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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1290-9215 | Registry Identifier | ICTRP | |
| 2023-508096-36 | Registry Identifier | CTIS |
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This is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 3 study for treatment of participants aged 12 years and older diagnosed with moderate-to-severe atopic dermatitis (AD).
The primary objective of ESTUARY is to assess the maintenance of treatment response on continued Q12W dosing compared to treatment withdrawal.
Study details include:
The study duration will be up to 68 weeks including a 52-week randomized double-blind period, and a 16-week safety follow-up for participants not entering the LTS17367 (RIVER-AD).
The study duration will be up to 52 weeks for participants entering the LTS17367 [RIVER-AD] study at the Week 52 visit of EFC17600 (ESTUARY).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amlitelimab dose 1 | Experimental | Subcutaneous injection as per protocol |
|
| Amlitelimab dose 2 | Experimental | Subcutaneous injection as per protocol |
|
| Placebo | Placebo Comparator | Subcutaneous injection as per protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlitelimab | Drug | Pharmaceutical form: Injection solution Route of administration: Subcutaneous (SC) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| US and US reference countries: Proportion of participants who are responders AND maintained vIGA-AD ≤2 without experiencing relapse among participants who were responders at baseline of ESTUARY | Clinical response is defined as having vIGA-AD 0 or 1. Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^. The validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The Eczema Area and Severity Index (EASI) is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". | Week 24 |
| EU, EU Reference Countries, and Japan: Proportion of participants who maintain treatment response in ESTUARY without experiencing relapse | Maintenance of clinical response is defined as having vIGA-AD 0 or 1 OR EASI-75^ OR vIGA-AD 0 or 1 and EASI-75^. Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who continue to be EASI-75^ among the participants who met EASI-75^ at baseline of ESTUARY | The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". |
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Inclusion Criteria:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cahaba Dermatology & Skin Health Center- Site Number : 8401066 | Birmingham | Alabama | 35244 | United States | ||
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| Label | URL |
|---|---|
| EFC17600 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| Placebo | Drug | Pharmaceutical form: Injection solution Route of administration: SC injection |
|
| Up to Week 48 |
| Proportion of participants who continue to be vIGA-AD 0 or 1 among participants who met vIGA-AD 0 or 1 at baseline of ESTUARY | The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). | Up to Week 48 |
| Proportion of participants who continue to be vIGA-AD 0 or 1 with presence of only barely perceptible erythema among the participants who were vIGA-AD 0 or 1 with presence of only barely perceptible erythema at baseline of ESTUARY | The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). Only barely perceptible erythema = no induration/papulation, no lichenification, no oozing or crusting. | Up to Week 48 |
| Proportion of participants who maintained weekly average of daily PP-NRS reduction of ≥4^ among the participants with weekly average of daily PP-NRS reduction of ≥ 4^ at baseline of ESTUARY | The Peak Pruritus-Numerical Rating Scale (PP-NRS) is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable. The symbol ^ represents "based on parent study baseline". | Up to Week 48 |
| Proportion of participants who maintain treatment response without experiencing relapse | Maintenance of treatment response is defined as having vIGA-AD 0 or 1 OR EASI-75^ OR vIGA-AD 0 or 1 and EASI-75^. Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. | Up to Week 48 |
| Percent change in EASI from parent study baseline | The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. | Parent study baseline to Week 48 |
| Proportion of participants who maintained EASI-75^ without experiencing relapse among the participants who met EASI-75^ at baseline of ESTUARY | Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". | Up to Week 48 |
| Proportion of participants with EASI-75^ | The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". | Up to Week 48 |
| Proportion of participants who continue to be EASI-90^ among the participants who met EASI-90^ at baseline of ESTUARY | The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-90 is 90% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". | Up to Week 48 |
| Proportion of participants with EASI-90^ | The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-90 is 90% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". | Up to Week 48 |
| Time to the first event of vIGA-AD ≥3 or loss of EASI-75^ among the participants who were vIGA-AD 0 or EASI-75^ at baseline of ESTUARY | The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". | Up to Week 48 |
| Proportion of participants with vIGA-AD 0 or 1 | The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). | Up to Week 48 |
