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.

Autor:	Khanna D; Division of Rheumatology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA., Evnin LB; Scleroderma Research Foundation, San Francisco, CA, USA., Assassi S; Division of Rheumatology, Department of Internal Medicine, University of Texas Health Science Center at Houston, Houston, TX, USA., Benton WW; Scleroderma Research Foundation, San Francisco, CA, USA.; Eicos Sciences, San Mateo, CA, USA., Gordon G; Scleroderma Research Foundation, San Francisco, CA, USA., Maslova K; Sanofi, Cambridge, MA, USA., Steffgen J; Therapeutic Area Inflammation Medicine, Boehringer Ingelheim International GmbH, Biberach, Germany., Maher TM; Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.; National Heart and Lung Institute, Imperial College London, London, UK.
Jazyk:	angličtina
Zdroj:	Journal of scleroderma and related disorders [J Scleroderma Relat Disord] 2024 Nov 05, pp. 23971983241278079. Date of Electronic Publication: 2024 Nov 05.
DOI:	10.1177/23971983241278079
Abstrakt:	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. Competing Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship and/or publication of this article: D.K., via his institution, has received industry-academic funding from Boehringer Ingelheim, BMS, Merck and GlaxoSmithKline R&D; and consultancy fees and/or on Scientific Advisory Board from AbbVie, Amgen, Argenx, AstraZeneca, Boehringer Ingelheim, BMS, Galapagos, GlaxoSmithKline, Merck, Mirador, Mitsubishi Tanabe Pharma Corporation, Novartis, Roche, Sanofi-Aventis and Zura Bio. L.B.E. currently represents MPM Capital on the Board of Directors for each of Photys Therapeutics, Trishula Therapeutics, Frontier Medicines, Redona Therapeutics and Umoja Biopharma. He is Chairman of the Board of Werewolf Therapeutics and owns stock in Eicos Sciences, an affiliate of CiVi Biopharma. S.A. declares grant support to his institution from Scleroderma Research Foundation, Boehringer Ingelheim, aTyr and Janssen, as well as personal consultancy fees from AbbVie, aTyr, AstraZeneca, Boehringer Ingelheim, CSL Behring and Merck. W.W.B. is a paid consultant of the Scleroderma Research Foundation. G.G. is an employee of the Scleroderma Research Foundation. K.M. is an employee of Sanofi. J.S. is an employee of Boehringer Ingelheim. T.M.M., via his institution, has received industry-academic funding from AstraZeneca and GlaxoSmithKline R&D; and consultancy or speaker fees from AstraZeneca, Bayer, Boehringer Ingelheim, BMS, CSL Behring, Endeavour, Fibrogen, Galapagos, Galecto, GlaxoSmithKline, IQVIA, Merck, Pliant, Pfizer, Qureight, Roche, Sanofi-Aventis, Structure Therapeutics, Trevi and Vicore. He is supported by a British Lung Foundation Chair in Respiratory Research (C17-3). (© The Author(s) 2024.)
Databáze:	MEDLINE
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