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



Status:Recruiting
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 54
Updated:12/20/2018
Start Date:July 13, 2018
End Date:October 10, 2019
Contact:LEO Pharma A/S
Email:disclosure@leo-pharma.com
Phone:(+1) 877-557-1168

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A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Effect of Tralokinumab on Vaccine Antibody Responses in Adults With Moderate-to-severe Atopic Dermatitis Who Are Candidates for Systemic Therapy

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.

Subjects with atopic dermatitis (AD) will be treated with either tralokinumab or dummy
treatment (placebo) for 16 weeks. All subjects will receive 2 vaccines at Week 12. The
vaccines are:

1. Tetanus (lockjaw), diphtheria (infection of the nose and throat), and pertussis
(whooping cough) vaccine. This combination vaccine is also known as the Tdap vaccine and
is used to prevent these 3 diseases.

2. Meningococcal vaccine. This vaccine is used to prevent meningococcal diseases (infection
of the brain and spinal cord) and blood poisoning.

The primary objective of the trial is to demonstrate non-inferiority of tralokinumab versus
placebo with respect to immune responses to concomitantly administered vaccines.

The secondary objective is to evaluate efficacy of tralokinumab concomitantly administered
with vaccines.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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 randomisation

- Treatment with systemic immunosuppressive/immunomodulating medications and/or systemic
corticosteroids within 4 weeks prior to randomisation

- Treatment with the topical medications topical corticosteroids (TCS), topical
calcineurin inhibitor (TCI) or phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks
prior to randomisation

- 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 randomisation

- History of a clinically significant infection (systemic infection or serious skin
infection requiring parenteral treatment) within 4 weeks prior to randomisation
We found this trial at
37
sites
Beverly Hills, California 90212
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Ann Arbor, Michigan 48103
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Atlanta, Georgia 30328
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Austin, Texas 78759
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Bakersfield, California 93301
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Bangor, Maine 04401
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Boston, Massachusetts 02115
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Boston, MA
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Brighton, Massachusetts 02135
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Brooklyn, New York 11201
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Centennial, Colorado 80112
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Chattanooga, Tennessee 37421
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Cincinnati, Ohio 45219
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Coral Gables, Florida 33134
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Cortland, New York 13045
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Dallas, Texas 75231
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Denver, Colorado 80206
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Doral, Florida 33122
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East Windsor, New Jersey 08520
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East Windsor, NJ
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Edmonton,
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Forest Hills, New York 11375
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Fort Smith, Arkansas 72916
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Fountain Valley, California 92708
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Frisco, Texas 75034
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Gahanna, Ohio 43230
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Hialeah, Florida 33012
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Los Angeles, California 90025
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Medford, Oregon 97504
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Missoula, Montana 59808
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New Albany, Indiana 47150
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New York, New York 10021
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Newport Beach, California 92660
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San Diego, California 92123
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South Bend, Indiana 46617
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South Burlington, Vermont 05403
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Southfield, Michigan 48034
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Spokane, Washington 99202
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Thornton, Colorado 80233
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