| Proportion of participants who are vIGA-AD 0 or 1 with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting) | The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). | Up to Week 48 |
| EU, EU Reference Countries, and Japan: Time to first event of vIGA-AD ≥3 or loss of EASI^75 among those participants who were vIGA-AD 0 or 1 at baseline of ESTUARY | The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". | Up to Week 48 |
| EU, EU Reference Countries, and Japan: Time to first event of vIGA-AD ≥3 or loss of EASI^75 among those participants who were vIGA-AD 0 at baseline of ESTUARY | The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". | Up to Week 48 |
| Proportion of participants with weekly average of daily PP-NRS reduction of ≥4^ | The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable. The symbol ^ represents "based on parent study baseline". | Parent study baseline to Week 48 |
| Proportion of participants who maintain PP-NRS ≤4 among participants who were PP-NRS ≤4 at baseline of ESTUARY | The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable. | Up to Week 48 |
| EU, EU Reference Countries, and Japan: Proportion of participants who maintain reduction in POEM ≥4^ among the participants with reduction in POEM ≥4^ at baseline of ESTUARY | The Patient Oriented Eczema Measure (POEM) is a 7-item self-assessment questionnaire that assesses disease symptoms on a 5-point scale; 0 (no days) to 4 (every day in the last week). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (very severe). Higher scores indicated more severe disease and poor quality of life. The symbol ^ represents "based on parent study baseline". | Up to Week 48 |
| EU, EU Reference Countries, and Japan: Proportion of participants with a reduction in CDLQI ≥6^ among participants aged ≥12 to <16 years old and with reduction in CDLQI ≥6^ at baseline of ESTUARY | The Children's Dermatology Quality of Life Index (CDLQI) is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in children aged 4-<16 years. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL. The symbol ^ represents "based on parent study baseline". | Up to Week 48 |
| EU, EU Reference Countries, and Japan: Proportion of participants with ≥ 4 reduction in DLQI ≥4^ among the participants aged ≥16 years old and with reduction in DLQI ≥4^ at baseline of ESTUARY | The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL. | Up to Week 48 |
| Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and/or Treatment-Emergent Adverse Events of Special Interest (AESI) | Up to week 68 |
| Pharmacokinetic: Serum amlitelimab concentrations | Up to Week 68 |
| Incidence of antidrug antibodies (ADAs) of amlitelimab | Up to Week 68 |
| Pharmacokinetic: maximum plasma concentration (Cmax) | Up to Week 68 |
| Pharmacokinetic: AUC4W and AUC12W | Cumulative area under the serum concentration curve over 4 weeks (AUC4W). Cumulative area under the serum concentration curve over 12 weeks (AUC12W). | Up to Week 4 and 12 |
| Proportion of participants who are EASI-75^ among participants who had EASI-75^ at baseline of ESTUARY and did not relapse by Week 12 | Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". | Up to Week 48 |
| Time to first recapture of EASI-75^ among participants who had EASI-75^ at baseline of ESTUARY and subsequently relapsed | Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". | Up to Week 48 |
| Proportion of participants who recapture EASI-75^ by visit among the participants who had EASI-75^ at baseline of ESTUARY and subsequently relapsed | Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". | Up to Week 48 |
| Proportion of participants who are EASI 90^ AND who maintain EASI-75^ without experiencing relapse among participants who had EASI-90^ at baseline of ESTUARY | Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". | Up to Week 48 |
| Proportion of participants who are EASI 90^ without experiencing relapse among participants who had EASI-90^ at baseline of ESTUARY | Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". | Up to Week 48 |
| Proportion of participants who are EASI-90^ among participants who had EASI-90^ at baseline of ESTUARY and did not relapse by Week 12. | Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". | Up to Week 48 |
| Proportion of participants who are vIGA-AD 0 or 1 AND who maintain vIGA-AD ≤2 without experiencing relapse among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY | Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". | Up to Week 48 |
| Proportion of participants who maintain vIGA-AD response within 1 point of baseline without experiencing relapse among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY | Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". | Up to Week 48 |
| Proportion of participants who maintain vIGA-AD 0 or 1 without experiencing relapse among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY | Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". | Up to Week 48 |
| Proportion of participants who are vIGA-AD 0 or 1 without experiencing relapse among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY | Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". | Up to Week 48 |
| Time to first recapture of vIGA-AD 0 or 1 among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY and subsequently relapsed | The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). | Up to Week 48 |
