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

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ClinicalTrials.gov Identifier: NCT03562377
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Tralokinumab Drug: Placebo Biological: Tdap vaccine Biological: Meningococcal vaccine Phase 2

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:

Neither the subject nor any of the investigator or LEO staff who are involved in the treatment or clinical evaluation and monitoring of the subjects will be aware of the treatment received. The packaging and labelling of tralokinumab/placebo will contain no evidence of their identity.

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.

Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 13, 2018
Estimated Primary Completion Date : July 4, 2019
Estimated Study Completion Date : October 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: 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.

Drug: 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.

Biological: 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.

Biological: 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 Comparator: 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.

Drug: Placebo
Placebo contains the same excipients in the same concentration only lacking tralokinumab.

Biological: 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.

Biological: 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.




Primary Outcome Measures :
  1. Positive anti-tetanus response at Week 16 [ Time Frame: Week 12 to Week 16 ]
    The antibody response to Tdap vaccine will be assessed by measuring serum anti-tetanus IgG by an immunoassay.

  2. Positive anti-meningococcal response at Week 16 [ Time Frame: Week 12 to Week 16 ]
    The antibody response to meningococcal vaccine will be assessed by measuring serum anti-meningococcal IgG by an immunoassay.


Secondary Outcome Measures :
  1. Subjects with Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Week 16 [ Time Frame: Week 0 to Week 16 ]
    The IGA is an instrument used in clinical trials to rate the severity of the subject's global atopic dermatitis and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

  2. Subjects achieving at least 75% reduction in Eczema Area and Severity Index (EASI) at Week 16. [ Time Frame: Week 0 to Week 16 ]

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis.

    The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.




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Ages Eligible for Study:   18 Years to 54 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03562377


Contacts
Contact: LEO Pharma A/S (+1) 877-557-1168 disclosure@leo-pharma.com

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Sponsors and Collaborators
LEO Pharma
Investigators
Study Director: Medical Expert LEO Pharma

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT03562377     History of Changes
Other Study ID Numbers: LP0162-1341
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vaccines
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs