NCT05388760|Active Not RecruitingPhase 2DMCFDA Drug

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

LEO Pharma ClinicalTrials.gov

Compare

4 other identifiers

LP0162-13352021-005573-12U1111-1282-43942024-512791-36-00

Study Type

interventional

Target

Locations

5 countries

Sites

Timeline

RegisteredMay 2022

StartedSep 2022

CompletionApr 2026

Brief 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. 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.

Trial Health

Monitor

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Sep 2022

Typical duration for phase_2

Geographic Reach

5 countries

11 active sites

Status

active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.6 years study duration

First Submitted

Initial submission to the registry

May 19, 2022

Completed

5 days until next milestone

First Posted

Study publicly available on registry

May 24, 2022

Completed

4 months until next milestone

Study Start

First participant enrolled

September 7, 2022

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2023

Completed

2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2026

Completed

Last Updated

January 26, 2026

Status Verified

November 1, 2025

Enrollment Period

1.1 years

First QC Date

May 19, 2022

Last Update Submit

January 21, 2026

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (4)

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 Outcomes (7)

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 Scoring Atopic Dermatitis (SCORAD)
from Week 0-Week 68
+2 more secondary outcomes

Study Arms (2)

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

Interventions

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.

Cohort 1 (6 to <12 years) - tralokinumab dose regimen ACohort 1 (6 to <12 years) - tralokinumab dose regimen B

Eligibility Criteria

Age6 Years - 11 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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.

You may not qualify if:

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).
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.
+1 more criteria

Contact the study team to confirm eligibility.