A Phase 3 interventional study of Tralokinumab + TCS and Placebo + TCS in Atopic Dermatitis, sponsored by LEO Pharma. Recruiting at 72 sites in 13 countries. Open to participants aged 6 Months to 11 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by LEO Pharma · Phase 3, Interventional, and Treatment
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.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 195 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →LEO Pharma is the lead sponsor of 225 studies on the registry; 5 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 24 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose and dosing frequency for each subject will depend on the subject's body weight.
Drug: Tralokinumab + TCS
Dose and dosing frequency for each subject will depend on the subject's body weight.
Drug: Placebo + TCS
Dose and dosing frequency for each subject will depend on the subject's body weight.
Drug: Tralokinumab + TCS
Drug page: Tralokinumab
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.
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.
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.
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
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.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: At week 16
Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
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.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
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.
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
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.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: At week 16
Having at least 50% reduction in EASI score in subjects aged 2 to <12 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: At week 16
Having at least 50% reduction in EASI score in subjects aged 6 month to <2 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: At week 16
Percent change in EASI in subjects aged 2 to <12 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: From baseline to week 16
Percent change in EASI in subjects aged 6 month to <2 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: From baseline to week 16
Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 2 to <12 years at screening.
The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis. The maximum total score is 103, with higher values indicating more severe disease.
Time frame: From baseline to week 16
Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 6 month to <2 years at screening.
The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis. The maximum total score is 103, with higher values indicating more severe disease.
Time frame: From baseline to week 16
Percent change in affected BSA in subjects aged 2 to <12 years at screening.
BSA is a body surface area.
Time frame: From baseline to week 16
Percent change in affected BSA in subjects aged 6 month to <2 years at screening.
BSA is a body surface area.
Time frame: From baseline to week 16
Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening.
The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
Time frame: From baseline to Week 16
Reduction in Child Worst Itch numeric rating score (NRS) (weekly average) ≥4 for subjects aged 6 to <12 years at screening.
The Child Worst Itch NRS assesses 'worst itch today' and 'worst itch last night' using a numerical rating scale from 0 to 10, where 0 represents 'Not itchy at all' and 10 represents 'Very itchy'.
Time frame: From baseline to Week 16
Reduction in Scratch Observer-Reported Outcome (ObsRO) (weekly average) ≥4 for subjects aged 2 to <6 years at screening.
The Scratch ObsRO NRS assesses 'worst scratching during the past 24 hours' using a numerical rating scale from 0 to 10, where 0 represents 'No scratching' and 10 represents 'Worst scratching possible'.
Time frame: From baseline to week 16
Reduction in Scratch Observer-Reported Outcome (ObsRO) (weekly average) ≥4 for subjects aged 6 months to <2 years years at screening.
The Scratch ObsRO NRS assesses 'worst scratching during the past 24 hours' using a numerical rating scale from 0 to 10, where 0 represents 'No scratching' and 10 represents 'Worst scratching possible'.
Time frame: From baseline to week 16
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.
The Child Worst Itch NRS assesses 'worst itch today' and 'worst itch last night' using a numerical rating scale from 0 to 10, where 0 represents 'Not itchy at all' and 10 represents 'Very itchy'. The Scratch ObsRO NRS assesses 'worst scratching during the past 24 hours' using a numerical rating scale from 0 to 10, where 0 represents 'No scratching' and 10 represents 'Worst scratching possible'.
Time frame: From baseline to week 16
Percent change in Patient-Oriented Eczema Measure (POEM) in subjects aged 2 to <12 years at screening.
The POEM is a validated questionnaire used to assess disease symptoms in atopic eczema patients in both clinical practice and clinical trials. The tool consists of 7 items each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Subjects will score how often they have experienced each symptom over the previous week on a 5-point categorical response scale (0 = 'no days'; 1 = '1 to 2 days'; 2 = '3 to 4 days'; 3 = '5 to 6'days; 4 = 'every day'). The total score is the sum of the 7 items (range 0 to 28) and reflects disease-related morbidity; a high score is indicative of a worse disease severity.
Time frame: From baseline to week 16
Percent change in Patient-Oriented Eczema Measure (POEM) in subjects aged 6 month to <2 years at screening.
The POEM is a validated questionnaire used to assess disease symptoms in atopic eczema patients in both clinical practice and clinical trials. The tool consists of 7 items each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Subjects will score how often they have experienced each symptom over the previous week on a 5-point categorical response scale (0 = 'no days'; 1 = '1 to 2 days'; 2 = '3 to 4 days'; 3 = '5 to 6'days; 4 = 'every day'). The total score is the sum of the 7 items (range 0 to 28) and reflects disease-related morbidity; a high score is indicative of a worse disease severity.
Time frame: From baseline to week 16
Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 2 to <12 years at screening.
