Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1)

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.

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 Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Tralokinumab

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia, 625 00
    • LEO Pharma Investigational Site
  • Prague, Czechia, 150 06
    • LEO Pharma Investigational Site
• France
  • Ardennes
    • Reims, Ardennes, France, 51100
      • LEO Pharma Investigational Site
• Netherlands
  • Rotterdam, Netherlands, 3011 TG
    • LEO Pharma Investigational Site
  • Utrecht, Netherlands, 3584 CX
    • LEO Pharma Investigational Site
• Spain
  • Alicante, Spain, 03010
    • LEO Pharma Investigational Site
  • Andalusia
    • Cadiz, Andalusia, Spain, 11009
      • LEO Pharma Investigational Site
  • Barcelona
    • Esplugues de Llobregat, Barcelona, Spain, 08950
      • LEO Pharma Investigational Site
• United Kingdom
  • London, United Kingdom, SE1 9RT
    • LEO Pharma Investigational Site
  • Sheffield, United Kingdom, S10 2TH
    • LEO Pharma Investigational Site
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M13 9WL
      • LEO Pharma Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 11 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• 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.

Exclusion Criteria:

• 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.

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 (6 to <12 years) - tralokinumab dose regimen A	Drug: Tralokinumab; 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.
Experimental: Cohort 1 (6 to <12 years) - tralokinumab dose regimen B	Drug: Tralokinumab; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ctrough (trough concentration)	at Week 16
Cmax (maximum serum concentration)	between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W)
AUC (area under the curve)	between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W)
Tmax (time to maximum serum concentration)	between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 0-Week 16
Anti-drug antibodies (status) in the initial treatment period		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.	Week 16-Week 68
Anti-drug antibodies (status) in the open-label treatment period		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.	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.	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.	from Week 0-Week 68

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Study Director: Medical Expert, LEO Pharma

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2022
• Primary Completion (Actual): October 20, 2023
• Study Completion (Actual): April 29, 2026

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; tralokinumab
• Other Study ID Numbers: LP0162-1335; 2021-005573-12 (EudraCT Number); U1111-1282-4394 (Other Identifier: World Health Organization (WHO)); 2024-512791-36-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
• IPD Sharing Access Criteria: De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No