Atopic Dermatitis
Conditions
Sponsors
LEO Pharma A/S, LEO Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD. -History of AD for 1 year or more. -History of topical corticosteroid and/or topical calcineurin inhibitor (TCI) treatment failure or subjects for whom these topical AD treatments are medically inadvisable. -AD involvement of 10% or more body surface area at screening and baseline. -Stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.
Exclusion criteria
Exclusion criteria: -Active dermatologic conditions that may confound the diagnosis of AD. -Use of tanning beds or phototherapy within 6 weeks prior to randomisation. -Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to randomisation. -Treatment with TCS, TCI, or topical phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks prior to randomisation. -Receipt of any marketed biological therapy (i.e. immunoglobulin, anti immunoglobulin E) including dupilumab or investigational biologic agents. -Active skin infection within 1 week prior to randomisation. -Clinically significant infection within 4 weeks prior to randomisation. -A helminth parasitic infection within 6 months prior to the date informed consent is obtained. -Tuberculosis requiring treatment within the 12 months prior to screening. -Known primary immunodeficiency disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy - | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy - | — |
Countries
Europe, Japan, North America, Oceania
Outcome results
None listed