Atopic DermatitisPhase 2ECZTRA 5NCT03562377

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

A Phase 2 study testing Tralokinumab, Tdap vaccine and Meningococcal vaccine in people with Atopic Dermatitis, run by LEO Pharma at 51 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 54 years
Conditions the study is for: Atopic Dermatitis
What is being tested?: Tralokinumab, Tdap vaccine and Meningococcal vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 215 participants
Where: 51 sitesin 2 countries
Study dates: 13 Jul 2018to 22 Nov 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 54 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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 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

Show all 10Show fewer

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

Trial locations and contacts

51 sites in 2 countries.

Country

City, postcode or hospital

51 sites in 2 countries

United States39 sites

Leo Pharma Investigational Site
Ann Arbor, Michigan, 48103
LEO Pharma Investigational Site
Atlanta, Georgia, 30328
Leo Pharma Investigational Site
Austin, Texas, 78759
LEO Pharma Investigational Site
Bakersfield, California, 93301
LEO Pharma Investigational Site
Bangor, Maine, 04401
Leo Pharma Investigational Site
Beverly Hills, California, 90212
Leo Pharma Investigational Site
Boston, Massachusetts, 02115
LEO Pharma Investigational Site
Brighton, Massachusetts, 02135
LEO Pharma Investigational Site
Brooklyn, New York, 11201
LEO Pharma Investigational Site
Centennial, Colorado, 80112
Leo Pharma Investigational Site
Chattanooga, Tennessee, 37421
Leo Pharma Investigational Site
Cincinnati, Ohio, 45219
LEO Pharma Investigational Site
Cincinnati, Ohio, 45231
Leo Pharma Investigational Site
Coral Gables, Florida, 33134
Leo Pharma Investigational Site
Cortland, New York, 13045
LEO Pharma Investigational Site
Dallas, Texas, 75225
LEO Pharma Investigational Site
Denver, Colorado, 80045
Leo Pharma Investigational Site
Doral, Florida, 33122
Leo Pharma Investigational Site
East Windsor, New Jersey, 08520
Leo Pharma Investigational Site
Forest Hills, New York, 11375
Leo Pharma Investigational Site
Fort Smith, Arkansas, 72916
Leo Pharma Investigational Site
Fountain Valley, California, 92708
Leo Pharma Investigational Site
Frisco, Texas, 75034
LEO Pharma Investigational Site
Gahanna, Ohio, 43230
Leo Pharma Investigational Site
Hialeah, Florida, 33012
Leo Pharma Investigational Site
Los Angeles, California, 90025
Leo Pharma Investigational Site
Los Angeles, California, 90045
Leo Pharma Investigational Site
Los Angeles, California, 90057
LEO Pharma Investigational Site
Medford, Oregon, 97504
Leo Pharma Investigational Site
Missoula, Montana, 59808
Leo Pharma Investigational Site
New Albany, Indiana, 47150
Leo Pharma Investigational Site
New York, New York, 10021
Leo Pharma Investigational Site
Newport Beach, California, 92660
LEO Pharma Investigational Site
San Diego, California, 92123
Leo Pharma Investigational Site
South Bend, Indiana, 46617
Leo Pharma Investigational Site
South Burlington, Vermont, 05403
LEO Pharma Investigational Site
Southfield, Michigan, 48034
Leo Pharma Investigational Site
Spokane, Washington, 99202
LEO Pharma Investigational Site
Thornton, Colorado, 80233

Other trials in United States

Canada12 sites

LEO Pharma Investigational Site
Edmonton, Alberta, T5K 1X3
LEO Pharma Investigational Site
Edmonton, Alberta, T6G 1C3
LEO Pharma Investigational Site
Hamilton, Ontario, L8S 1G5
LEO Pharma Investigational Site
London, Ontario, N6H 5L5
LEO Pharma Investigational Site
Oakville, Ontario, L6J 7W5
LEO Pharma Investigational Site
Peterborough, Ontario, K9J 5K2
LEO Pharma Investigational Site
Richmond Hill, Ontario, L4B 1A5
LEO Pharma Investigational Site
St. John's, Newfoundland and Labrador, A1A 4Y3
LEO Pharma Investigational Site
Toronto, Ontario, M4V 1R2
LEO Pharma Investigational Site
Vancouver, British Colombia, V6H 4E1
LEO Pharma Investigational Site
Verdun, Quebec, H4G 3E7
LEO Pharma Investigational Site
Windsor, Ontario, N8X 2G1

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions: Atopic Dermatitis
Being tested: Tralokinumab, Placebo, Tdap vaccine, Meningococcal vaccine
Medical subject headings: Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TralokinumabDrug
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.
PlaceboDrug
Placebo contains the same excipients in the same concentration only lacking tralokinumab.
Tdap vaccineBiological
Tetanus (lockjaw), diphtheria (infection of the nose and throat), and pertussis (whooping cough) vaccine. All subjects will receive 1 dose at Week 12.
Meningococcal vaccineBiological
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.

