A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids

Launched by SANOFI · Jan 16, 2024

Nctid: NCT06224348

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D003876", "term"=>"Dermatitis, Atopic"}, {"id"=>"D003872", "term"=>"Dermatitis"}], "ancestors"=>[{"id"=>"D012871", "term"=>"Skin Diseases"}, {"id"=>"D012873", "term"=>"Skin Diseases, Genetic"}, {"id"=>"D030342", "term"=>"Genetic Diseases, Inborn"}, {"id"=>"D017443", "term"=>"Skin Diseases, Eczematous"}, {"id"=>"D006969", "term"=>"Hypersensitivity, Immediate"}, {"id"=>"D006967", "term"=>"Hypersensitivity"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M7067", "name"=>"Dermatitis", "asFound"=>"Dermatitis", "relevance"=>"HIGH"}, {"id"=>"M7071", "name"=>"Dermatitis, Atopic", "asFound"=>"Dermatitis Atopic", "relevance"=>"HIGH"}, {"id"=>"M7655", "name"=>"Eczema", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}, {"id"=>"M15676", "name"=>"Skin Diseases, Genetic", "relevance"=>"LOW"}, {"id"=>"M23686", "name"=>"Genetic Diseases, Inborn", "relevance"=>"LOW"}, {"id"=>"M19712", "name"=>"Skin Diseases, Eczematous", "relevance"=>"LOW"}, {"id"=>"M10018", "name"=>"Hypersensitivity", "relevance"=>"LOW"}, {"id"=>"M10020", "name"=>"Hypersensitivity, Immediate", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D065095", "term"=>"Calcineurin Inhibitors"}], "ancestors"=>[{"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M21860", "name"=>"Pharmaceutical Solutions", "relevance"=>"LOW"}, {"id"=>"M30452", "name"=>"Calcineurin Inhibitors", "asFound"=>"Three times weekly", "relevance"=>"HIGH"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Pharmaceutical Solutions", "abbrev"=>"PhSol"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "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"=>"ESTIMATED", "count"=>496}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-01-18", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-12", "completionDateStruct"=>{"date"=>"2026-01-21", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-12-09", "studyFirstSubmitDate"=>"2024-01-16", "studyFirstSubmitQcDate"=>"2024-01-16", "lastUpdatePostDateStruct"=>{"date"=>"2024-12-10", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-10-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"EU, EU reference countries, and Japan: Proportion of participants with Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 24", "timeFrame"=>"Week 24", "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"=>"EU, EU reference countries, and Japan: Proportion of participants reaching 75% reduction from baseline in Eczema Area and Severity Index (EASI) score (EASI-75) at Week 24", "timeFrame"=>"Week 24", "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"=>"US and US reference countries: Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 24", "timeFrame"=>"Week 24", "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)."}], "secondaryOutcomes"=>[{"measure"=>"Proportion of participants reaching EASI-75 at Week 24 (for US and US reference countries only)", "timeFrame"=>"Week 24", "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."}, {"measure"=>"Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting) and a reduction from baseline of ≥2 points", "timeFrame"=>"Baseline to Week 24", "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"=>"Proportion of participants with ≥4-point reduction in weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) from baseline in participants with baseline weekly average of daily PP-NRS ≥4", "timeFrame"=>"Baseline to Week 24", "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"=>"Proportion of participants reaching EASI-75", "timeFrame"=>"Baseline to Week 20", "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."}, {"measure"=>"Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points", "timeFrame"=>"Baseline to Week 20", "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"=>"Proportion of participants with vIGA-AD 0 (clear)", "timeFrame"=>"Week 24", "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"=>"Proportion of participants reaching EASI-90", "timeFrame"=>"Baseline to Week 24", "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."}, {"measure"=>"Proportion of participants reaching EASI-100", "timeFrame"=>"Baseline to Week 24", "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."}, {"measure"=>"Proportion of participants with PP-NRS 0 or 1", "timeFrame"=>"Baseline to Week 2", "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"=>"Change in Dermatology Life Quality Index (DLQI) from baseline in participants with age ≥16 years old", "timeFrame"=>"Baseline to Week 24", "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"=>"Proportion of participants with a reduction in DLQI ≥4 from baseline in participants with age ≥16 years old and with DLQI baseline ≥4", "timeFrame"=>"Baseline to Week 24", "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"=>"Change in Children Dermatology Life Quality Index (CDLQI) from baseline in participants with age ≥12 to <16 years old", "timeFrame"=>"Baseline to Week 24", "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."}, {"measure"=>"Proportion of participants with a reduction in CDLQI ≥6 from baseline in participants with age ≥12 to <16 years old and with CDLQI baseline ≥6", "timeFrame"=>"Baseline to Week 24", "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."}, {"measure"=>"Change in Hospital Anxiety Depression Scale (HADS) from baseline", "timeFrame"=>"Baseline to Week 24", "description"=>"The HADS is 14-item questionnaire with two subscales: anxiety \\& depression. Each subscale (anxiety \\& depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state."