| Proportion of participants who recapture vIGA-AD 0 or 1 among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY and subsequently relapsed | The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). | Up to Week 48 |
| Proportion of participants who are vIGA-AD 0 or 1 among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY and did not relapse by Week 12 | Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". | Up to Week 48 |
| Proportion of participants who are vIGA-AD 0 or 1 with only barely perceptible erythema AND who maintain vIGA-AD ≤2 without experiencing relapse among participants who had vIGA-AD 0 or 1 with only barely perceptible erythema at baseline of ESTUARY | Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". Only barely perceptible erythema = no induration/papulation, no lichenification, no oozing or crusting. | Up to Week 48 |
| Proportion of participants who are vIGA-AD 0 or 1 with presence of only barely perceptible erythema among participants who had vIGA-AD 0 or 1 with presence of only barely perceptible erythema at baseline of ESTUARY and did not relapse by Week 12 | Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". Only barely perceptible erythema = no induration/papulation, no lichenification, no oozing or crusting. | Up to Week 48 |
| Proportion of participants who maintain weekly average of daily PP-NRS reduction of ≥4^ without experiencing relapse among participants with weekly average of daily PP NRS reduction of ≥4^ at baseline of ESTUARY | Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". | Up to Week 48 |
| Proportion of participants who maintain PP NRS ≤4 without experiencing relapse among participants who had PP-NRS ≤4 at baseline of ESTUARY | Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". | Up to Week 48 |
| Proportion of participants who achieve PP-NRS reduction of ≥4 | The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable. | Up to Week 48 |
| Proportion of participants who achieve PP-NRS ≤4 | The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable. | Up to Week 48 |
| Duration of maintained response without relapse | Maintenance of clinical response is defined as having vIGA-AD 0 or 1 OR EASI-75^ OR vIGA-AD 0 or 1 and EASI-75^. Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75^ is 75% reduction from baseline in EASI score. The symbol ^ represents "based on parent study baseline". | Up to Week 48 |
| Percent change in Head & Neck EASI sub-score from the parent study baseline among participants with Head & Neck EASI sub-score >0 at baseline of the parent study | The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Four body areas are considered separately: Head & Neck, Trunk including genital area, Upper extremities and Lower extremities including the buttocks. Head & Neck sub-score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. | From parent study baseline to Week 48 |
| Proportion of participants Head & Neck EASI sub-score EASI-75^ among participants with Head & Neck EASI sub-score >0 at baseline of the parent study | The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Four body areas are considered separately: Head & Neck, Trunk including genital area, Upper extremities and Lower extremities including the buttocks. Head & Neck sub-score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. Head & Neck EASI sub-score EASI-75 is 75% reduction from baseline in Head & Neck EASI sub-score. The symbol ^ represents "based on parent study baseline" | From parent study baseline to Week 48 |
| Proportion of participants with Head & Neck EASI sub-score EASI-90^ among participants with Head & Neck EASI sub-score >0 at baseline of parent study | The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Four body areas are considered separately: Head & Neck, Trunk including genital area, Upper extremities and Lower extremities including the buttocks. Head & Neck sub-score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. Head & Neck EASI sub-score EASI-90 is 90% reduction from baseline in Head & Neck EASI sub-score. The symbol ^ represents "based on parent study baseline" | From parent study baseline to Week 48 |
| Center for Dermatology and Plastic Surgery- Site Number : 8401119 |
| Scottsdale |
| Arizona |
| 85260 |
| United States |
| Scottsdale Clinical Trials- Site Number : 8401149 | Scottsdale | Arizona | 85260 | United States |
| Eclipse Clinical Research- Site Number : 8401158 | Tucson | Arizona | 85745 | United States |
| Johnson Dermatology- Site Number : 8401076 | Fort Smith | Arkansas | 72916 | United States |
| Encino Research Center- Site Number : 8401042 | Encino | California | 91436 | United States |
| First OC Dermatology- Site Number : 8401025 | Fountain Valley | California | 92708 | United States |
| Center for Dermatology Clinical Research- Site Number : 8401018 | Fremont | California | 94538 | United States |
| Marvel Clinical Research- Site Number : 8401102 | Huntington Beach | California | 92647 | United States |
| Sunwise Clinical Research- Site Number : 8401022 | Lafayette | California | 94549 | United States |
| Torrance Clinical Research - Narbonne Avenue- Site Number : 8401027 | Lomita | California | 90717 | United States |
