Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
LEO Pharma
Age
12–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age 12 to 17.
Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
History of AD for ≥1 year.
History of topical corticosteroid (TCS; Europe: Class 3 or higher; US: Class 4 or lower) and/or topical calcineurin inhibitor (TCI) treatment failure or subjects for whom these topical AD treatments are medically inadvisable.
AD involvement of ≥10% body surface area at screening and baseline.
Stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.
You may not be if
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.
Clareo Health | Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).
