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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1275-9715 | Registry Identifier | ICTRP | |
| 2022-501196-41 | Registry Identifier | CTIS |
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This is a parallel group, Phase 3, multinational, multicenter, randomized, double blind, placebo-controlled, 3-arm monotherapy study for treatment of participants diagnosed with moderate to severe atopic dermatitis (AD), whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for SC injection compared with placebo in participants with moderate to severe AD aged 12 years and older.
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 | Injection solution 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:
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale Clinical Trials- Site Number : 8401149 | Scottsdale | Arizona | 85260 | United States | ||
| First OC Dermatology- Site Number : 8401025 |
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| Label | URL |
|---|---|
| EFC17559 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 | Injection solution SC injection |
|
| 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 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 24 |
| 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 |
| 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 |
| Proportion of participants with vIGA-AD 0 | 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 |
| 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 SD-NRS | 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 |
| 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 |
| Fountain Valley |
| California |
| 92708 |
| United States |
| Center for Dermatology Clinical Research- Site Number : 8401018 | Fremont | California | 94538 | United States |
| Sunwise Clinical Research- Site Number : 8401022 | Lafayette | California | 94549 | United States |
| Carbon Health - North Hollywood - NoHo West- Site Number : 8401218 | North Hollywood | California | 91606 | United States |
| Northridge Clinical Trials - Northridge- Site Number : 8401080 | Northridge | California | 91325 | United States |
| St Jude Clinical Research- Site Number : 8401287 | Doral | Florida | 33172 | United States |
| Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8401286 | Fort Myers | Florida | 33919 | United States |
| Direct Helpers Research Center- Site Number : 8401056 | Hialeah | Florida | 33012 | United States |
| Encore Medical Research- Site Number : 8401030 | Hollywood | Florida | 33021 | United States |
| Florida International Research Center- Site Number : 8401091 | Miami | Florida | 33173 | United States |
| Miami Dermatology and Laser Research- Site Number : 8401086 | Miami | Florida | 33173 | United States |
| Clinical Neuroscience Solutions - Orlando - South Delaney Avenue- Site Number : 8401035 | Orlando | Florida | 32806 | United States |
| Cleaver Medical Group Dermatology- Site Number : 8401139 | Cumming | Georgia | 30040 | United States |
| Skin Care Physicians of Georgia - Macon- Site Number : 8401034 | Macon | Georgia | 31217 | United States |
| Javara Research - Thomasville- Site Number : 8401189 | Thomasville | Georgia | 31792 | United States |
| Rophe Adult & Pediatric Medicine- Site Number : 8401289 | Union City | Georgia | 30291 | United States |
| Skin Sciences- Site Number : 8401039 | Louisville | Kentucky | 40217 | United States |
| MedPharmics - Covington- Site Number : 8401137 | Covington | Louisiana | 70433 | United States |
| MedPharmics - Lafeyette- Site Number : 8401152 | Lafayette | Louisiana | 70508 | United States |
| Massachusetts General Hospital- Site Number : 8401192 | Boston | Massachusetts | 02114 | United States |
| Metro Boston Clinical Partners- Site Number : 8401128 | Needham | Massachusetts | 02492 | United States |
| Revival Research - Doral- Site Number : 8401012 | Dearborn | Michigan | 33122 | United States |
| Henry Ford Hospital- Site Number : 8401044 | Detroit | Michigan | 48202 | United States |
| SKY Integrative Medical Center/SKYCRNG - Ridgeland- Site Number : 8401058 | Ridgeland | Mississippi | 39157 | United States |
| MediSearch Clinical Trials- Site Number : 8401140 | Saint Joseph | Missouri | 64506 | United States |
| Somnos Clinical Research- Site Number : 8401203 | Lincoln | Nebraska | 68510 | United States |
| Universal Dermatology- Site Number : 8401224 | Fairport | New York | 14450 | United States |
| Sadick Research Group - New York - Park Avenue- Site Number : 8401050 | New York | New York | 10075 | United States |
| CHEAR Center- Site Number : 8401123 | The Bronx | New York | 10459 | United States |
| Onsite Clinical Solutions - Charlotte - Blakeney Park Drive- Site Number : 8401124 | Charlotte | North Carolina | 28277 | United States |
