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

Official title

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)

Overview

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.

Interventions

• Drug Tralokinumab + TCS
  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 adjust
• Drug Placebo + TCS
  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 adjust

Primary outcome measures

• 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]
• Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening. [Time frame: At week 16]

Secondary outcome measures (12)

• Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: At week 16]
• Having at least 50% reduction in EASI score in subjects aged 2 to <12 years at screening. [Time frame: At week 16]
• Having at least 50% reduction in EASI score in subjects aged 6 month to <2 years at screening. [Time frame: At week 16]
• Percent change in EASI in subjects aged 2 to <12 years at screening. [Time frame: From baseline to week 16]
• Percent change in EASI in subjects aged 6 month to <2 years at screening. [Time frame: From baseline to week 16]
• Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 2 to <12 years at screening. [Time frame: From baseline to week 16]
• Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 6 month to <2 years at screening. [Time frame: From baseline to week 16]
• Percent change in affected BSA in subjects aged 2 to <12 years at screening. [Time frame: From baseline to week 16]
• Percent change in affected BSA in subjects aged 6 month to <2 years at screening. [Time frame: From baseline to week 16]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 15 centers

• Leo Pharma Investigational site — Birmingham
• Leo Pharma Investigational site — North Little Rock
• Leo Pharma Investigational site — Palo Alto
• Leo Pharma Investigational site — Sacramento
• Leo Pharma Investigational site — San Diego
• Leo Pharma Investigational site — San Diego
• Leo Pharma Investigational site — Jacksonville
• Leo Pharma Investigational site — Miami
• … and 7 more centers

Canada · 10 centers

• Leo Pharma Investigational site — Burlington
• Leo Pharma Investigational site — Calgary
• Leo Pharma Investigational site — Calgary
• Leo Pharma Investigational site — Edmonton
• Leo Pharma Investigational site — Edmonton
• Leo Pharma Investigational site — Hamilton
• Leo Pharma Investigational site — Niagara Falls
• Leo Pharma Investigational site — Saskatoon
• … and 2 more centers

South Korea · 9 centers

• Leo Pharma Investigational site — Ansan-si
• Leo Pharma Investigational site — Gwangju
• Leo Pharma Investigational site — Seoul
• Leo Pharma Investigational site — Seoul
• Leo Pharma Investigational site — Seoul
• Leo Pharma Investigational site — Seoul
• Leo Pharma Investigational site — Seoul
• Leo Pharma Investigational site — Seoul
• … and 1 more center

Poland · 8 centers

• Leo Pharma Investigational site — Gdansk
• Leo Pharma Investigational site — Krakow
• Leo Pharma Investigational site — Lodz
• Leo Pharma Investigational site — Ostrowiec Świętokrzyski
• Leo Pharma Investigational site — Rzeszów
• Leo Pharma Investigational site — Tarnów
• Leo Pharma Investigational site — Warsaw
• Leo Pharma Investigational site — Warsaw

Germany · 6 centers

• Leo Pharma Investigational site — Buxtehude
• Leo Pharma Investigational site — Dresden
• Leo Pharma Investigational site — Mainz
• Leo Pharma Investigational site — Osnabrück
• Leo Pharma Investigational site — Tübingen
• Leo Pharma Investigational site — Wuppertal

Italy · 5 centers

• Leo Pharma Investigational site — Ancona
• Leo Pharma Investigational site — Brescia
• Leo Pharma Investigational site — Padova
• Leo Pharma Investigational site — Roma
• Leo Pharma Investigational site — Rome

Belgium · 4 centers

• Leo Pharma Investigational site — Brussels
• Leo Pharma Investigational site — Ghent
• Leo Pharma Investigational site — Leuven
• Leo Pharma Investigational site — Liège

United Kingdom · 4 centers

• Leo Pharma Investigational site — Lincoln
• Leo Pharma Investigational site — London
• Leo Pharma Investigational site — Sheffield
• Leo Pharma Investigational site — Southampton

Croatia · 3 centers

• Leo Pharma Investigational site — Rijeka
• Leo Pharma Investigational site — Zagreb
• Leo Pharma Investigational site — Zagreb

Spain · 3 centers

• Leo Pharma Investigational site — Alicante
• Leo Pharma Investigational site — Madrid
• Leo Pharma Investigational site — Valencia

Ireland · 2 centers

• Leo Pharma Investigational site — Cork
• Leo Pharma Investigational site — Crumlin

Romania · 2 centers

• Leo Pharma Investigational site — Brasov
• Leo Pharma Investigational site — Iași

Netherlands · 1 center

• Leo Pharma Investigational site — Utrecht

Identifiers

NCT: NCT06311682 · LP0162-1336 · U1111-1285-6559 · 2023-503630-44-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