Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 3

Completed · Phase 3 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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 (AD). Secondary objectives: To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, and health-related quality of life compared with placebo in combination with TCS. To assess the safety of tralokinumab in combination with TCS when used to treat moderate-to-severe AD for 32 weeks.

Key facts

Study ID

NCT03363854

Run by

LEO Pharma

People needed

380

Starts

2018-02-22

Expected to finish

2019-09-26

Last updated by the study team

2025-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• California Dermatology & Clinical Research Institute — Encinitas, California, United States
• First OC Dermatology — Fountain Valley, California, United States
• Center for Dermatology Clinical Research — Fremont, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• Danbury Clinical Research — Danbury, Connecticut, United States
• International Dermatology Research — Miami, Florida, United States
• L & C Professional Medical Research — Miami, Florida, United States
• Lenus Research & Medical Group — Sweetwater, Florida, United States
• Olympian Clinical Research — Tampa, Florida, United States
• Medical Dermatology Specialists — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Indiana Clinical Trials Center — Plainfield, Indiana, United States
• Study Center — Bangor, Maine, United States
• Respiratory Medicine Research — Ypsilanti, Michigan, United States
• Mount Sinai West Dermatoogy — New York, New York, United States
• Wake Research — Raleigh, North Carolina, United States
• Dermatologists of Greater Columbus — Bexley, Ohio, United States
• Oregon Dermatology & Research — Portland, Oregon, United States
• National Allergy and Asthma Research, LLC — North Charleston, South Carolina, United States
• University Hospital Antwerp — Antwerp, Belgium
• Universitair ziekenhuis Brussel — Brussels, Belgium
• Cliniques Universitaires St-Luc — Brussels, Belgium
• LEO Pharma Investigational Site — Loverval, Belgium
• University of Alabama-Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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