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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tralokinumab
Placebo
Tdap vaccine
Meningococcal vaccine
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 54 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Leo Pharma Investigational Site
  • LEO Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • LEO Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • LEO Pharma Investigational Site
  • Leo Pharma Investigational Site
  • LEO Pharma Investigational Site
  • Leo Pharma Investigational Site
  • LEO Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • LEO Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • LEO Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • Leo Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site
  • LEO Pharma Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tralokinumab

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
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.
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.
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.

Full Information

First Posted
June 8, 2018
Last Updated
October 14, 2022
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT03562377
Brief Title
Vaccine Responses in Tralokinumab-Treated Atopic Dermatitis - ECZTRA 5 (ECZema TRAlokinumab Trial No. 5)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 13, 2018 (Actual)
Primary Completion Date
September 17, 2019 (Actual)
Study Completion Date
November 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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: > 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.> 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tralokinumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tralokinumab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo contains the same excipients in the same concentration only lacking tralokinumab.
Intervention Type
Biological
Intervention Name(s)
Tdap vaccine
Intervention Description
Tetanus (lockjaw), diphtheria (infection of the nose and throat), and pertussis (whooping cough) vaccine. All subjects will receive 1 dose at Week 12.
Intervention Type
Biological
Intervention Name(s)
Meningococcal vaccine
Intervention Description
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 Measure Information:
Title
Positive Anti-tetanus Response at Week 16
Description
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
Title
Positive Anti-meningococcal Response at Week 16
Description
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
Secondary Outcome Measure Information:
Title
Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
Description
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
Title
Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 16.
Description
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
Title
Number of AEs.
Description
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
Title
Presence of Anti-drug Antibodies (ADA).
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Expert
Organizational Affiliation
LEO Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Leo Pharma Investigational Site
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
LEO Pharma Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80233
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Doral
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Leo Pharma Investigational Site
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Leo Pharma Investigational Site
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Leo Pharma Investigational Site
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Cortland
State/Province
New York
ZIP/Postal Code
13045
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Forest Hills
State/Province
New York
ZIP/Postal Code
11375
Country
United States
Facility Name
Leo Pharma Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Gahanna
State/Province
Ohio
ZIP/Postal Code
43230
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75225
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Facility Name
Leo Pharma Investigational Site
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
LEO Pharma Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5K 1X3
Country
Canada
Facility Name
LEO Pharma Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C3
Country
Canada
Facility Name
LEO Pharma Investigational Site
City
Vancouver
State/Province
British Colombia
ZIP/Postal Code
V6H 4E1
Country
Canada
Facility Name
LEO Pharma Investigational Site
City
Saint John's
State/Province
New Foundland & Labrador
ZIP/Postal Code
A1A 4Y3
Country
Canada
Facility Name
LEO Pharma Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1G5
Country
Canada
Facility Name
LEO Pharma Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Facility Name
LEO Pharma Investigational Site
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 7W5
Country
Canada
Facility Name
LEO Pharma Investigational Site
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
LEO Pharma Investigational Site
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 1A5
Country
Canada
Facility Name
LEO Pharma Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4V 1R2
Country
Canada
Facility Name
LEO Pharma Investigational Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 2G1
Country
Canada
Facility Name
LEO Pharma Investigational Site
City
Verdun
State/Province
Quebec
ZIP/Postal Code
H4G 3E7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
IPD Sharing Time Frame
Data is available to request after results of the trial are available on leopharmatrials.com
IPD Sharing Access Criteria
Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.
IPD Sharing URL
http://leopharmatrials.com/for-professionals
Citations:
PubMed Identifier
36082590
Citation
Simpson EL, Merola JF, Silverberg JI, Reich K, Warren RB, Staumont-Salle D, Girolomoni G, Papp K, de Bruin-Weller M, Thyssen JP, Zachariae R, Olsen CK, Wollenberg A. Safety of tralokinumab in adult patients with moderate-to-severe atopic dermatitis: pooled analysis of five randomized, double-blind, placebo-controlled phase II and phase III trials. Br J Dermatol. 2022 Dec;187(6):888-899. doi: 10.1111/bjd.21867. Epub 2022 Oct 26.
Results Reference
derived

Learn more about this trial

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

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