Siegfried, Elaine C.
Cork, Michael J.
Katoh, Norito
Zhang, Haixin
Chuang, Chien-Chia
Thomas, Ryan B.
Rossi, Ana B.
Cyr, Sonya L.
Zhang, Annie
Clinical trials referenced in this document:
Documents that mention this clinical trial
Dupilumab Provides Clinically Meaningful Responses in Children Aged 6–11 Years with Severe Atopic Dermatitis: Post Hoc Analysis Results from a Phase III Trial
https://doi.org/10.1007/s40257-023-00791-7
Definition of Clinically Meaningful Within-Patient Changes in POEM and CDLQI in Children 6 to 11 Years of Age with Severe Atopic Dermatitis
https://doi.org/10.1007/s13555-021-00543-7
Funding for this research was provided by:
Sanofi and Regeneron Pharmaceuticals, Inc.
Article History
Accepted: 7 May 2023
First Online: 10 June 2023
Declarations
:
: Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan) that support the methods and findings reported in this manuscript. Individual anonymized participant data will be considered for sharing once the product and indication has been approved by major health authorities (e.g., FDA, EMA, PMDA), if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification. Submit requests to ExternalRef removed.
: This research was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. ClinicalTrials.gov Identifier: NCT03345914. The study sponsors participated in the study design; collection, analysis, and interpretation of the data; writing of the report; and the decision to submit the article for publication. Medical writing and editorial assistance were provided by Liselotte van Delden of Excerpta Medica, and was funded by Sanofi and Regeneron Pharmaceuticals Inc., according to the Good Publication Practice guideline.
: Elaine C. Siegfried: Dermavant, Eli Lilly, Pfizer, Regeneron Pharmaceuticals Inc., Verrica Pharmaceuticals—consultant; GlaxoSmithKline, LEO Pharma, Novan—data and safety monitoring board; Eli Lilly, Janssen, Regeneron Pharmaceuticals Inc., Stiefel, Verrica Pharmaceuticals—Principal Investigator in clinical trials. Michael J. Cork: AbbVie, Astellas Pharma, Boots, Dermavant, Galapagos, Galderma, Hyphens Pharma, Johnson & Johnson, LEO Pharma, L’Oréal, Menlo Therapeutics, Novartis, Oxagen, Pfizer, Procter & Gamble, Reckitt Benckiser, Regeneron Pharmaceuticals Inc., Sanofi—investigator and/or consultant. Norito Katoh: AbbVie, Celgene Japan, Janssen Pharmaceuticals, Kyowa Kirin, LEO Pharma, Lilly Japan, Maruho, Mitsubishi Tanabe Pharma, Sanofi, Taiho Pharmaceutical, Torii Pharmaceutical—speaker/consultant honoraria; A2 Healthcare, AbbVie, Boehringer Ingelheim Japan, Eisai, Janssen Pharmaceuticals, Kyowa Kirin, LEO Pharma, Lilly Japan, Maruho, Sun Pharma, Taiho Pharmaceutical, Torii Pharmaceutical—investigator grants. Haixin Zhang, Ryan B. Thomas, Sonya L. Cyr: Regeneron Pharmaceuticals Inc.—employees and shareholders. Chien-Chia Chuang, Ana B. Rossi, Annie Zhang: Sanofi—employees, may hold stock and/or stock options in the company.
: This study was conducted in accordance with ethical standards of the responsible committees and the Declaration of Helsinki and with the International Council for Harmonisation guidelines for Good Clinical Practice. The trial was overseen by an independent data and safety monitoring board. The protocol was reviewed and approved by institutional review boards/ethics committees at all centers.
: Written informed consent was obtained from all patients or their proxies.
: The authors affirm that human research participants provided informed consent for publication of the images in Figures InternalRef removed and InternalRef removed. The participant has consented to the submission of the case report to the journal.Patients signed informed consent regarding publishing their data and photographs.
: AZ and SC contributed to manuscript concept and design. ECS and MJC contributed to data acquisition. All authors interpreted the data, provided critical feedback on the manuscript, approved the final manuscript for submission, and are accountable for the accuracy and integrity of the manuscript.
: Not applicable.