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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
215
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 contains the same excipients in the same concentration only lacking tralokinumab.
Tetanus (lockjaw), diphtheria (infection of the nose and throat), and pertussis (whooping cough) vaccine. All subjects will receive 1 dose at Week 12.
Positive Anti-tetanus Response at Week 16
The antibody response to Tdap vaccine will be assessed by measuring serum anti-tetanus IgG by an immunoassay. A positive response is defined as a 3-fold IgG increase compared to Week 12 if IgG ≤1.0 IU/mL at Week 12; or IgG ≥2.5 IU/mL if IgG \>1.0 IU/mL at Week 12.
Time frame: Week 12 to Week 16
Positive Anti-meningococcal Response at Week 16
The antibody response to meningococcal vaccine will be assessed by measuring serum anti-meningococcal IgG by an immunoassay. A positive response is defined as at least a 3-fold increase compared to Week 12.
Time frame: Week 12 to Week 16
Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at 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).
Time frame: Week 0 to Week 16
Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at 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.
Time frame: Week 0 to Week 16
Number of AEs.
Overall summary of AEs during the treatment period is presented. For list of SAEs and frequent AEs by MedDRA system organ class (SOC) and preferred term (PT) during the entire trial period (including safety follow-up), see Adverse Events Overview section.
Time frame: Week 0 to Week 16
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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.
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
...and 41 more locations
Presence of Anti-drug Antibodies (ADA).
ADA levels were measured using a validated bioanalytical method. Data were reported in the following categories: positive (presence of ADA at baseline and/or presence of ADA at at least 1 post-baseline assessment), perishing (presence of ADA at baseline and absence of ADA at all post-baseline assessments), negative (absence of ADA at all assessments), no post-baseline ADA assessment.
Time frame: Week 0 to Week 16