protocolSection identificationModule nctId: NCT06311682, orgStudyIdInfo id: LP0162-1336, secondaryIdInfos id: U1111-1285-6559, type: OTHER, domain: World Health Organization (WHO), secondaryIdInfos id: 2023-503630-44, type: OTHER, domain: European Medicines Agency (EMA), briefTitle: 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, acronym: TRAPEDS 2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-24, primaryCompletionDateStruct date: 2026-03-26, completionDateStruct date: 2028-04-28, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: LEO Pharma, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Atopic Dermatitis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study design is parallel for children and a single group for infants., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: For subjects aged 2 to \<12 years at screening, the trial is double-blind to ensure an objective evaluation of efficacy and safety of the Investigational Medicinal Product (IMP). The subject, the subject's caregiver(s), and the investigator involved in the clinical evaluation and monitoring of the subjects will not be aware of the treatment from baseline to Week 16. However, the site staff that responsible for administering tralokinumab will be aware of the treatment allocation as tralokinumab is visibly different from placebo and has a higher viscosity, requiring more pressure to depress the plunger during injections., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 195, type: ESTIMATED, armsInterventionsModule interventions name: Tralokinumab + TCS, interventions name: Placebo + TCS, outcomesModule primaryOutcomes 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., primaryOutcomes measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: 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., secondaryOutcomes measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Having at least 50% reduction in EASI score in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Having at least 50% reduction in EASI score in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in EASI in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in EASI in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in affected BSA in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in affected BSA in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening., secondaryOutcomes measure: Reduction in Child Worst Itch numeric rating score (NRS) (weekly average) ≥4 for subjects aged 6 to <12 years at screening., secondaryOutcomes measure: Reduction in Scratch Observer-Reported Outcome (ObsRO) (weekly average) ≥4 for subjects aged 2 to <6 years at screening., secondaryOutcomes measure: Reduction in Scratch Observer-Reported Outcome (ObsRO) (weekly average) ≥4 for subjects aged 6 months to <2 years years at screening., secondaryOutcomes measure: Reduction of ≥4 in Child Worst Itch NRS (weekly average) for subjects aged 6 to <12 years at screening or Scratch ObsRO (weekly average) for subjects aged 2 to <6 years at screening., secondaryOutcomes measure: Percent change in Patient-Oriented Eczema Measure (POEM) in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in Patient-Oriented Eczema Measure (POEM) in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Change in Child Worst Itch NRS (weekly average) for subjects aged 6 to <12 years at screening., secondaryOutcomes measure: Change in Scratch Observer-Reported Outcome (ObsRO) (weekly average) in subjects aged 2 to <6 years at screening., secondaryOutcomes measure: Change in Scratch Observer-Reported Outcome (ObsRO) (weekly average) in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥6 for subjects aged 4 to <12 years at screening., secondaryOutcomes measure: Number of treatment-emergent adverse events (AEs) per subject aged 2 to <12 years at screening., secondaryOutcomes measure: Number of treatment-emergent adverse events (AEs) per subject aged 6 month to <2 years at screening., secondaryOutcomes measure: Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Rescue treatment use (yes/no) in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Rescue treatment use (yes/no) in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Number of TCS free days in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Number of TCS free days in subjects aged 6 month to <2 years at screening., secondaryOutcomes 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., secondaryOutcomes measure: 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., secondaryOutcomes measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in EASI in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in EASI in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in affected body surface area (BSA) in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in affected body surface area (BSA) in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in Children's Dermatology Life Quality Index (CDLQI) in subjects aged 4 to <12 years at screening., secondaryOutcomes measure: Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥6 for subjects aged 4 to <12 years at screening., secondaryOutcomes measure: Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Number of treatment-emergent adverse events (AEs) per subject aged 2 to <12 years at screening., secondaryOutcomes measure: Number of treatment-emergent adverse events (AEs) per subject aged 6 month to <2 years at screening., secondaryOutcomes measure: Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Number of treatment-emergent adverse events (AEs) per subject aged 2 to <12 years at screening., secondaryOutcomes measure: Number of treatment-emergent adverse events (AEs) per subject aged 6 month to <2 years at screening., secondaryOutcomes 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., secondaryOutcomes measure: 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., secondaryOutcomes measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in EASI in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in EASI in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening., secondaryOutcomes measure: Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥ 6 for subjects aged 4 to <12 years at screening., secondaryOutcomes 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., secondaryOutcomes measure: 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., secondaryOutcomes measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in EASI in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in EASI in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening., secondaryOutcomes measure: Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥ 6 for subjects aged 4 to <12 years at screening., secondaryOutcomes 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., secondaryOutcomes measure: 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., secondaryOutcomes measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in EASI in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in EASI in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening., secondaryOutcomes measure: Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening., secondaryOutcomes measure: Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening., secondaryOutcomes measure: Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥ 6 for subjects aged 4 to <12 years at screening., eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 11 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False