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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1285-6559 | Other Identifier | World Health Organization (WHO) | |
| 2023-503630-44-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tralokinumab + TCS for subjects aged 2 to <12 years | Experimental | Dose and dosing frequency for each subject will depend on the subject's body weight. |
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| Placebo + TCS for subjects aged 2 to <12 years | Experimental | Dose and dosing frequency for each subject will depend on the subject's body weight. |
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| Tralokinumab + TCS for subjects aged 6 months to <2 years | Experimental | Dose and dosing frequency for each subject will depend on the subject's body weight. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tralokinumab + TCS | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | At week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure | Contact | +45 4494 5888 | disclosure@leo-pharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leo Pharma Investigational site | Recruiting | Birmingham | Alabama | 35209 | United States | |
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The study design is parallel for children and a single group for infants.
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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.
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| Placebo + TCS | Drug | 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. |
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| 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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'. | 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'. | 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'. | 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'. | 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. | 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. | 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. | 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. | 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. | 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. | 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'. | 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'. | 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'. | 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. | 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. | 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. | From baseline to week 16 |
| Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 2 to <12 years at screening. | From baseline to week 16 |
| Presence of treatment-emergent anti-drug antibodies (yes/no) in subjects aged 6 month to <2 years at screening. | From baseline to week 16 |
| Rescue treatment use (yes/no) in subjects aged 2 to <12 years at screening. | From baseline to week 16 |
| Rescue treatment use (yes/no) in subjects aged 6 month to <2 years at screening. | From baseline to week 16 |
| Number of TCS free days in subjects aged 2 to <12 years at screening. | TCS- tropical corticosteroids. | From baseline to week 16 |
| Number of TCS free days in subjects aged 6 month to <2 years at screening. | TCS- tropical corticosteroids. | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From baseline to week 52 |
| Percent change in affected body surface area (BSA) in subjects aged 2 to <12 years at screening. | From baseline to week 52 |
| Percent change in affected body surface area (BSA) in subjects aged 6 month to <2 years at screening. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From baseline to week 196 |
| Leo Pharma Investigational site |
| Recruiting |
| North Little Rock |
| Arkansas |
| 72117 |
| United States |
| Leo Pharma Investigational site | Recruiting | Palo Alto | California | 94304 | United States |
| Leo Pharma Investigational site | Recruiting | Sacramento | California | 95816 | United States |
| Leo Pharma Investigational site | Withdrawn | San Diego | California | 92108 | United States |
| Leo Pharma Investigational site | Recruiting | San Diego | California | 92123 | United States |
| Leo Pharma Investigational site | Recruiting | Jacksonville | Florida | 32256 | United States |
| Leo Pharma Investigational site | Recruiting | Miami | Florida | 33156 | United States |
| Leo Pharma Investigational site | Recruiting | Tampa | Florida | 33613 | United States |
| Leo Pharma Investigational site | Recruiting | Macon | Georgia | 31217 | United States |
| Leo Pharma Investigational site | Recruiting | Waterford | Michigan | 48328 | United States |
| Leo Pharma Investigational site | Recruiting | Tulsa | Oklahoma | 74136 | United States |
| Leo Pharma Investigational site | Recruiting | Portland | Oregon | 97239 | United States |
| Leo Pharma Investigational site | Recruiting | Charleston | South Carolina | 27420 | United States |
| Leo Pharma Investigational site | Recruiting | Norfolk | Virginia | 23502 | United States |
