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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506558-20 | Registry Identifier | CTIS | |
| U1111-1275-9760 | Registry Identifier | ICTRP |
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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).
The 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.
Study details include:
At the end of the treatment period, participants will have an option to enter a separate study: the blinded extension study EFC17600 (ESTUARY).
For 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.
For 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.
The 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amlitelimab dose 1 | Experimental | Subcutaneous injection as per protocol |
|
| Amlitelimab dose 2 | Experimental | Subcutaneous injection as per protocol |
|
| Placebo | Placebo Comparator | Subcutaneous injection as per protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlitelimab | Drug | Pharmaceutical form: Injection solution Route of administration: SC injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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). | Week 24 |
| 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 | 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. | Week 24 |
| 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 | 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). | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants reaching EASI-75 at Week 24 (for US and US reference countries only) | 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. | Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cahaba Dermatology & Skin Health Center- Site Number : 8401066 | Birmingham | Alabama | 35244 | United States | ||
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| Label | URL |
|---|---|
| EFC17561 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| Placebo | Drug | Pharmaceutical form: injection solution Route of administration: SC injection |
|
| Topical corticosteroids | Drug | Pharmaceutical form: Topical formulation Route of administration: Topical |
|
| Topical calcineurin inhibitors | Drug | Pharmaceutical form: Topical formulation Route of administration: Topical |
|
| 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 | 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). | Baseline to Week 24 |
| 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 | 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. | Baseline to Week 24 |
| Proportion of participants reaching EASI-75 | The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score. | Baseline to Week 20 |
| Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points | 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). | Baseline to Week 20 |
| Proportion of participants with vIGA-AD 0 (clear) | 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). | Week 24 |
| Proportion of participants reaching EASI-90 | The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-90 is 90% reduction from baseline in EASI score. | Baseline to Week 24 |
| Proportion of participants reaching EASI-100 | 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. | Baseline to Week 24 |
| Proportion of participants with PP-NRS 0 or 1 | 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. | Baseline to Week 2 |
| Change in Dermatology Life Quality Index (DLQI) from baseline in participants with age ≥16 years old | 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. | Baseline to Week 24 |
| Proportion of participants with a reduction in DLQI ≥4 from baseline in participants with age ≥16 years old and with DLQI baseline ≥4 | 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. | Baseline to Week 24 |
| Change in Children Dermatology Life Quality Index (CDLQI) from baseline in participants with age ≥12 to <16 years old | 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. | Baseline to Week 24 |
| 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 | 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. | Baseline to Week 24 |
| Change in Hospital Anxiety Depression Scale (HADS) from baseline | 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. | Baseline to Week 24 |
| Proportion of participants with HADS subscale Anxiety (HADS-A) <8 in participants with baseline HADS-A ≥8 | HADS-A score ranges 0-21 with higher score indicating a poorer state. | Baseline to Week 24 |
| Proportion of participants with HADS subscale Depression (HADS-D) <8 in participants with HADS-D baseline ≥8 | HADS-D score ranges 0-21 with higher score indicating a poorer state. | Baseline to Week 24 |
| Absolute change in weekly average of daily Skin Pain-Numerical Rating Scale (SP-NRS) from baseline | 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. | Baseline to Week 24 |
| 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 | 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. | Baseline to Week 24 |
| Absolute change in weekly average of daily Sleep Disturbance-Numerical Rating Scale (SD-NRS) from baseline | 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. | Baseline to Week 24 |
| 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 | 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. | Baseline to Week 24 |
| Percent change in weekly average of daily SP-NRS from baseline | 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. | Baseline to Week 24 |
| Percent change in weekly average of daily SD-NRS from baseline | 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. | Baseline to Week 24 |
| Percent change in EASI score from baseline | The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. | Baseline to Week 24 |
| Percent change in weekly average of daily PP-NRS from baseline | 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. | Baseline to Week 24 |
| Absolute change in weekly average of daily PP-NRS from baseline | 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. | Baseline to Week 24 |
| Proportion of participants reaching EASI-50 | 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. | Baseline to Week 24 |
| Proportion of participants with EASI ≤7 | 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. | Baseline to Week 24 |
| Change in percent Body Surface Area (BSA) affected by AD from baseline | Baseline to Week 24 |
| Percent change in Scoring Atopic Dermatitis (SCORAD) index from baseline | 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). | Baseline to Week 24 |
| Absolute change in SCORAD index from baseline | 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). | Baseline to Week 24 |
| Proportion of participants with a reduction in SCORAD ≥ 8.7 points from baseline in participants with baseline SCORAD score ≥ 8.7 | 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). | Baseline to Week 24 |
| Change in Patient Oriented Eczema Measure (POEM) from baseline | 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. | Baseline to Week 24 |
| Proportion of participants with a reduction in POEM ≥4 from baseline in participants with POEM Baseline ≥4 | 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. | Baseline to Week 24 |
| Proportion of participants with rescue medication use | Baseline to Week 24 |
| Cumulative amount of topical corticosteroids (TCS) consumption | Baseline to Week 24 |
| Percentage of TCS/topical calcineurin inhibitors (TCI) free days | Baseline to Week 24 |
| 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) | Baseline to Week 40 |
| Serum amlitelimab concentrations | Baseline to Week 40 |
| Incidence of antidrug antibodies (ADAs) of amlitelimab | Baseline to Week 40 |
| Johnson Dermatology- Site Number : 8401076 |
| Fort Smith |
| Arkansas |
| 72916 |
| United States |
| Encino Research Center- Site Number : 8401042 | Encino | California | 91436 | United States |
| Marvel Clinical Research- Site Number : 8401102 | Huntington Beach | California | 92647 | United States |
| LA Universal Research Center- Site Number : 8401064 | Los Angeles | California | 90057 | United States |
| Cura Clinical Research- Site Number : 8401141 | Palmdale | California | 93551 | United States |
| Integrative Skin Science and Research- Site Number : 8401275 | Sacramento | California | 95815 | United States |
| Southern California Dermatology- Site Number : 8401043 | Santa Ana | California | 92701 | United States |
| Skin Care Research - Hollywood- Site Number : 8401071 | Hollywood | Florida | 33021 | United States |
| Clever Medical Research- Site Number : 8401160 | Miami | Florida | 33126 | United States |
| Acevedo Clinical Research Associates- Site Number : 8401088 | Miami | Florida | 33142 | United States |
