Atopic DermatitisPhase 2NCT05388760
Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1)
A Phase 2 study testing Tralokinumab in people with Atopic Dermatitis, run by LEO Pharma at 11 sites in 5 countries.
Trial summary
The main purpose of this trial is to investigate what happens to the trial drug in the body and to confirm that it is safe to use and effective for treating atopic dermatitis (AD) in children. The trial will last up to maximum of approximately 194 weeks, and there will be up to 59 visits. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Tralokinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 7 Sep 2022to 29 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of AD (as defined by Hanifin and Rajka criteria for AD).
- Age 6 to <12 years at time of the baseline visit.
- Body weight at baseline of ≥17 kg.
- History of AD for ≥ 12 months at screening.
- History of TCS and/or TCI treatment failure (due to inadequate response or intolerance) or subjects for whom these topical AD treatments are medically inadvisable.
- AD involvement of ≥10% body surface area at screening and baseline.
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- An EASI score of ≥16 at screening and at baseline.
- An Investigator's Global Assessment (IGA) score of ≥3 at screening and at baseline.
- Emollient twice daily (or more) for at least 14 days prior to baseline.
Who cannot join
- Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment.
- Treatment with topical PDE-4 inhibitor within 2 weeks prior to randomization.
- Treatment with the following immunomodulatory medications or bleach baths within 4 weeks prior to baseline:
- Systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, JAK inhibitors).
- Systemic corticosteroid use (excludes topical, inhaled, ophthalmic, or intranasal delivery).
- 3 or more bleach baths during any week within the 4 weeks.
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- Receipt of any marketed biological therapy or investigational biologic agents (including immunoglobulin, anti-IgE, or dupilumab):
- Any cell-depleting agents, including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer.
- Other biologics (including dupilumab): within 3 months or 5 halflives, whichever is longer, prior to baseline.
- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals, or antiprotozoals within 2 weeks before the baseline visit.
- History of malignancy at any time before the baseline visit.
- History of anaphylaxis following any biological therapy.
- History of immune complex disease.
- Active or suspected endoparasitic infections.
- History of past or current tuberculosis or other mycobacterial infection.
- Established diagnosis of a primary immunodeficiency disorder.
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
Spain3 sites
LEO Pharma Investigational Site
Alicante, 03010
LEO Pharma Investigational Site
Cadiz, Andalusia, 11009
LEO Pharma Investigational Site
Esplugues de Llobregat, Barcelona, 08950
United Kingdom3 sites
LEO Pharma Investigational Site
London, SE1 9RT
LEO Pharma Investigational Site
Manchester, Greater Manchester, M13 9WL
LEO Pharma Investigational Site
Sheffield, S10 2TH
Czechia2 sites
LEO Pharma Investigational Site
Brno, 625 00
LEO Pharma Investigational Site
Prague, 150 06
Netherlands2 sites
LEO Pharma Investigational Site
Rotterdam, 3011 TG
LEO Pharma Investigational Site
Utrecht, 3584 CX
About this study
Official title: A Single (Assessor) Blinded, Randomized, Parallel-group, Monotherapy Trial to Evaluate the Pharmacokinetics and Safety of Tralokinumab in Children (Age 6 to <12 Years) With Moderate-to-severe Atopic Dermatitis
The main purpose of this trial is to investigate what happens to the trial drug in the body and to confirm that it is safe to use and effective for treating atopic dermatitis (AD) in children.
The trial will last up to maximum of approximately 194 weeks, and there will be up to 59 visits. The visits will be held approximately every second week for the first 68 weeks, then the visits will be held every six weeks for the rest of the treatment period. From week 26, every second visit will be held by phone and every second visit will be held on site.
Read more
The first part of the trial is called a screening period and will last between 2 and 6 weeks. After the screening period, the trial drug will be administered to the child by subcutaneous (SC) injection. The treatment period with tralokinumab is divided in 3 parts: 1.) initial treatment period for 16 weeks, 2.) open-label treatment period for 52 weeks and 3.) long-term extension treatment period for up to 106 weeks followed by a 14-week safety follow-up period.
All children will use an emollient twice daily (or more) for at least 14 days prior to start of treatment and will continue this treatment throughout the trial. If medically necessary, rescue treatment for AD is allowed at the discretion of the trial doctor.
- Conditions
- Atopic Dermatitis
- Being tested
- Tralokinumab
- 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
A loading dose under the skin (s.c.) at first treatment visit and then injections in accordance with a pre-defined schedule for 16 weeks (initial treatment) followed by a maintenance treatment for 52 weeks (open-label treatment) and a long-term extension treatment period for up to 106 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (6 to <12 years) - tralokinumab dose regimen A | Experimental | Not described Receives: Drug: Tralokinumab |
| Cohort 1 (6 to <12 years) - tralokinumab dose regimen B | Experimental | Not described Receives: Drug: Tralokinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ctrough (trough concentration)
Measured: at Week 16
Cmax (maximum serum concentration)
Measured: between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W)
AUC (area under the curve)
Measured: between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W)
Tmax (time to maximum serum concentration)
Measured: between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W)
Secondary outcomes (7)
Number of treatment-emergent adverse events in the initial treatment period
An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An event will be considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
Measured: Week 0-Week 16
Anti-drug antibodies (status) in the initial treatment period
Measured: Week 0-Week 16
Number of treatment-emergent adverse events in the open-label treatment period
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An event will be considered treatment-emergent if started after the first use of IMP or if started before the first use of IMP and worsened in severity after first dose of IMP.
Measured: Week 16-Week 68
Anti-drug antibodies (status) in the open-label treatment period
Measured: Week 16-Week 68
Change in Scoring Atopic Dermatitis (SCORAD)
The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis (AD) lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
Measured: from Week 0-Week 68
Change in Patient-Oriented Eczema Measure (POEM)
The POEM is a validated questionnaire used to assess disease symptoms in atopic eczema patients in both clinical practice and clinical trials (30, 31). The tool consists of 7 items each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). POEM for proxy completion is used, where the caregiver will report their perception of how often the subject has experienced each symptom over the previous week on 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 (range 0 to 28) and reflects disease-related morbidity; a high score is indicative of a worse disease severity.
Measured: from Week 0-Week 68
Change in Eczema Area and Severity Index (EASI)
The EASI 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 or more extensive condition.
Measured: from Week 0-Week 68
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start7 Sep 2022
- Primary completion20 Oct 2023
- Study completion29 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 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
- NCT05388760
- Sponsor's protocol ID
- LP0162-1335
- Other IDs
- 2021-005573-12, U1111-1282-4394, 2024-512791-36-00
- Status last verified
- May 2026
- First submitted
- 19 May 2022
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single (Assessor) Blinded, Randomized, Parallel-group, Monotherapy Trial to Evaluate the Pharmacokinetics and Safety of Tralokinumab in Children (Age 6 to <12 Years) With Moderate-to-severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05388760
- Acronym / sponsor ID
- LP0162-1335
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this trial is to investigate what happens to the trial drug in the body and to confirm that it is safe to use and effective for treating atopic dermatitis (AD) in children.
The trial will last up to maximum of approximately 194 weeks, and there will be up to 59 visits. The visits will be held approximately every second week for the first 68 weeks, then the visits will be held every six weeks for the rest of the treatment period. From week 26, every second visit will be held by phone and every second visit will be held on site.
The first part of the trial is called a screening period and will last between 2 and 6 weeks. After the screening period, the trial drug will be administered to the child by subcutaneous (SC) injection. The treatment period with tralokinumab is divided in 3 parts: 1.) initial treatment period for 16 weeks, 2.) open-label treatment period for 52 weeks and 3.) long-term extension treatment period for up to 106 weeks followed by a 14-week safety follow-up period.
All children will use an emollient twice daily (or more) for at least 14 days prior to start of treatment and will continue this treatment throughout the trial. If medically necessary, rescue treatment for AD is allowed at the discretion of the trial doctor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (6 to <12 years) - tralokinumab dose regimen A | Experimental | Drug: Tralokinumab |
| Cohort 1 (6 to <12 years) - tralokinumab dose regimen B | Experimental | Drug: Tralokinumab |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Diagnosis of AD (as defined by Hanifin and Rajka criteria for AD).
- Age 6 to <12 years at time of the baseline visit.
- Body weight at baseline of ≥17 kg.
- History of AD for ≥ 12 months at screening.
- History of TCS and/or TCI treatment failure (due to inadequate response or intolerance) or subjects for whom these topical AD treatments are medically inadvisable.
Key exclusion criteria (16 listed)
- Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment.
- Treatment with topical PDE-4 inhibitor within 2 weeks prior to randomization.
- Treatment with the following immunomodulatory medications or bleach baths within 4 weeks prior to baseline:
- Receipt of any marketed biological therapy or investigational biologic agents (including immunoglobulin, anti-IgE, or dupilumab):
- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals, or antiprotozoals within 2 weeks before the baseline visit.
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 |
|---|---|---|
| TralokinumabA loading dose under the skin (s.c.) at first treatment visit and then injections in accordance with a pre-defined schedule for 16 weeks (initial treatment) followed by a maintenance treatment for 52 weeks (open-label treatment) and a long-term extension treatment period for up to 106 weeks. | Drug | Cohort 1 (6 to <12 years) - tralokinumab dose regimen A, Cohort 1 (6 to <12 years) - tralokinumab dose regimen B |
Primary outcome
Ctrough (trough concentration)
Time frame: at Week 16
Cmax (maximum serum concentration)
Time frame: between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W)
AUC (area under the curve)
Time frame: between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W)
Tmax (time to maximum serum concentration)
Time frame: between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W)
7 secondary outcomes
Number of treatment-emergent adverse events in the initial treatment period
Time frame: Week 0-Week 16
Anti-drug antibodies (status) in the initial treatment period
Time frame: Week 0-Week 16
Number of treatment-emergent adverse events in the open-label treatment period
Time frame: Week 16-Week 68
Anti-drug antibodies (status) in the open-label treatment period
Time frame: Week 16-Week 68
Change in Scoring Atopic Dermatitis (SCORAD)
Time frame: from Week 0-Week 68
Change in Patient-Oriented Eczema Measure (POEM)
Time frame: from Week 0-Week 68
Change in Eczema Area and Severity Index (EASI)
Time frame: from Week 0-Week 68
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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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
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tralokinumab in people with Atopic Dermatitis, run by LEO Pharma at 11 sites in 5 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 9 inclusion and 16 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 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain, United Kingdom, Czechia, Netherlands, France. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ctrough (trough concentration) (time frame: at Week 16). The study lists 4 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 14 May 2026.