Faculty, Staff and Student Publications
Language
English
Publication Date
6-1-2025
Journal
Journal of Scleroderma and Related Disorders
DOI
10.1177/23971983241278079
PMID
39544897
PMCID
PMC11559531
PubMedCentral® Posted Date
11-5-2024
PubMedCentral® Full Text Version
Post-print
Abstract
Objective: Safe, effective therapies are urgently needed for patients with systemic sclerosis. However, clinical trial recruitment is challenging given the limited number of people with systemic sclerosis and further restrictions imposed by eligibility criteria. Innovative approaches are needed to accelerate development of new therapies. This article describes the rationale and trial design for CONQUEST (NCT06195072), a novel platform clinical trial sponsored by the Scleroderma Research Foundation, a not-for-profit organization.
Methods: CONQUEST is a multicentre, double-blind, randomized, placebo-controlled, Phase 2b platform trial evaluating the efficacy, safety and pharmacodynamics of multiple investigational products to treat early active systemic sclerosis with interstitial lung disease versus placebo. The primary objective is to evaluate change from baseline to Week 52 in forced vital capacity (mL). Secondary objectives include evaluating changes from baseline to Week 52 in high-resolution computed-tomography-assessed lung involvement and dyspnoea, and overall treatment response (measured using the revised composite response index in diffuse systemic sclerosis score in participants with diffuse cutaneous systemic sclerosis).
Results: Patients will be enrolled across more than 150 centres in over 25 countries. Recruitment started on 15 April 2024.
Conclusion: As the first platform clinical trial in the rheumatology field, CONQUEST aims to meaningfully accelerate the development of new therapies for early active systemic sclerosis. Depending on regimen-specific results, trial data could be used to plan and design a Phase 3 trial or may be used alone or together with another registrational trial to establish substantial evidence of effectiveness and safety. The first molecules to be studied, amlitelimab and nerandomilast, both have a strong scientific rationale to modify underlying disease processes in systemic sclerosis.
Keywords
Systemic sclerosis, scleroderma, interstitial lung disease, platform trial, randomized clinical trial, study design, amlitelimab, nerandomilast
Published Open-Access
yes
Recommended Citation
Khanna, Dinesh; Evnin, Luke B; Assassi, Shervin; et al., "Design of Conquest, a Novel, Randomized, Placebo-Controlled, Phase 2b Platform Clinical Trial To Investigate New Treatments for Patients With Early Active Systemic Sclerosis With Interstitial Lung Disease" (2025). Faculty, Staff and Student Publications. 3539.
https://digitalcommons.library.tmc.edu/uthmed_docs/3539
Comments
ClinicalTrials.gov:
Platform Clinical Study for Conquering Scleroderma (CONQUEST); NCT06195072; https://www.clinicaltrials.gov/study/NCT06195072