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

Dinesh Khanna; Luke B Evnin; Shervin Assassi; Wade W Benton; Gregory Gordon; Karina Maslova; Juergen Steffgen; Toby M Maher

doi:10.1177/23971983241278079

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

J Scleroderma Relat Disord. 2024 Nov 5:23971983241278079. doi: 10.1177/23971983241278079. Online ahead of print.

Authors

Dinesh Khanna¹, Luke B Evnin², Shervin Assassi³, Wade W Benton^{2

4}, Gregory Gordon², Karina Maslova⁵, Juergen Steffgen⁶, Toby M Maher^{7

8}

Affiliations

¹ Division of Rheumatology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
² Scleroderma Research Foundation, San Francisco, CA, USA.
³ Division of Rheumatology, Department of Internal Medicine, University of Texas Health Science Center at Houston, Houston, TX, USA.
⁴ Eicos Sciences, San Mateo, CA, USA.
⁵ Sanofi, Cambridge, MA, USA.
⁶ Therapeutic Area Inflammation Medicine, Boehringer Ingelheim International GmbH, Biberach, Germany.
⁷ Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
⁸ National Heart and Lung Institute, Imperial College London, London, UK.

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.

Clinicaltrialsgov: Platform Clinical Study for Conquering Scleroderma (CONQUEST); NCT06195072; https://www.clinicaltrials.gov/study/NCT06195072.

Keywords: Systemic sclerosis; amlitelimab; interstitial lung disease; nerandomilast; platform trial; randomized clinical trial; scleroderma; study design.

Associated data

ClinicalTrials.gov/NCT06195072