Vaccine Responses in Tralokinumab-Treated Atopic Dermatitis - ECZTRA 5 (ECZema TRAlokinumab Trial No. 5)

Completed · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

The purpose of this trial is to test if treatment with the trial drug, tralokinumab, can affect the body's immune response to vaccines. The trial will also evaluate the efficacy of tralokinumab when it is given concomitantly with vaccines. The trial includes a screening period of 2 to 6 weeks, a treatment period of 16 weeks (Weeks 0 to 16), and a 14-week off-treatment follow-up period for the assessment of safety (Weeks 16 to 30). Eligible subjects may transfer to an open-label, long-term trial at Week 16 or later.

Key facts

Study ID

NCT03562377

Run by

LEO Pharma

People needed

215

Starts

2018-07-13

Expected to finish

2019-11-22

Last updated by the study team

2025-03-11

Who can join

Age: 18 and older, up to 54. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 to 54 years
• Diagnosis of AD as defined by 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 or for whom topical treatments are otherwise medically inadvisable
• 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
• Subjects must have applied a 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 administration of the meningococcal vaccine provided in this trial is contraindicated or medically inadvisable, according to local label of the vaccine
• Subjects for whom administration of the tetanus, diphtheria, and pertussis vaccine provided in this trial is contraindicated or medically inadvisable, according to local label of the vaccine
• Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment
• Use of tanning beds or phototherapy within 6 weeks prior to randomization
• Treatment with systemic immunosuppressive/immunomodulating medications and/or systemic corticosteroids within 4 weeks prior to randomization
• Treatment with the topical medications topical corticosteroids (TCS), topical calcineurin inhibitor (TCI) or phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks prior to randomization
• Receipt of any vaccine (except influenza virus vaccines) within 3 months prior to screening, any meningococcal vaccine within 1 year prior to screening, or any tetanus-, diphtheria-, or pertussis-containing vaccine within 5 years prior to screening
• Receipt of any marketed (i.e. immunoglobulin, anti-IgE) or investigational biologic agent, including dupilumab
• History of any active skin infection within 1 week prior to randomization
• History of a clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to randomization

Where it is running

• LEO Pharma Investigational Site — Bakersfield, California, United States
• Leo Pharma Investigational Site — Beverly Hills, California, United States
• Leo Pharma Investigational Site — Fountain Valley, California, United States
• Leo Pharma Investigational Site — Los Angeles, California, United States
• Leo Pharma Investigational Site — Los Angeles, California, United States
• Leo Pharma Investigational Site — Los Angeles, California, United States
• Leo Pharma Investigational Site — Newport Beach, California, United States
• LEO Pharma Investigational Site — San Diego, California, United States
• LEO Pharma Investigational Site — Centennial, Colorado, United States
• LEO Pharma Investigational Site — Denver, Colorado, United States
• LEO Pharma Investigational Site — Thornton, Colorado, United States
• Leo Pharma Investigational Site — Coral Gables, Florida, United States
• Leo Pharma Investigational Site — Doral, Florida, United States
• Leo Pharma Investigational Site — Hialeah, Florida, United States
• LEO Pharma Investigational Site — Atlanta, Georgia, United States
• Leo Pharma Investigational Site — New Albany, Indiana, United States
• Leo Pharma Investigational Site — South Bend, Indiana, United States
• LEO Pharma Investigational Site — Bangor, Maine, United States
• Leo Pharma Investigational Site — Boston, Massachusetts, United States
• LEO Pharma Investigational Site — Brighton, Massachusetts, United States
• Leo Pharma Investigational Site — Ann Arbor, Michigan, United States
• LEO Pharma Investigational Site — Southfield, Michigan, United States
• Leo Pharma Investigational Site — Missoula, Montana, United States
• Leo Pharma Investigational Site — East Windsor, New Jersey, United States
• Leo Pharma Investigational Site — Fort Smith, Arkansas, United States

Full record on ClinicalTrials.gov

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