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
NCT ID: NCT06311682
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
195 participants
INTERVENTIONAL
2024-06-10
2028-04-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).
NCT03526861
Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 3
NCT03363854
Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7
NCT03761537
Tralokinumab in Combination With Topical Corticosteroids in Japanese Subjects With Moderate-to-severe Atopic Dermatitis
NCT04587453
Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1)
NCT05388760
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tralokinumab + TCS for subjects aged 2 to <12 years
Dose and dosing frequency for each subject will depend on the subject's body weight.
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 adjusted according to the subject's body weight at weeks 16, 32, 52, 64, 88, 112, 136, 160, and 184.
Placebo + TCS for subjects aged 2 to <12 years
Dose and dosing frequency for each subject will depend on the subject's body weight.
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 adjusted according to the subject's body weight at weeks 16, 32, 52, 64, 88, 112, 136, 160, and 184.
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.
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 adjusted according to the subject's body weight at weeks 16, 32, 52, 64, 88, 112, 136, 160, and 184.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 adjusted according to the subject's body weight at weeks 16, 32, 52, 64, 88, 112, 136, 160, and 184.
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 adjusted according to the subject's body weight at weeks 16, 32, 52, 64, 88, 112, 136, 160, and 184.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
6 Months
11 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
LEO Pharma
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Expert
Role: STUDY_DIRECTOR
LEO Pharma
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Leo Pharma Investigational site
Birmingham, Alabama, United States
Leo Pharma Investigational site
North Little Rock, Arkansas, United States
Leo Pharma Investigational site
Palo Alto, California, United States
Leo Pharma Investigational site
Sacramento, California, United States
Leo Pharma Investigational site
San Diego, California, United States
Leo Pharma Investigational site
San Diego, California, United States
Leo Pharma Investigational site
Jacksonville, Florida, United States
Leo Pharma Investigational site
Miami, Florida, United States
Leo Pharma Investigational site
Tampa, Florida, United States
Leo Pharma Investigational site
Macon, Georgia, United States
Leo Pharma Investigational site
Waterford, Michigan, United States
Leo Pharma Investigational site
Tulsa, Oklahoma, United States
Leo Pharma Investigational site
Portland, Oregon, United States
Leo Pharma Investigational site
Charleston, South Carolina, United States
Leo Pharma Investigational site
Norfolk, Virginia, United States
Leo Pharma Investigational site
Brussels, , Belgium
Leo Pharma Investigational site
Ghent, , Belgium
Leo Pharma Investigational site
Leuven, , Belgium
Leo Pharma Investigational site
Liège, , Belgium
Leo Pharma Investigational site
Burlington, , Canada
Leo Pharma Investigational site
Calgary, , Canada
Leo Pharma Investigational site
Calgary, , Canada
Leo Pharma Investigational site
Edmonton, , Canada
Leo Pharma Investigational site
Edmonton, , Canada
Leo Pharma Investigational site
Hamilton, , Canada
Leo Pharma Investigational site
Niagara Falls, , Canada
Leo Pharma Investigational site
Saskatoon, , Canada
Leo Pharma Investigational site
Windsor, , Canada
Leo Pharma Investigational site
Winnipeg, , Canada
Leo Pharma Investigational site
Rijeka, , Croatia
Leo Pharma Investigational site
Zagreb, , Croatia
Leo Pharma Investigational site
Buxtehude, , Germany
Leo Pharma Investigational site
Dresden, , Germany
Leo Pharma Investigational site
Mainz, , Germany
Leo Pharma Investigational site
Osnabrück, , Germany
Leo Pharma Investigational site
Tübingen, , Germany
Leo Pharma Investigational site
Wuppertal, , Germany
Leo Pharma Investigational site
Cork, , Ireland
Leo Pharma Investigational site
Crumlin, , Ireland
Leo Pharma Investigational site
Ancona, , Italy
Leo Pharma Investigational site
Brescia, , Italy
Leo Pharma Investigational site
Padua, , Italy
Leo Pharma Investigational site
Roma, , Italy
Leo Pharma Investigational site
Rome, , Italy
Leo Pharma Investigational site
Utrecht, , Netherlands
Leo Pharma Investigational site
Gdansk, , Poland
Leo Pharma Investigational site
Krakow, , Poland
Leo Pharma Investigational site
Lodz, , Poland
Leo Pharma Investigational site
Ostrowiec Świętokrzyski, , Poland
Leo Pharma Investigational site
Rzeszów, , Poland
Leo Pharma Investigational site
Tarnów, , Poland
Leo Pharma Investigational site
Warsaw, , Poland
Leo Pharma Investigational site
Warsaw, , Poland
Leo Pharma Investigational site
Brasov, , Romania
Leo Pharma Investigational site
Iași, , Romania
Leo Pharma Investigational site
Ansan-si, , South Korea
Leo Pharma Investigational site
Gwangju, , South Korea
Leo Pharma Investigational site
Seoul, , South Korea
Leo Pharma Investigational site
Seoul, , South Korea
Leo Pharma Investigational site
Seoul, , South Korea
Leo Pharma Investigational site
Seoul, , South Korea
Leo Pharma Investigational site
Seoul, , South Korea
Leo Pharma Investigational site
Seoul, , South Korea
Leo Pharma Investigational site
Seoul, , South Korea
Leo Pharma Investigational site
Alicante, , Spain
Leo Pharma Investigational site
Madrid, , Spain
Leo Pharma Investigational site
Valencia, , Spain
Leo Pharma Investigational site
Lincoln, , United Kingdom
Leo Pharma Investigational site
London, , United Kingdom
Leo Pharma Investigational site
Sheffield, , United Kingdom
Leo Pharma Investigational site
Southampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1285-6559
Identifier Type: OTHER
Identifier Source: secondary_id
2023-503630-44-00
Identifier Type: CTIS
Identifier Source: secondary_id
LP0162-1336
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.