Atopic DermatitisPhase 3ECZTRA 8NCT04587453
Tralokinumab in Combination With Topical Corticosteroids in Japanese Subjects With Moderate-to-severe Atopic Dermatitis
A Phase 3 study testing Tralokinumab and Topical corticosteroids (TCS) in people with Atopic Dermatitis, run by LEO Pharma at 25 sites in Japan.
Trial summary
Primary objective: To evaluate the efficacy of tralokinumab in combination with topical corticosteroids (TCS) compared with placebo in combination with TCS in treating moderate-to-severe atopic dermatitis (AD). 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 and Topical corticosteroids (TCS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 25 sitesJapan
- Study dates
- 27 Oct 2020to 15 Jul 2021
- 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
- Japanese subject aged 18 years and above.
- Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
- History of AD for 1 year or more.
- A recent history (within 1 year before screening) of inadequate response to treatment with topical medication.
- AD involvement of 10% or more body surface area at screening and at baseline according to component A of SCORAD.
- 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 TCS are medically inadvisable e.g. due to important side effects or safety risks in the opinion of the investigator.
- 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 drugs and/or systemic corticosteroids within 4 weeks prior to randomisation.
- Treatment with TCS, topical calcineurin inhibitors, topical phosphodiesterase-4 inhibitors, or topical Janus kinase inhibitors within 2 weeks prior to randomisation.
- Receipt of any marketed biological therapy (i.e. immunoglobulin, anti-immunoglobulin E) including dupilumab or investigational biologic agents 3 to 6 months prior to randomisation.
Show all 11Show fewer
- Active skin infections within 1 week prior to randomisation.
- Clinically significant infection within 4 weeks prior to randomisation.
- A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
- Tuberculosis requiring treatment within the 12 months prior to screening.
- Known primary immunodeficiency disorder.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Japan25 sites
LEO Investigational Site
Asahikawa, Hokkaido, 070-8610
LEO Investigational Site
Chikushino-shi, Fukuoka, 818-0083
LEO Investigational Site
Chuo-Ku-Sapporo, Hokkaido, 060-0063
LEO Investigational Site
Fukuoka, 814-0171
LEO Investigational Site
Ichikawa, Chiba, 272-0143
LEO Investigational Site
Ichikawa-shi, Chiba, 272-0033
LEO Investigational Site
Kagoshima, Kagoshima-ken, 890-0063
LEO Investigational Site
Kamigyō-ku, Kyoto, 602-8566
LEO Investigational Site
Kawasaki-shi, Kanagawa, 211-0063
LEO Investigational Site
Koto-ku, Tokyo, 136-0074
LEO Investigational Site
Nagoya, Aichi-ken, 457-8510
LEO Investigational Site
Nishinomiya, Hyōgo, 663-8186
LEO Investigational Site
Nonoichi, Ishikawa-ken, 921-8801
LEO Investigational Site
Obihiro-shi, Hokkaido, 080-0013
LEO Investigational Site
Osaka, Osaka, 532-0003
LEO Investigational Site
Sakai-shi, Osaka, 593-8324
LEO Investigational Site
Sapporo, Hokkaido, 060-0807
LEO Investigational Site
Sapporo, Hokkaido, 063-0812
LEO Investigational Site
Setagaya City, Tokyo, 158-0097
LEO Investigational Site
Shinjuku-ku, Tokyo, 160-0023
LEO Investigational Site
Shinjuku-ku, Tokyo, 169-0075
LEO Investigational Site
Tokyo, Minato, 108-0014
LEO Investigational Site
Toyonaka-shi, Osaka, 560-0085
LEO Investigational Site
Yokohama, Kanagawa, 220-6208
LEO Investigational Site
Yokohama, Kanagawa, 221-0825
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Japanese Subjects With Moderate-to-severe Atopic Dermatitis Who Are Candidates for Systemic Therapy
Primary objective:
To evaluate the efficacy of tralokinumab in combination with topical corticosteroids (TCS) compared with placebo in combination with TCS in treating moderate-to-severe atopic dermatitis (AD).
Secondary objectives:
To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, health-related quality of life, and health care resource utilisation compared with placebo in combination with TCS.
To assess the safety of tralokinumab in combination with TCS when used to treat moderate-to-severe AD for 16 weeks.
- Conditions
- Atopic Dermatitis
- Being tested
- Tralokinumab, Placebo, Topical corticosteroids (TCS)
- 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 immunoglobulin G4 subclass that specifically binds to human interleukin-13 (IL-13) and blocks the interaction with 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.
