Vaccine Responses in Tralokinumab-Treated Atopic Dermatitis - ECZTRA 5 (ECZema TRAlokinumab Trial No. 5)
NCT ID: NCT03562377
Last Updated: 2025-03-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
215 participants
INTERVENTIONAL
2018-07-13
2019-11-22
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Since tralokinumab and placebo are visually distinct and not matched for viscosity, they will be handled and administered by a qualified, unblinded healthcare professional at the trial site who will not be involved in the management of trial subjects.
Study Groups
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Tralokinumab
Week 0 to 16:
Tralokinumab will be given as subcutaneous injections.
Subjects will receive a tralokinumab loading dose at Day 0 followed by tralokinumab injection regimen A. The last administration will occur at Week 14.
Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.
Tdap vaccine
Tetanus (lockjaw), diphtheria (infection of the nose and throat), and pertussis (whooping cough) vaccine. All subjects will receive 1 dose at Week 12.
Meningococcal vaccine
This vaccine is used to prevent meningococcal diseases (infection of the brain and spinal cord) and blood poisoning. All subjects will receive 1 dose at Week 12.
Placebo
Placebo (dummy treatment) will be given as subcutaneous injections.
Subjects will receive a placebo loading dose at Day 0 followed by placebo injection regimen A. The last administration will occur at Week 14.
Placebo
Placebo contains the same excipients in the same concentration only lacking tralokinumab.
Tdap vaccine
Tetanus (lockjaw), diphtheria (infection of the nose and throat), and pertussis (whooping cough) vaccine. All subjects will receive 1 dose at Week 12.
Meningococcal vaccine
This vaccine is used to prevent meningococcal diseases (infection of the brain and spinal cord) and blood poisoning. All subjects will receive 1 dose at Week 12.
Interventions
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Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.
Placebo
Placebo contains the same excipients in the same concentration only lacking tralokinumab.
Tdap vaccine
Tetanus (lockjaw), diphtheria (infection of the nose and throat), and pertussis (whooping cough) vaccine. All subjects will receive 1 dose at Week 12.
Meningococcal vaccine
This vaccine is used to prevent meningococcal diseases (infection of the brain and spinal cord) and blood poisoning. All subjects will receive 1 dose at Week 12.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
54 Years
ALL
No
Sponsors
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LEO Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Expert
Role: STUDY_DIRECTOR
LEO Pharma
Locations
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Leo Pharma Investigational Site
Fort Smith, Arkansas, United States
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
Brooklyn, New York, United States
Leo Pharma Investigational Site
Cortland, New York, United States
Leo Pharma Investigational Site
Forest Hills, New York, United States
Leo Pharma Investigational Site
New York, New York, United States
Leo Pharma Investigational Site
Cincinnati, Ohio, United States
LEO Pharma Investigational Site
Cincinnati, Ohio, United States
LEO Pharma Investigational Site
Gahanna, Ohio, United States
LEO Pharma Investigational Site
Medford, Oregon, United States
Leo Pharma Investigational Site
Chattanooga, Tennessee, United States
Leo Pharma Investigational Site
Austin, Texas, United States
LEO Pharma Investigational Site
Dallas, Texas, United States
Leo Pharma Investigational Site
Frisco, Texas, United States
Leo Pharma Investigational Site
South Burlington, Vermont, United States
Leo Pharma Investigational Site
Spokane, Washington, United States
LEO Pharma Investigational Site
Edmonton, Alberta, Canada
LEO Pharma Investigational Site
Edmonton, Alberta, Canada
LEO Pharma Investigational Site
Vancouver, British Colombia, Canada
LEO Pharma Investigational Site
St. John's, Newfoundland and Labrador, Canada
LEO Pharma Investigational Site
Hamilton, Ontario, Canada
LEO Pharma Investigational Site
London, Ontario, Canada
LEO Pharma Investigational Site
Oakville, Ontario, Canada
LEO Pharma Investigational Site
Peterborough, Ontario, Canada
LEO Pharma Investigational Site
Richmond Hill, Ontario, Canada
LEO Pharma Investigational Site
Toronto, Ontario, Canada
LEO Pharma Investigational Site
Windsor, Ontario, Canada
LEO Pharma Investigational Site
Verdun, Quebec, Canada
Countries
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References
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Reich K, Langley RG, Salvador JFS, Staumont-Salle D, Costanzo A, Pink AE, Paller AS, Katoh N, Wollenberg A, Warren RB, Blauvelt A, Oland CB, Tindberg AM, Gjerum L, Simpson EL. Safety of tralokinumab in patients with moderate-to-severe atopic dermatitis followed for up to 4.5 years: an integrated analysis of 8 clinical trials. Br J Dermatol. 2025 Aug 29:ljaf309. doi: 10.1093/bjd/ljaf309. Online ahead of print.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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LP0162-1341
Identifier Type: -
Identifier Source: org_study_id
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