Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT06241118
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2024-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'C117268', 'term': 'pimecrolimus'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, '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': 390}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-09-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2024-01-26', 'studyFirstSubmitQcDate': '2024-01-26', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-25', '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 36', 'timeFrame': 'Week 36', '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 (EASI75) at Week 36', 'timeFrame': 'Week 36', '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 36', 'timeFrame': 'Week 36', '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 36 (for US and US reference countries only)', 'timeFrame': 'Week 36', '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 36', '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 36', '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 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 of 0 (clear) or 1 (almost clear) 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 reaching EASI-90', 'timeFrame': 'Baseline to Week 36', '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 36', '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 ≤1', 'timeFrame': 'Baseline to Week 36', '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 36', '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 36', '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', 'timeFrame': 'Baseline to Week 36', '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 36', '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 36', '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 36', '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 36', '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 36', '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 36', '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 SP-NRS from baseline', 'timeFrame': 'Baseline to Week 36', '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 vIGA-AD 0 (clear)', 'timeFrame': 'Baseline to Week 36', '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': 'Absolute change in weekly average of daily Sleep Disturbance-Numerical Rating Scale (SD-NRS) from baseline', 'timeFrame': 'Baseline to Week 36', '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 36', '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 SD-NRS', 'timeFrame': 'Baseline to Week 36', '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 36', '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 36', '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 36', '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 36', '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 36', '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 36'}, {'measure': 'Percent change in Scoring Atopic Dermatitis (SCORAD) index from baseline', 'timeFrame': 'Baseline to Week 36', '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 36', '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 36', '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 Patient Oriented Eczema Measure (POEM) ≥4 from baseline in participants with POEM Baseline ≥4', 'timeFrame': 'Baseline to Week 36', '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': 'Change in POEM from baseline', 'timeFrame': 'Baseline to Week 36', '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 36'}, {'measure': 'Time to onset of effect on PP-NRS as measured by proportion of participants with an improvement (reduction) in PP-NRS by ≥4', 'timeFrame': 'Baseline to Week 36', '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': 'Percentage of TCS/TCI free days', 'timeFrame': 'Baseline to Week 36'}, {'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 52'}, {'measure': 'Serum amlitelimab concentrations', 'timeFrame': 'Baseline to Week 52'}, {'measure': 'Incidence of antidrug antibodies (ADAs) of amlitelimab', 'timeFrame': 'Baseline to Week 52'}, {'measure': 'Time to onset of effect on vIGA-AD as measured by proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear) and a reduction from baseline ≥2 during the 36-week treatment period', 'timeFrame': 'Baseline to Week 36', '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': 'Time to onset of effect on EASI as measured by proportion of participants reaching a 75% reduction from baseline in EASI score during the 36-week treatment period', 'timeFrame': 'Baseline to Week 36', '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dermatitis Atopic']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://sanofi.trialsummaries.com/Study/StudyDetails?id=25595&tenant=MT_SNY_9011', 'label': 'EFC17599 Plain Language Results Summary'}]}, '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 AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy.\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 have had an inadequate response to prior biologic or an oral JAKi therapy.\n\nStudy details include:\n\nAt the end of the treatment period, participants will have the option to enter the Long-Term Safety Study LTS17367 (RIVER-AD).\n\nThe study duration will be up to 56 weeks for participants not entering the long-term safety study (LTS17367 \\[RIVER-AD\\]) including a 2 to 4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up.\n\nThe study duration will be up to 40 weeks for participants entering the long-term safety study (LTS17367 \\[RIVER-AD\\]) including a 2 to 4-week screening and a 36-week randomized double-blind period.\n\nThe total treatment duration will be up to 36 weeks. The total number of visits will be up to 13 visits (or 12 visits for those entering the long-term safety study 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 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 prior to screening visit of inadequate response to a biologic AD medication or an oral JAKi therapy.