Topical corticosteroids (TCS)Other
TCS administered as needed.
| Study group | Role | What they receive |
|---|---|---|
| Tralokinumab+TCS | Experimental | Week 0 to Week 16: Tralokinumab will be given as subcutaneous injections. Participants will receive tralokinumab loading dose on Day 0 followed by multiple tralokinumab injections. The last administration will occur at Week 14. Topical corticosteroids (TCS) will be administered as needed. Receives: Drug: Tralokinumab; Other: Topical corticosteroids (TCS) |
| Placebo+TCS | Placebo comparator | Week 0 to Week 16: Placebo will be given as subcutaneous injections. Participants will receive placebo loading dose on Day 0 followed by multiple placebo injections. The last administration will occur at Week 14. Topical corticosteroids (TCS) will be administered as needed. Receives: Drug: Placebo; Other: Topical corticosteroids (TCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 participant's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: Week 16
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16
Eczema Area and Severity Index (EASI) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. EASI is a composite index with scores ranging from 0 to 72, where higher values indicate a more severe or more extensive condition.
Measured: Week 0 to Week 16
Secondary outcomes (11)
Change in Scoring Atopic Dermatitis (SCORAD) Total Score From Baseline to Week 16
SCORAD is a validated tool to evaluate the AD disease based on 3 components:
- A) The extent of AD lesions. Assessed as percentage of each defined body area and reported as sum of all areas (max score = 100%).
- B) The severity of AD lesions. The intensity of 6 specific symptoms on a representative area was assessed using the scale: 0 = none/absent, 1 = mild, 2 = moderate, 3 = severe (max score = 18).
- C) Subjective symptoms. The itch and sleeplessness over the last 3 days/nights was recorded for each symptom by the subject on a VAS scale: 0 = no itch or trouble sleeping, 10 = unbearable itch or a lot of trouble sleeping (max score = 20).
The SCORAD was calculated as: A/5+7B/2+C. The maximum total score is 103, with higher values indicating more severe disease.
Measured: Week 0 to Week 16
Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16.
DLQI consists of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their health-related quality of life over the past 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 (ranging from 0 to 30), with higher scores indicating poorer health-related quality of life.
Measured: Week 0 to Week 16
Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) Score (Weekly Average) of at Least 4 From Baseline to Week 16
Participants assessed the itch for the past 24 hours using the Worst Daily Pruritus NRS, consisting of 11 points, with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.
Measured: Week 0 to Week 16
At Least 90% Reduction in EASI (EASI90) at Week 16
EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. EASI is a composite index with scores ranging from 0 to 72, where higher values indicate a more severe or more extensive condition.
Measured: Week 0 to Week 16
At Least 50% Reduction in EASI (EASI50) at Week 16
EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. EASI is a composite index with scores ranging from 0 to 72, where higher values indicate a more severe or more extensive condition.
Measured: Week 0 to Week 16
Percentage Change in EASI Score From Baseline to Week 16
EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. EASI is a composite index with scores ranging from 0 to 72, where higher values indicate a more severe or more extensive condition.
Measured: Week 0 to Week 16
Change in Worst Daily Pruritus NRS Score (Weekly Average) From Baseline to Week 16
Participants assessed the itch for the past 24 hours using the Worst Daily Pruritus NRS, consisting of 11 points, with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.
Measured: Week 0 to Week 16
Change in Eczema-related Sleep NRS Score (Weekly Average) From Baseline to Week 16
Participants rated how much their eczema interfered with their sleep the last night using an 11-point NRS (0 indicating that it 'did not interfere' and 10 indicating that it 'completely interfered').
Measured: Week 0 to Week 16
Change in Patient-Oriented Eczema Measure (POEM) Score Form Baseline to Week 16
POEM consists of 7 items, each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Participants score how often they have experienced each symptom over the previous week, using a 5-point categorical response scale (0=no days; 1=1 to 2 days; 2=3 to 4 days; 3=5 to 6 days; 4=every day). The total score is the sum of the 7 items (ranging from 0 to 28) and reflects disease-related morbidity; higher scores indicate more severe disease.
Measured: Week 0 to Week 16
Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject
Number of events divided by patient years of exposure (= rate).
Measured: Week 0 to Week 16
Number of Subjects With Presence of Treatment-emergent Anti-drug Antibodies (ADA) From Baseline to Week 16
Anti-tralokinumab antibody levels were analyzed using a validated bioanalytical method. Positive treatment-emergent ADA was defined as ADA negative or missing at baseline, and at least one positive post-baseline ADA response. Negative treatment-emergent ADA was defined as ADA negative or missing at baseline, and all post-baseline ADA assessments negative.
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.
