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

Conditions

• Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

6 Months - 11 Years

Healthy Volunteers

Not accepted

Interventions

• Tralokinumab + TCS — DRUG
  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 — DRUG
  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.

Study Details

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.

Key Dates

Start date

Jun 10, 2024

Status verified

Mar 2026

Primary completion

Oct 20, 2026

Completion

Apr 28, 2028

Study Design

Enrollment

195 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tralokinumab + TCS for subjects aged 2 to <12 years
  Dose and dosing frequency for each subject will depend on the subject's body weight.
• Experimental: Placebo + TCS for subjects aged 2 to <12 years
  Dose and dosing frequency for each subject will depend on the subject's body weight.
• Experimental: Tralokinumab + TCS for subjects aged 6 months to <2 years
  Dose and dosing frequency for each subject will depend on the subject's body weight.

Primary Outcome Measure

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. [ Time Frame: At week 16 ]

Central Contacts

• Clinical Disclosure
  +45 4494 5888
  [email protected]

Locations (15)

Find similar trials in Birmingham, AL

Related Studies

• Ethnic Differences in Mechanisms of Action of Dupilumab
  PHASE4 · Recruiting · University of Michigan · Ann Arbor, Michigan
• A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
  PHASE3 · Enrolling By Invitation · Eli Lilly and Company · Birmingham, Alabama
• Molecular Signatures of Cutaneous Dupilumab Response
  PHASE4 · Recruiting · University of California, San Francisco · San Francisco, California
• Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT
  Recruiting · University of California, San Diego · La Jolla, California