\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': 'NCT06241118', 'acronym': 'AQUA', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor', '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 (AD) Who Are on Background Topical Corticosteroids and Have Had an Inadequate Response to Prior Biologic Therapy or Oral Janus Kinase (JAK) Inhibitor Treatment', 'orgStudyIdInfo': {'id': 'EFC17599'}, 'secondaryIdInfos': [{'id': '2023-508099-12', 'type': 'REGISTRY', 'domain': 'CTIS'}, {'id': 'U1111-1295-3059', '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 tacrolimus or pimecrolimus']}, {'type': 'EXPERIMENTAL', 'label': 'Amlitelimab dose 2', 'description': 'Subcutaneous injection as per protocol', 'interventionNames': ['Drug: Amlitelimab', 'Drug: Topical corticosteroids', 'Drug: Topical tacrolimus or pimecrolimus']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subcutaneous injection as per protocol', 'interventionNames': ['Drug: Placebo', 'Drug: Topical corticosteroids', 'Drug: Topical tacrolimus or pimecrolimus']}], 'interventions': [{'name': 'Amlitelimab', 'type': 'DRUG', 'otherNames': ['SAR445229'], 'description': 'Pharmaceutical form: Injection solution Route of administration: Subcutaneous', 'armGroupLabels': ['Amlitelimab dose 1', 'Amlitelimab dose 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Pharmaceutical form: Injection solution Route of administration: Subcutaneous', 'armGroupLabels': ['Placebo']}, {'name': 'Topical corticosteroids', 'type': 'DRUG', 'description': 'Pharmaceutical form: Various Topical formulation Route of administration: Topical', 'armGroupLabels': ['Amlitelimab dose 1', 'Amlitelimab dose 2', 'Placebo']}, {'name': 'Topical tacrolimus or pimecrolimus', 'type': 'DRUG', 'description': 'Pharmaceutical form: Various Topical formulation Route of administration: Topical', 'armGroupLabels': ['Amlitelimab dose 1', 'Amlitelimab dose 2', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Alabama at Birmingham- Site Number : 8401267', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Center for Dermatology and Plastic Surgery- Site Number : 8401119', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '72117', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Arkansas Dermatology- Site Number : 8401244', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'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': '94538', 'city': 'Fremont', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Center for Dermatology Clinical Research- Site Number : 8401018', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Long Beach Clinical Trials- Site Number : 8401188', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', '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', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'LA Universal Research Center- Site Number : 8401064', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University Dermatology Trials- Site Number : 8401339', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Rady Children's Hospital- Site Number : 8401291", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Therapeutics Clinical Research- Site Number : 8401283', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80033', 'city': 'Wheat Ridge', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245', 'geoPoint': {'lat': 39.7661, 'lon': -105.07721}}, {'zip': '33436', 'city': 'Boynton Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Encore 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'Incheon-gwangyeoksi', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Investigational Site Number : 4100015'}, {'zip': '03722', 'city': 'Seoul', 'state': 'Seoul-teukbyeolsi', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Investigational Site Number : 4100007', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07441', 'city': 'Seoul', 'state': 'Seoul-teukbyeolsi', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Investigational Site Number : 4100001', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona [Barcelona]', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Investigational Site Number : 7240002', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '28222', 'city': 'Majadahonda', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Investigational Site Number : 7240017', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'zip': '28223', 'city': 'Pozuelo de Alarcón', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Investigational Site Number : 7240016', 'geoPoint': {'lat': 40.43293, 'lon': -3.81338}}, {'zip': '41013', 'city': 'Seville', 'state': 'Sevilla', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Investigational Site Number : 7240020', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '03010', 'city': 'Alicante', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Investigational Site Number : 7242505', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '28046', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Investigational Site Number : 7242503', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '833', 'city': 'Kaohsiung City', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Taiwan', 'facility': 'Investigational Site Number : 1583201', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'Investigational Site Number : 1580001', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'Investigational Site Number : 1580003', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '333', 'city': 'Taoyuan', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'Investigational Site Number : 1583203', 'geoPoint': {'lat': 24.99368, 'lon': 121.29696}}, {'zip': '27310', 'city': 'Gaziantep', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Investigational Site Number : 7920008', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}, {'zip': '34093', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Investigational Site Number : 7920005', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34098', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Investigational Site 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'Investigational Site Number : 8260012', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'E11 1NR', 'city': 'London', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Investigational Site Number : 8262603', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW10 9NH', 'city': 'London', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Investigational Site Number : 8260015', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'PO3 6DW', 'city': 'Portsmouth', 'state': 'Hampshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Investigational Site Number : 8260003', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}, {'zip': 'LS7 4SA', 'city': 'Leeds', 'state': 'North Yorkshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Investigational Site Number : 8260009', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'NG17 4JL', 'city': 'Nottingham', 'state': 'Nottinghamshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Investigational Site Number : 8260010', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'L7 8XP', 'city': 'Liverpool', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Investigational Site Number : 8260008', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}], 'centralContacts': [{'name': 'Trial Transparency email recommended (Toll free for US & Canada)', 'role': 'CONTACT', 'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'phoneExt': 'option 6'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "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"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}