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

Atopic Dermatitis Clinical Trial

— ECZTRA 5  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03562377
• Other study ID #: LP0162-1341
• Status: Completed
• Phase: Phase 2
• Start date: July 13, 2018
• Est. completion date: November 22, 2019

Study information

• Verified date: January 2021
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: November 22, 2019
• Est. primary completion date: September 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 54 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Canada	LEO Pharma Investigational Site	Edmonton	Alberta
Canada	LEO Pharma Investigational Site	Edmonton	Alberta
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	Saint John's	New Foundland & Labrador
Canada	LEO Pharma Investigational Site	Toronto	Ontario
Canada	LEO Pharma Investigational Site	Vancouver	British Colombia
Canada	LEO Pharma Investigational Site	Verdun	Quebec
Canada	LEO Pharma Investigational Site	Windsor	Ontario
United States	Leo Pharma Investigational Site	Ann Arbor	Michigan
United States	LEO Pharma Investigational Site	Atlanta	Georgia
United States	Leo Pharma Investigational Site	Austin	Texas
United States	LEO Pharma Investigational Site	Bakersfield	California
United States	LEO Pharma Investigational Site	Bangor	Maine
United States	Leo Pharma Investigational Site	Beverly Hills	California
United States	Leo Pharma Investigational Site	Boston	Massachusetts
United States	LEO Pharma Investigational Site	Brighton	Massachusetts
United States	LEO Pharma Investigational Site	Brooklyn	New York
United States	LEO Pharma Investigational Site	Centennial	Colorado
United States	Leo Pharma Investigational Site	Chattanooga	Tennessee
United States	Leo Pharma Investigational Site	Cincinnati	Ohio
United States	LEO Pharma Investigational Site	Cincinnati	Ohio
United States	Leo Pharma Investigational Site	Coral Gables	Florida
United States	Leo Pharma Investigational Site	Cortland	New York
United States	LEO Pharma Investigational Site	Dallas	Texas
United States	LEO Pharma Investigational Site	Denver	Colorado
United States	Leo Pharma Investigational Site	Doral	Florida
United States	Leo Pharma Investigational Site	East Windsor	New Jersey
United States	Leo Pharma Investigational Site	Forest Hills	New York
United States	Leo Pharma Investigational Site	Fort Smith	Arkansas
United States	Leo Pharma Investigational Site	Fountain Valley	California
United States	Leo Pharma Investigational Site	Frisco	Texas
United States	LEO Pharma Investigational Site	Gahanna	Ohio
United States	Leo Pharma Investigational Site	Hialeah	Florida
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	Medford	Oregon
United States	Leo Pharma Investigational Site	Missoula	Montana
United States	Leo Pharma Investigational Site	New Albany	Indiana
United States	Leo Pharma Investigational Site	New York	New York
United States	Leo Pharma Investigational Site	Newport Beach	California
United States	LEO Pharma Investigational Site	San Diego	California
United States	Leo Pharma Investigational Site	South Bend	Indiana
United States	Leo Pharma Investigational Site	South Burlington	Vermont
United States	LEO Pharma Investigational Site	Southfield	Michigan
United States	Leo Pharma Investigational Site	Spokane	Washington
United States	LEO Pharma Investigational Site	Thornton	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 12 to Week 16
Primary	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.	Week 12 to Week 16
Secondary	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).	Week 0 to Week 16
Secondary	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.	Week 0 to Week 16
Secondary	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.	Week 0 to Week 16
Secondary	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.	Week 0 to Week 16