A randomised, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroid in subjects with moderate-to-severe atopic dermatitis who are candidates for systemic therapy

EO Pharma A/S0 sites380 target enrollmentJanuary 24, 2018

Overview

No summary available.

Registry

who.int

Start Date

January 24, 2018

End Date

September 26, 2019

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

EO Pharma A/S

•Age 18 and above.
•Diagnosis of AD as defined by the Hanifin and Rajka (1980\) criteria for AD.
•History of AD for \=1 year.
•Subjects who have a recent history of inadequate response to treatment with topical medications.
•AD involvement of \=10% body surface area at screening and baseline.
•An EASI score of \=12 at screening and 16 at baseline.
•An IGA score of \=3 at screening and at baseline.
•A Worst Daily Pruritus NRS average score of \=4 during the week prior to baseline.
•Stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.
•Are the trial subjects under 18? no

•Subjects for whom TCSs are medically inadvisable e.g., due to important side effects or safety risks in the opinion of the investigator.
•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.