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Atopic DermatitisPhase 3ECZTRA 7NCT03761537

Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7

A Phase 3 study testing Tralokinumab in people with Atopic Dermatitis, run by LEO Pharma at 74 sites in 7 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

Primary objective: To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating severe AD in subjects who are not adequately controlled with or have contraindications to oral cyclosporine A (CSA). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atopic Dermatitis
What is being tested?
Tralokinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
277 participants
Where
74 sitesin 7 countries
Study dates
13 Dec 2018to 28 Sep 2020
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 and above
  • Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD
  • History of AD for 1 year or more
  • Subjects with a history within 1 year prior to screening of inadequate response to treatment with topical medications or subjects for whom topical treatments are otherwise medically inadvisable
  • AD involvement of 10% (or more) body surface area at screening and baseline (visit 3) according to component A of SCORAD
  • Documented history of either no previous CSA exposure and not currently a candidate for CSA treatment OR previous exposure to CSA in which case CSA treatment should not be continued or restarted
  • 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 TCSs are medically inadvisable in the opinion of the investigator
  • Use of tanning beds or phototherapy (NBUVB, UVB, UVA1, PUVA), within 6 weeks prior to randomisation
  • Treatment with immunomodulatory medications or bleach baths within 4 weeks prior to randomisation
  • Treatment with topical phosphodiesterase-4 (PDE-4) inhibitor within 2 weeks prior to randomisation
  • Receipt of any marketed or investigational biologic agent (e.g. cell-depleting agents or dupilumab) within 6 months prior to randomisation or until cell counts return to normal, whichever is longer
  • History of any active skin infection within 1 week prior to randomisation
Show all 10Show fewer
  • History of a clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to randomisation
  • A helminth parasitic infection within 6 months prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy
  • Tuberculosis requiring treatment within the 12 months prior to screening. Evaluation will be according to local guidelines as per local standard of care
  • History of any known primary immunodeficiency disorder including a positive HIV test at screening, or the subject taking antiretroviral medications

Trial locations and contacts

74 sites in 7 countries.