| Dermatology Research Associates - Los Angeles- Site Number : 8401092 | Los Angeles | California | 90045 | United States |
| LA Universal Research Center- Site Number : 8401064 | Los Angeles | California | 90057 | United States |
| Northridge Clinical Trials - Northridge- Site Number : 8401080 | Northridge | California | 91325 | United States |
| Cura Clinical Research - Oxnard- Site Number : 8401142 | Oxnard | California | 93030 | United States |
| Southern California Dermatology- Site Number : 8401043 | Santa Ana | California | 92701 | United States |
| Clinical Science Institute- Site Number : 8401028 | Santa Monica | California | 90404 | United States |
| UConn Health - Farmington- Site Number : 8401115 | Farmington | Connecticut | 06030 | United States |
| Pediatric Skin Research- Site Number : 8401198 | Coral Gables | Florida | 33146 | United States |
| St. Jude Clinical Research- Site Number : 8401287 | Doral | Florida | 33172 | United States |
| Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8401286 | Fort Myers | Florida | 33919 | United States |
| Direct Helpers Research Center- Site Number : 8401056 | Hialeah | Florida | 33012 | United States |
| Encore Medical Research - Hollywood- Site Number : 8401030 | Hollywood | Florida | 33024 | United States |
| Clever Medical Research- Site Number : 8401160 | Miami | Florida | 33126 | United States |
| Acevedo Clinical Research Associates- Site Number : 8401088 | Miami | Florida | 33142 | United States |
| Florida International Research Center- Site Number : 8401091 | Miami | Florida | 33173 | United States |
| Miami Dermatology and Laser Research - Miami - Southwest 87th Avenue- Site Number : 8401086 | Miami | Florida | 33173 | United States |
| Anchor Medical Research- Site Number : 8401300 | Miami | Florida | 33176 | United States |
| Savin Medical Group - Miami Lakes- Site Number : 8401085 | Miami Lakes | Florida | 33014 | United States |
| Nuline Clinical Trial Center- Site Number : 8401161 | Pompano Beach | Florida | 33060 | United States |
| Global Clinical Professionals (GCP)- Site Number : 8401045 | St. Petersburg | Florida | 33705 | United States |
| Clinical Research Trials of Florida- Site Number : 8401023 | Tampa | Florida | 33607 | United States |
| AllerVie Clinical Research - Columbus- Site Number : 8401104 | Columbus | Georgia | 31904 | United States |
| Cleaver Medical Group- Site Number : 8401138 | Dawsonville | Georgia | 30534 | United States |
| First Georgia Physician Group- Site Number : 8401190 | Fayetteville | Georgia | 30214 | United States |
| Skin Care Physicians of Georgia - Macon- Site Number : 8401034 | Macon | Georgia | 31217 | United States |
| Javara Research - Thomasville- Site Number : 8401189 | Thomasville | Georgia | 31792 | United States |
| Rophe Adult & Pediatric Medicine- Site Number : 8401289 | Union City | Georgia | 30291 | United States |
| NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8401038 | Skokie | Illinois | 60077 | United States |
| Dawes Fretzin Clinical Research- Site Number : 8401015 | Indianapolis | Indiana | 46256 | United States |
| Equity Medical - Bowling Green- Site Number : 8401296 | Bowling Green | Kentucky | 42104 | United States |
| Skin Sciences- Site Number : 8401039 | Louisville | Kentucky | 40217 | United States |
| MedPharmics - Covington- Site Number : 8401137 | Covington | Louisiana | 70433 | United States |
| BRCR Global Gretna- Site Number : 8401243 | Gretna | Louisiana | 70053 | United States |
| Velocity Clinical Research - Lafayette- Site Number : 8401152 | Lafayette | Louisiana | 70508 | United States |
| MetroBoston Clinical Partners - Brighton- Site Number : 8401128 | Brighton | Massachusetts | 02135 | United States |
| Henry Ford Hospital- Site Number : 8401044 | Detroit | Michigan | 48202 | United States |
| Revival Research Institute - Troy- Site Number : 8401012 | Troy | Michigan | 48084 | United States |
| Oakland Medical Center- Site Number : 8401116 | Troy | Michigan | 48085 | United States |
| Allergy & Immunology Associates of Ann Arbor- Site Number : 8401078 | Ypsilanti | Michigan | 48197 | United States |
| SKY Integrative Medical Center/SKYCRNG - Ridgeland- Site Number : 8401058 | Ridgeland | Mississippi | 39157 | United States |
| Skin Specialists- Site Number : 8401068 | Omaha | Nebraska | 68144 | United States |
| Jubilee Clinical Research- Site Number : 8401054 | Las Vegas | Nevada | 89106 | United States |
| Care Access - Hoboken- Site Number : 8401132 | Hoboken | New Jersey | 07030 | United States |
| The University of New Mexico- Site Number : 8401263 | Albuquerque | New Mexico | 87106 | United States |
| Equity Medical- Site Number : 8401239 | New York | New York | 10023 | United States |
| Icahn School of Medicine at Mount Sinai- Site Number : 8401129 | New York | New York | 10029 | United States |
| Sadick Research Group - New York - Park Avenue- Site Number : 8401050 | New York | New York | 10075 | United States |
| OptiSkin- Site Number : 8401163 | New York | New York | 10128 | United States |
| AXIS Clinicals - Fargo- Site Number : 8401196 | Fargo | North Dakota | 58103 | United States |
| Bexley Dermatology Research- Site Number : 8401051 | Bexley | Ohio | 43209 | United States |
| Apex Clinical Research Center- Site Number : 8401237 | Mayfield Heights | Ohio | 44124 | United States |
| Oregon Medical Research Center- Site Number : 8401017 | Portland | Oregon | 97201 | United States |