| Leo Pharma Investigational site | Withdrawn | Brussels | 1020 | Belgium |
| Leo Pharma Investigational site | Active, not recruiting | Ghent | 9000 | Belgium |
| Leo Pharma Investigational site | Withdrawn | Leuven | 3000 | Belgium |
| Leo Pharma Investigational site | Withdrawn | Liège | 4000 | Belgium |
| Leo Pharma Investigational site | Recruiting | Burlington | L7L 6W6 | Canada |
| Leo Pharma Investigational site | Withdrawn | Calgary | Calgary | Canada |
| Leo Pharma Investigational site | Recruiting | Calgary | T2J 7E1 | Canada |
| Leo Pharma Investigational site | Recruiting | Edmonton | T5J 3S9 | Canada |
| Leo Pharma Investigational site | Recruiting | Edmonton | T6G 1C3 | Canada |
| Leo Pharma Investigational site | Recruiting | Hamilton | L8S 1G5 | Canada |
| Leo Pharma Investigational site | Recruiting | Niagara Falls | L2H 1H5 | Canada |
| Leo Pharma Investigational site | Recruiting | Saskatoon | S7K 2C1 | Canada |
| Leo Pharma Investigational site | Recruiting | Windsor | N8X2G1 | Canada |
| Leo Pharma Investigational site | Recruiting | Winnipeg | R3M 3Z4 | Canada |
| Leo Pharma Investigational site | Active, not recruiting | Rijeka | 51000 | Croatia |
| Leo Pharma Investigational site | Active, not recruiting | Zagreb | 10000 | Croatia |
| Leo Pharma Investigational site | Withdrawn | Zagreb | 10000 | Croatia |
| Leo Pharma Investigational site | Withdrawn | Buxtehude | 21614 | Germany |
| Leo Pharma Investigational site | Withdrawn | Dresden | 01307 | Germany |
| Leo Pharma Investigational site | Withdrawn | Mainz | 55131 | Germany |
| Leo Pharma Investigational site | Withdrawn | Osnabrück | 49074 | Germany |
| Leo Pharma Investigational site | Active, not recruiting | Tübingen | 72076 | Germany |
| Leo Pharma Investigational site | Withdrawn | Wuppertal | 42283 | Germany |
| Leo Pharma Investigational site | Active, not recruiting | Cork | T12 DFK4 | Ireland |
| Leo Pharma Investigational site | Active, not recruiting | Crumlin | D12N512 | Ireland |
| Leo Pharma Investigational site | Withdrawn | Ancona | 60126 | Italy |
| Leo Pharma Investigational site | Active, not recruiting | Brescia | 25123 | Italy |
| Leo Pharma Investigational site | Active, not recruiting | Padova | 35128 | Italy |
| Leo Pharma Investigational site | Active, not recruiting | Roma | 00168 | Italy |
| Leo Pharma Investigational site | Active, not recruiting | Rome | 00165 | Italy |
| Leo Pharma Investigational site | Active, not recruiting | Utrecht | 3584 CW | Netherlands |
| Leo Pharma Investigational site | Active, not recruiting | Gdansk | 80-546 | Poland |
| Leo Pharma Investigational site | Active, not recruiting | Krakow | 30-002 | Poland |
| Leo Pharma Investigational site | Active, not recruiting | Lodz | 90-436 | Poland |
| Leo Pharma Investigational site | Active, not recruiting | Ostrowiec Świętokrzyski | 27-400 | Poland |
| Leo Pharma Investigational site | Active, not recruiting | Rzeszów | 35-055 | Poland |
| Leo Pharma Investigational site | Active, not recruiting | Tarnów | 33-100 | Poland |
| Leo Pharma Investigational site | Active, not recruiting | Warsaw | 02-953 | Poland |
| Leo Pharma Investigational site | Active, not recruiting | Warsaw | 02-962 | Poland |
| Leo Pharma Investigational site | Active, not recruiting | Brasov | 500091 | Romania |
| Leo Pharma Investigational site | Active, not recruiting | Iași | 700259 | Romania |
| Leo Pharma Investigational site | Active, not recruiting | Ansan-si | 15355 | South Korea |
| Leo Pharma Investigational site | Active, not recruiting | Gwangju | 61453 | South Korea |
| Leo Pharma Investigational site | Active, not recruiting | Seoul | 02447 | South Korea |
| Leo Pharma Investigational site | Active, not recruiting | Seoul | 03080 | South Korea |
| Leo Pharma Investigational site | Active, not recruiting | Seoul | 03722 | South Korea |
| Leo Pharma Investigational site | Active, not recruiting | Seoul | 05030 | South Korea |
| Leo Pharma Investigational site | Withdrawn | Seoul | 06273 | South Korea |
| Leo Pharma Investigational site | Withdrawn | Seoul | 06591 | South Korea |
| Leo Pharma Investigational site | Active, not recruiting | Seoul | 139-711 | South Korea |
| Leo Pharma Investigational site | Active, not recruiting | Alicante | 03010 | Spain |
| Leo Pharma Investigational site | Withdrawn | Madrid | 28046 | Spain |
| Leo Pharma Investigational site | Active, not recruiting | Valencia | 46014 | Spain |
| Leo Pharma Investigational site | Active, not recruiting | Lincoln | LN2 5QY | United Kingdom |
| Leo Pharma Investigational site | Active, not recruiting | London | WC1N 3JH | United Kingdom |
| Leo Pharma Investigational site | Active, not recruiting | Sheffield | S10 2TH | United Kingdom |
| Leo Pharma Investigational site | Active, not recruiting | Southampton | SO16 6YD | United Kingdom |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C574065 | tralokinumab |
| D008965 | Molasses |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
Not provided
Not provided