NCT06311682|RecruitingPhase 3DMCFDA Drug

A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and Infants With Moderate-to-severe Atopic Dermatitis

TRAPEDS 2

A Phase 3 Multi-center Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children (Age 2 to <12 Years) and Infants (Age 6 Months to <2 Years) With Moderate-to-severe Atopic Dermatitis. The Trial is Randomized, Double-blind, Placebo-controlled, and Parallel-group for Children (Age 2 to <12 Years) and Open-label and Single-group for Infants (Age 6 Months to <2 Years)

LEO Pharma ClinicalTrials.gov

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3 other identifiers

LP0162-1336U1111-1285-65592023-503630-44-00

Study Type

interventional

Target

195

Locations

13 countries

Sites

Timeline

RegisteredMar 2024

StartedJun 2024

CompletionApr 2028

Brief Summary

The purpose of this trial is to test whether treatment with tralokinumab (administered subcutaneous injections \[SC\]) in combination with topical corticosteroids (TCS) is safe and effective to treat moderate-to-severe atopic dermatitis (AD) in children and infants. This will be judged by a range of assessments that rate the severity and extent of atopic dermatitis and its symptoms, as well as general health status and quality of life. The trial will last for up to 4 years. There will be visits every 2 weeks for the first year and every 6 weeks thereafter. Some of the visits will be conducted by phone. The study involves two different age groups: children aged 2 to under 12 years and infants aged 6 months to under 2 years. This trial compares tralokinumab +TCS to placebo + TCS for children with moderate-to-severe AD and evaluates tralokinumab + TCS for infants with moderate-to-severe AD. Infants will not receive placebo. All subjects will go through a screening process, which is the first part of the trial and will last up to 4 weeks. During this period, it will be checked if the child or infant meets the criteria to participate in the trial. The children will be randomly assigned to receive tralokinumab + TCS or placebo + TCS for the initial 16 weeks, with the treatment being double-blinded. During the first 16 weeks, children will have a 2 out of 3 chance of getting tralokinumab and a 1 out of 3 chance of getting placebo. Thereafter, all subjects will receive tralokinumab + TCS. The infants will receive tralokinumab + TCS as open-label treatment for the entire treatment period, meaning that the participants will know they are receiving tralokinumab. After stopping treatment, all participants will enter a 4-week safety follow-up period.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

195

participants targeted

Target at P25-P50 for phase_3

Timeline

24mo left

Started Jun 2024

Typical duration for phase_3

Geographic Reach

13 countries

72 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.9 years study duration

Study Progress49%

Jun 2024Apr 2028

First Submitted

Initial submission to the registry

March 8, 2024

Completed

7 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed

3 months until next milestone

Study Start

First participant enrolled

June 10, 2024

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2026

Expected

1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2028

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

2.4 years

First QC Date

March 8, 2024

Last Update Submit

March 19, 2026

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening.
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
At week 16
Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
At week 16

Secondary Outcomes (95)

Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
At week 16
Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
At week 16
Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 6 month to <2 years at screening.
At week 16
Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
At week 16
Having at least 50% reduction in EASI score in subjects aged 2 to <12 years at screening.
At week 16
+90 more secondary outcomes

Study Arms (3)

Tralokinumab + TCS for subjects aged 2 to <12 years

EXPERIMENTAL

Dose and dosing frequency for each subject will depend on the subject's body weight.

Drug: Tralokinumab + TCS

Placebo + TCS for subjects aged 2 to <12 years

EXPERIMENTAL

Dose and dosing frequency for each subject will depend on the subject's body weight.

Drug: Placebo + TCS

Tralokinumab + TCS for subjects aged 6 months to <2 years

EXPERIMENTAL

Dose and dosing frequency for each subject will depend on the subject's body weight.

Drug: Tralokinumab + TCS

Interventions

Placebo + TCSDRUG

The trial medication will be given under the skin (SC). Dose and dosing frequency for each subject will depend on the subject's body weight. Subjects who will receive treatment every two weeks will receive a loading dose corresponding to a double dose at baseline. Subjects who will receive treatment every 4 weeks will receive a staggered loading dose at baseline and Week 2. After the loading dose, they will continue to receive treatment every 4 weeks. The dose and dosing frequency will be adjusted according to the subject's body weight at weeks 16, 32, 52, 64, 88, 112, 136, 160, and 184.

Placebo + TCS for subjects aged 2 to <12 years

Tralokinumab + TCSDRUG

Tralokinumab + TCS for subjects aged 2 to <12 yearsTralokinumab + TCS for subjects aged 6 months to <2 years

Eligibility Criteria

Age6 Months - 11 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Age 6 months to \<12 years at screening.
Body weight ≥9 kg at screening.
Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
History of AD for: ≥12 months for subjects aged ≥6 years at screening and ≥3 months for subjects aged 6 months to \<6 years at screening.
Documented inadequate response to mid-strength TCS within 6 months before the screening visit.
AD involvement of ≥10% body surface area at screening and baseline according to component A of SCORAD.
An EASI score of ≥16 at screening and baseline.
An IGA score of ≥3 at screening and baseline.
A Child Worst Itch NRS average score of ≥4 (subjects aged ≥6 years at screening) or a Scratch ObsRO average score of ≥4 (subjects aged \<6 years at screening) during the week prior to baseline.

You may not qualify if:

Treatment with the topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), topical phosphodiesterase-4 inhibitors (PDE-4), and topical Janus kinase inhibitors (JAK) within 1 week prior to baseline.
Treatment with bleach baths within 1 week prior to baseline.
Treatment with the immunomodulatory medications systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, Janus kinase inhibitors) and systemic corticosteroids (excludes inhaled, ophthalmic, or intranasal delivery) within 4 weeks prior to baseline.
Use of tanning beds or phototherapy within 4 weeks prior to baseline.
Treatment with a live (attenuated) or non-live vaccine within 30 days prior to the baseline visit.
Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment such as seborrheic dermatitis, active skin infection, scabies, cutaneous T cell lymphoma, or psoriasis.
Clinically significant active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals or antiprotozoal within 2 weeks before the baseline visit.
History of past or current hepatitis B or C including a positive hepatitis B or C test at screening.

Contact the study team to confirm eligibility.