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
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
Interventions
Tralokinumab + TCS
Placebo + TCS
Conditions
Locations
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Birmingham, Alabama 35209
United States
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North Little Rock, Arkansas 72117
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Palo Alto, California 94304
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Sacramento, California 95816
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San Diego, California 92108
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San Diego, California 92123
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Jacksonville, Florida 32256
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Miami, Florida 33156
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Tampa, Florida 33613
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Macon, Georgia 31217
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Waterford, Michigan 48328
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Tulsa, Oklahoma 74136
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Portland, Oregon 97239
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Charleston, South Carolina 27420
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Norfolk, Virginia 23502
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Brussels, 1020
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Ghent, 9000
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Leuven, 3000
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Liège, 4000
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Burlington, L7L 6W6
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Calgary, Calgary
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Calgary, T2J 7E1
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Edmonton, T5J 3S9
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Edmonton, T6G 1C3
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Hamilton, L8S 1G5
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Niagara Falls, L2H 1H5
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Saskatoon, S7K 2C1
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Windsor, N8X2G1
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Winnipeg, R3M 3Z4
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Rijeka, 51000
Croatia
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Zagreb, 10000
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Zagreb, 10000
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Buxtehude, 21614
Germany
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Dresden, 01307
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Mainz, 55131
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Osnabrück, 49074
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Tübingen, 72076
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Wuppertal, 42283
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Cork, T12 DFK4
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Crumlin, D12N512
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Ancona, 60126
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Brescia, 25123
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Padova, 35128
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Roma, 00168
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Rome, 00165
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Utrecht, 3584 CW
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Gdansk, 80-546
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Krakow, 30-002
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Lodz, 90-436
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Ostrowiec Świętokrzyski, 27-400
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Rzeszów, 35-055
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Tarnów, 33-100
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Warsaw, 02-953
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Warsaw, 02-962
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Brasov, 500091
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Iași, 700259
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Gwangju, 61453
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Seoul, 02447
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Seoul, 03080
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Seoul, 03722
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Seoul, 05030
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Seoul, 06273
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Seoul, 06591
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Seoul, 139-711
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Alicante, 03010
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Madrid, 28046
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Valencia, 46014
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Lincoln, LN2 5QY
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London, WC1N 3JH
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Sheffield, S10 2TH
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Southampton, SO16 6YD
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