Perugino, Cory
Culver, Emma L.
Khosroshahi, Arezou http://orcid.org/0000-0001-8365-8497
Zhang, Wen
Della-Torre, Emanuel
Okazaki, Kazuichi
Tanaka, Yoshiya http://orcid.org/0000-0002-0807-7139
Löhr, Matthias
Schleinitz, Nicolas
Falloon, Judith
She, Dewei
Cimbora, Daniel
Stone, John H. http://orcid.org/0000-0001-6588-9435
Clinical trials referenced in this document:
Documents that mention this clinical trial
IgG4-related disease administered dupilumab: case series and review of the literature
https://doi.org/10.1136/rmdopen-2023-003026
POS0347 INSIGHTS INTO THE DESIGN AND STUDY POPULATION OF MITIGATE: THE FIRST MULTINATIONAL RANDOMIZED CONTROLLED CLINICAL TRIAL IN IgG4 RELATED DISEASE (IgG4-RD), EVALUATING THE EFFICACY AND SAFETY OF INEBILIZUMAB
https://doi.org/10.1136/annrheumdis-2024-eular.5619
Efficacy and Safety of Inebilizumab in IgG4-Related Disease: Protocol for a Randomized Controlled Trial
https://doi.org/10.1007/s40744-023-00593-7
Funding for this research was provided by:
Horizon Therapeutics
Article History
Received: 11 July 2023
Accepted: 8 August 2023
First Online: 4 October 2023
Declarations
:
: Cory Perugino receives consulting fees from Horizon Therapeutics and funding from the National Institutes of Health (NIH/NIAMS K08AR079615). Emma L. Culver receives funding from the National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) Oxford and receives consulting fees from Horizon Therapeutics. Arezou Khosroshahi has participated in advisory boards and served in a consulting role for Viela Bio, Horizon Therapeutics, and Sanofi, and has received grants from Pfizer unrelated to this manuscript. Wen Zhang received consulting fees from Horizon Therapeutics. Emanuel Della-Torre received consulting fees from Horizon Therapeutics. Kazuichi Okazaki has nothing to disclose. Yoshiya Tanaka has received speaking fees and/or honoraria from Behringer-Ingelheim, Eli Lilly, AbbVie, Gilead, AstraZeneca, Bristol-Myers, Chugai, Daiichi-Sankyo, Eisai, Pfizer, Mitsubishi-Tanabe, GlaxoSmithKline, received research grants from Asahi-Kasei, AbbVie, Chugai, Eisai, Takeda, Daiichi-Sankyo, Behringer-Ingelheim. Matthias Löhr has nothing to disclose. Nicolas Schleinitz has participated in advisory boards and received consulting fees from Viela Bio and Horizon Therapeutics. Judith Falloon is a former employee of Horizon Therapeutics and owns stock. Dewei She and Daniel Cimbora are employees of Horizon Therapeutics and own stock. John H. Stone has received consulting fees from Horizon Therapeutics, is the global Principal Investigator of the MITIGATE trial, and receives funding from the National Institutes of Health (NIH/NIAID UM1AI144295).
: The study protocol has been approved by health authorities in 22 countries around the world, and by institutional review boards at 80 sites (Supplementary Table S1). The study will be performed in line with the Helsinki Declaration and informed consent for participation will be received from all participants prior to the conduct of any study-related procedures. Trial results will be disseminated in the form of congress abstracts/presentations and peer-reviewed publication(s).