74 sites in 7 countries

Poland16 sites

  • Leo Pharma Investigationel Site

    Bialystok, 15-375

  • Leo Pharma Investigationel Site

    Bochnia, 32-700

  • Leo Pharma Investigationel Site

    Bydgoszcz, 85-094

  • Leo Pharma Investigationel Site

    Gdansk, 80-546

  • Leo Pharma Investigationel Site

    Krakow, 30-149

  • Leo Pharma Investigationel Site

    Krakow, 31-530

  • Leo Pharma Investigationel Site

    Krakow, 31-559

  • Leo Pharma Investigationel Site

    Lodz, 90-242

  • Leo Pharma Investigationel Site

    Lodz, 90-752

  • Leo Pharma Investigationel Site

    Lublin, 20-081

  • Leo Pharma Investigationel Site

    Poznan, 60-369

  • Leo Pharma Investigationel Site

    Rzeszów, 35-312

  • Leo Pharma Investigationel Site

    Warsaw, 01-817

  • Leo Pharma Investigationel Site

    Warsaw, 02-625

  • Leo Pharma Investigationel Site

    Warsaw, 02-953

  • Leo Pharma Investigationel Site

    Wroclaw, 51-685

Other trials in Poland

Germany15 sites

  • Leo Pharma Investigationel Site

    Aachen, 52074

  • Leo Pharma Investigationel Site

    Augsburg, 86150

  • Leo Pharma Investigationel Site

    Bad Bentheim, 48455

  • Leo Pharma Investigationel Site

    Berlin, 10117,

  • Leo Pharma Investigationel Site

    Dresden, 01307

  • Leo Pharma Investigationel Site

    Dülmen, 48249

  • Leo Pharma Investigationel Site

    Frankfurt, 60590

  • Leo Pharma Investigationel Site

    Halle, 06097

  • Leo Pharma Investigationel Site

    Hanover, 30159

  • Leo Pharma Investigationel Site

    Jena, 07743

  • Leo Pharma Investigationel Site

    Kiel, 24105

  • Leo Pharma Investigationel Site

    Mainz, 55128

  • Leo Pharma Investigationel Site

    München, 80337

  • Leo Pharma Investigationel Site

    Osnabrück, 49074

  • Leo Pharma Investigationel Site

    Selters, 56242

Other trials in Germany

Spain12 sites

  • Leo Pharma Investigationel Site

    Alicante, 03010

  • Leo Pharma Investigationel Site

    Barcelona, 08036

  • Leo Pharma Investigationel Site

    Barcelona, 08041

  • Leo Pharma Investigationel Site

    Barcelona, 08907

  • Leo Pharma Investigationel Site

    Bilbao, 48013

  • Leo Pharma Investigationel Site

    Córdoba, 14004

  • Leo Pharma Investigationel Site

    Granada, Andalusia, 18014

  • Leo Pharma Investigationel Site

    Madrid, 28006

  • Leo Pharma Investigationel Site

    Madrid, 28046

  • Leo Pharma Investigationel Site

    Madrid, 28942

  • Leo Pharma Investigationel Site

    Pamplona, 31008

  • Leo Pharma Investigationel Site

    Seville, 41007

Other trials in Spain

Belgium11 sites

  • Leo Pharma Investigationel Site

    Brussels, 1090

  • Leo Pharma Investigationel Site

    Brussels, 1200

  • Leo Pharma Investigationel Site

    Edegem, 2650

  • Leo Pharma Investigationel Site

    Ghent, 9000

  • Leo Pharma Investigationel Site

    Ghent, B-9000

  • Leo Pharma Investigationel Site

    Herstal, B-4040

  • Leo Pharma Investigationel Site

    Kortrijk, 8500

  • Leo Pharma Investigationel Site

    Leuven, 3000

  • Leo Pharma Investigationel Site

    Liège, 4000

  • Leo Pharma Investigationel Site

    Loverval, 6280

  • Leo Pharma Investigationel Site

    Maldegem, 9990

Other trials in Belgium

Czechia9 sites

  • Leo Pharma Investigationel Site

    Karlovy Vary, 36001

  • Leo Pharma Investigationel Site

    Kutná Hora, 284 01

  • Leo Pharma Investigationel Site

    Ostrava, 70852

  • Leo Pharma Investigationel Site

    Pardubice, 53002

  • Leo Pharma Investigationel Site

    Prague, 11000

  • Leo Pharma Investigationel Site

    Prague, 120 00

  • Leo Pharma Investigationel Site

    Prague, 130 00

  • Leo Pharma Investigationel Site

    Prague, 15006

  • Leo Pharma Investigationel Site

    Prague, 180 81

Other trials in Czechia

United Kingdom6 sites

  • Leo Pharma Investigationel Site

    Bradford, BD5 0NA

  • Leo Pharma Investigationel Site

    Cottingham, HU16 5JQ

  • Leo Pharma Investigationel Site

    Kirkcaldy, KY2 5AH

  • Leo Pharma Investigationel Site

    London, E11 1NR

  • Leo Pharma Investigationel Site

    Southampton, SO16 6YD

  • Leo Pharma Investigationel Site

    Wakefield, WF1 4DG

Other trials in United Kingdom

France5 sites

  • Leo Pharma Investigationel Site

    Grenoble, 38000

  • Leo Pharma Investigationel Site

    Nice, 06202

  • Leo Pharma Investigationel Site

    Paris, 75010

  • Leo Pharma Investigationel Site

    Pierre-Bénite, 69495

  • Leo Pharma Investigationel Site

    Valence, 26000

Other trials in France

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre, Phase 3 Trial Investigating the Efficacy, Safety, and Tolerability of Tralokinumab Administered in Combination With Topical Corticosteroids to Adult Subjects With Severe Atopic Dermatitis

Primary objective:

To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating severe AD in subjects who are not adequately controlled with or have contraindications to oral cyclosporine A (CSA).

