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Authors
Baldasaro, Jessica
Sanchez, Robert J.
Hartford, Christopher
Dahir, Kathryn M.
Keen, Richard
Funck-Brentano, Thomas
Pignolo, Robert J.
Davis, Michelle
Altman, Danielle E.
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Clinical Trials BETA
Clinical trials referenced in this document:
nct03188666 at ClinicalTrials.govDocuments that mention this clinical trial
Content Validation of the Flares Diary: A Qualitative Analysis of the Flares Experience Within the Fibrodysplasia Ossificans Progressiva (FOP) Population
https://doi.org/10.1007/s12325-026-03506-6
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Funding
Funding for this research was provided by:
Regeneron Pharmaceuticals
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Article History
Received: 17 November 2025
Accepted: 20 January 2026
First Online: 10 March 2026
Declarations
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: Jessica Baldasaro and Danielle E. Altman are employees of Modus Outcomes. Robert J. Sanchez and Christopher Hartford are employees of and stockholders in Regeneron Pharmaceuticals, Inc. Kathryn M. Dahir is a principal investigator on the Regeneron Pharmaceuticals, Inc. LUMINA-1 trial. The project described was supported by CTSA award No. UL1 TR002243 from the National Center for Advancing Translational Sciences. Its contents are solely the responsibility of the authors/sponsor and do not necessarily represent official views of the National Center for Advancing Translational Sciences or the National Institutes of Health. Richard Keen is a principal investigator of clinical trials sponsored by Clementia/Ipsen and Regeneron Pharmaceuticals, Inc; and a non-paid member of the International Clinical Council on FOP and the IFOPA FOP registry medical advisory board. Thomas Funck-Brentano is a principal investigator for trials sponsored by Regeneron Pharmaceuticals, Inc., Ipsen, and Incyte. Robert J. Pignolo is a principal investigator of the Regeneron Pharmaceuticals, Inc. LUMINA-1 and Clementia/Ipsen MOVE trials; and a founding member and past president of the International Clinical Council (ICC) on FOP. At the time of the study, Michelle Davis was a non-paid member of the Rare Bone Disease Alliance Steering Committee.
: Ethical approval for this study was provided by the Western Institutional Review Board-Copernicus Group (WCG ® IRB) for research in the United States and Canada. For LUMINA-1 trial participants who participated at trial sites in the European Union, regulatory oversight was granted under the aegis of the clinical trial. In the UK, institutional review board oversight was not required as confirmed by the Health Research Authority decision tool for ethics review requirements; . All participants provided written informed consent to be included in the study and for the results of the study to be published.