}, {"measure"=>"Proportion of participants with HADS subscale Anxiety (HADS-A) <8 in participants with baseline HADS-A ≥8", "timeFrame"=>"Baseline to Week 24", "description"=>"HADS-A score ranges 0-21 with higher score indicating a poorer state."}, {"measure"=>"Proportion of participants with HADS subscale Depression (HADS-D) <8 in participants with HADS-D baseline ≥8", "timeFrame"=>"Baseline to Week 24", "description"=>"HADS-D score ranges 0-21 with higher score indicating a poorer state."}, {"measure"=>"Absolute change in weekly average of daily Skin Pain-Numerical Rating Scale (SP-NRS) from baseline", "timeFrame"=>"Baseline to Week 24", "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"=>"Proportion of participants with a reduction in weekly average of daily SP-NRS ≥4 from baseline in participants with baseline weekly average of daily SP-NRS ≥4", "timeFrame"=>"Baseline to Week 24", "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"=>"Absolute change in weekly average of daily Sleep Disturbance-Numerical Rating Scale (SD-NRS) from baseline", "timeFrame"=>"Baseline to Week 24", "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"=>"Proportion of participants with a reduction in weekly average of daily SD-NRS ≥3 from baseline in participants with Baseline weekly average of daily SD-NRS ≥3", "timeFrame"=>"Baseline to Week 24", "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"=>"Percent change in weekly average of daily SP-NRS from baseline", "timeFrame"=>"Baseline to Week 24", "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"=>"Percent change in weekly average of daily SD-NRS from baseline", "timeFrame"=>"Baseline to Week 24", "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"=>"Percent change in EASI score from baseline", "timeFrame"=>"Baseline to Week 24", "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"=>"Percent change in weekly average of daily PP-NRS from baseline", "timeFrame"=>"Baseline to Week 24", "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"=>"Absolute change in weekly average of daily PP-NRS from baseline", "timeFrame"=>"Baseline to Week 24", "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"=>"Proportion of participants reaching EASI-50", "timeFrame"=>"Baseline to Week 24", "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."}, {"measure"=>"Proportion of participants with EASI ≤7", "timeFrame"=>"Baseline to Week 24", "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"=>"Change in percent Body Surface Area (BSA) affected by AD from baseline", "timeFrame"=>"Baseline to Week 24"}, {"measure"=>"Percent change in Scoring Atopic Dermatitis (SCORAD) index from baseline", "timeFrame"=>"Baseline to Week 24", "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"=>"Absolute change in SCORAD index from baseline", "timeFrame"=>"Baseline to Week 24", "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"=>"Proportion of participants with a reduction in SCORAD ≥ 8.7 points from baseline in participants with baseline SCORAD score ≥ 8.7", "timeFrame"=>"Baseline to Week 24", "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"=>"Change in Patient Oriented Eczema Measure (POEM) from baseline", "timeFrame"=>"Baseline to Week 24", "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"=>"Proportion of participants with a reduction in POEM ≥4 from baseline in participants with POEM Baseline ≥4", "timeFrame"=>"Baseline to Week 24", "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"=>"Proportion of participants with rescue medication use", "timeFrame"=>"Baseline to Week 24"}, {"measure"=>"Cumulative amount of topical corticosteroids (TCS) consumption", "timeFrame"=>"Baseline to Week 24"}, {"measure"=>"Percentage of TCS/topical calcineurin inhibitors (TCI) free days", "timeFrame"=>"Baseline to Week 24"}, {"measure"=>"Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs), experienced Treatment-Emergent Serious Adverse Events (TESAEs) and/or Treatment-Emergent Adverse Events of Special Interest (AESI)", "timeFrame"=>"Baseline to Week 40"}, {"measure"=>"Serum amlitelimab concentrations", "timeFrame"=>"Baseline to Week 40"}, {"measure"=>"Incidence of antidrug antibodies (ADAs) of amlitelimab", "timeFrame"=>"Baseline to Week 40"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Dermatitis Atopic"]}, "descriptionModule"=>{"briefSummary"=>"This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe atopic dermatitis (AD) with a history of inadequate response of topical treatment, on background topical corticosteroid (TCS) and/or topical calcineurin inhibitor (TCI).\n\nThe purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate to severe AD aged 12 years and older on background TCS and/or TCI.\n\nStudy details include:\n\nAt the end of the treatment period, participants will have an option to enter a separate study: the blinded extension study EFC17600 (ESTUARY).\n\nFor participants not entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 44 weeks including a 2 to 4-week screening, a 24-week randomized double-blind period, and a 16-week safety follow-up.\n\nFor participants entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 28 weeks including a 2 to 4-week screening and a 24-week randomized double-blind period.\n\nThe total treatment duration will be up to 24 weeks. The total number of visits will be up to 10 visits (or 9 visits for those entering the blinded extension study EFC17600 (ESTUARY)."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"12 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Participants must be 12 years of age (when signing informed consent form)\n* Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)\n* Documented history (within 6 months before screening) of inadequate response to topical treatments, and/or inadequate response to systemic therapies (within 12 months before screening)\n* v-IGA-AD of 3 or 4 at baseline visit\n* EASI score of 16 or higher at baseline\n* AD involvement of 10% or more of BSA at baseline\n* Weekly average of daily PP-NRS of ≥ 4 at baseline visit.\n* Able and willing to comply with requested study visits and procedures\n* Body weight ≥25 kg\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Skin co-morbidity that would adversely affect the ability to undertake AD assessments\n* Known history of or suspected significant current immunosuppression\n* Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured \\>5 years prior to baseline)\n* History of solid organ or stem cell transplant\n* Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline\n* Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit\n* Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB\n* Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit\n* In the Investigator's opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening\n* History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP)\n\nThe above information is not intended to contain all considerations relevant to a potential participation in a clinical trial"}, "identificationModule"=>{"nctId"=>"NCT06224348", "acronym"=>"SHORE", "briefTitle"=>"A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Sanofi"}, "officialTitle"=>"A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids", "orgStudyIdInfo"=>{"id"=>"EFC17561"}, "secondaryIdInfos"=>[{"id"=>"2023-506558-20", "type"=>"REGISTRY", "domain"=>"CTIS"}, {"id"=>"U1111-1275-9760", "type"=>"REGISTRY", "domain"=>"ICTRP"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Amlitelimab dose 1", "description"=>"Subcutaneous injection as per protocol", "interventionNames"=>["Drug: Amlitelimab", "Drug: Topical corticosteroids", "Drug: Topical calcineurin inhibitors"]}, {"type"=>"EXPERIMENTAL", "label"=>"Amlitelimab dose 2", "description"=>"Subcutaneous injection as per protocol", "interventionNames"=>["Drug: Amlitelimab", "Drug: Topical corticosteroids", "Drug: Topical calcineurin inhibitors"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo", "description"=>"Subcutaneous injection as per protocol", "interventionNames"=>["Drug: Placebo", "Drug: Topical corticosteroids", "Drug: Topical calcineurin inhibitors"]}], "interventions"=>[{"name"=>"Amlitelimab", "type"=>"DRUG", "otherNames"=>["SAR445229"], "description"=>"Pharmaceutical form: Injection solution Route of administration: SC injection", "armGroupLabels"=>["Amlitelimab dose 1", "Amlitelimab dose 2"]}, {"name"=>"Placebo", "type"=>"DRUG", "description"=>"Pharmaceutical form: injection solution Route of administration: SC injection", "armGroupLabels"=>["Placebo"]}, {"name"=>"Topical corticosteroids", "type"=>"DRUG", "description"=>"Pharmaceutical form: Topical formulation Route of administration: Topical", "armGroupLabels"=>["Amlitelimab dose 1", "Amlitelimab dose 2", "Placebo"]}, {"name"=>"Topical calcineurin inhibitors", "type"=>"DRUG", "description"=>"Pharmaceutical form: Topical formulation Route of administration: Topical", "armGroupLabels"=>["Amlitelimab dose 1", "Amlitelimab dose 2", "Placebo"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35244", "city"=>"Birmingham", "state"=>"Alabama", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Cahaba Dermatology & Skin Health Center- Site Number : 8401066", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"zip"=>"72916", "city"=>"Fort Smith", "state"=>"Arkansas", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Johnson Dermatology- Site Number : 8401076", "geoPoint"=>{"lat"=>35.38592, "lon"=>-94.39855}}, {"zip"=>"91436", "city"=>"Encino", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Encino Research Center- Site Number : 8401042", "geoPoint"=>{"lat"=>34.15917, "lon"=>-118.50119}}, {"zip"=>"92647", "city"=>"Huntington Beach", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Marvel Clinical Research- Site Number : 8401102", "geoPoint"=>{"lat"=>33.6603, "lon"=>-117.99923}}, {"zip"=>"90057", "city"=>"Los Angeles", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"LA Universal Research Center- Site Number : 8401064", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"93551", "city"=>"Palmdale", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Cura Clinical Research- Site Number : 8401141", "geoPoint"=>{"lat"=>34.57943, "lon"=>-118.11646}}, {"zip"=>"95815", "city"=>"Sacramento", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Integrative Skin Science and Research- Site Number : 8401275", "geoPoint"=>{"lat"=>38.58157, "lon"=>-121.4944}}, {"zip"=>"92701", "city"=>"Santa Ana", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Southern California Dermatology- Site Number : 8401043", "geoPoint"=>{"lat"=>33.74557, "lon"=>-117.86783}}, {"zip"=>"80109", "city"=>"Castle Rock", "state"=>"Colorado", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Clarity Dermatology / Physicians Research Group II, LLC- Site Number : 8401229", "geoPoint"=>{"lat"=>39.37221, "lon"=>-104.85609}}, {"zip"=>"33021", 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