A phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis.

"Declarations Ethics approval and consent to participateThe study was conducted according to the principles defined in the Declaration of Helsinki and Good Clinical Practices. All participating investigators obtained full ethics or institutional review board approval according to their local regulations. The Ethik-Kommission des Landes Berlin, Landesamt für Gesundheit und Soziales, Berlin, provided approval for the lead site in Germany (reference# 18/0339 – EK 12/15). Written informed consent was obtained from all participating patients. Consent for publicationNot applicable. Competing interestsWAS: Received consulting fees and grants from AbbVie, GSK, Novartis, Roche, and Sanofi; speakers bureau for AbbVie, Chugai, GSK, Novartis, Roche, and Sanofi; has been an investigator on clinical trials for AbbVie, GSK, Novartis, and Sanofi. BD: Consultant for Sanofi and Roche Chugai; speakers bureau for Roche Chugai and Cipla; received grant/research support from Sanofi, Roche, and AbbVie. JS, YX, and YL: Employees of Sanofi and may hold stocks or stock options in the company. AG: Employee and shareholder of Regeneron Pharmaceuticals, Inc at the time of the conduct of study. MCN and BA: Employees and shareholders of Regeneron Pharmaceuticals, Inc. SHU: Consultant for Sanofi, Kiniksa, and Janssen; received grant/research support from Genentech. SLM: Consultant on behalf of her institution for Roche/Chugai, Sanofi, AbbVie, and AstraZeneca; received speaker fees for her institution from Pfizer and Vifor; received grant/research support from Vifor – all outside the submitted work; received support from Roche/Chugai to attend EULAR 2019 and from Pfizer to attend ACR Convergence 2021;  SLM is supported by the NIHR Biomedical Research Centre. MAG: Received grant/research support from AbbVie, MSD, Janssen, and Roche; received consultation fees/participation from company-sponsored speakers bureaus tied to AbbVie, Pfizer, Roche, Sanofi, Eli Lilly, Celgene, and MSD. RS: Consultant for Sanofi, GSK, Novartis, ChemoCentryx, Roche-Genentech, and AbbVie; received grant/research support from GSK, ChemoCentryx, Corbus, InflaRx, and Boehringer Ingelheim. KJW: Paid instructor for ChemoCentryx; received grant/research support from Eli Lilly, Kiniksa, and GSK; received consulting fees from Sanofi. PMV: Received speaker, advisory fees, and/or research support from Roche, MSD, AbbVie, Sanofi, Grünenthal, Amgen, Chugai, BMS, Janssen, and Drossapharm. FB: Received grants and personal fees from Horizon Therapeutics, AbbVie, and Sanofi; received grants from Mundipharma; received grants, personal fees, and non-financial support from Roche; received personal fees from Galapagos outside the submitted work. JHS: Consultant for and received research funds from Roche. Competing interests WAS: Received consulting fees and grants from AbbVie, GSK, Novartis, Roche, and Sanofi; speakers bureau for AbbVie, Chugai, GSK, Novartis, Roche, and Sanofi; has been an investigator on clinical trials for AbbVie, GSK, Novartis, and Sanofi. BD: Consultant for Sanofi and Roche Chugai; speakers bureau for Roche Chugai and Cipla; received grant/research support from Sanofi, Roche, and AbbVie. JS, YX, and YL: Employees of Sanofi and may hold stocks or stock options in the company. AG: Employee and shareholder of Regeneron Pharmaceuticals, Inc at the time of the conduct of study. MCN and BA: Employees and shareholders of Regeneron Pharmaceuticals, Inc. SHU: Consultant for Sanofi, Kiniksa, and Janssen; received grant/research support from Genentech. SLM: Consultant on behalf of her institution for Roche/Chugai, Sanofi, AbbVie, and AstraZeneca; received speaker fees for her institution from Pfizer and Vifor; received grant/research support from Vifor – all outside the submitted work; received support from Roche/Chugai to attend EULAR 2019 and from Pfizer to attend ACR Convergence 2021;  SLM is supported by the NIHR Biomedical Research Centre. MAG: Received grant/research support from AbbVie, MSD, Janssen, and Roche; received consultation fees/participation from company-sponsored speakers bureaus tied to AbbVie, Pfizer, Roche, Sanofi, Eli Lilly, Celgene, and MSD. RS: Consultant for Sanofi, GSK, Novartis, ChemoCentryx, Roche-Genentech, and AbbVie; received grant/research support from GSK, ChemoCentryx, Corbus, InflaRx, and Boehringer Ingelheim. KJW: Paid instructor for ChemoCentryx; received grant/research support from Eli Lilly, Kiniksa, and GSK; received consulting fees from Sanofi. PMV: Received speaker, advisory fees, and/or research support from Roche, MSD, AbbVie, Sanofi, Grünenthal, Amgen, Chugai, BMS, Janssen, and Drossapharm. FB: Received grants and personal fees from Horizon Therapeutics, AbbVie, and Sanofi; received grants from Mundipharma; received grants, personal fees, and non-financial support from Roche; received personal fees from Galapagos outside the submitted work. JHS: Consultant for and received research funds from Roche."

"Funding This study was funded by Sanofi and Regeneron Pharmaceuticals, Inc."

"Trial registration ClinicalTrials.gov NCT03600805. Registered on July 26, 2018."