Back to Trials
NCT06311682PHASE3Recruiting

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

LEO Pharma

Start Date

6/10/2024

Completion Date

4/28/2028

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.

Eligibility Criteria

Age Range: No minimum to 11 years

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.

Interventions

DRUG

Tralokinumab + TCS

DRUG

Placebo + TCS

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Atopic Dermatitis

Locations

Leo Pharma Investigational site

Birmingham, Alabama 35209

United States

Leo Pharma Investigational site

North Little Rock, Arkansas 72117

United States

Leo Pharma Investigational site

Palo Alto, California 94304

United States

Leo Pharma Investigational site

Sacramento, California 95816

United States

Leo Pharma Investigational site

San Diego, California 92108

United States

Leo Pharma Investigational site

San Diego, California 92123

United States

Leo Pharma Investigational site

Jacksonville, Florida 32256

United States

Leo Pharma Investigational site

Miami, Florida 33156

United States

Leo Pharma Investigational site

Tampa, Florida 33613

United States

Leo Pharma Investigational site

Macon, Georgia 31217

United States

Leo Pharma Investigational site

Waterford, Michigan 48328

United States

Leo Pharma Investigational site

Tulsa, Oklahoma 74136

United States

Leo Pharma Investigational site

Portland, Oregon 97239

United States

Leo Pharma Investigational site

Charleston, South Carolina 27420

United States

Leo Pharma Investigational site

Norfolk, Virginia 23502

United States

Leo Pharma Investigational site

Brussels, 1020

Belgium

Leo Pharma Investigational site

Ghent, 9000

Belgium

Leo Pharma Investigational site

Leuven, 3000

Belgium

Leo Pharma Investigational site

Liège, 4000

Belgium

Leo Pharma Investigational site

Burlington, L7L 6W6

Canada

Leo Pharma Investigational site

Calgary, Calgary

Canada

Leo Pharma Investigational site

Calgary, T2J 7E1

Canada

Leo Pharma Investigational site

Edmonton, T5J 3S9

Canada

Leo Pharma Investigational site

Edmonton, T6G 1C3

Canada

Leo Pharma Investigational site

Hamilton, L8S 1G5

Canada

Leo Pharma Investigational site

Niagara Falls, L2H 1H5

Canada

Leo Pharma Investigational site

Saskatoon, S7K 2C1

Canada

Leo Pharma Investigational site

Windsor, N8X2G1

Canada

Leo Pharma Investigational site

Winnipeg, R3M 3Z4

Canada

Leo Pharma Investigational site

Rijeka, 51000

Croatia

Leo Pharma Investigational site

Zagreb, 10000

Croatia

Leo Pharma Investigational site

Zagreb, 10000

Croatia

Leo Pharma Investigational site

Buxtehude, 21614

Germany

Leo Pharma Investigational site

Dresden, 01307

Germany

Leo Pharma Investigational site

Mainz, 55131

Germany

Leo Pharma Investigational site

Osnabrück, 49074

Germany

Leo Pharma Investigational site

Tübingen, 72076

Germany

Leo Pharma Investigational site

Wuppertal, 42283

Germany

Leo Pharma Investigational site

Cork, T12 DFK4

Ireland

Leo Pharma Investigational site

Crumlin, D12N512

Ireland

Leo Pharma Investigational site

Ancona, 60126

Italy

Leo Pharma Investigational site

Brescia, 25123

Italy

Leo Pharma Investigational site

Padova, 35128

Italy

Leo Pharma Investigational site

Roma, 00168

Italy

Leo Pharma Investigational site

Rome, 00165

Italy

Leo Pharma Investigational site

Utrecht, 3584 CW

Netherlands

Leo Pharma Investigational site

Gdansk, 80-546

Poland

Leo Pharma Investigational site

Krakow, 30-002

Poland

Leo Pharma Investigational site

Lodz, 90-436

Poland

Leo Pharma Investigational site

Ostrowiec Świętokrzyski, 27-400

Poland

Leo Pharma Investigational site

Rzeszów, 35-055

Poland

Leo Pharma Investigational site

Tarnów, 33-100

Poland

Leo Pharma Investigational site

Warsaw, 02-953

Poland

Leo Pharma Investigational site

Warsaw, 02-962

Poland

Leo Pharma Investigational site

Brasov, 500091

Romania

Leo Pharma Investigational site

Iași, 700259

Romania

Leo Pharma Investigational site

Ansan-si, 15355

South Korea

Leo Pharma Investigational site

Gwangju, 61453

South Korea

Leo Pharma Investigational site

Seoul, 02447

South Korea

Leo Pharma Investigational site

Seoul, 03080

South Korea

Leo Pharma Investigational site

Seoul, 03722

South Korea

Leo Pharma Investigational site

Seoul, 05030

South Korea

Leo Pharma Investigational site

Seoul, 06273

South Korea

Leo Pharma Investigational site

Seoul, 06591

South Korea

Leo Pharma Investigational site

Seoul, 139-711

South Korea

Leo Pharma Investigational site

Alicante, 03010

Spain

Leo Pharma Investigational site

Madrid, 28046

Spain

Leo Pharma Investigational site

Valencia, 46014

Spain

Leo Pharma Investigational site

Lincoln, LN2 5QY

United Kingdom

Leo Pharma Investigational site

London, WC1N 3JH

United Kingdom

Leo Pharma Investigational site

Sheffield, S10 2TH

United Kingdom

Leo Pharma Investigational site

Southampton, SO16 6YD

United Kingdom