| Oregon Medical Research Center- Site Number : 8401017 | Portland | Oregon | 97201 | United States |
| Vial Health - DermDox Dermatology- Site Number : 8401031 | Camp Hill | Pennsylvania | 17011 | United States |
| Paddington Testing Company- Site Number : 8401041 | Philadelphia | Pennsylvania | 19103 | United States |
| Clinical Research of Philadelphia- Site Number : 8401193 | Philadelphia | Pennsylvania | 19114 | United States |
| Tribe Clinical Research - 525 Verdae Boulevard- Site Number : 8401225 | Greenville | South Carolina | 29607 | United States |
| Dermatology Treatment and Research Center- Site Number : 8401164 | Dallas | Texas | 75230 | United States |
| Skin Specialist of Addison- Site Number : 8401208 | Dallas | Texas | 75254 | United States |
| Texas Dermatology and Laser Specialists- Site Number : 8401131 | San Antonio | Texas | 78218 | United States |
| Stryde Research - Epiphany Dermatology- Site Number : 8401185 | Southlake | Texas | 76092 | United States |
| Springville Dermatology - Springville- Site Number : 8401106 | Springville | Utah | 84663 | United States |
| Virginia Dermatology & Skin Cancer Center- Site Number : 8401047 | Norfolk | Virginia | 23502 | United States |
| Investigational Site Number : 0320023 | Buenos Aires | Buenos Aires F.D. | 1028 | Argentina |
| Investigational Site Number : 0320024 | SAN Miguel de Tucumã¡n | Tucumán Province | T4000 | Argentina |
| Investigational Site Number : 0320022 | Buenos Aires | 1012 | Argentina |
| Investigational Site Number : 0320010 | Buenos Aires | 1414 | Argentina |
| Investigational Site Number : 0360010 | Westmead | New South Wales | 2145 | Australia |
| Investigational Site Number : 0360007 | Woolloongabba | Queensland | 4102 | Australia |
| Investigational Site Number : 0360008 | Melbourne | Victoria | 3002 | Australia |
| Investigational Site Number : 0360006 | Melbourne | Victoria | 3004 | Australia |
| Investigational Site Number : 0361006 | Traralgon | Victoria | 3844 | Australia |
| Centro de Pesquisas da Clínica IBIS- Site Number : 0760002 | Salvador | Estado de Bahia | 41820-020 | Brazil |
| Hospital São Domingos- Site Number : 0760028 | Bequimão | Maranhão | 65060-645 | Brazil |
| Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760022 | Curitiba | Paraná | 80060-900 | Brazil |
| PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR- Site Number : 0760023 | Curitiba | Paraná | 80230-130 | Brazil |
| Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005 | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Clinica de Alergia Martti Antila- Site Number : 0760006 | Sorocaba | São Paulo | 18040-425 | Brazil |
| CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760018 | Rio de Janeiro | 22241-180 | Brazil |
| Faculdade de Medicina do ABC- Site Number : 0760001 | Santo André | 09060-650 | Brazil |
| Centro de Desenvolvimento em Estudos ClÌnicos Brasil- Site Number : 0760014 | São Paulo | 04020-060 | Brazil |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760012 | São Paulo | 05403-000 | Brazil |
| Investigational Site Number : 1240031 | Edmonton | Alberta | T5K 2V4 | Canada |
| Investigational Site Number : 1240040 | Surrey | British Columbia | V3R 6A7 | Canada |
| Investigational Site Number : 1240033 | Ajax | Ontario | L1S 7K8 | Canada |
| Investigational Site Number : 1240055 | Hamilton | Ontario | L8S 1G5 | Canada |
| Investigational Site Number : 1240029 | London | Ontario | N6A 2C2 | Canada |
| Investigational Site Number : 1241108 | Niagara Falls | Ontario | L2H 1H5 | Canada |
| Investigational Site Number : 1240034 | Ottawa | Ontario | K1H 7X8 | Canada |
| Investigational Site Number : 1240013 | Toronto | Ontario | M3B 3N1 | Canada |
| Investigational Site Number : 1240035 | Toronto | Ontario | M5A 3R6 | Canada |
| Investigational Site Number : 1240043 | Saint-Jérôme | Quebec | J7Z 7E2 | Canada |
| Investigational Site Number : 1240028 | Regina | Saskatchewan | S4V 1R9 | Canada |
| Investigational Site Number : 1240036 | Saskatoon | Saskatchewan | S7K 0H6 | Canada |
| Investigational Site Number : 1520009 | Osorno | Reg Metropolitana de Santiago | 5311523 | Chile |
| Investigational Site Number : 1520008 | Santiago | Reg Metropolitana de Santiago | 7500587 | Chile |
| Investigational Site Number : 1520002 | Santiago | Reg Metropolitana de Santiago | 7580206 | Chile |
| Investigational Site Number : 1520003 | Santiago | Reg Metropolitana de Santiago | 7640881 | Chile |
| Investigational Site Number : 1520010 | Santiago | Reg Metropolitana de Santiago | 8330034 | Chile |
| Investigational Site Number : 1520011 | Santiago | Reg Metropolitana de Santiago | 8380456 | Chile |
| Investigational Site Number : 1520005 | Santiago | Reg Metropolitana de Santiago | 8380465 | Chile |
| Investigational Site Number : 1520001 | Santiago | Reg Metropolitana de Santiago | 8420383 | Chile |
| Investigational Site Number : 1520006 | Viña del Mar | Valparaiso | 2530900 | Chile |
| Investigational Site Number : 1520012 | Talcahuano | 2687000 | Chile |
| Investigational Site Number : 1560042 | Beijing | 100034 | China |
| Investigational Site Number : 1560060 | Chengdu | 610072 | China |
| Investigational Site Number : 1560068 | Chengdu | 610091 | China |
| Investigational Site Number : 1560057 | Chongqing | 400016 | China |
| Investigational Site Number : 1560065 | Chongqing | 400065 | China |
| Investigational Site Number : 1560058 | Guangzhou | 510630 | China |
| Investigational Site Number : 1560059 | Jinan | 250014 | China |
| Investigational Site Number : 1560064 | Shenzhen | 518026 | China |
| Investigational Site Number : 2500008 | Antony | 92160 | France |
| Investigational Site Number : 2500009 | Nantes | 44093 | France |
| Investigational Site Number : 2500003 | Paris | 75010 | France |
| Investigational Site Number : 2500007 | Reims | 51100 | France |
| Investigational Site Number : 2500010 | Romans-sur-Isère | 26102 | France |
| 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 : 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 : 3000004 | Athens | 124 62 | Greece |
| Investigational Site Number : 3000001 | Athens | 161 21 | Greece |
| Investigational Site Number : 3000002 | Thessaloniki | 546 42 | Greece |
| Investigational Site Number : 3000003 | Thessaloniki | 564 29 | Greece |
| Investigational Site Number : 3560001 | Ahmedabad | 380016 | India |
| Investigational Site Number : 3560005 | Belagavi | 590002 | India |
| Investigational Site Number : 3560008 | Bengaluru | 560090 | India |
| Investigational Site Number : 3560004 | Chandigarh | 160012 | India |
| Investigational Site Number : 3560006 | Haryāna | 121002 | India |
| Investigational Site Number : 3560007 | Kolkata | 700073 | India |
| Investigational Site Number : 3560002 | Nagpur | 440015 | India |
| Investigational Site Number : 3560003 | Pune | 411057 | India |
| Investigational Site Number : 3760004 | Afula | 1834111 | Israel |
| Investigational Site Number : 3760005 | Beersheba | 8457108 | Israel |
| Investigational Site Number : 3760001 | Haifa | 3109601 | Israel |
| Investigational Site Number : 3760003 | Jerusalem | 9112001 | Israel |
| Investigational Site Number : 3760006 | Petah Tikva | 4920235 | Israel |
| Investigational Site Number : 3760002 | Petah Tikva | 4941492 | Israel |
| Investigational Site Number : 6160006 | Gdansk | Pomeranian Voivodeship | 80-546 | Poland |
| Investigational Site Number : 6160003 | Katowice | Silesian Voivodeship | 40-611 | Poland |
| Investigational Site Number : 6162406 | Krakow | 31-209 | Poland |
| Investigational Site Number : 6160002 | Lodz | 90-265 | Poland |
| Investigational Site Number : 6160004 | Lublin | 20-607 | Poland |
| Investigational Site Number : 6160011 | Olsztyn | 11-041 | Poland |
| Investigational Site Number : 6160010 | Tarnów | 33-100 | Poland |
| Investigational Site Number : 6160009 | Warsaw | 02-625 | Poland |
| Investigational Site Number : 6160007 | Warsaw | 02-962 | Poland |
| Investigational Site Number : 4100008 | Daegu | Daegu | 41944 | South Korea |
| Investigational Site Number : 4100002 | Ansan-si | Gyeonggi-do | 15355 | South Korea |
| Investigational Site Number : 4100014 | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Investigational Site Number : 4100009 | Suwon | Gyeonggi-do | 16499 | South Korea |
| Investigational Site Number : 4100003 | Yangsan | Gyeongsangnam-do | 50612 | South Korea |
| Investigational Site Number : 4100015 | Bupyeong-gu | Incheon-gwangyeoksi | 21431 | South Korea |
| Investigational Site Number : 4100010 | Seoul | Seoul-teukbyeolsi | 01812 | South Korea |
| Investigational Site Number : 4100013 | Seoul | Seoul-teukbyeolsi | 03080 | South Korea |
| Investigational Site Number : 4100007 | Seoul | Seoul-teukbyeolsi | 03722 | South Korea |
| Investigational Site Number : 4100006 | Seoul | Seoul-teukbyeolsi | 05030 | South Korea |
| Investigational Site Number : 4100011 | Seoul | Seoul-teukbyeolsi | 06591 | South Korea |
| Investigational Site Number : 4100017 | Seoul | Seoul-teukbyeolsi | 07804 | South Korea |
| Investigational Site Number : 4100012 | Gwangju | 61453 | South Korea |
| Investigational Site Number : 1583201 | Kaohsiung City | 833 | Taiwan |
| Investigational Site Number : 1583202 | Taichung | 402 | Taiwan |
| Investigational Site Number : 1580001 | Taipei | 100 | Taiwan |
| Investigational Site Number : 1580003 | Taipei | Taiwan |
| Investigational Site Number : 1583203 | Taoyuan City | 333 | Taiwan |
| 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 |
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