San Francisco, CA (June 25, 2024)—CONQUEST, a highly innovative platform clinical trial conceived of and led by the Scleroderma Research Foundation (SRF) and designed to rapidly advance promising treatments for scleroderma, is now enrolling patients at centers across the US. Patients can now enroll at sites in the United States, which can be found online at conquestssc-trial.org. The SRF developed CONQUEST with input from expert scleroderma clinicians and insights from potential partners, including inaugural participants, Sanofi and Boehringer Ingelheim. The first patient entered the study in April 2024, and now the groundbreaking effort is rapidly expanding, with CONQUEST trial sites opening across the US and plans for more in over 30 countries.
“With a long history of supporting innovative research, the Scleroderma Research Foundation is uniting the global community. By establishing a network of high-performing centers, and with the vital participation of people living with this disease, we can accelerate efforts to advance novel therapies for treating scleroderma,” said Dr. Gregory Gordon, Chief Medical Officer of the SRF. “We look forward to how CONQUEST will benefit the scleroderma community by enabling the successful development of new drugs. This groundbreaking effort is a testament to our unwavering commitment to ultimately find a cure for this disease, and it would not be possible without the dedicated patients who join us as clinical trial participants.”
Ramping up globally, 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. The anticipated geographic distribution of the patients enrolled is approximately a third from each of Europe and the United States, with the remainder enrolling elsewhere in the world.
This milestone highlights the SRF’s contributions to Scleroderma Awareness Month, a now-global initiative in June dedicated to raising awareness about scleroderma. The first ever Scleroderma Awareness Month was established by the US Congress in 1992, after the successful lobbying of SRF-Founder Sharon Monsky.
The CONQUEST global footprint is expected to include sites in Argentina, Australia, Austria, Belgium, Canada, Chile, China, Denmark, France, Germany, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, South Korea, Spain, Switzerland, Taiwan, Thailand, the United Kingdom, as well as the United States. Other countries may be considered as the trial progresses. Utilizing the platform design of the CONQUEST study, future iterations are expected to add new experimental treatments continuously.
For more information about how patients can enroll in 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:
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- 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, aims to enroll patients across more than 150 centers in more than 30 countries. CONQUEST allows multiple therapies to be evaluated under a common trial infrastructure with a common control arm.
CONQUEST will initially enroll approximately 430 patients but with the advantages of the platform design, only approximately 145 patients will be randomized to the placebo arm (to receive standard-of-care). Accordingly, the design 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. Sanofi and Boehringer Ingelheim are the inaugural partners for CONQUEST, which was first announced on August 1, 2023.
