Patients applied moisturizers twice daily for 7 or more days before randomization and throughout the study. A 35-day screening period preceded initiation of the study drug. Systemic nonsteroidal immunosuppressants, systemic or topical corticosteroids, topical calcineurin inhibitors, and topical crisaborole could be used only as rescue treatment by patients with intolerable AD symptoms at the discretion of the investigator (additional details in eMethods in Supplement 2 ). Patients who completed the 16-week treatment period were eligible to participate in an open-label extension study (R668-AD-1434, LIBERTY AD PED-OLE, NCT02612454 ); patients not enrolling in the open-label extension study were followed up for 12 additional weeks.
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Atopic Dermatitis Treatment Protocol
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Corresponding Organization : Regeneron (United States)
Other organizations : Oregon Health & Science University, Northwestern University, Saint Louis University, National Jewish Health, University of Colorado Denver, Peninsula Research, SKiN Health, Queen's University, Probity Medical Research, University of Rochester Medical Center, Icahn School of Medicine at Mount Sinai, Rockefeller University, Eastern Virginia Medical School, Oregon Medical Research Center, Institute for Advanced Medical Research, Georgetown University, Sanofi (United States), Sanofi (France)
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Variable analysis
independent variables
- Treatment with study drug
- Outcome of AD symptoms
- Patients applied moisturizers twice daily for 7 or more days before randomization and throughout the study
- A 35-day screening period preceded initiation of the study drug
- Systemic nonsteroidal immunosuppressants, systemic or topical corticosteroids, topical calcineurin inhibitors, and topical crisaborole could be used only as rescue treatment by patients with intolerable AD symptoms at the discretion of the investigator
- Patients not enrolling in the open-label extension study were followed up for 12 additional weeks (potential negative control)
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