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)

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503630-44-00

Acronym

LP0162-1336

Enrollment

112

Registered

2024-10-07

Start date

2024-11-20

Completion date

Unknown

Last updated

2025-11-05

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

Conditions

Treatment of moderate-to-severe Atopic dermatitis

Brief summary

IGA 0/1 at Week 16, EASI75 at Week 16

Interventions

DRUGAdtralza 150 mg solution for injection in pre-filled syringe

DRUGThe placebo presentation is a pre-filled syringe containing the same excipients in the same amounts as the IMP.

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
IGA 0/1 at Week 16, EASI75 at Week 16	—

Countries

Belgium, Croatia, Czechia, Denmark, Germany, Ireland, Italy, Netherlands, Poland, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026