CONQUEST, focuses on early, active systemic sclerosis with interstitial lung disease (SSc-ILD), a serious complication that is the leading cause of death in scleroderma.
“The launch of the CONQUEST trial marks a significant milestone in our efforts to advance scleroderma research,” said Dr. Luke Evnin, Chairman of the Board for the SRF. “And, we are very pleased that the Journal of Scleroderma and Related Disorders is publishing this manuscript allowing us to share the highly innovative design that underscores the potential of CONQUEST to accelerate the development of novel therapies for this challenging disease.”
The article details key features of CONQUEST, including its ability to test multiple investigational products in parallel and sequentially, with a shared placebo group that reduces the number of patients needed. It also describes the trial’s global scope, involving over 150 sites in more than 30 countries, and its perpetual design allowing new treatments to be added over time. The first two investigational therapies being studied in CONQUEST are amlitelimab and nerandomilast.
The SRF developed CONQUEST with input from expert scleroderma clinicians and insights from potential partners, including inaugural participants, Sanofi and Boehringer Ingelheim. Recruitment for CONQUEST began in April 2024. The SRF will oversee the effort to enroll over 430 patients throughout the first iteration of this trial, with approximately two-thirds of these patients on active trial therapy.
For more information about CONQUEST, visit conquestssc-trial.org.
About the Scleroderma Research Foundation
The Scleroderma Research Foundation (SRF), a 501(c)(3) organization, was established in 1987 with a mission to fund and facilitate the most promising, highest-quality research aimed at new treatments and, ultimately, a cure for scleroderma. Led by a Scientific Advisory Board composed of some of the most highly regarded scientists in the nation, the SRF’s research program actively seeks out the leading scientific minds from disparate fields including autoimmunity, immunology, genetics, and fibrosis to join the scleroderma research community. In addition to its core research program, the SRF recently announced the initiation of CONQUEST, a global platform clinical trial. The SRF has also led the formation of two other large-scale projects aimed at accelerating scleroderma research:
- CONQUER, the first nationwide longitudinal registry for scleroderma patients, and
- The GRASP Project, a research initiative designed to characterize the unique clinical characteristics and genetics of scleroderma in the African American community.
The SRF is also dedicated to educating people living with scleroderma and their caregivers as they learn how to manage the challenges of the disease.
About CONQUEST
Building off an innovation first implemented over a decade ago to accelerate oncology drug development, the Scleroderma Research Foundation (SRF) platform clinical trial is the first of its kind in rare autoimmune diseases. In its initial iteration, CONQUEST will focus on early progressive scleroderma by enrolling those patients with evidence of interstitial lung disease secondary to scleroderma (SSc-ILD). In the future, the CONQUEST platform may be expanded to address other manifestations of scleroderma. The ground-breaking effort, conceived and led by the SRF, is very patient-centric since patients generally enroll in a trial to get access to novel medicines. However, the trial retains high statistical power for analysis of efficacy endpoints since the data from the placebo patients from all concurrently enrolled sub-protocols (e.g. Sanofi and Boehringer Ingelheim) will be pooled for efficacy analysis.
This efficiency is not available in traditional trials and is one of the features that underscore the uniqueness of CONQUEST. By assembling a global network of high-performing centers that are dedicated to treating scleroderma, the SRF, and its pharmaceutical partners expect to make enduring contributions to the scleroderma community by creating an ecosystem designed to enable success in new drug development.