The POEM is a validated questionnaire used to assess disease symptoms in atopic eczema patients in both clinical practice and clinical trials. The tool consists of 7 items each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Subjects will score how often they have experienced each symptom over the previous week on a 5-point categorical response scale (0 = 'no days'; 1 = '1 to 2 days'; 2 = '3 to 4 days'; 3 = '5 to 6'days; 4 = 'every day'). The total score is the sum of the 7 items (range 0 to 28) and reflects disease-related morbidity; a high score is indicative of a worse disease severity.
Time frame: From baseline to week 16
Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 6 month to <2 years at screening.
The POEM is a validated questionnaire used to assess disease symptoms in atopic eczema patients in both clinical practice and clinical trials. The tool consists of 7 items each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Subjects will score how often they have experienced each symptom over the previous week on a 5-point categorical response scale (0 = 'no days'; 1 = '1 to 2 days'; 2 = '3 to 4 days'; 3 = '5 to 6'days; 4 = 'every day'). The total score is the sum of the 7 items (range 0 to 28) and reflects disease-related morbidity; a high score is indicative of a worse disease severity.
Time frame: From baseline to week 16
Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening.
The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
Time frame: From baseline to week 16
Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening.
The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
Time frame: From baseline to week 16
Change in Child Worst Itch NRS (weekly average) for subjects aged 6 to <12 years at screening.
The Scratch ObsRO NRS assesses 'worst scratching during the past 24 hours' using a numerical rating scale from 0 to 10, where 0 represents 'No scratching' and 10 represents 'Worst scratching possible'.
Time frame: From baseline to week 16
Change in Scratch Observer-Reported Outcome (ObsRO) (weekly average) in subjects aged 2 to <6 years at screening.
The Scratch ObsRO NRS assesses 'worst scratching during the past 24 hours' using a numerical rating scale from 0 to 10, where 0 represents 'No scratching' and 10 represents 'Worst scratching possible'.
Time frame: From baseline to week 16
Change in Scratch Observer-Reported Outcome (ObsRO) (weekly average) in subjects aged 6 month to <2 years at screening.
The Scratch ObsRO NRS assesses 'worst scratching during the past 24 hours' using a numerical rating scale from 0 to 10, where 0 represents 'No scratching' and 10 represents 'Worst scratching possible'.
Time frame: From baseline to week 16
Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥6 for subjects aged 4 to <12 years at screening.
The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
Time frame: From baseline to week 16
Number of treatment-emergent adverse events (AEs) per subject aged 2 to <12 years at screening.
An adverse event (AE) is any unexpected medical issue that happens to a person who is taking a medication or participating in a study. It could be a symptom, disease, or abnormal test result, even if it's not necessarily caused by the medication being used.
Time frame: From baseline to week 16
Number of treatment-emergent adverse events (AEs) per subject aged 6 month to <2 years at screening.
An adverse event (AE) is any unexpected medical issue that happens to a person who is taking a medication or participating in a study. It could be a symptom, disease, or abnormal test result, even if it's not necessarily caused by the medication being used.
Time frame: From baseline to week 16
Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 2 to <12 years at screening.
Time frame: From baseline to week 16
Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 6 month to <2 years at screening.
Time frame: From baseline to week 16
Rescue treatment use (yes/no) in subjects aged 2 to <12 years at screening.
Time frame: From baseline to week 16
Rescue treatment use (yes/no) in subjects aged 6 month to <2 years at screening.
Time frame: From baseline to week 16
Number of TCS free days in subjects aged 2 to <12 years at screening.
TCS- tropical corticosteroids.
Time frame: From baseline to week 16
Number of TCS free days in subjects aged 6 month to <2 years at screening.
TCS- tropical corticosteroids.
Time frame: From baseline to week 16
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.
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Time frame: At week 52
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.
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Time frame: At week 52
Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: At week 52
Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: At week 52
Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: At week 52
Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: At week 52
Percent change in EASI in subjects aged 2 to <12 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: From baseline to week 52
Percent change in EASI in subjects aged 6 month to <2 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: From baseline to week 52
Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 2 to <12 years at screening.
The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis. The maximum total score is 103, with higher values indicating more severe disease.
Time frame: From baseline to week 52
Percent change in Scoring Atopic Dermatitis (SCORAD) in subjects aged 6 month to <2 years at screening.
The SCORAD is a validated tool to evaluate the extent and severity of atopic dermatitis. The maximum total score is 103, with higher values indicating more severe disease.
Time frame: From baseline to week 52
Percent change in affected body surface area (BSA) in subjects aged 2 to <12 years at screening.
Time frame: From baseline to week 52
Percent change in affected body surface area (BSA) in subjects aged 6 month to <2 years at screening.
Time frame: From baseline to week 52
Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening.
The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
Time frame: From baseline to week 52
Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening.
The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
Time frame: From baseline to week 52
Percent change in Children's Dermatology Life Quality Index (CDLQI) in subjects aged 4 to <12 years at screening.
The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
Time frame: From baseline to week 52
Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥6 for subjects aged 4 to <12 years at screening.
The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
Time frame: From baseline to week 52
Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 2 to <12 years at screening.