Secondary objectives:

To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, and health-related quality of life compared to placebo in combination with TCS.

To evaluate the safety of tralokinumab in combination with TCS when treating severe AD in subjects who are not adequately controlled with or have contraindications to oral CSA compared to placebo in combination with TCS.

Being tested
Tralokinumab, Placebo
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 (SC) administration.

  • PlaceboOther

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

Study groups in NCT03761537
Study groupRoleWhat they receive
Tralokinumab + TCSExperimental4 subcutaneous (SC) injections of tralokinumab 150 mg as a loading dose on Day 0, followed by 2 SC injections of tralokinumab 150 mg every 2 weeks (Q2W) regimen for 26 weeks. The last administration of the Investigational Medicinal Product (IMP) occurred at Week 24. From Day 0 to Week 24, a Topical corticosteroid (TCS) cream was dispensed to the participants at each IMP dosing visit (e.g., Q2W). Participants were instructed to treat active lesions as needed and to discontinue the TCS treatment when control was achieved.
Receives: Drug: Tralokinumab
Placebo + TCSPlacebo comparator4 subcutaneous (SC) injections of placebo as a loading dose on Day 0, followed by 2 SC injections of placebo every 2 weeks (Q2W) regimen for 26 weeks. The last administration of the Investigational Medicinal Product (IMP) occurred at Week 24. From Day 0 to Week 24, a Topical corticosteroid (TCS) cream was dispensed to the participants at each IMP dosing visit (e.g., Q2W). Participants were instructed to treat active lesions as needed and to discontinue the TCS treatment when control was achieved.
Receives: Other: Placebo

What is being measured

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

  1. At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 16

    EASI (Eczema Area and Severity Index) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. 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

Secondary outcomes (11)

  1. Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 16

    Subjects will assess their worst itch severity over the past 24 hours using an 11-point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.

    Measured: Week 0 to Week 16

  2. Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 16

    SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.

    Measured: Week 0 to Week 16

  3. Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 16

    DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their health-related quality of life (HRQoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = not at all ∕not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor HRQoL.

    Measured: Week 0 to Week 16

  4. Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16

    IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

    Measured: Week 16

  5. At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 26

    EASI (Eczema Area and Severity Index) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. 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 26

  6. Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 26

    Subjects will assess their worst itch severity over the past 24 hours using an 11-point numeric rating scale ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.

    Measured: Week 0 to Week 26

  7. Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 26

    SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.

    Measured: Week 0 to Week 26

  8. Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 26

    DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their health-related quality of life (HRQoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = not at all ∕not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor HRQoL.

    Measured: Week 0 to Week 26

  9. Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 26

    IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

    Measured: Week 26

  10. Frequency of Anti-drug Antibodies (ADA) From Week 0 to Week 40

    Presence of ADA from Week 0 to Week 40 was measured. 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 40

  11. Number of Adverse Events From Week 0 to Week 40

    All adverse events are presented below under Adverse Events

    Measured: Week 0 to Week 40

Timeline

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

  1. First posted3 Dec 2018
  2. Study start13 Dec 2018
  3. Primary completion21 Apr 2020
  4. Study completion28 Sep 2020

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
277 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03761537
Sponsor's protocol ID
LP0162-1346
Acronym
ECZTRA 7
Status last verified
May 2023
First submitted
30 Nov 2018
Last updated
11 Mar 2025
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tralokinumab in people with Atopic Dermatitis, run by LEO Pharma at 74 sites in 7 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 7 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 74 sites in Poland, Germany, Spain, Belgium, Czechia and 2 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 26 Oct 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?

At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 16 (time frame: Week 0 to Week 16). 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 NCT03761537.

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.

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