The Goal of CONQUEST
First and foremost, the SRF expects to make an enduring contribution to the scleroderma community by creating an ecosystem designed to enable rapid and efficient development of novel drugs for scleroderma patients.
The long-term goal of CONQUEST is to continue to attract new drugs to the platform trial and create a continuous flow of potentially impactful new therapies for our rare autoimmune 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 SRF 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
In its initial iteration, CONQUEST will evaluate 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.
We are excited and honored to partner with Sanofi and another pharmaceutical company for the initiation of CONQUEST. These pharmaceutical leaders have investigational products in development for the treatment of conditions associated with inflammation and/or fibrosis.
More about CONQUEST.
The CONQUEST Steering Committee
Meet the people providing external oversight of CONQUEST.