WASOG Clinical Trial Endpoint Task Force: Executive Summary

Robert P. Baughman; Elyse E. Lower; Daniel A. Culver; Marc A. Judson; Athol U. Wells

doi:10.36141/svdld.v42i3.17859

WASOG Clinical Trial Endpoint Task Force: Executive Summary

Authors

Robert P. Baughman Editor-in-chief, Sarcoidosis, Vasculitis and Diffuse Lung Diseases; University of Cincinnati, Department of Medicine, Cincinnati, OH, USA
Elyse E. Lower University of Cincinnati, Department of Medicine, Cincinnati, OH, USA
Daniel A. Culver Department of Pulmonary Medicine and Critical Care, Cleveland Clinic, Cleveland, OH, USA
Marc A. Judson Albany Medical College, Department of Medicine, Division of Pulmonary and Critical Care Medicine, Albany, NY, USA
Athol U. Wells Interstitial Lung Disease Unit, Royal Brompton Hospital, London, UK; National Heart and Lung Institute, Imperial College London, London, UK; Margaret Turner Warwick Centre for Fibrosing Lung Disease, Imperial College London, London, UK

Keywords:

clinical trial , prednisone, spirometry, health-related quality of life

Abstract

Over the past few years, an increased number of clinical trials have been performed evaluating specific therapies for pulmonary and cardiac sarcoidosis. However, a lack of consensus remains for appropriate clinical trial endpoints. In 2024, the World Association of Sarcoidosis and Other Granulomatous disease (WASOG) established a clinical trial endpoint Task Force to update the 2011 WASOG Task Force. This initiative was spearheaded by five sarcoidosis specialists (RPB, EEL, DAC, MAJ, AUW) and enlisted a total of 55 stakeholders, including 37 health care providers, 14 industry representatives, and 4 patients. In March 2025, 46 stakeholders participated in a one-day meeting which included twenty focused talks regarding clinical trial endpoints for pulmonary and cardiac sarcoidosis trials. A compilation of individual talk summaries was prepared and distributed to all stakeholders, including those unable to attend the meeting. Based on feedback from all stakeholders, the team leaders developed a series of statements reflecting the presentations and discussions with subsequent anonymous voting by all stakeholders. The majority of the voters endorsed thirteen specific clinical trial endpoint statements: two evaluating overall trial design, seven regarding pulmonary sarcoidosis, and four discussing cardiac sarcoidosis.

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