| Best Skin Research - Camp Hill- Site Number : 8401031 | Camp Hill | Pennsylvania | 17011 | United States |
| Paddington Testing Company- Site Number : 8401041 | Philadelphia | Pennsylvania | 19103 | United States |
| Clinical Research of Philadelphia- Site Number : 8401193 | Philadelphia | Pennsylvania | 19114 | United States |
| Dermatology Associates of Plymouth Meeting- Site Number : 8401147 | Plymouth Meeting | Pennsylvania | 19462 | United States |
| Columbia Dermatology & Aesthetics- Site Number : 8401166 | Columbia | South Carolina | 29212 | United States |
| Tribe Clinical Research - Greenville - Verdae Boulevard- Site Number : 8401225 | Greenville | South Carolina | 29607 | United States |
| Health Concepts- Site Number : 8401059 | Rapid City | South Dakota | 57702 | United States |
| Arlington Research Center- Site Number : 8401248 | Arlington | Texas | 76011 | United States |
| Dermatology Treatment and Research Center- Site Number : 8401164 | Dallas | Texas | 75230 | United States |
| Derm Texas- Site Number : 8401217 | Dallas | Texas | 75235 | United States |
| Prolato Clinical Research Center- Site Number : 8401209 | Houston | Texas | 77054 | United States |
| SMS Clinical Research- Site Number : 8401182 | Mesquite | Texas | 75149 | United States |
| Synapse Clinical Research - Missouri City- Site Number : 8401148 | Missouri City | Texas | 77459 | United States |
| Texas Dermatology and Laser Specialists - San Antonio - Oakwell Court- Site Number : 8401131 | San Antonio | Texas | 78218 | United States |
| Stryde Research - Epiphany Dermatology- Site Number : 8401185 | Southlake | Texas | 76092 | United States |
| Complete Dermatology - Sugar Land- Site Number : 8401061 | Sugar Land | Texas | 77479 | United States |
| Tanner Clinic - Layton Antelope A- Site Number : 8401151 | Layton | Utah | 84041 | United States |
| Care Access - Arlington- Site Number : 8401134 | Arlington | Virginia | 22206 | United States |
| Virginia Dermatology & Skin Cancer Center- Site Number : 8401047 | Norfolk | Virginia | 23502 | United States |
| Investigational Site Number : 0320021 | Berazategui | Buenos Aires | 1886 | Argentina |
| Investigational Site Number : 0320017 | Pilar | Buenos Aires | 1629 | Argentina |
| Investigational Site Number : 0320006 | Rosario | Santa Fe Province | 2000 | Argentina |
| Investigational Site Number : 0320007 | Rosario | Santa Fe Province | 2000 | Argentina |
| Investigational Site Number : 0320015 | Rosario | Santa Fe Province | 2000 | Argentina |
| Investigational Site Number : 0320024 | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Investigational Site Number : 0320020 | San Miguel de Tucumán | Tucumán Province | T4000AXL | Argentina |
| Investigational Site Number : 0320022 | Buenos Aires | 1012 | Argentina |
| Investigational Site Number : 0320023 | Buenos Aires | 1028 | Argentina |
| Investigational Site Number : 0320011 | Buenos Aires | 1035 | Argentina |
| Investigational Site Number : 0320016 | Buenos Aires | 1055 | Argentina |
| Investigational Site Number : 0320008 | Buenos Aires | 1061 | Argentina |
| Investigational Site Number : 0320001 | Buenos Aires | 1121 | Argentina |
| Investigational Site Number : 0320018 | Buenos Aires | 1178 | Argentina |
| Investigational Site Number : 0320010 | Buenos Aires | 1414 | Argentina |
| Investigational Site Number : 0320002 | Buenos Aires | 1425 | Argentina |
| Investigational Site Number : 0320004 | Buenos Aires | 1425 | Argentina |
| Investigational Site Number : 0320009 | Buenos Aires | 1425 | Argentina |
| Investigational Site Number : 0320019 | Buenos Aires | 1426 | Argentina |
| Investigational Site Number : 0320005 | Buenos Aires | 1427 | Argentina |
| Investigational Site Number : 0320012 | Corrientes | 3400 | Argentina |
| Investigational Site Number : 0320013 | Mendoza | 5500 | Argentina |
| Investigational Site Number : 0360010 | Westmead | New South Wales | 2145 | Australia |
| Investigational Site Number : 0360007 | Woolloongabba | Queensland | 4102 | Australia |
| Investigational Site Number : 0360008 | Melbourne | Victoria | 3002 | Australia |
| Investigational Site Number : 0360006 | Melbourne | Victoria | 3004 | Australia |
| Investigational Site Number : 0361006 | Traralgon | Victoria | 3844 | Australia |
| Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760017 | Vitória | Espírito Santo | 29055-450 | Brazil |
| Centro de Pesquisas da Clínica IBIS- Site Number : 0760002 | Salvador | Estado de Bahia | 41820-020 | Brazil |
| Hospital São Domingos- Site Number : 0760028 | Bequimão | Maranhão | 65060-645 | Brazil |
| Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760022 | Curitiba | Paraná | 80060-900 | Brazil |
| PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR- Site Number : 0760023 | Curitiba | Paraná | 80230-130 | Brazil |
| Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005 | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760024 | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760015 | Ribeirão Preto | São Paulo | 14049-900 | Brazil |
| Faculdade de Medicina do ABC- Site Number : 0760001 | Santo André | São Paulo | 09060-650 | Brazil |
| Clinica de Alergia Martti Antila- Site Number : 0760006 | Sorocaba | São Paulo | 18040-425 | Brazil |
| CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760018 | Rio de Janeiro | 22241-180 | Brazil |
| Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760010 | São Paulo | 01323-020 | Brazil |
| Centro de Desenvolvimento em Estudos ClÌnicos Brasil- Site Number : 0760014 | São Paulo | 04020-060 | Brazil |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760012 | São Paulo | 05403-000 | Brazil |
| Investigational Site Number : 1002007 | Dupnitsa | 2600 | Bulgaria |
| Investigational Site Number : 1002004 | Pleven | 5800 | Bulgaria |
| Investigational Site Number : 1002005 | Sofia | 1431 | Bulgaria |
| Investigational Site Number : 1240039 | Calgary | Alberta | T2J 7E1 | Canada |
| Investigational Site Number : 1240031 | Edmonton | Alberta | T5K 2V4 | Canada |
| Investigational Site Number : 1240045 | Red Deer | Alberta | T4P 1K4 | Canada |
| Investigational Site Number : 1240046 | Kelowna | British Columbia | V1Y 4N7 | Canada |
| Investigational Site Number : 1240040 | Surrey | British Columbia | V3R 6A7 | Canada |
| Investigational Site Number : 1240030 | Surrey | British Columbia | V3V 0C6 | Canada |
| Investigational Site Number : 1240041 | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Investigational Site Number : 1240033 | Ajax | Ontario | L1S 7K8 | Canada |
| Investigational Site Number : 1240029 | London | Ontario | L6A 2C2 | Canada |
| Investigational Site Number : 1241106 | Markham | Ontario | L3P 1X3 | Canada |
| Investigational Site Number : 1240008 | Mississauga | Ontario | L5H 1G9 | Canada |
| Investigational Site Number : 1241108 | Niagara Falls | Ontario | L2H 1H5 | Canada |
| Investigational Site Number : 1240034 | Ottawa | Ontario | K1K 4L2 | Canada |
| Investigational Site Number : 1240038 | Richmond Hill | Ontario | L4E 4L6 | Canada |
| Investigational Site Number : 1240012 | Toronto | Ontario | M3H 5Y8 | Canada |
| Investigational Site Number : 1240035 | Toronto | Ontario | M5A 3R6 | Canada |
| Investigational Site Number : 1241107 | Waterloo | Ontario | N2J 1C4 | Canada |
| Investigational Site Number : 1240006 | Québec | Quebec | G1W 4R4 | Canada |
| Investigational Site Number : 1240028 | Regina | Saskatchewan | S4V 1R9 | Canada |
| Investigational Site Number : 1240036 | Saskatoon | Saskatchewan | S7K 0H6 | Canada |
| Investigational Site Number : 1520012 | Talcahuano | Biobio | 2687000 | Chile |
| Investigational Site Number : 1520004 | Valdivia | Los Ríos Region | 5110683 | Chile |
| Investigational Site Number : 1520009 | Osorno | Reg Metropolitana de Santiago | 5311523 | Chile |
| Investigational Site Number : 1520013 | Santiago | Reg Metropolitana de Santiago | 7500505 | Chile |
| Investigational Site Number : 1520008 | Santiago | Reg Metropolitana de Santiago | 7500587 | Chile |
| Investigational Site Number : 1520002 | Santiago | Reg Metropolitana de Santiago | 7580206 | Chile |
| Investigational Site Number : 1520003 | Santiago | Reg Metropolitana de Santiago | 7640881 | Chile |
| Investigational Site Number : 1520014 | Santiago | Reg Metropolitana de Santiago | 7750000 | Chile |
| Investigational Site Number : 1520010 | Santiago | Reg Metropolitana de Santiago | 8330034 | Chile |
| Investigational Site Number : 1520011 | Santiago | Reg Metropolitana de Santiago | 8380456 | Chile |
| Investigational Site Number : 1520005 | Santiago | Reg Metropolitana de Santiago | 8380465 | Chile |
| Investigational Site Number : 1520001 | Santiago | Reg Metropolitana de Santiago | 8420383 | Chile |
| Investigational Site Number : 1520015 | Quillota | Valparaiso | 2260877 | Chile |
| Investigational Site Number : 1520006 | Viña del Mar | Valparaiso | 2530900 | Chile |
| Investigational Site Number : 1560042 | Beijing | 100034 | China |
| Investigational Site Number : 1560004 | Beijing | 100191 | China |
| Investigational Site Number : 1560030 | Beijing | 100730 | China |
| Investigational Site Number : 1560050 | Changsha | 410011 | China |
| Investigational Site Number : 1560022 | Chengdu | 610041 | China |
| Investigational Site Number : 1560060 | Chengdu | 610072 | China |
| Investigational Site Number : 1560068 | Chengdu | 610091 | China |
| Investigational Site Number : 1560057 | Chongqing | 400016 | China |
| Investigational Site Number : 1560065 | Chongqing | 400065 | China |
| Investigational Site Number : 1560043 | Fuzhou | 350005 | China |
| Investigational Site Number : 1560021 | Guangzhou | 510018 | China |
| Investigational Site Number : 1560025 | Guangzhou | 510080 | China |
| Investigational Site Number : 1560058 | Guangzhou | 510630 | China |
| Investigational Site Number : 1560044 | Hangzhou | 310003 | China |
| Investigational Site Number : 1560002 | Hangzhou | 310006 | China |
| Investigational Site Number : 1560006 | Hangzhou | 310009 | China |
| Investigational Site Number : 1560029 | Hangzhou | 310014 | China |
| Investigational Site Number : 1560007 | Jinan | 250013 | China |
| Investigational Site Number : 1560051 | Nanchang | 330001 | China |
| Investigational Site Number : 1560024 | Ningbo | 315010 | China |
| Investigational Site Number : 1560001 | Shanghai | 200040 | China |
| Investigational Site Number : 1560005 | Shanghai | 200443 | China |
| Investigational Site Number : 1560041 | Shenyang | 110001 | China |
| Investigational Site Number : 1560026 | Shenyang | 110179 | China |
| Investigational Site Number : 1560064 | Shenzhen | 518026 | China |
