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Completed

NCT Number: NCT05388760

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

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

LEO Pharma Investigational Site, Brno, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tralokinumab

Drug

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.

Primary outcomes

  1. Ctrough (trough concentration)

    Time frame: at Week 16

  2. Cmax (maximum serum concentration)

    Time frame: between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W)

  3. AUC (area under the curve)

    Time frame: between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W)

  4. Tmax (time to maximum serum concentration)

    Time frame: between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W)

Secondary outcomes

  1. Number of treatment-emergent adverse events in the initial treatment period

    Time frame: Week 0-Week 16

    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.

  2. Anti-drug antibodies (status) in the initial treatment period

    Time frame: Week 0-Week 16

  3. Number of treatment-emergent adverse events in the open-label treatment period

    Time frame: Week 16-Week 68

    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.

  4. Anti-drug antibodies (status) in the open-label treatment period

    Time frame: Week 16-Week 68

  5. Change in Scoring Atopic Dermatitis (SCORAD)

    Time frame: from Week 0-Week 68

    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.

  6. Change in Patient-Oriented Eczema Measure (POEM)

    Time frame: from Week 0-Week 68

    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.

  7. Change in Eczema Area and Severity Index (EASI)

    Time frame: from Week 0-Week 68

    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.

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2026
First posted
May 24, 2022
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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