Interleukin-33 antibody failed to demonstrate benefit in a phase II, double-blind, randomized, placebo-controlled study in adult patients with moderate-to-severe atopic dermatitis
Funding sources: this study was funded by Eli Lilly and Company.
Conflicts of interest: V.L. is a principal investigator for Eli Lilly and Company. V.P. is a principal investigator for Eli Lilly and Company, Novartis, Sanofi, and AbbVie. V.P. receives support for attending meetings from AbbVie, and medical writing fees from Eli Lilly and Company, Novartis and AbbVie. J.P.L. institutions have received payments from Eli Lilly and Company, AbbVie, Amgen, Boehringer Ingelheim, Celgene, Galderma International, Janssen, LEO Pharma and Merck. J.P.L. has received payments from Eli Lilly and Company, Boehringer Ingelheim, Celgene, Galderma International, LEO Pharma, Novartis, Pierre Fabre and Sanofi. J.K., A.J.O., D.E.J., J.T.S., C.-Y.C., J.C. and P.K. are Eli Lilly and Company employees and may be stockholders.
Data availability: Eli 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 USA 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, 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.
Ethics statement: all investigational sites received approval from the appropriate authorized institutional review board or ethics committee.
Open Research
DATA AVAILABILITY STATEMENT
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, 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.