| Investigational Site Number : 1560023 | Wenzhou | 325035 | China |
| Investigational Site Number : 1560049 | Wuhan | 430022 | China |
| Investigational Site Number : 1560003 | Wuxi | 214000 | China |
| Investigational Site Number : 1560028 | Zhenjiang | 212000 | China |
| Investigational Site Number : 2032106 | Kutná Hora | 284 01 | Czechia |
| Investigational Site Number : 2032105 | Nový Jičín | 741 00 | Czechia |
| Investigational Site Number : 2030010 | Olomouc | 779 00 | Czechia |
| Investigational Site Number : 2032104 | Ostrava | 702 00 | Czechia |
| Investigational Site Number : 2030009 | Pilsen | 323 00 | Czechia |
| Investigational Site Number : 2030008 | Prague | 110 01 | Czechia |
| Investigational Site Number : 2030011 | Prague | 150 00 | Czechia |
| Investigational Site Number : 2030006 | Prague | 160 00 | Czechia |
| Investigational Site Number : 2080002 | Aalborg | 9000 | Denmark |
| Investigational Site Number : 2080001 | Aarhus | 8200 | Denmark |
| Investigational Site Number : 2080003 | Herlev | 2730 | Denmark |
| Investigational Site Number : 2500008 | Antony | 92160 | France |
| Investigational Site Number : 2500013 | Nice | 06202 | France |
| Investigational Site Number : 2500003 | Paris | 75010 | France |
| Investigational Site Number : 2500006 | Pierre-Bénite | 69495 | France |
| Investigational Site Number : 2500007 | Reims | 51100 | France |
| Investigational Site Number : 2500010 | Romans-sur-Isère | 26102 | France |
| Investigational Site Number : 2500012 | Rouen | 76031 | France |
| Investigational Site Number : 2500002 | Toulouse | 31059 | France |
| Investigational Site Number : 2760020 | Augsburg | 86150 | Germany |
| Investigational Site Number : 2760009 | Bad Bentheim | 48455 | Germany |
| Investigational Site Number : 2760017 | Hamburg | 20095 | Germany |
| Investigational Site Number : 2760021 | Hamburg | 20354 | Germany |
| Investigational Site Number : 2762208 | Kiel | 24105 | Germany |
| Investigational Site Number : 2760016 | Mainz | 55128 | Germany |
| Investigational Site Number : 2762201 | Münster | 48149 | Germany |
| Investigational Site Number : 2760019 | Witten | 58453 | Germany |
| Investigational Site Number : 3000001 | Athens | 161 21 | Greece |
| Investigational Site Number : 3000002 | Thessaloniki | 54643 | Greece |
| Investigational Site Number : 3560001 | Ahmedabad | 380016 | India |
| Investigational Site Number : 3560005 | Belagavi | 590002 | India |
| Investigational Site Number : 3560004 | Chandigarh | 160012 | India |
| Investigational Site Number : 3560006 | Faridabad | 121002 | India |
| Investigational Site Number : 3560007 | Kolkata | 700073 | India |
| Investigational Site Number : 3560002 | Nagpur | 441203 | India |
| Investigational Site Number : 3560003 | Pune | 411057 | India |
| Investigational Site Number : 3760004 | Afula | 1834111 | Israel |
| Investigational Site Number : 3760005 | Beersheba | 8457108 | Israel |
| Investigational Site Number : 3760001 | Haifa | 3109601 | Israel |
| Investigational Site Number : 3760003 | Jerusalem | 9112001 | Israel |
| Investigational Site Number : 3760006 | Petah Tikva | 4920235 | Israel |
| Investigational Site Number : 3760002 | Petah Tikva | 4941492 | Israel |
| Investigational Site Number : 3800003 | Milan | Milano | 20122 | Italy |
| Investigational Site Number : 3800018 | Rozzano | Milano | 20089 | Italy |
| Investigational Site Number : 3800013 | Rome | Roma | 00133 | Italy |
| Investigational Site Number : 3800012 | Bologna | 40138 | Italy |
| Investigational Site Number : 3800009 | Catania | 95123 | Italy |
| Investigational Site Number : 3800011 | L’Aquila | 67100 | Italy |
| Investigational Site Number : 3800008 | Pisa | 56126 | Italy |
| Investigational Site Number : 3800022 | Vicenza | 36100 | Italy |
| Investigational Site Number : 3920009 | Chitose | Hokkaido | 066-0021 | Japan |
| Investigational Site Number : 3923114 | Obihiro | Hokkaido | 080-0013 | Japan |
| Investigational Site Number : 3920008 | Sapporo | Hokkaido | 064-0921 | Japan |
| Investigational Site Number : 3920006 | Kobe | Hyōgo | 653-0836 | Japan |
| Investigational Site Number : 3920005 | Sagamihara | Kanagawa | 252-0315 | Japan |
| Investigational Site Number : 3923113 | Yokohama | Kanagawa | 221-0825 | Japan |
| Investigational Site Number : 3920010 | Miyagi-gun | Miyagi | 981-0112 | Japan |
| Investigational Site Number : 3920011 | Sendai | Miyagi | 981-3133 | Japan |
| Investigational Site Number : 3923109 | Habikino | Osaka | 583-8588 | Japan |
| Investigational Site Number : 3923110 | Sakai | Osaka | 593-8324 | Japan |
| Investigational Site Number : 3920002 | Iruma | Saitama | 350-0495 | Japan |
| Investigational Site Number : 3923106 | Mibu | Tochigi | 321-0293 | Japan |
| Investigational Site Number : 3920004 | Chūō | Tokyo | 104-0031 | Japan |
| Investigational Site Number : 3923107 | Minato | Tokyo | 108-0014 | Japan |
| Investigational Site Number : 3920001 | Tachikawa | Tokyo | 190-0023 | Japan |
| Investigational Site Number : 3923108 | Kagoshima | 890-0063 | Japan |
| Investigational Site Number : 3923102 | Kyoto | 602-8566 | Japan |
| Investigational Site Number : 3920003 | Kyoto | 606-8507 | Japan |
| Investigational Site Number : 4840011 | Monterrey | Nuevo León | 64460 | Mexico |
| Investigational Site Number : 4840005 | Monterrey | Nuevo León | 64718 | Mexico |