Study groups in NCT03562377
Study group	Role	What they receive
Tralokinumab	Experimental	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. Receives: Drug: Tralokinumab; Biological: Tdap vaccine; Biological: Meningococcal vaccine
Placebo	Placebo comparator	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. Receives: Drug: Placebo; Biological: Tdap vaccine; Biological: Meningococcal vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Week 12 to Week 16

Secondary outcomes (4)

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).
Measured: 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.
Measured: 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.
Measured: Week 0 to Week 16
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.
Measured: Week 0 to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jul 201822 Nov 2019

First posted19 Jun 2018
Study start13 Jul 2018
Primary completion17 Sep 2019
Study completion22 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Atopic DermatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 215 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03562377
Sponsor's protocol ID: LP0162-1341
Acronym: ECZTRA 5
Status last verified: Jan 2021
First submitted: 8 Jun 2018
Last updated: 11 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
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First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
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A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
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RecruitingPhase 3
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All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03562377
Acronym / sponsor ID: ECZTRA 5 / LP0162-1341
Conditions: Atopic Dermatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 215 participants (actual)
Lead sponsor: LEO PharmaIndustry (pharma, biotech, devices)
Study start: 13 Jul 2018 (actual)
Primary completion: 17 Sep 2019 (actual)
Study completion: 22 Nov 2019 (actual)
First posted: 19 Jun 2018 (actual)
Results: Posted 5 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Tralokinumab	Experimental	Drug: Tralokinumab, Biological: Tdap vaccine, Biological: Meningococcal vaccineWeek 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	Placebo comparator	Drug: Placebo, Biological: Tdap vaccine, Biological: Meningococcal vaccinePlacebo (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.

Who may qualify

Ages: 18 to 54 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (10 listed)

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 randomization
Treatment with systemic immunosuppressive/immunomodulating medications and/or systemic corticosteroids within 4 weeks prior to randomization

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TralokinumabTralokinumab 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.	Drug	Tralokinumab
PlaceboPlacebo contains the same excipients in the same concentration only lacking tralokinumab.	Drug	Placebo
Tdap vaccineTetanus (lockjaw), diphtheria (infection of the nose and throat), and pertussis (whooping cough) vaccine. All subjects will receive 1 dose at Week 12.	Biological	Placebo, Tralokinumab
Meningococcal vaccineThis 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.	Biological	Placebo, Tralokinumab

Primary outcome

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. 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
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. A positive response is defined as at least a 3-fold increase compared to Week 12.

4 secondary outcomes

Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
Time frame: Week 0 to Week 16
Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 16.
Time frame: Week 0 to Week 16
Number of AEs.
Time frame: Week 0 to Week 16
Presence of Anti-drug Antibodies (ADA).
Time frame: Week 0 to Week 16

Results and safety

Results posted to the registry on 5 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tralokinumab	107	100
Placebo	108	89

Primary outcome: Positive Anti-tetanus Response at Week 16

Time frame: Week 12 to Week 16. Count of participants. Unit: Participants

Measure	Tralokinumab n = 87	Placebo n = 76
Value	80	73

Tralokinumab vs Placebo: Risk Difference (RD): -4.1 (95% CI -11.3 to 3.1), Mantel Haenszel

Population analysed: The per protocol analysis set was used for the primary analysis, excluding participants who did not provide vaccine response data at Week 12 (1 participant in the tralokinumab group and 2 participants in the placebo group).

Primary outcome: Positive Anti-meningococcal Response at Week 16

Time frame: Week 12 to Week 16. Count of participants. Unit: Participants

Measure	Tralokinumab n = 86	Placebo n = 76
Value	74	64

Tralokinumab vs Placebo: Risk Difference (RD): 1.8 (95% CI -9.2 to 12.8), Mantel Haenszel

Population analysed: The per protocol analysis set was used for the primary analysis, excluding participants who did not provide vaccine response data at Week 12 (2 participants in each treatment group).

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were collected from time of first trial-related activity after the subject had signed the ICF until completion of the clinical trial (defined as the safety follow up visit at Week 30). Non-serious AEs possibly/probably related to IMP and ongoing at the time of trial completion were followed up for 2 weeks or until final outcome, whichever came first. Serious AEs were followed up until final outcome had been established.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tralokinumab	3 of 107 (2.8%)	27 of 107 (25.2%)	1 of 107
Placebo	3 of 107 (2.8%)	25 of 107 (23.4%)	0 of 107

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Atopic Dermatitis

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Expert study director

LEO Pharma

51 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tralokinumab, Tdap vaccine and Meningococcal vaccine in people with Atopic Dermatitis, run by LEO Pharma at 51 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive Anti-tetanus Response at Week 16 (time frame: Week 12 to Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03562377.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.