Tralokinumab monotherapy for children with moderate-to-severe atopic dermatitis. TRAPEDS 1 (TRAlokinumab PEDiatric trial no. 1)

A single (assessor) blinded, randomised, parallel-group, monotherapy trial to evaluate the pharmacokinetic and safety of tralokinumab in children (age 2 to <12 years) with moderate-to-severe atopic dermatitis. - TRAPEDS 1

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005573-12-CZ

Enrollment

Registered

2022-04-20

Start date

2022-09-02

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic dermatitis MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858

Interventions

Product Name: Tralokinumab Product Code: CAT-354 Pharmaceutical Form: Solution for injection INN or Proposed INN: Tralokinumab CAS Number: 1044515-88-9 Other descriptive name: CAT-354 Concentration un

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Diagnosis of AD (as defined by Hanifin and Rajka criteria for AD). - Age 2 to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To establish the PK profile after multiple SC administrations of tralokinumab in children with moderate-to-severe AD.;Secondary Objective: To assess the safety and tolerability of multiple SC administrations of tralokinumab in children with moderate-to-severe AD.;Primary end point(s): Primary Endpoints (PK parameters): - Trough concentration (Ctrough) at Week 16. - Maximum serum concentration (Cmax) between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).* - Area under the curve (AUC) between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).* - Time to maximum serum concentration (Tmax) between Week 12-Week14 for Q2W (Week 12-Week 16 for Q4W).* The endpoint will also be summarised by dosing interval within the low dose level ;Timepoint(s) of evaluation of this end point: Primary Endpoints (PK parameters): - Trough concentration (Ctrough) at Week 16. - Maximum serum concentration (Cmax) between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W). - Area under the curve (AUC) between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).* - Time to maximum serum concentration (Tmax) between Week 12-Week14 for Q2W (Week 12-Week 16 for Q4W).* *The endpoint will also be summarised by dosing interval within the low dose level	—

Measure

Time frame

Main Objective: To establish the PK profile after multiple SC administrations of tralokinumab in children with moderate-to-severe AD.;Secondary Objective: To assess the safety and tolerability of multiple SC administrations of tralokinumab in children with moderate-to-severe AD.;Primary end point(s): Primary Endpoints (PK parameters): - Trough concentration (Ctrough) at Week 16. - Maximum serum concentration (Cmax) between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).* - Area under the curve (AUC) between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).* - Time to maximum serum concentration (Tmax) between Week 12-Week14 for Q2W (Week 12-Week 16 for Q4W).* *The endpoint will also be summarised by dosing interval within the low dose level ;Timepoint(s) of evaluation of this end point: Primary Endpoints (PK parameters): - Trough concentration (Ctrough) at Week 16. - Maximum serum concentration (Cmax) between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).* - Area under the curve (AUC) between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).* - Time to maximum serum concentration (Tmax) between Week 12-Week14 for Q2W (Week 12-Week 16 for Q4W).* *The endpoint will also be summarised by dosing interval within the low dose level

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Secondary

Measure	Time frame
Secondary end point(s): To assess the safety and tolerability of multiple SC administrations of tralokinumab in children with moderate-to-severe AD. To evaluate the efficacy of tralokinumab on severity and extent of AD, and on patient-reported outcomes, in children with moderate-to-severe AD.;Timepoint(s) of evaluation of this end point: Secondary Endpoints: - Number of treatment emergent adverse events in the initial treatment period (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 (Week 16-Week 68). - Anti-drug antibodies (status) in the open-label treatment period (Week 16-Week 68) - Change in SCORAD from Week 0-Week 68. - Change in POEM from Week 0-Week 68. - Change in EASI from Week 0 to Week 68.	—

Measure

Time frame

Secondary end point(s): To assess the safety and tolerability of multiple SC administrations of tralokinumab in children with moderate-to-severe AD. To evaluate the efficacy of tralokinumab on severity and extent of AD, and on patient-reported outcomes, in children with moderate-to-severe AD.;Timepoint(s) of evaluation of this end point: Secondary Endpoints: - Number of treatment emergent adverse events in the initial treatment period (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 (Week 16-Week 68). - Anti-drug antibodies (status) in the open-label treatment period (Week 16-Week 68) - Change in SCORAD from Week 0-Week 68. - Change in POEM from Week 0-Week 68. - Change in EASI from Week 0 to Week 68.

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Countries

Czechia, Czech Republic, France, Netherlands, Spain, United Kingdom

Contacts

Public ContactGlobal Regulatory Affairs

LEO Pharma A/S

raleodk@leo-pharma.com+4544945855

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026