CONQUEST Trials
Driving Therapeutic Discovery
CONQUEST Trials
Driving Therapeutic Discovery
Mobilizing a global network to accelerate therapeutic discoveries
CONQUEST is a global, perpetual, platform clinical trial developed by the Scleroderma Research Foundation (SRF) in coordination with partner biopharmaceutical companies to accelerate the clinical development of agents for scleroderma.
Through CONQUEST, the SRF has galvanized a collaboration like no scleroderma nonprofit has before, uniting researchers across five continents in a coordinated effort to find better treatments.
About CONQUEST
CONQUEST is a highly innovative platform clinical trial developed by the Scleroderma Research Foundation (SRF). CONQUEST is designed to rapidly advance promising treatments for scleroderma and to identify those agents that should progress from phase 2b to phase 3 clinical trials.
To date, there have been only modest therapeutic advances for scleroderma. However, several emerging therapies have the potential to address autoimmunity and fibrosis—hallmark features of scleroderma. Therefore, the rationale for testing many of these agents in scleroderma is strong. CONQUEST arrives at the right time to support pharmaceutical companies considering scleroderma as a lead indication.
CONQUEST is based on a model first created over a decade ago to accelerate oncology drug development. This international, multicenter, randomized, double-blind, placebo-controlled, phase 2 platform clinical trial is the first of its kind in rare autoimmune diseases.
At this stage, the primary objective of CONQUEST is to rapidly evaluate potential treatments for interstitial lung disease associated with systemic sclerosis (SSc-ILD). Secondary objectives include global SSc outcomes, including some focused on skin and other aspects of the disease.
CONQUEST’s Design: How It Works and Why It Is Unique
CONQUEST allows multiple therapies to be evaluated under a common trial infrastructure with a common control arm.
CONQUEST sets up an innovative “infrastructure” to bring multiple phase 2-ready drugs into clinical development, sharing a network of aligned trial centers, for which initiation and implementation requirements have already been met. This efficiency is not available in traditional trials and are the features that underscore its “unique-ness.”
CONQUEST Conceptual Study Design
International, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2b Platform Clinical Trial
How CONQUEST’s protocol accelerates the clinical trial process
CONQUEST uses a master protocol that provides a regulatory framework to study multiple potential treatments for scleroderma. Like other platform trials, this provides multiple efficiencies not available in traditional clinical trial protocols, including:
- New agents may enter and leave CONQUEST without halting patient enrollment or resubmitting the entire clinical trial protocol for regulatory review
- The trial infrastructure is built once but remains open with substantial efficiencies for each cycle and enabling knowledge gained to improve the trial over time
- A common control group is enrolled that serves multiple experimental arms
Benefits to All Stakeholders
CONQUEST provides a win-win for all stakeholders—patients, physicians, and innovators—as compared to conventional trials.
- Smaller sample sizes
- Fewer patients on placebo
- Reduced costs
- Better inferences for regulators
- Ability to share the accumulated learnings across the entire scleroderma research community
- Reduced time to complete trial and faster timelines to data
- Efficient start-up: time and effort required to set up a new regimen; sites opened ONCE
- High-quality execution – best sites retained
- Network of selected investigators and sites, uniformity of data collection, monitoring, recruitment, retention strategies, and other shared services
- Sample size savings from shared controls across concurrent regimens
- Reduced number of patients on placebo → a win for patients
- Reduced costs of trial (fewer total patients required)
- Better disease learning
- Community owns the placebo data and samples and learnings from each “cycle,” enabling iterative improvements
The SRF’s Role in CONQUEST
The Scleroderma Research Foundation serves as the sponsor of the FDA-approved investigational new drug application (IND) overseeing a highly accomplished global contract research organization (CRO) to execute the trial.
CONQUEST oversight activities will be managed by an internal team of 5-8 experienced clinical development professionals. This SRF team works closely in partnership with the pharmaceutical companies that have agreed to put their phase 2-ready investigational agents/drugs into CONQUEST. External oversight of CONQUEST is provided by the CONQUEST Steering Committee and the CONQUEST Data Monitoring Committee.
How Data Are Shared
As the investigational drugs move through phase 2b, and outcomes data are collected, SRF works closely with its pharmaceutical partners to disseminate news about the outcome(s) with a given investigational drug.
Data sharing is extremely important to us. Beyond the proprietary data, the SRF will own the data from the placebo patients, and we believe these data will be an important component of a growing asset base that has the potential to identify and accelerate novel therapies for scleroderma.
The Inaugural Iteration of CONQUEST
Product Focus
In its initial iteration, CONQUEST is evaluating the safety and efficacy of investigational products focused on interstitial lung disease associated with systemic sclerosis (SSc-ILD), one of the most life-threatening complications of the disease. In the future, CONQUEST will be expanded to address other manifestations of scleroderma.
