Ethics Approval

The ADmirable clinical trial was conducted in accordance with ethical principles outlined in the Declaration of Helsinki, Council for International Organizations of Medical Sciences, and Good Clinical Practice guidelines. The ADmirable trial protocol was approved by the Advarra Institutional Review Board on 17 October 2022 (IRB #: Pro00066938). Additionally, Advarra approved the study at each participating center (Supplement 1, Table S1). All investigation sites received approval from the appropriate authorized institutional review board or ethics committee. The ADmirable study is registered on ClinicalTrials.gov (NCT05372419).

Consent to Participate

Informed consent was obtained from all patients before study procedures were initiated. For patients considered to be minors, the written consent of the parent or legal guardian, as well as the assent of the minor, was obtained.

Consent to Publish

The authors affirm that human research participants provided informed consent for publication of the images in Figures 3a, 3b, and 3c.

Funding and Role of the Funder/Sponsor

This study was funded by Eli Lilly and Company. Eli Lilly and Company had a role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Almirall, S.A. has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including atopic dermatitis, in Europe. Lilly has exclusive rights for development and commercialization of lebrikizumab in the United States and the rest of the world outside of Europe.

Competing Interests

Andrew Alexis has received grant support (funds to institution) from Leo, Amgen, Galderma, Arcutis, Dermavant, Abbvie, Castle Advisory board/Consulting: Leo, Galderma, Pfizer, Sanofi-Regeneron, Genzyme, Dermavant, Beiersdorf, Ortho, L’Oréal, BMS, Bausch health, UCB, Arcutis, Janssen, Allergan, Almirall, Abbvie, Amgen, VisualDx, Eli Lilly and Company, Swiss American, Cutera, Cara, EPI, Incyte, Castle, Apogee, Canfield, Alphyn, Avita Medical, Genentech; has served as a speaker for Regeneron, SANOFI-Genzyme, BMS, L’Oreal, Janssen, and J&J; has received royalties from Springer, Wiley-Blackwell, Wolters Kluwer Health; and has received equipment from Aerolase. Ali Moiin has received reimbursement for travel costs from and conducted clinical trials for Eli Lilly and Company. Jill Waibel has served as a consultant, investigator, and/or on scientific advisory boards for Allergan (Consultant), Amgen (Clinical Trial), ArgenX (Clinical Trial), Bellamia (Advisory Board), Bristol Myers Squibb (Clinical Trial), Candela (Speaker, Consultant, Advisory Board), Cytrellis Biosystems (Advisory Board, Consultant, Clinical Trial), Eli Lilly and Company (Clinical Trial, Speaker), Emblation (Clinical Trial), Galderma (Clinical Trial, Consultant), Horizon (Clinical Trial), Janssen/J&J (Clinical Trial), Lumenis (Advisory Board, Consultant, Speaker), Neuronetics (Clinical Trial), Pfizer (Clinical Trial), P & G (Consultant), RegenX (Clinical Consultant, Clinical Trial, Board of Directors), Sanofi (Clinical Trial), Skinceuticals (Clinical Trial, Consultant, Advisory Board), and Shanghai Biopharma, PWB (Clinical Trial); and has received a VA Merit Grant for Amputated Veterans. Paul Wallace has served as a principal investigator, advisor and/or speaker for Abbvie, Amgen, Arcutis, Biogen, Bristol Myers, Celgene, Centocor, Cynosure, Eli Lilly and Company, Genentech, GlaxoSmithKline, Merck, Novartis, Pfizer, Sanofi-Aventis, and UCB; and has received equipment (loan to institution) from Cynosure. David Cohen reports no financial conflicts of interest. Vivian Laquer conducts research for Abbvie, Acelyrin, Acrotech, Amgen, Argenx, Arcutis, Aslan, Biofrontera, Bristol Meyers Squibb, Cara, Dermavant, Eli Lilly and Company, Galderma, Horizon Therapeutics, Incyte, Janssen, Leo, Novartis, Padagis, Pfizer, Q32, Rapt, Sun, UCB, and Ventyx. Pearl Kwong is a principal investigator for Eli Lilly and Company, Pfizer, Dermavant, Incyte, Arcutis, Galderma, Novartis, Abbvie, CastleCreek Biosciences, Amgen, and UCB; a consultant/advisor for Leo, Galderma, Pfizer, Eli Lilly and Company, Incyte, EPI Health, Novan, Verrica, BMS, Sanofi-Regeneron, UCB, and Ortho; and a speaker for Abbvie, Regeneron Sanofi, Incyte, Verrica, Sun Pharma, Ortho, L’Oréal, EPI, and Arcutis. Amber Reck Atwater is a former employee of Eli Lilly and Company. Jennifer Proper, Evangeline Pierce, Christopher Schuster, Maria Silk, Sreekumar Pillai, and Maria Jose Rueda are employees and shareholders of Eli Lilly and Company. Angela Moore has received research grants or honoraria from Abbvie, Acrotech, Arcutis, Bristol Meyers Squibb, Cara, Eli Lilly and Company, Galderma, Incyte, Janssen J&J, Pfizer, Rapt, and Sanofi-Regeneron.

Authors’ Contribution

A. Alexis has contributed to conception of the study and interpretation of the data. A. Moiin has contributed to conception of the work. A. Moore, J. Waibel, and P. Wallace have contributed to acquisition and interpretation of data. D. Cohen and V. Laquer have contributed to acquisition of data. P. Kwong has contributed to interpretation of data. A. Atwater, M. Silk, E. Pierce, S. Pillai, and M.J. Rueda have contributed to study conception, design, analysis, and data interpretation. J. Proper has contributed to study analysis and interpretation. C. Schuster has contributed to data interpretation. All authors contributed to the drafting or critical review of the manuscript and give final approval of the manuscript.

Prior Meeting Presentation

Initial baseline characteristics were presented at Maui Derm for Dermatologists, 22 January 2024, Maui, USA. An interim analysis of the results was presented at the American Academy of Dermatology Annual Meeting, 10 March 2024, San Diego, USA. Primary results were presented at the Fall Clinical Dermatology Conference, 24 October 2024, Las Vegas, USA. The 24-week results were presented at the Revolutionizing Atopic Dermatitis (RAD) Conference 2025, June 7, 2025, Nashville, USA.

Data Availability

Lilly provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the US and EU and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, and blank or annotated case report forms will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at www.vivli.org.

Code Availability

Not applicable.