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Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).
Not Recruiting
Trial ID: NCT03526861
Purpose
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.
Official Title
A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Tralokinumab Monotherapy in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) Who Are Candidates for Systemic Therapy
Stanford Investigator(s)
Joyce Teng, MD, PhD
Professor of Dermatology and, by courtesy, of Pediatrics
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Intervention(s):
drug: Tralokinumab
drug: Placebos
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Elidia Tafoya
650-724-1982