Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).

Completed · Phase 3 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

Primary objective: To evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to \<18 years) with moderate-to-severe AD. Secondary objectives: To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health-related quality of life compared with placebo. To investigate the safety, immunogenicity, and tolerability of SC administration of tralokinumab compared with placebo when used to treat adolescent subjects (age 12 to \<18 years) with moderate-to-severe AD.

Key facts

Study ID

NCT03526861

Run by

LEO Pharma

People needed

301

Starts

2018-06-19

Expected to finish

2021-03-16

Last updated by the study team

2025-03-11

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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.

Where it is running

• LEO Pharma Investigational Site — Fort Smith, Arkansas, United States
• Leo Pharma Investigational Site — Fountain Valley, California, United States
• LEO Pharma Investigational Site — Los Angeles, California, United States
• LEO Pharma Investigational Site — San Francisco, California, United States
• LEO Pharma Investigational Site — Stanford, California, United States
• LEO Pharma Investigational Site — New Haven, Connecticut, United States
• LEO Pharma Investigational Site — Miami, Florida, United States
• Leo Pharma Investigational Site — Albany, Georgia, United States
• LEO Pharma Investigational Site — Chicago, Illinois, United States
• LEO Pharma Investigational Site — Louisville, Kentucky, United States
• LEO Pharma Investigational Site — Baton Rouge, Louisiana, United States
• LEO Pharma Investigational Site — Ann Arbor, Michigan, United States
• LEO Pharma Investigational Site — Ypsilanti, Michigan, United States
• LEO Pharma Investigational Site — Minneapolis, Minnesota, United States
• LEO Pharma Investigational Site — East Windsor, New Jersey, United States
• LEO Pharma Investigational Site — Corning, New York, United States
• Leo Pharma Investigational Site — New York, New York, United States
• LEO Pharma Investigational Site — High Point, North Carolina, United States
• LEO Pharma Investigational Site — Bexley, Ohio, United States
• Leo Pharma Investigational Site — Tulsa, Oklahoma, United States
• LEO Pharma Investigational Site — Portland, Oregon, United States
• LEO Pharma Investigational Site — Portland, Oregon, United States
• LEO Pharma Investigational Site — Philadelphia, Pennsylvania, United States
• Leo Pharma Investigational Site — North Charleston, South Carolina, United States
• LEO Pharma Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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