- First posted14 Oct 2020
- Study start27 Oct 2020
- Primary completion6 Jul 2021
- Study completion15 Jul 2021
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587453
- Sponsor's protocol ID
- LP0162-1343
- Acronym
- ECZTRA 8
- Status last verified
- Aug 2022
- First submitted
- 29 Sep 2020
- 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
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, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Japanese Subjects With Moderate-to-severe Atopic Dermatitis Who Are Candidates for Systemic Therapy
- ClinicalTrials.gov ID
- NCT04587453
- Acronym / sponsor ID
- ECZTRA 8 / LP0162-1343
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 6 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Posted 22 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective:
To evaluate the efficacy of tralokinumab in combination with topical corticosteroids (TCS) compared with placebo in combination with TCS in treating moderate-to-severe atopic dermatitis (AD).
Secondary objectives:
To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, health-related quality of life, and health care resource utilisation compared with placebo in combination with TCS.
To assess the safety of tralokinumab in combination with TCS when used to treat moderate-to-severe AD for 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tralokinumab+TCS | Experimental | Drug: Tralokinumab, Other: Topical corticosteroids (TCS)Week 0 to Week 16: Tralokinumab will be given as subcutaneous injections. Participants will receive tralokinumab loading dose on Day 0 followed by multiple tralokinumab injections. The last administration will occur at Week 14. Topical corticosteroids (TCS) will be administered as needed. |
| Placebo+TCS | Placebo comparator | Drug: Placebo, Other: Topical corticosteroids (TCS)Week 0 to Week 16: Placebo will be given as subcutaneous injections. Participants will receive placebo loading dose on Day 0 followed by multiple placebo injections. The last administration will occur at Week 14. Topical corticosteroids (TCS) will be administered as needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Japanese subject aged 18 years and above.
- Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
- History of AD for 1 year or more.
- A recent history (within 1 year before screening) of inadequate response to treatment with topical medication.
- AD involvement of 10% or more body surface area at screening and at baseline according to component A of SCORAD.
Key exclusion criteria (11 listed)
- Subjects for whom TCS are medically inadvisable e.g. due to important side effects or safety risks in the opinion of the investigator.
- 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 drugs and/or systemic corticosteroids within 4 weeks prior to randomisation.
- Treatment with TCS, topical calcineurin inhibitors, topical phosphodiesterase-4 inhibitors, or topical Janus kinase inhibitors within 2 weeks prior to randomisation.
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 immunoglobulin G4 subclass that specifically binds to human interleukin-13 (IL-13) and blocks the interaction with IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration. | Drug | Tralokinumab+TCS |
| PlaceboPlacebo contains the same excipients in the same concentration only lacking tralokinumab. | Drug | Placebo+TCS |
| Topical corticosteroids (TCS)TCS administered as needed. | Other | Placebo+TCS, Tralokinumab+TCS |
Primary outcome
Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
Time frame: Week 16
IGA is an instrument used in clinical trials to rate the severity of the participant's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16
Time frame: Week 0 to Week 16
Eczema Area and Severity Index (EASI) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. EASI is a composite index with scores ranging from 0 to 72, where higher values indicate a more severe or more extensive condition.
11 secondary outcomes
Change in Scoring Atopic Dermatitis (SCORAD) Total Score From Baseline to Week 16
Time frame: Week 0 to Week 16
Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16.
Time frame: Week 0 to Week 16
Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) Score (Weekly Average) of at Least 4 From Baseline to Week 16
Time frame: Week 0 to Week 16
At Least 90% Reduction in EASI (EASI90) at Week 16
Time frame: Week 0 to Week 16
At Least 50% Reduction in EASI (EASI50) at Week 16
Time frame: Week 0 to Week 16
Percentage Change in EASI Score From Baseline to Week 16
Time frame: Week 0 to Week 16
Change in Worst Daily Pruritus NRS Score (Weekly Average) From Baseline to Week 16
Time frame: Week 0 to Week 16
Change in Eczema-related Sleep NRS Score (Weekly Average) From Baseline to Week 16
Time frame: Week 0 to Week 16
Change in Patient-Oriented Eczema Measure (POEM) Score Form Baseline to Week 16
Time frame: Week 0 to Week 16
Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject
Time frame: Week 0 to Week 16
Number of Subjects With Presence of Treatment-emergent Anti-drug Antibodies (ADA) From Baseline to Week 16
Time frame: Week 0 to Week 16
Results and safety
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
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tralokinumab and Topical corticosteroids (TCS) in people with Atopic Dermatitis, run by LEO Pharma at 25 sites in Japan.
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 6 inclusion and 11 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 25 sites in Japan. 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 22 Sep 2022). 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?
Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16 (time frame: 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?
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.