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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506557-38 | Registry Identifier | CTIS | |
| U1111-1275-9665 | Registry Identifier | ICTRP |
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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 | 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 patient's potential participation in a clinical trial.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Dermatology and Plastic Surgery- Site Number : 8401119 | Scottsdale | Arizona | 85260 | United States | ||
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| Label | URL |
|---|---|
| EFC17560 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 |
|
| 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 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 |
| 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 |
| Percentage of participants who experience Treatment-Emergent Adverse Events (TEAEs), experience 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 |
| Eclipse Clinical Research- Site Number : 8401158 |
| Tucson |
| Arizona |
| 85745 |
| United States |
| Torrance Clinical Research- Site Number : 8401027 | Lomita | California | 90717 | United States |
| Dermatology Research Associates - Los Angeles- Site Number : 8401092 | Los Angeles | California | 90045 | United States |
| Allergy & Asthma Associates of Southern California - Mission Viejo- Site Number : 8401079 | Mission Viejo | California | 92691 | United States |
| Cura Clinical Research - Oxnard- Site Number : 8401142 | Oxnard | California | 93030 | United States |
| Clinical Science Institute- Site Number : 8401028 | Santa Monica | California | 90404 | United States |
| University of Connecticut Health Center- Site Number : 8401115 | Farmington | Connecticut | 06032 | United States |
| Pediatric Skin Research- Site Number : 8401198 | Coral Gables | Florida | 33146 | United States |
| Skin Care Research - Hollywood- Site Number : 8401071 | Hollywood | Florida | 33021 | United States |
| Savin Medical Group - Miami- Site Number : 8401085 | Miami | Florida | 33126 | United States |
| Anchor Medical Research- Site Number : 8401300 | Miami | Florida | 33176 | United States |
| Accel Research - Nona Pediatric Center- Site Number : 8401081 | Orlando | Florida | 32829 | United States |
| Nuline Clinical Trial Center- Site Number : 8401161 | Pompano Beach | Florida | 33060 | United States |
| Clinical Research Trials of Florida- Site Number : 8401023 | Tampa | Florida | 33607 | United States |
| AllerVie Clinical Research - Columbus- Site Number : 8401104 | Columbus | Georgia | 31904 | United States |
| First Georgia Physician Group- Site Number : 8401190 | Fayetteville | Georgia | 30214 | United States |
| Access Dermatology- Site Number : 8401296 | Bowling Green | Kentucky | 42104 | United States |
| MedPharmics - Covington- Site Number : 8401137 | Covington | Louisiana | 70433 | United States |
| Care Access Research - Marriottsville- Site Number : 8401126 | Marriottsville | Maryland | 21104 | United States |
| Tufts Medical Center Site Number : 8401201 | Boston | Massachusetts | 02111 | United States |
| University Of Mississippi Medical Center- Site Number : 8401184 | Jackson | Mississippi | 39216 | United States |
| Care Access - Hoboken- Site Number : 8401132 | Hoboken | New Jersey | 07030 | United States |
| University of New Mexico Comprehensive Cancer Center- Site Number : 8401263 | Albuquerque | New Mexico | 87102 | United States |
| OmeraNY- Site Number : 8401156 | Brooklyn | New York | 11220 | United States |
| Equity Medical- Site Number : 8401239 | New York | New York | 10023 | United States |
| Montefiore Medical Center - Moses Campus- Site Number : 8401150 | The Bronx | New York | 10467 | United States |
| Red River Research Partners- Site Number : 8401196 | Fargo | North Dakota | 58103 | United States |
| Bexley Dermatology Research- Site Number : 8401051 | Bexley | Ohio | 43209 | United States |
| Velocity Clinical Research - Springdale- Site Number : 8401153 | Cincinnati | Ohio | 45246 | United States |
| Dermatology Associates of Plymouth Meeting- Site Number : 8401147 | Plymouth Meeting | Pennsylvania | 19462 | United States |
| PEAK Research- Site Number : 8401083 | Upper Saint Clair | Pennsylvania | 15241 | United States |
| Columbia Dermatology & Aesthetics- Site Number : 8401166 | Columbia | South Carolina | 29212 | United States |
| Health Concepts- Site Number : 8401059 | Rapid City | South Dakota | 57702 | United States |
| Arlington Research Center- Site Number : 8401248 | Arlington | Texas | 76011 | United States |
| Derm Texas- Site Number : 8401217 | Dallas | Texas | 75235 | United States |
| Center for Clinical Studies - Houston - Binz Street- Site Number : 8401063 | Houston | Texas | 77004 | United States |
| Prolato Clinical Research Center- Site Number : 8401209 | Houston | Texas | 77054 | United States |
| Sienna Dermatology- Site Number : 8401148 | Missouri City | Texas | 77459 | United States |
| Progressive Clinical Research - San Antonio- Site Number : 8401016 | San Antonio | Texas | 78229 | United States |
| Advanced Research Institute - Odgen- Site Number : 8401057 | Ogden | Utah | 84405 | United States |
| Care Access - Arlington- Site Number : 8401134 | Arlington | Virginia | 22206 | United States |
| Velocity Clinical Research - Hampton- Site Number : 8401154 | Hampton | Virginia | 23666 | United States |
| Investigational Site Number : 0320021 | Berazategui | Buenos Aires | 1886 | Argentina |
| Investigational Site Number : 0320017 | Pilar | Buenos Aires | 1629 | Argentina |
| Investigational Site Number : 0320006 | Rosario | Santa Fe Province | 2000 | Argentina |
| Investigational Site Number : 0320007 | Rosario | Santa Fe Province | 2000 | Argentina |
| Investigational Site Number : 0320015 | Rosario | Santa Fe Province | 2000 | Argentina |
| Investigational Site Number : 0320016 | Buenos Aires | 1055 | Argentina |
| Investigational Site Number : 0320001 | Buenos Aires | 1121 | Argentina |
| Investigational Site Number : 0320002 | Buenos Aires | 1425 | Argentina |
| Investigational Site Number : 0320009 | Buenos Aires | 1425 | Argentina |
| Investigational Site Number : 1002008 | Gabrovo | 5300 | Bulgaria |
| Investigational Site Number : 1002004 | Pleven | 5800 | Bulgaria |
| Investigational Site Number : 1002005 | Sofia | 1431 | Bulgaria |
| Investigational Site Number : 1520004 | Valdivia | Los Ríos Region | 5110683 | Chile |
| Investigational Site Number : 1520013 | Santiago | Reg Metropolitana de Santiago | 7500505 | Chile |
| Investigational Site Number : 1520003 | Santiago | Reg Metropolitana de Santiago | 7640881 | Chile |
| Investigational Site Number : 1520014 | Santiago | Reg Metropolitana de Santiago | 7750495 | Chile |
| Investigational Site Number : 1520015 | Quillota | Valparaiso | 2260877 | Chile |
| Investigational Site Number : 1560004 | Beijing | 100191 | China |
| Investigational Site Number : 1560030 | Beijing | 100730 | China |
| Investigational Site Number : 1560022 | Chengdu | 610041 | China |
| Investigational Site Number : 1560021 | Guangzhou | 510018 | China |
| Investigational Site Number : 1560025 | Guangzhou | 510080 | China |
| Investigational Site Number : 1560002 | Hangzhou | 310006 | China |
| Investigational Site Number : 1560006 | Hangzhou | 310009 | China |
| Investigational Site Number : 1560029 | Hangzhou | 310014 | China |
| Investigational Site Number : 1560007 | Jinan | 250013 | China |
| Investigational Site Number : 1560024 | Ningbo | 315010 | China |
| Investigational Site Number : 1560001 | Shanghai | 200040 | China |
| Investigational Site Number : 1560005 | Shanghai | 200443 | China |
| Investigational Site Number : 1560026 | Shenyang | 110179 | China |
| Investigational Site Number : 1560023 | Wenzhou | 325035 | China |
| Investigational Site Number : 1560003 | Wuxi | 214000 | China |
| Investigational Site Number : 1560028 | Zhenjiang | 212000 | China |
| Investigational Site Number : 2032106 | Kutná Hora | 284 01 | Czechia |
| Investigational Site Number : 2030010 | Olomouc | 779 00 | Czechia |
| Investigational Site Number : 2032104 | Ostrava | 702 00 | Czechia |
| Investigational Site Number : 2030011 | Prague | 150 00 | Czechia |
| Investigational Site Number : 2030006 | Prague | 160 00 | Czechia |
| Investigational Site Number : 2080002 | Aalborg | 9000 | Denmark |
| Investigational Site Number : 2080001 | Aarhus | 8200 | Denmark |
| Investigational Site Number : 2080003 | Herlev | 2730 | Denmark |
| Investigational Site Number : 3800018 | Rozzano | Milano | 20089 | Italy |
| Investigational Site Number : 3800013 | Rome | Roma | 00133 | Italy |
| Investigational Site Number : 3800009 | Catania | 95123 | Italy |
| Investigational Site Number : 3800008 | Pisa | 56126 | Italy |
| Investigational Site Number : 3800022 | Vicenza | 36100 | 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 : 3923109 | Habikino | Osaka | 583-8588 | 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 : 3923108 | Kagoshima | 890-0063 | Japan |
| Investigational Site Number : 3923102 | Kyoto | 602-8566 | Japan |
| Investigational Site Number : 3920003 | Kyoto | 606-8507 | Japan |
| Investigational Site Number : 4840011 | Monterrey | Nuevo León | 64460 | Mexico |
| Investigational Site Number : 4840005 | Monterrey | Nuevo León | 64718 | Mexico |
| Investigational Site Number : 4840012 | Aguascalientes | 20127 | Mexico |
| Investigational Site Number : 4840009 | Durango | 34000 | Mexico |
| Investigational Site Number : 4840003 | Veracruz | 91900 | Mexico |
| Investigational Site Number : 6200005 | Lisbon | 1169-050 | Portugal |
| Investigational Site Number : 6200004 | Lisbon | 1649-035 | Portugal |
| Investigational Site Number : 6200001 | Lisbon | 1998-018 | Portugal |
| Investigational Site Number : 6200003 | Porto | 4099-001 | Portugal |
| Investigational Site Number : 7100004 | Boksburg | 1459 | South Africa |
| Investigational Site Number : 7100010 | Cape Town | 7533 | South Africa |
| Investigational Site Number : 7100009 | Cape Town | 7708 | South Africa |
| Investigational Site Number : 7100012 | Durban | 3630 | South Africa |
| Investigational Site Number : 7100001 | Durban | 4058 | South Africa |
| Investigational Site Number : 7100015 | Johannesburg | 1500 | South Africa |
| Investigational Site Number : 7100007 | Johannesburg | 2196 | South Africa |
| Investigational Site Number : 7100003 | Pretoria | 0009 | South Africa |
| Investigational Site Number : 7240012 | Las Palmas de Gran Canaria | Las Palmas | 35010 | Spain |
| Investigational Site Number : 7240018 | Granada | 18014 | Spain |
| Investigational Site Number : 7240029 | Madrid | 28007 | Spain |
| Investigational Site Number : 7242503 | Madrid | 28046 | Spain |
| Investigational Site Number : 7520006 | Älvsjö | 125 44 | Sweden |
| Investigational Site Number : 7520001 | Örebro | 701 85 | Sweden |
| Investigational Site Number : 7920001 | Antalya | 07070 | 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 : 7920004 | Kayseri | 38039 | Turkey (Türkiye) |
| Investigational Site Number : 7920011 | Mersin | 33343 | Turkey (Türkiye) |
| Investigational Site Number : 7920007 | Samsun | 55139 | Turkey (Türkiye) |
| Investigational Site Number : 8260003 | Portsmouth | Hampshire | PO3 6DW | United Kingdom |
| Investigational Site Number : 8262602 | London | London, City of | SE1 7EH | United Kingdom |
| Investigational Site Number : 8262601 | London | London, City of | SE1 9RT | United Kingdom |
| Investigational Site Number : 8260006 | Glasgow | G3 8SJ | United Kingdom |
| Investigational Site Number : 8260004 | Leicester | LE2 0TA | United Kingdom |
| 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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