| Palm Springs Community Health Center- Site Number : 8401264 | Miami Lakes | Florida | 33016 | United States |
| Global Clinical Professionals (GCP)- Site Number : 8401045 | St. Petersburg | Florida | 33705 | United States |
| University of South Florida- Site Number : 8401070 | Tampa | Florida | 33612 | United States |
| Avita Clinical Research- Site Number : 8401073 | Tampa | Florida | 33613 | United States |
| Cleaver Medical Group- Site Number : 8401138 | Dawsonville | Georgia | 30534 | United States |
| NorthShore University HealthSystem - Skokie Hospital- Site Number : 8401038 | Skokie | Illinois | 60076 | United States |
| Dawes Fretzin Clinical Research- Site Number : 8401015 | Indianapolis | Indiana | 46256 | United States |
| BRCR Global Gretna- Site Number : 8401243 | Gretna | Louisiana | 70053 | United States |
| Velocity Clinical Research - New Orleans- Site Number : 8401155 | New Orleans | Louisiana | 70119 | United States |
| Oakland Medical Center- Site Number : 8401116 | Troy | Michigan | 48085 | United States |
| Allergy & Immunology Associates of Ann Arbor- Site Number : 8401078 | Ypsilanti | Michigan | 48197 | United States |
| Dermatology and Skin Cancer Lee's Summit- Site Number : 8401157 | Lee's Summit | Missouri | 64064 | United States |
| Skin Specialists- Site Number : 8401068 | Omaha | Nebraska | 68144 | United States |
| Jubilee Clinical Research- Site Number : 8401054 | Las Vegas | Nevada | 89106 | United States |
| Allcutis Research - Portsmouth- Site Number : 8401082 | Portsmouth | New Hampshire | 03801 | United States |
| Equity Medical- Site Number : 8401239 | New York | New York | 10023 | United States |
| Icahn School of Medicine at Mount Sinai- Site Number : 8401129 | New York | New York | 10029 | United States |
| OptiSkin- Site Number : 8401163 | New York | New York | 10128 | United States |
| Apex Clinical Research Center- Site Number : 8401237 | Mayfield Heights | Ohio | 44124 | United States |
| Essential Medical Research- Site Number : 8401183 | Tulsa | Oklahoma | 74137 | United States |
| Vial Health - DermDox Dermatology- Site Number : 8401031 | Camp Hill | Pennsylvania | 17011 | United States |
| Clinical Research Center of the Carolinas- Site Number : 8401067 | Charleston | South Carolina | 29407 | United States |
| SMS Clinical Research- Site Number : 8401182 | Mesquite | Texas | 75149 | United States |
| Sienna Dermatology- Site Number : 8401148 | Missouri City | Texas | 77459 | United States |
| Texas Dermatology and Laser Specialists- Site Number : 8401131 | San Antonio | Texas | 78218 | United States |
| Discovery Clinical Trials - San Antonio - Stone Oak Parkway- Site Number : 8401026 | San Antonio | Texas | 78258 | United States |
| Complete Dermatology - Sugar Land- Site Number : 8401061 | Sugar Land | Texas | 77479 | United States |
| Cope Family Medicine - Ogden Clinic- Site Number : 8401114 | Bountiful | Utah | 84010 | United States |
| Tanner Clinic - Layton Antelope A- Site Number : 8401151 | Layton | Utah | 84041 | United States |
| Investigational Site Number : 0320005 | CABA | Buenos Aires F.D. | 1427 | Argentina |
| Investigational Site Number : 0320011 | Buenos Aires | 1035 | Argentina |
| Investigational Site Number : 0320019 | Buenos Aires | 1056 | Argentina |
| Investigational Site Number : 0320008 | Buenos Aires | 1061 | Argentina |
| Investigational Site Number : 0320018 | Buenos Aires | 1178 | Argentina |
| Investigational Site Number : 0320010 | Buenos Aires | 1414 | Argentina |
| Investigational Site Number : 0320004 | Buenos Aires | 1425 | Argentina |
| Investigational Site Number : 0320012 | Corrientes | 3400 | Argentina |
| Investigational Site Number : 0320013 | Mendoza | 5500 | Argentina |
| Investigational Site Number : 0320020 | San Miguel de Tucumán | 4000 | Argentina |
| Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760017 | Vitória | Espírito Santo | 29055-450 | Brazil |
| Centro de Pesquisas da Clínica IBIS- Site Number : 0760002 | Salvador | Estado de Bahia | 41820-020 | Brazil |
| PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR- Site Number : 0760023 | Curitiba | Paraná | 80230-130 | Brazil |
| Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005 | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760024 | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760015 | Ribeirão Preto | São Paulo | 14049-900 | Brazil |