The POEM is a validated questionnaire used to assess disease symptoms in atopic eczema patients in both clinical practice and clinical trials. The tool consists of 7 items each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Subjects will score how often they have experienced each symptom over the previous week on a 5-point categorical response scale (0 = 'no days'; 1 = '1 to 2 days'; 2 = '3 to 4 days'; 3 = '5 to 6'days; 4 = 'every day'). The total score is the sum of the 7 items (range 0 to 28) and reflects disease-related morbidity; a high score is indicative of a worse disease severity.
Time frame: From baseline to week 52
Reduction of in Patient-Oriented Eczema Measure (POEM) ≥6 in subjects aged 6 month to <2 years at screening.
The POEM is a validated questionnaire used to assess disease symptoms in atopic eczema patients in both clinical practice and clinical trials. The tool consists of 7 items each addressing a specific symptom (itching, sleep, bleeding, weeping, cracking, flaking, and dryness). Subjects will score how often they have experienced each symptom over the previous week on a 5-point categorical response scale (0 = 'no days'; 1 = '1 to 2 days'; 2 = '3 to 4 days'; 3 = '5 to 6'days; 4 = 'every day'). The total score is the sum of the 7 items (range 0 to 28) and reflects disease-related morbidity; a high score is indicative of a worse disease severity.
Time frame: From baseline to week 52
Number of treatment-emergent adverse events (AEs) per subject aged 2 to <12 years at screening.
An adverse event (AE) is any unexpected medical issue that happens to a person who is taking a medication or participating in a study. It could be a symptom, disease, or abnormal test result, even if it's not necessarily caused by the medication being used.
Time frame: From week 16 to 52
Number of treatment-emergent adverse events (AEs) per subject aged 6 month to <2 years at screening.
An adverse event (AE) is any unexpected medical issue that happens to a person who is taking a medication or participating in a study. It could be a symptom, disease, or abnormal test result, even if it's not necessarily caused by the medication being used.
Time frame: From week 16 to 52
Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 2 to <12 years at screening.
It measures whether the developed antibodies in response to the treatment have any effect on the safety and effectiveness of the treatment.
Time frame: From week 16 to 52
Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 6 month to <2 years at screening.
It measures whether the developed antibodies in response to the treatment have any effect on the safety and effectiveness of the treatment.
Time frame: From week 16 to 52
Number of treatment-emergent adverse events (AEs) per subject aged 2 to <12 years at screening.
An adverse event (AE) is any unexpected medical issue that happens to a person who is taking a medication or participating in a study. It could be a symptom, disease, or abnormal test result, even if it's not necessarily caused by the medication being used.
Time frame: From week 52 to end of treatment
Number of treatment-emergent adverse events (AEs) per subject aged 6 month to <2 years at screening.
An adverse event (AE) is any unexpected medical issue that happens to a person who is taking a medication or participating in a study. It could be a symptom, disease, or abnormal test result, even if it's not necessarily caused by the medication being used.
Time frame: From week 52 to end of treatment
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.
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Time frame: At week 100
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.
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Time frame: At week 100
Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: At week 100
Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: At week 100
Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: At week 100
Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: At week 100
Percent change in EASI in subjects aged 2 to <12 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: From baseline to week 100
Percent change in EASI in subjects aged 6 month to <2 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: From baseline to week 100
Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening.
The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
Time frame: From baseline to week 100
Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening.
The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
Time frame: From baseline to week 100
Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening.
The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
Time frame: From baseline to week 100
Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥ 6 for subjects aged 4 to <12 years at screening.
The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
Time frame: From baseline to week 100
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.
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Time frame: At week 148
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.
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Time frame: At week 148
Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: At week 148
Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: At week 148
Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: At week 148
Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: At week 148
Percent change in EASI in subjects aged 2 to <12 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: From baseline to week 148
Percent change in EASI in subjects aged 6 month to <2 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: From baseline to week 148
Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening.
The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
Time frame: From baseline to week 148
Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening.
The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
Time frame: From baseline to week 148
Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening.
The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
Time frame: From baseline to week 148
Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥ 6 for subjects aged 4 to <12 years at screening.
The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
Time frame: From baseline to week 148
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.
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Time frame: At week 196
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.
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Time frame: At week 196
Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: At week 196
Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: At week 196
Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: At week 196
Having at least 90% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 6 month to <2 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: At week 196
Percent change in EASI in subjects aged 2 to <12 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: From baseline to week 196
Percent change in EASI in subjects aged 6 month to <2 years at screening.
The EASI is a validated measure to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Time frame: From baseline to week 196
Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 2 to <12 years at screening.
The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
Time frame: From baseline to week 196
Percent change in Scoring Atopic Dermatitis (SCORAD) sleep loss in subjects aged 6 month to <2 years at screening.
The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
Time frame: From baseline to week 196
Percent change in Children's Dermatology Life Quality Index (CDLQI) for subjects aged 4 to <12 years at screening.
The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
Time frame: From baseline to week 196
Reduction in Children's Dermatology Life Quality Index (CDLQI) ≥ 6 for subjects aged 4 to <12 years at screening.
The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
Time frame: From baseline to week 196
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Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Tralokinumab