Pharmaceutical Partners
We are excited and honored to partner with Sanofi and Boehringer Ingleheim for the initiation of CONQUEST. These pharmaceutical leaders have investigational products in development for the treatment of conditions associated with inflammation and/or fibrosis.
CONQUEST, a Platform Clinical Trial (2023)
Get acquainted with CONQUEST, an innovative platform trial designed to rapidly evaluate promising treatments for scleroderma-associated lung disease.
The CONQUEST Steering Committee – A Trial Guided by Experts in the Field
To ensure that CONQUEST meets the highest standards of quality, the Scleroderma Research Foundation has assembled an expert team to guide and implement this innovative trial.
Dinesh Khanna, MD, MSc, Co-Chair
University of Michigan School of Medicine
Toby Maher, MD, PhD, Co-Chair
Keck School of Medicine, University of Southern California
Yannick Allanore, MD, PhD
Hôpital Cochin
Shervin Assassi, MD, MS
McGovern Medical School, UTHealth Houston
Murray Baron, MD
Jewish General Hospital/McGill University
Elana Bernstein, MD
Columbia University
Vincent Cottin, MD, PhD
Louis Pradel University Hospital/Claude Bernard University
Francesco del Galdo, MD, PhD
University of Leeds
Christopher Denton, PhD
Royal Free Hospital/University College London
Jeska de Vries-Bouwstra, MD, PhD
Leiden University Medical Centre
Oliver Distler, MD
University Hospital Zurich
Tracy Frech, MD, MS
Vanderbilt Health
Jessica Gordon, MD
Hospital for Special Surgery
Kristin Highland, MD
Cleveland Clinic
Anna-Maria Hoffmann-Vold, MD, PhD
Oslo University Hospital
Laura Hummers, MD
Johns Hopkins Medicine
Yasuhiro Kondoh, MD, PhD
Aichi Medical University
Masataka Kuwana, MD, PhD
Nippon Medical School
Marco Matucci-Cerinic, MD, PhD
Careggi University Hospital/University of Florence
Virginia Steen, MD
Georgetown University Medical Center
Luke Evnin, PhD, SRF representative non-voting member
Scleroderma Research Foundation
Greg Gordon, MD, JD, Non-voting member
Scleroderma Research Foundation, CONQUEST Study Team
CONQUEST FAQs
Medpace, Inc is the CRO that will execute CONQUEST.
Learn more about Medpace here. – https://www.medpace.com/
As the investigational drugs move through phase 2b, and outcomes data are collected, the Scleroderma Research Foundation (SRF) will work closely with its pharmaceutical partners to disseminate news about the outcome(s) with a given investigational drug. Data sharing is extremely important to us. Beyond the proprietary data, the SRF will own the data from the placebo patients, and we believe these data will be an important component of a growing asset base that has the potential to identify and accelerate novel therapies for scleroderma.
Scleroderma manifests in patients with many different types of additional physiologic disorders. So, there are other indications for which the platform may be relevant beyond SSc-ILD. We are actively considering additional protocols to address other disease manifestations. Further afield, CONQUEST’s design may also be relevant outside scleroderma, and we are happy to share our learnings outside of our disease community to support other rare disease communities.
As the investigational drugs move through phase 2b, and outcomes data are collected, the Scleroderma Research Foundation (SRF) will work closely with its pharmaceutical partners to disseminate news about the outcome(s) with a given investigational drug. Data sharing is extremely important to us. Beyond the proprietary data, the SRF will own the data from the placebo patients, and we believe these data will be an important component of a growing asset base that has the potential to identify and accelerate novel therapies for scleroderma.
The Scleroderma Research Foundation (SRF) was founded to fund and facilitate the most promising, highest quality research aimed at improved therapies and, ultimately, a cure for scleroderma. We are the country’s first and leading nonprofit investor in medical research into scleroderma.
CONQUEST is a highly innovative platform clinical trial developed by the SRF. The SRF serves as the sponsor of the FDA-approved investigational new drug application (IND).
CONQUEST oversight activities are managed by an internal team of 5-8 experienced clinical development professionals. This SRF team works closely in partnership with the pharmaceutical companies that have agreed to put their phase 2-ready investigational agents/drugs into CONQUEST. External oversight of CONQUEST is provided by the CONQUEST Steering Committee and the CONQUEST Data Monitoring Committee.
The SRF would support its pharmaceutical partners’ efforts to present their data from the CONQUEST trial, as requested.
No, this is NOT a revenue generating program per se. However, the SRF does collect a modest overhead charge to offset its internal costs for administrative oversight of CONQUEST and to support the expansion of future trials.
For Media inquiries, Hannah Young: hannah@sclerodermaresearch.org
For CONQUEST inquiries: info@conquestssc.org
For all other inquiries: info@sclerodermaresearch.org
CONQUEST in The News
Contact Information
Please email info@conquestssc.org.