| Faculdade de Medicina do ABC- Site Number : 0760001 | Santo André | 09060-650 | Brazil |
| Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760010 | São Paulo | 01323-020 | Brazil |
| Hospital das Clinicas FMUSP- Site Number : 0760012 | São Paulo | 05403-000 | Brazil |
| Investigational Site Number : 1002007 | Dupnitsa | 2600 | Bulgaria |
| Investigational Site Number : 1002004 | Pleven | 5800 | Bulgaria |
| Investigational Site Number : 1002009 | Sofia | 1431 | Bulgaria |
| Investigational Site Number : 1002006 | Sofia | 1592 | Bulgaria |
| Investigational Site Number : 1240039 | Calgary | Alberta | T2J 7E1 | Canada |
| Investigational Site Number : 1240045 | Red Deer | Alberta | T4P 1K4 | Canada |
| Investigational Site Number : 1240046 | Kamloops | British Columbia | V1Y 4N7 | Canada |
| Investigational Site Number : 1240030 | Surrey | British Columbia | V3V 0C6 | Canada |
| Investigational Site Number : 1240041 | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Investigational Site Number : 1240057 | Brampton | Ontario | L6Z1Y4 | Canada |
| Investigational Site Number : 1241106 | Markham | Ontario | L3P 1X2 | Canada |
| Investigational Site Number : 1240008 | Mississauga | Ontario | L5H 1G9 | Canada |
| Investigational Site Number : 1240004 | Peterborough | Ontario | K9J5K2 | Canada |
| Investigational Site Number : 1240038 | Richmond Hill | Ontario | L4E 4L6 | Canada |
| Investigational Site Number : 1240012 | Toronto | Ontario | M3H 5Y8 | Canada |
| Investigational Site Number : 1241107 | Waterloo | Ontario | N2J 1C4 | Canada |
| Investigational Site Number : 1240006 | Québec | Quebec | G1W 4R4 | Canada |
| Investigational Site Number : 1520009 | Osorno | Reg Metropolitana de Santiago | 5311523 | Chile |
| Investigational Site Number : 1520008 | Santiago | Reg Metropolitana de Santiago | 7500588 | Chile |
| Investigational Site Number : 1520002 | Santiago | Reg Metropolitana de Santiago | 7580206 | Chile |
| Investigational Site Number : 1520003 | Santiago | Reg Metropolitana de Santiago | 7640881 | Chile |
| Investigational Site Number : 1520011 | Santiago | Reg Metropolitana de Santiago | 8380456 | Chile |
| Investigational Site Number : 1520005 | Santiago | Reg Metropolitana de Santiago | 8380465 | Chile |
| Investigational Site Number : 1520001 | Santiago | Reg Metropolitana de Santiago | 8420383 | Chile |
| Investigational Site Number : 1520006 | Viña del Mar | Valparaiso | 2530900 | Chile |
| Investigational Site Number : 1520010 | Santiago | 8330032 | Chile |
| Investigational Site Number : 1520012 | Talcahuano | 2687000 | Chile |
| Investigational Site Number : 1560050 | Changsha | 410011 | China |
| Investigational Site Number : 1560060 | Chengdu | 610072 | China |
| Investigational Site Number : 1560043 | Fuzhou | 350005 | China |
| Investigational Site Number : 1560021 | Guangzhou | 510018 | China |
| Investigational Site Number : 1560044 | Hangzhou | 310003 | China |
| Investigational Site Number : 1560006 | Hangzhou | 310009 | China |
| Investigational Site Number : 1560051 | Nanchang | 330001 | China |
| Investigational Site Number : 1560005 | Shanghai | 200443 | China |
| Investigational Site Number : 1560041 | Shenyang | 110001 | China |
| Investigational Site Number : 1560047 | Tianjin | 300052 | China |
| Investigational Site Number : 1560049 | Wuhan | 430022 | China |
| Investigational Site Number : 1560003 | Wuxi | 214000 | China |
| Investigational Site Number : 2032105 | Nový Jičín | 741 01 | Czechia |
| Investigational Site Number : 2030010 | Olomouc | 779 00 | Czechia |
| Investigational Site Number : 2032104 | Ostrava | 702 00 | Czechia |
| Investigational Site Number : 2030009 | Pilsen | 323 00 | Czechia |
| Investigational Site Number : 2030008 | Prague | 110 00 | Czechia |
| Investigational Site Number : 2030008 | Prague | 110 01 | Czechia |
| Investigational Site Number : 2030011 | Prague | 150 00 | Czechia |
| Investigational Site Number : 2500011 | Bordeaux | 33000 | France |
| Investigational Site Number : 2500009 | Nantes | 44093 | France |
| Investigational Site Number : 2500013 | Nice | 06202 | France |
| Investigational Site Number : 2500006 | Pierre-Bénite | 69495 | France |
| Investigational Site Number : 2500010 | Romans-sur-Isère | 26102 | France |
| Investigational Site Number : 2500012 | Rouen | 76031 | France |
