Status:
COMPLETED
Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 3
Lead Sponsor:
LEO Pharma
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary objective: To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating moderate-to-severe atopic dermatitis (...
Eligibility Criteria
Inclusion
- 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.
- Stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.
Exclusion
- Subjects for whom TCS 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, topical calcineurin inhibitors (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 within 3 months or 5 half-lives, whichever is longer prior to randomisation.
- 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.
Key Trial Info
Start Date :
February 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2019
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT03363854
Start Date
February 22 2018
End Date
September 26 2019
Last Update
March 11 2025
Active Locations (66)
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1
University of Alabama-Birmingham
Birmingham, Alabama, United States, 35233
2
California Dermatology & Clinical Research Institute
Encinitas, California, United States, 92024
3
First OC Dermatology
Fountain Valley, California, United States, 92708
4
Center for Dermatology Clinical Research
Fremont, California, United States, 94538