| Investigational Site Number : 4840012 | Aguascalientes | 20127 | Mexico |
| Investigational Site Number : 4840009 | Durango | 34000 | Mexico |
| Investigational Site Number : 4840003 | Veracruz | 91900 | Mexico |
| Investigational Site Number : 6162406 | Krakow | Lesser Poland Voivodeship | 31-209 | Poland |
| Investigational Site Number : 6160010 | Tarnów | Lesser Poland Voivodeship | 33-100 | Poland |
| Investigational Site Number : 6160004 | Lublin | Lublin Voivodeship | 20-607 | Poland |
| Investigational Site Number : 6160002 | Lodz | Lódzkie | 90-265 | Poland |
| Investigational Site Number : 6160009 | Warsaw | Masovian Voivodeship | 02-625 | Poland |
| Investigational Site Number : 6160007 | Warsaw | Masovian Voivodeship | 02-962 | Poland |
| Investigational Site Number : 6160006 | Gdansk | Pomeranian Voivodeship | 80-546 | Poland |
| Investigational Site Number : 6160003 | Katowice | Silesian Voivodeship | 40-611 | Poland |
| Investigational Site Number : 6200005 | Lisbon | 1169-050 | Portugal |
| Investigational Site Number : 6200004 | Lisbon | 1649-035 | Portugal |
| Investigational Site Number : 6200001 | Lisbon | 1998-018 | Portugal |
| Investigational Site Number : 6200003 | Porto | 4099-001 | Portugal |
| Investigational Site Number : 7100015 | Benoni | 1500 | South Africa |
| Investigational Site Number : 7100010 | Cape Town | 7533 | South Africa |
| Investigational Site Number : 7100009 | Cape Town | 7708 | South Africa |
| Investigational Site Number : 7100012 | Durban | 3630 | South Africa |
| Investigational Site Number : 7100001 | Durban | 4058 | South Africa |
| Investigational Site Number : 7100007 | Johannesburg | 2196 | South Africa |
| Investigational Site Number : 7100003 | Pretoria | 0009 | South Africa |
| Investigational Site Number : 4100008 | Daegu | Daegu | 41944 | South Korea |
| Investigational Site Number : 4100012 | Gwangju | Gwangju | 61453 | South Korea |
| Investigational Site Number : 4100002 | Ansan-si | Gyeonggi-do | 15355 | South Korea |
| Investigational Site Number : 4100014 | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Investigational Site Number : 4100009 | Suwon | Gyeonggi-do | 16499 | South Korea |
| Investigational Site Number : 4100003 | Yangsan | Gyeongsangnam-do | 50612 | South Korea |
| Investigational Site Number : 4100015 | Bupyeong-gu | Incheon-gwangyeoksi | 21431 | South Korea |
| Investigational Site Number : 4100010 | Seoul | Seoul-teukbyeolsi | 01812 | South Korea |
| Investigational Site Number : 4100013 | Seoul | Seoul-teukbyeolsi | 03080 | South Korea |
| Investigational Site Number : 4100007 | Seoul | Seoul-teukbyeolsi | 03722 | South Korea |
| Investigational Site Number : 4100006 | Seoul | Seoul-teukbyeolsi | 05030 | South Korea |
| Investigational Site Number : 4100011 | Seoul | Seoul-teukbyeolsi | 06591 | South Korea |
| Investigational Site Number : 4100017 | Seoul | Seoul-teukbyeolsi | 07804 | South Korea |
| Investigational Site Number : 7240010 | Esplugues de Llobregat | Barcelona [Barcelona] | 08950 | Spain |
| Investigational Site Number : 7240008 | Bilbao | Basque Country | 48013 | Spain |
| Investigational Site Number : 7240012 | Las Palmas de Gran Canaria | Las Palmas | 35010 | Spain |
| Investigational Site Number : 7240015 | Pamplona | Navarre | 31008 | Spain |
| Investigational Site Number : 7240014 | Vigo | Pontevedra [Pontevedra] | 36206 | Spain |
| Investigational Site Number : 7240020 | Seville | Sevilla | 41013 | Spain |
| Investigational Site Number : 7240023 | Burjassot - Valencia | Valenciana, Comunidad | 46100 | Spain |
| Investigational Site Number : 7242505 | Alicante | 03010 | Spain |
| Investigational Site Number : 7240018 | Granada | 18014 | Spain |
| Investigational Site Number : 7240019 | Granada | 18016 | Spain |
| Investigational Site Number : 7240029 | Madrid | 28007 | Spain |
| Investigational Site Number : 7242503 | Madrid | 28046 | Spain |
| Investigational Site Number : 7520006 | Älvsjö | 125 44 | Sweden |
| Investigational Site Number : 1583201 | Kaohsiung City | 833 | Taiwan |
| Investigational Site Number : 1583202 | Taichung | 402 | Taiwan |
| Investigational Site Number : 1580001 | Taipei | 100 | Taiwan |
| Investigational Site Number : 1580003 | Taipei | 112 | Taiwan |
| Investigational Site Number : 7920001 | Antalya | 07070 | Turkey (Türkiye) |
| Investigational Site Number : 7920005 | Istanbul | 34093 | Turkey (Türkiye) |
| Investigational Site Number : 7920006 | Istanbul | 34093 | Turkey (Türkiye) |
| Investigational Site Number : 7920002 | Istanbul | 34098 | Turkey (Türkiye) |
| Investigational Site Number : 7920009 | Istanbul | 34662 | Turkey (Türkiye) |
| Investigational Site Number : 7920004 | Kayseri | 38039 | Turkey (Türkiye) |
| Investigational Site Number : 7920011 | Mersin | 34343 | Turkey (Türkiye) |
| Investigational Site Number : 7920007 | Samsun | 55139 | Turkey (Türkiye) |
| Investigational Site Number : 8260003 | Portsmouth | Hampshire | PO3 6DW | United Kingdom |
| Investigational Site Number : 8260004 | Leicester | Leicestershire | LE2 0TA | United Kingdom |
| Investigational Site Number : 8262601 | London | London, City of | SE1 9RT | United Kingdom |
| Investigational Site Number : 8262602 | London | London, City of | SE1 9RT | United Kingdom |
| Investigational Site Number : 8260006 | Glasgow | G3 8SJ | 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