| Investigational Site Number : 2500016 | Saint-Pierre | 97410 | France |
| Investigational Site Number : 2500002 | Toulouse | 31059 | France |
| Investigational Site Number : 2760020 | Augsburg | 86150 | Germany |
| Investigational Site Number : 2760009 | Bad Bentheim | 48455 | Germany |
| Investigational Site Number : 2760014 | Buxtehude | 21614 | Germany |
| Investigational Site Number : 2760017 | Hamburg | 20095 | Germany |
| Investigational Site Number : 2760021 | Hamburg | 20354 | Germany |
| Investigational Site Number : 2762208 | Kiel | 24105 | Germany |
| Investigational Site Number : 2760018 | Magdeburg | 39104 | Germany |
| Investigational Site Number : 2760016 | Mainz | 55128 | Germany |
| Investigational Site Number : 2762201 | Münster | 48149 | Germany |
| Investigational Site Number : 2760019 | Witten | 58453 | Germany |
| Investigational Site Number : 3800003 | Milan | Lombardy | 20122 | Italy |
| Investigational Site Number : 3800012 | Bologna | 40138 | Italy |
| Investigational Site Number : 3800011 | L’Aquila | 67100 | Italy |
| Investigational Site Number : 3800008 | Pisa | 56126 | Italy |
| Investigational Site Number : 3800019 | Torette | 60020 | Italy |
| Investigational Site Number : 3920009 | Chitose | Hokkaido | 066-0021 | Japan |
| Investigational Site Number : 3923114 | Obihiro | Hokkaido | 080-0013 | Japan |
| Investigational Site Number : 3920008 | Sapporo | Hokkaido | 064-0921 | Japan |
| Investigational Site Number : 3920006 | Kobe | Hyōgo | 653-0836 | Japan |
| Investigational Site Number : 3920005 | Sagamihara | Kanagawa | 252-0315 | Japan |
| Investigational Site Number : 3923113 | Yokohama | Kanagawa | 221-0825 | Japan |
| Investigational Site Number : 3920010 | Miyagi-gun | Miyagi | 981-0112 | Japan |
| Investigational Site Number : 3920011 | Sendai | Miyagi | 981-3133 | Japan |
| Investigational Site Number : 3923110 | Sakai | Osaka | 593-8324 | Japan |
| Investigational Site Number : 3920002 | Iruma | Saitama | 350-0495 | Japan |
| Investigational Site Number : 3923106 | Mibu | Tochigi | 321-0293 | Japan |
| Investigational Site Number : 3920004 | Chūō | Tokyo | 104-0031 | Japan |
| Investigational Site Number : 3923107 | Minato | Tokyo | 108-0014 | Japan |
| Investigational Site Number : 3920001 | Tachikawa | Tokyo | 190-0023 | Japan |
| Investigational Site Number : 3923109 | Habikino | 583-8588 | Japan |
| Investigational Site Number : 3923108 | Kagoshima | 890-0063 | Japan |
| Investigational Site Number : 3923102 | Kyoto | 602-8566 | Japan |
| Investigational Site Number : 3920003 | Kyoto | 606-8507 | Japan |
| Investigational Site Number : 3923113 | Yokohama | 221-0825 | Japan |
| Investigational Site Number : 7240019 | Granada | Andalusia | 18012 | Spain |
| Investigational Site Number : 7240020 | Seville | Andalusia | 41013 | Spain |
| Investigational Site Number : 7240008 | Bilbao | Bizkaia | 48013 | Spain |
| Investigational Site Number : 7240010 | Esplugues de Llobregat | Catalunya [Cataluña] | 08950 | Spain |
| Investigational Site Number : 7240015 | Pamplona | Navarre | 31008 | Spain |
| Investigational Site Number : 7242502 | Manises | Valencia | 46940 | Spain |
| Investigational Site Number : 7240023 | Burjassot | Valenciana, Comunidad | 46100 | Spain |
| Investigational Site Number : 7242505 | Alicante | 03010 | Spain |
| Investigational Site Number : 7240013 | Madrid | 28031 | Spain |
| Investigational Site Number : 7240014 | Vigo | 36206 | Spain |
| Investigational Site Number : 7920010 | Ankara | 06560 | Turkey (Türkiye) |
| Investigational Site Number : 7920001 | Antalya | 07070 | Turkey (Türkiye) |
| Investigational Site Number : 7920008 | Gaziantep | 27310 | Turkey (Türkiye) |
| Investigational Site Number : 7920003 | Istanbul | 34010 | Turkey (Türkiye) |
| Investigational Site Number : 7920005 | Istanbul | 34093 | Turkey (Türkiye) |
| Investigational Site Number : 7920006 | Istanbul | 34093 | Turkey (Türkiye) |
| Investigational Site Number : 7920002 | Istanbul | 34098 | Turkey (Türkiye) |
| Investigational Site Number : 7920009 | Istanbul | 34662 | Turkey (Türkiye) |
| Investigational Site Number : 7920004 | Kayseri | 38039 | Turkey (Türkiye) |
| Investigational Site Number : 7920007 | Samsun | 55139 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D065095 | Calcineurin Inhibitors |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided