Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:18 AM
Study NCT ID:
NCT06407934
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2024-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'Colombia', 'Croatia', 'Ireland', 'Malaysia', 'Netherlands', 'Peru', 'Singapore', 'Slovakia', 'Tunisia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1541}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-03-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2024-05-06', 'studyFirstSubmitQcDate': '2024-05-06', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Responders from parent studies: Proportion of participants who maintain treatment response in ESTUARY.', 'timeFrame': 'Week 48', 'description': 'Maintenance of clinical response is defined as having validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) 0 (clear) or 1 (almost clear) OR 75% reduction in Eczema Area and Severity Index (EASI) compared to parent study baseline EASI (EASI-75\\^) OR vIGA-AD 0 (clear) or 1 (almost clear) and EASI-75\\^.\n\nThe 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).\n\nThe 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.'}], 'secondaryOutcomes': [{'measure': 'Responders from parent studies: Proportion of participants who continue to be EASI-75^ among the participants who met EASI-75^ at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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".'}, {'measure': 'Responders from parent studies: Proportion of participants who continue to be vIGA-AD 0 (clear) or 1 (almost clear) among participants who met vIGA-AD 0 (clear) or 1 (almost clear) at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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).'}, {'measure': 'Responders from parent studies: Proportion of participants who continue to be vIGA-AD 0 or 1 with presence of only barely perceptible erythema among those who are vIGA-AD 0 or 1 with presence of only barely perceptible erythema at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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), 1 (almost clear) to 4 (severe). Barely perceptible erythema with no induration/papulation, no lichenification, no oozing or crusting.'}, {'measure': 'Responders from parent studies: 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', 'timeFrame': 'Up to Week 48', 'description': '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".'}, {'measure': 'Responders from parent studies: Proportion of participants who maintain vIGA-AD ≤1 and PP-NRS ≤1 at Week 48 of ESTUARY among participants who were vIGA-AD ≤1 and PP-NRS ≤1 at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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 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.'}, {'measure': 'Responders from parent studies: Proportion of participants who maintain vIGA-AD ≤2 and PP-NRS ≤4 at Week 48 of ESTUARY among participants who were vIGA-AD ≤2 and PP-NRS ≤4 at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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 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.'}, {'measure': 'Responders from parent studies: Proportion of participants who maintain treatment response', 'timeFrame': 'Up to Week 44', 'description': 'Maintenance of treatment response is defined as having vIGA-AD 0 (clear) or 1 (almost clear) OR 75% reduction in EASI compared to parent study baseline EASI (EASI-75\\^) OR vIGA-AD 0 (clear) or 1 (almost clear) and 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).\n\nThe 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.'}, {'measure': 'Responders from parent studies: Percent change in EASI from parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': '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.'}, {'measure': 'Responders from parent studies: Proportion of participants who maintained EASI-75^ among the participants who met EASI-75^ at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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".'}, {'measure': 'Responders from parent studies: Proportion of participants with EASI-75^', 'timeFrame': 'Parent study baseline to Week 48', 'description': '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".'}, {'measure': 'Responders from parent studies: Proportion of participants who continue to be EASI-50^ among the participants who met EASI-50^ at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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-50 is 50% reduction from baseline in EASI score. The symbol \\^ represents "based on parent study baseline".'}, {'measure': 'Responders from parent studies: Proportion of participants with EASI-50^', 'timeFrame': 'Parent study baseline to Week 48', 'description': '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-50 is 50% reduction from baseline in EASI score. The symbol \\^ represents "based on parent study baseline".'}, {'measure': 'Responders from parent studies: Proportion of participants who continue to be EASI-90^ among the participants who met EASI-90^ at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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".'}, {'measure': 'Responders from parent studies: Proportion of participants with EASI-90^', 'timeFrame': 'Parent study baseline to Week 48', 'description': '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".'}, {'measure': 'Responders from parent studies: Proportion of participants who continue to be EASI-100^ among the participants who met EASI-100^ at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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-100 is 100% reduction from baseline in EASI score. The symbol \\^ represents "based on parent study baseline".'}, {'measure': 'Responders from parent studies: Proportion of participants with EASI-100^', 'timeFrame': 'Parent study baseline to Week 48', 'description': '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-100 is 100% reduction from baseline in EASI score. The symbol \\^ represents "based on parent study baseline".'}, {'measure': 'Responders from parent studies: Time to the first event of loss of EASI-75^ response among the participants who were EASI-75^ responders at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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".'}, {'measure': 'Responders from parent studies: Time to the first event of loss of EASI-50^ response among the participants who were EASI-50^ responders at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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-50 is 50% reduction from baseline in EASI score. The symbol \\^ represents "based on parent study baseline".'}, {'measure': 'Responders from parent studies: Time to the first event of loss of EASI-90^ response among the participants who were EASI-90^ responders at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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".'}, {'measure': 'Responders from parent studies: Time to the first event of loss of EASI-100^ among participants who were EASI-100^ at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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-100\\^ is 100% reduction from baseline in EASI score. The symbol \\^ represents "based on parent study baseline".'}, {'measure': 'Responders from parent studies: Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear)', 'timeFrame': 'Up to Week 48', 'description': '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).'}, {'measure': 'Responders from parent studies: Proportion of participants who are vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting)', 'timeFrame': 'Up to Week 48', 'description': '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).'}, {'measure': 'Responders from parent studies: Time to first event of vIGA-AD ≥1 among those participants who were vIGA-AD 0 (clear) at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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).'}, {'measure': 'Responders from parent studies: Time to first event of vIGA-AD ≥2 among those participants who were vIGA AD 0 (clear) or 1 (almost clear) at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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).'}, {'measure': 'Responders from parent studies: Time to first event of vIGA-AD ≥3 (moderate or severe) among those participants who were vIGA-AD 0 (clear) or 1 (almost clear) at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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).'}, {'measure': 'Responders from parent studies: Time to first event of vIGA-AD ≥3 (moderate or severe) among those participants who were vIGA-AD 0 (clear) at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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).'}, {'measure': 'Responders from parent studies: Proportion of participants who have an increase of ≥2 points in vIGA-AD from ESTUARY baseline among the participants who were vIGA-AD 0 (clear) or 1 (almost clear) at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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).'}, {'measure': 'Responders from parent studies: Proportion of participants who have an increase of ≥2 points in vIGA-AD from ESTUARY baseline among the participants who were vIGA-AD 3 (moderate) at baseline of parent study', 'timeFrame': 'Up to Week 48', 'description': '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).'}, {'measure': 'Responders from parent studies: Proportion of participants who have an increase of ≥2 points in vIGA-AD from ESTUARY baseline among the participants who were vIGA-AD 4 (severe) at baseline of parent study', 'timeFrame': 'Up to Week 48', 'description': '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).'}, {'measure': 'Responders from parent studies: Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear) and/or EASI-75^ among the participants who were vIGA-AD 0 (clear) or 1 (almost clear) and/or EASI-75^ at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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".'}, {'measure': 'Responders from parent studies: Proportion of participants with ≥ 4 points reduction in weekly average of daily PP-NRS from parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': '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.'}, {'measure': 'Responders from parent studies: Percent change in weekly average of daily PP-NRS from parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': '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.'}, {'measure': 'Responders from parent studies: Absolute change in weekly average of daily PP-NRS from parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': '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.'}, {'measure': 'Responders from parent studies: Proportion of participants who maintained PP-NRS 0 or 1 among the participants who were PP-NRS 0 or 1 at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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.'}, {'measure': 'Responders from parent studies:Proportion of participants who maintained vIGA-AD 0 or 1 and/or EASI-75^ and weekly average of daily (WAD) PP-NRS reduction ≥4^ among those who were vIGA-AD 0 or 1 and/or EASI-75^ and WAD PP-NRS reduction ≥4^ at ESTUARY BL', 'timeFrame': 'Up to Week 48', 'description': '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), 1 (almost 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 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". BL=baseline.'}, {'measure': 'Responders from parent studies: Proportion of participants who continue to be vIGA-AD 0 (clear) among the participants who were vIGA- AD 0 (clear) at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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).'}, {'measure': 'Responders from parent studies: Proportion of participants who maintain vIGA-AD 0 to 2 (clear, almost clear, and mild disease) among participants who were vIGA-AD 0 to 2 (clear, almost clear, and mild disease) at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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).'}, {'measure': 'Responders from parent studies: Proportion of participants who maintain PP-NRS ≤4 among participants who were PP-NRS ≤4 at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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.'}, {'measure': 'Responders from parent studies: Absolute change in weekly average of daily SD-NRS from parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': 'The Sleep Disturbance-Numerical Rating Scale (SD-NRS) is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.'}, {'measure': 'Responders from parent studies: Proportion of participants who maintained weekly average of daily SD-NRS reduction of ≥3^ among the participants with weekly average of daily SD-NRS reduction of ≥3^ at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': 'The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all. The symbol \\^ represents "based on parent study baseline".'}, {'measure': 'Responders from parent studies: Proportion of participants with ≥3 points reduction in weekly average of daily SD-NRS from parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': 'The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.'}, {'measure': 'Responders from parent studies: Proportion of participants with ≥4 points reduction in weekly average of daily SP-NRS from parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': 'The Skin Pain-Numerical Rating Scale (SP-NRS) is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.'}, {'measure': 'Responders from parent studies: Proportion of participants who maintained weekly average of daily SP-NRS reduction of ≥4^ among the participants with weekly average of daily SP-NRS reduction of ≥4^ at ESTUARY baseline', 'timeFrame': 'Up to Week 48', 'description': 'The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable. The symbol \\^ represents "based on parent study baseline".'}, {'measure': 'Responders from parent studies: Absolute change in weekly average of daily SP-NRS from parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': 'The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.'}, {'measure': 'Responders from parent studies: Proportion of participants who maintained SCORAD ≥8.7^ among participants with reduction in SCORAD ≥8.7^ at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': 'The Scoring Atopic Dermatitis (SCORAD) index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease). The symbol \\^ represents "based on parent study baseline".'}, {'measure': 'Responders from parent studies: Percent change in SCORAD index from parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': 'The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).'}, {'measure': 'Responders from parent studies: Absolute change in SCORAD index from parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': 'The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).'}, {'measure': 'Responders from parent studies: Change in percent Body Surface Area (BSA) affected by AD from parent study baseline', 'timeFrame': 'Parent study baseline to Week 48'}, {'measure': 'Responders from parent studies: Proportion of participants who maintained POEM ≥4 among the participants with reduction in POEM ≥4 at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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.'}, {'measure': 'Responders from parent studies: Change in POEM from parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': 'The 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.'}, {'measure': 'Responders from parent studies: Proportion of participants with a reduction in CDLQI ≥6^ among participants aged ≥12 to <16 years old and with CDLQI baseline ≥6', 'timeFrame': 'Parent study baseline to Week 48', 'description': '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".'}, {'measure': 'Responders from parent studies: Change in CDLQI^ in participants with age ≥12 to <16 years old', 'timeFrame': 'Parent study baseline to Week 48', 'description': 'The 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".'}, {'measure': 'Responders from parent studies: Change in Dermatology Life Quality Index (DLQI^) in participants with age ≥16 years among the participants with DLQI ≥4 at parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': '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. The symbol \\^ represents "based on parent study baseline".'}, {'measure': 'Responders from parent studies: Proportion of participants with ≥4 points reduction in DLQI from parent study baseline among the participants with DLQI ≥4 at parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': '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.'}, {'measure': 'Responders from parent studies: Proportion of participants with HADS-D <8 among the participants who had HADS-D ≥8 at parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': 'The Hospital Anxiety Depression Scale-Depression (HADS-D) ranges 0-21 with higher score indicating a poorer state.'}, {'measure': 'Responders from parent studies: Proportion of participants with HADS-A <8 among the participants who had HADS-A ≥8 at parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': 'The Hospital Anxiety Depression Scale-Anxiety (HADS-A) ranges 0-21 with higher score indicating a poorer state.'}, {'measure': 'Responders from parent studies: Proportion of participants requiring rescue medication during the study up to Week 48 of ESTUARY', 'timeFrame': 'Up to Week 48'}, {'measure': 'Responders from parent studies: Time to first rescue medication initiation', 'timeFrame': 'Up to Week 48'}, {'measure': 'Responders from parent studies: Proportion of participants who are vIGA-AD ≤1 and PP-NRS ≤1', 'timeFrame': 'Up to Week 48', 'description': '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).\n\nThe 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.'}, {'measure': 'Responders from parent studies: Proportion of participants who are vIGA-AD ≤2 and PP-NRS ≤4', 'timeFrame': 'Up to Week 48', 'description': '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).\n\nThe 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.'}, {'measure': 'Responders from parent studies: Proportion of participants who are "vIGA-AD ≤1 or EASI ≤3" and PP-NRS ≤1', 'timeFrame': 'Up to Week 48', 'description': '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).\n\nThe 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.\n\nThe 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.'}, {'measure': 'Responders from parent studies: Proportion of participants who are "vIGA-AD ≤ 2 or EASI ≤7" AND PP-NRS ≤4', 'timeFrame': 'Up to Week 48', 'description': '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).\n\nThe 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.\n\nThe 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.'}, {'measure': 'Responders from parent studies: Proportion of participants who maintain "vIGA-AD ≤1 or EASI ≤3" AND PP-NRS ≤1 among participants who were "vIGA-AD ≤1 or EASI ≤3" and PP-NRS ≤1 (VLDA) at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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).\n\nThe 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.\n\nThe 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.'}, {'measure': 'Responders from parent studies: Proportion of participants who maintain "vIGA-AD ≤2 or EASI ≤7" AND PP-NRS ≤4 among participants who were "vIGA-AD ≤2 or EASI ≤7" AND PP-NRS ≤4 (LDA) at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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).\n\nThe 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.\n\nThe 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.'}, {'measure': 'Responders from parent studies: Proportion of participants who are flare free over the 48-week period', 'timeFrame': 'Up to Week 48', 'description': 'Flare is defined as exacerbation of pruritus, assessed using the Peak-Pruritus Numerical Rating Scale (PP-NRS)'}, {'measure': 'Responders from parent studies: For those participants who experience flare, time to first flare', 'timeFrame': 'Up to Week 48', 'description': 'Flare is defined as exacerbation of pruritus, assessed using the Peak-Pruritus Numerical Rating Scale (PP-NRS)'}, {'measure': 'Non-responders from parent studies: Percent change in EASI from parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': '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.'}, {'measure': 'Non-responders from parent studies: Proportion of participants with EASI-75^', 'timeFrame': 'Parent study baseline to Week 48', 'description': '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".'}, {'measure': 'Non-responders from parent studies: Proportion of participants who continue to be EASI-50^ among the participants who met EASI-50^ at baseline of ESTUARY', 'timeFrame': 'Up to Week 48', 'description': '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-50 is 50% reduction from baseline in EASI score. The symbol \\^ represents "based on parent study baseline".'}, {'measure': 'Non-responders from parent studies: Proportion of participants with EASI-50^', 'timeFrame': 'Parent study baseline to Week 48', 'description': '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-50 is 50% reduction from baseline in EASI score. The symbol \\^ represents "based on parent study baseline".'}, {'measure': 'Non-responders from parent studies: Proportion of participants with EASI-90^', 'timeFrame': 'Parent study baseline to Week 48', 'description': '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".'}, {'measure': 'Non-responders from parent studies: Proportion of participants with EASI-100^', 'timeFrame': 'Parent study baseline to Week 48', 'description': '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-100 is 100% reduction from baseline in EASI score. The symbol \\^ represents "based on parent study baseline".'}, {'measure': 'Non-responders from parent studies: Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear)', 'timeFrame': 'Up to Week 48', 'description': '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).'}, {'measure': 'Non-responders from parent studies: Proportion of participants who are vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting)', 'timeFrame': 'Up to Week 48', 'description': '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).'}, {'measure': 'Non-responders from parent studies: Proportion of participants with ≥ 4 points reduction in weekly average of daily PP-NRS from parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': '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.'}, {'measure': 'Non-responders from parent studies: Percent change in weekly average of daily PP-NRS from parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': '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.'}, {'measure': 'Non-responders from parent studies: Absolute change in weekly average of daily PP-NRS from parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': '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.'}, {'measure': 'Non-responders from parent studies: Absolute change in weekly average of daily SD-NRS from parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': 'The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.'}, {'measure': 'Non-responders from parent studies: Proportion of participants with ≥3 points reduction in weekly average of daily SD-NRS from parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': 'The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.'}, {'measure': 'Non-responders from parent studies: Proportion of participants with ≥ 4 points reduction in weekly average of daily SP-NRS from parent study baseline [', 'timeFrame': 'Parent study baseline to Week 48', 'description': 'The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.'}, {'measure': 'Non-responders from parent studies: Absolute change in weekly average of daily SP-NRS from parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': 'The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.'}, {'measure': 'Non-responders from parent studies: Proportion of participants with a reduction in CDLQI ≥6^ among participants aged ≥12 to <16 years old and with CDLQI ≥6 at parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': 'The CDLQI 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. The symbol \\^ represents "based on parent study baseline".'}, {'measure': 'Non-responders from parent studies: Change in CDLQI^ in participants with age ≥12 to <16 years old', 'timeFrame': 'Parent study baseline to Week 48', 'description': 'The CDLQI 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. The symbol \\^ represents "based on parent study baseline".'}, {'measure': 'Non-responders from parent studies: Change in DLQI^ in participants with age ≥16 years among the participants with DLQI ≥4 at parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': '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. The symbol \\^ represents "based on parent study baseline".'}, {'measure': 'Non-responders from parent studies: Proportion of participants with ≥4 points reduction in DLQI from parent study baseline among the participants with DLQI ≥4 at parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': '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.'}, {'measure': 'Non-responders from parent studies: Proportion of participants with HADS-D <8 among the participants who had HADS-D ≥8 at parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': 'The Hospital Anxiety Depression Scale-Depression (HADS-D) ranges 0-21 with higher score indicating a poorer state.'}, {'measure': 'Non-responders from parent studies: Proportion of participants with HADS-A <8 among the participants who had HADS-A ≥8 at parent study baseline', 'timeFrame': 'Parent study baseline to Week 48', 'description': 'The Hospital Anxiety Depression Scale-Anxiety (HADS-A) ranges 0-21 with higher score indicating a poorer state.'}, {'measure': 'All participants: 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)', 'timeFrame': 'Up to week 68'}, {'measure': 'All participants: Serum amlitelimab concentrations measured at prespecified timepoints', 'timeFrame': 'Up to Week 68'}, {'measure': 'All participants: Incidence of antidrug antibodies (ADAs) of amlitelimab', 'timeFrame': 'Up to Week 68'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dermatitis Atopic']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.trialsummaries.com/Study/StudyDetails?id=25741&tenant=MT_SNY_9011', 'label': 'EFC17600 Plain Language Results Summary'}]}, 'descriptionModule': {'briefSummary': '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).\n\nThe main objective of this study is to evaluate if those participants who received amlitelimab dose 1 in the parent studies (EFC17559 \\[COAST-1\\], EFC17560 \\[COAST 2\\], EFC17561 \\[SHORE\\]) and were responders can maintain their response either remaining at dose 1 or switching to dose 2 of amlitelimab compared to treatment withdrawal.\n\nStudy details include:\n\nThe 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).\n\nThe study duration will be up to 52 weeks for participants entering the LTS17367 \\[RIVER-AD\\] study at the Week 52 visit of EFC17600 (ESTUARY).\n\nThe total treatment duration will be up to 52 weeks. The total number of visits will be up to 15 visits (or 14 visits for those entering LTS17367 \\[RIVER-AD\\] study).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants must be at least 12 years of age inclusive, at the time the informed consent is signed.\n* Must have participated, received study treatment without permanent investigational medicinal product (IMP) discontinuation, and adequately completed the assessments required for the treatment period in one of the three 24-week parent studies EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE) for moderate-to-severe AD.\n* Able and willing to comply with requested study visit and procedures.\n* Body weight must be ≥ 25 kg.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Developed a medical condition that would preclude participation as described in Exclusion Criteria or Permanent Discontinuation of EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) clinical trial protocols.\n* Having received any prohibited medication or procedure for AD that resulted in IMP discontinuation in the parent study EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE).\n* Participants who, during their participation in the parent study EFC17559 (COAST-1) /EFC17560 (COAST-2)/EFC17561 (SHORE), developed an adverse event (AE) or a serious adverse event (SAE) deemed related to amlitelimab, which in the opinion of the Investigator could indicate that continued treatment with amlitelimab may present an unreasonable risk for the participant.\n* Participants who have had IMP permanently discontinued for any reason before or at the time of the planned first dose in the EFC17600 (ESTUARY) study.\n* Conditions in the parent study EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) that led to Investigator - or Sponsor-initiated withdrawal of participant from the study (eg, non-compliance, inability to complete study assessments, etc.).\n* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT06407934', 'acronym': 'ESTUARY', 'briefTitle': 'A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Phase 3, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group 52-week Extension Study to Evaluate the Treatment Response and Safety of Two Amlitelimab Dose Regimens Administered by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'EFC17600'}, 'secondaryIdInfos': [{'id': 'U1111-1290-9215', 'type': 'REGISTRY', 'domain': 'ICTRP'}, {'id': '2023-508096-36', 'type': 'REGISTRY', 'domain': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amlitelimab dose 1', 'description': 'Subcutaneous injection as per protocol', 'interventionNames': ['Drug: Amlitelimab']}, {'type': 'EXPERIMENTAL', 'label': 'Amlitelimab dose 2', 'description': 'Subcutaneous injection as per protocol', 'interventionNames': ['Drug: Amlitelimab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subcutaneous injection as per protocol', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Amlitelimab', 'type': 'DRUG', 'otherNames': ['SAR445229'], 'description': 'Pharmaceutical form: Injection solution\n\nRoute of administration: Subcutaneous (SC) injection', 'armGroupLabels': ['Amlitelimab dose 1', 'Amlitelimab dose 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Pharmaceutical form: Injection solution\n\nRoute of administration: SC injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35244', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cahaba Dermatology & Skin Health Center- Site Number : 8401066', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Center for Dermatology and Plastic Surgery- Site Number : 8401119', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Scottsdale Clinical Trials- Site Number : 8401149', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85745', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Eclipse Clinical Research- Site Number : 8401158', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72916', 'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Johnson Dermatology- Site Number : 8401076', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Encino Research Center- Site Number : 8401042', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'First OC Dermatology- Site Number : 8401025', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Center for Dermatology Clinical Research- Site Number : 8401018', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Marvel Clinical Research- Site Number : 8401102', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '94549', 'city': 'Lafayette', 'state': 'California', 'country': 'United States', 'facility': 'Sunwise Clinical Research- Site Number : 8401022', 'geoPoint': {'lat': 37.88576, 'lon': -122.11802}}, {'zip': '90717', 'city': 'Lomita', 'state': 'California', 'country': 'United States', 'facility': 'Torrance Clinical Research - Narbonne Avenue- Site Number : 8401027', 'geoPoint': {'lat': 33.79224, 'lon': -118.31507}}, {'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology Research Associates - Los Angeles- Site Number : 8401092', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'LA Universal Research Center- Site Number : 8401064', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91325', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Northridge Clinical Trials - Northridge- Site Number : 8401080', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '93030', 'city': 'Oxnard', 'state': 'California', 'country': 'United States', 'facility': 'Cura Clinical Research - Oxnard- Site Number : 8401142', 'geoPoint': {'lat': 34.1975, 'lon': -119.17705}}, {'zip': '92701', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Dermatology- Site Number : 8401043', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Science Institute- Site Number : 8401028', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'UConn Health - Farmington- Site Number : 8401115', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Pediatric Skin Research- Site Number : 8401198', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33172', 'city': 'Doral', 'state': 'Florida', 'country': 'United States', 'facility': 'St. Jude Clinical Research- Site Number : 8401287', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '33919', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8401286', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Direct Helpers Research Center- Site Number : 8401056', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Encore Medical Research - Hollywood- Site Number : 8401030', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clever Medical Research- Site Number : 8401160', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33142', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Acevedo Clinical Research Associates- Site Number : 8401088', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida International Research Center- Site Number : 8401091', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Dermatology and Laser Research - Miami - Southwest 87th Avenue- Site Number : 8401086', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Anchor Medical Research- Site Number : 8401300', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Savin Medical Group - Miami Lakes- Site Number : 8401085', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '33060', 'city': 'Pompano Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Nuline Clinical Trial Center- Site Number : 8401161', 'geoPoint': {'lat': 26.23786, 'lon': -80.12477}}, {'zip': '33705', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Global Clinical Professionals (GCP)- Site Number : 8401045', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Trials of Florida- Site Number : 8401023', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'AllerVie Clinical Research - Columbus- Site Number : 8401104', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '30534', 'city': 'Dawsonville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Cleaver Medical Group- Site Number : 8401138', 'geoPoint': {'lat': 34.42121, 'lon': -84.11908}}, {'zip': '30214', 'city': 'Fayetteville', 'state': 'Georgia', 'country': 'United States', 'facility': 'First Georgia Physician Group- Site Number : 8401190', 'geoPoint': {'lat': 33.44873, 'lon': -84.45493}}, {'zip': '31217', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Skin Care Physicians of Georgia - Macon- Site Number : 8401034', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '31792', 'city': 'Thomasville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Javara Research - Thomasville- Site Number : 8401189', 'geoPoint': {'lat': 30.83658, 'lon': -83.97878}}, {'zip': '30291', 'city': 'Union City', 'state': 'Georgia', 'country': 'United States', 'facility': 'Rophe Adult & Pediatric Medicine- Site Number : 8401289', 'geoPoint': {'lat': 33.58706, 'lon': -84.54243}}, {'zip': '60077', 'city': 'Skokie', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8401038', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Dawes Fretzin Clinical Research- Site Number : 8401015', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '42104', 'city': 'Bowling Green', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Equity Medical - Bowling Green- Site Number : 8401296', 'geoPoint': {'lat': 36.99032, 'lon': 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