A Phase 2 Randomized, Double-Blind,
Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous
Lirentelimab in Adult Subjects with Moderate-to-Severe Atopic Dermatitis
Inadequately Controlled by Topical Treatments
Study treatment will be administered subcutaneously every two weeks for 12 weeks beginning at randomization. Subjects will be observed for at least 1 hour after each injection.
Following the double-blind period of the study, subjects will be given the option of entering the open label extension (OLE) period of the study, contingent on meeting certain study criteria. Subjects will receive 7 doses of 300 mg study drug during the OLE period.
The total study duration for each subject in the double-blind period of the study will be approximately 7 months. If a subject chooses to enter the OLE period, the total study duration will be approximately 9 months, which includes:
A screening period of approximately 2 weeks prior to study drug administration.
A treatment period of 12 weeks (administration of study drug or placebo every 2 weeks for 7 doses). An optional open-label period of 12 weeks (administration of study drug every 2 weeks for 7 doses).
A follow-up period of 12 weeks after the last dose of study drug in the OLE period.
Subjects who do not enter the OLE period of the study will be followed for 12 weeks after the last dose in the double-blind period of the study.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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