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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508099-12 | Registry Identifier | CTIS | |
| U1111-1295-3059 | 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 AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy.
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 have had an inadequate response to prior biologic or an oral JAKi therapy.
Study details include:
At the end of the treatment period, participants will have the option to enter the Long-Term Safety Study LTS17367 (RIVER-AD).
The 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.
The 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.
The 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).
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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: Subcutaneous |
|
| 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 36 | 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 36 |
| 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 | 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 36 |
| 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 | 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 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants reaching EASI-75 at Week 36 (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 36 |
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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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency email recommended (Toll free for US & Canada) | Contact | 800-633-1610 | option 6 | Contact-US@sanofi.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham- Site Number : 8401267 | Recruiting | Birmingham | Alabama | 35233 | United States | |
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| Label | URL |
|---|---|
| EFC17599 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: Subcutaneous |
|
| Topical corticosteroids | Drug | Pharmaceutical form: Various Topical formulation Route of administration: Topical |
|
| Topical tacrolimus or pimecrolimus | Drug | Pharmaceutical form: Various 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 36 |
| 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 36 |
| 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 24 |
| 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 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 36 |
| 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 36 |
| Proportion of participants with PP-NRS ≤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 36 |
| 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 36 |
| 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 36 |
| Change in Children Dermatology Life Quality Index (CDLQI) from baseline in participants with age ≥12 to <16 years | 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 36 |
| 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 36 |
| 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 36 |
| 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 36 |
| 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 36 |
| 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 36 |
| 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 36 |
| 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 36 |
| 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). | Baseline to Week 36 |
| 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 36 |
| 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 36 |
| 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 36 |
| 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 36 |
| 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 36 |
| 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 36 |
| 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 36 |
| 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 36 |
| Change in percent Body Surface Area (BSA) affected by AD from baseline | Baseline to Week 36 |
| 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 36 |
| 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 36 |
| 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 36 |
| Proportion of participants with a reduction in Patient Oriented Eczema Measure (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 36 |
| Change in 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 36 |
| Proportion of participants with rescue medication use | Baseline to Week 36 |
| Time to onset of effect on PP-NRS as measured by proportion of participants with an improvement (reduction) in PP-NRS by ≥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 36 |
| Percentage of TCS/TCI free days | Baseline to Week 36 |
| 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 52 |
| Serum amlitelimab concentrations | Baseline to Week 52 |
| Incidence of antidrug antibodies (ADAs) of amlitelimab | Baseline to Week 52 |
| 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 | 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 36 |
| 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 | 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 36 |
| Center for Dermatology and Plastic Surgery- Site Number : 8401119 |
| Recruiting |
| Scottsdale |
| Arizona |
| 85260 |
| United States |
| Arkansas Dermatology - North Little Rock- Site Number : 8401244 | Recruiting | North Little Rock | Arkansas | 72117 | United States |
| Encino Research Center- Site Number : 8401042 | Recruiting | Encino | California | 91436 | United States |
| Center for Dermatology Clinical Research- Site Number : 8401018 | Recruiting | Fremont | California | 94538 | United States |
| Long Beach Clinical Trials- Site Number : 8401188 | Recruiting | Long Beach | California | 90806 | United States |
| Dermatology Research Associates - Los Angeles- Site Number : 8401092 | Recruiting | Los Angeles | California | 90045 | United States |
| LA Universal Research Center- Site Number : 8401064 | Recruiting | Los Angeles | California | 90057 | United States |
| University Dermatology Trials- Site Number : 8401339 | Recruiting | Newport Beach | California | 92660 | United States |
| Rady Children's Hospital- Site Number : 8401291 | Recruiting | San Diego | California | 92123 | United States |
| Therapeutics Clinical Research- Site Number : 8401283 | Recruiting | San Diego | California | 92123 | United States |
| Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245 | Recruiting | Wheat Ridge | Colorado | 80033 | United States |
| Encore Medical Research of Boynton Beach- Site Number : 8401030 | Recruiting | Boynton Beach | Florida | 33436 | United States |
| St. Jude Clinical Research- Site Number : 8401287 | Recruiting | Doral | Florida | 33172 | United States |
| Apex Clinical Research - Jacksonville- Site Number : 8401332 | Recruiting | Jacksonville | Florida | 32256 | United States |
| Clever Medical Research- Site Number : 8401160 | Recruiting | Miami | Florida | 33126 | United States |
| Global Clinical Professionals (GCP)- Site Number : 8401045 | Recruiting | St. Petersburg | Florida | 33714 | United States |
| Avita Clinical Research- Site Number : 8401073 | Recruiting | Tampa | Florida | 33613 | United States |
| Northwestern University- Site Number : 8401285 | Recruiting | Chicago | Illinois | 60611 | United States |
| NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8401038 | Recruiting | Skokie | Illinois | 60077 | United States |
| Dawes Fretzin Clinical Research- Site Number : 8401015 | Recruiting | Indianapolis | Indiana | 46256 | United States |
| Equity Medical - Bowling Green- Site Number : 8401296 | Recruiting | Bowling Green | Kentucky | 42104 | United States |
| Tandem Clinical Research - Metairie- Site Number : 8401187 | Recruiting | Metairie | Louisiana | 70006 | United States |
| University of Michigan Health System - Ann Arbor- Site Number : 8401290 | Recruiting | Ann Arbor | Michigan | 48109 | United States |
| MI Skin Center- Site Number : 8401307 | Recruiting | Northville | Michigan | 48167 | United States |
| Skin Specialists- Site Number : 8401068 | Recruiting | Omaha | Nebraska | 68144 | United States |
| Schweiger Dermatology Group - East Windsor- Site Number : 8401338 | Recruiting | East Windsor | New Jersey | 08520 | United States |
| The University of New Mexico- Site Number : 8401263 | Recruiting | Albuquerque | New Mexico | 87106 | United States |
| Equity Medical- Site Number : 8401239 | Recruiting | New York | New York | 10023 | United States |
| Sadick Research Group - New York - Park Avenue- Site Number : 8401050 | Recruiting | New York | New York | 10075 | United States |
| Cincinnati Children's Hospital Medical Center- Site Number : 8401279 | Recruiting | Cincinnati | Ohio | 45229 | United States |
| Oregon Health & Science University (OHSU)- Site Number : 8401247 | Recruiting | Portland | Oregon | 97239 | United States |
| Paddington Testing Company- Site Number : 8401041 | Recruiting | Philadelphia | Pennsylvania | 19103 | United States |
| Clinical Research of Philadelphia- Site Number : 8401193 | Recruiting | Philadelphia | Pennsylvania | 19114 | United States |
| Medical University of South Carolina - Charleston - Jonathan Lucas Street- Site Number : 8401282 | Recruiting | Charleston | South Carolina | 29425 | United States |
| Arlington Research Center- Site Number : 8401248 | Recruiting | Arlington | Texas | 76011 | United States |
| McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8401288 | Recruiting | Bellaire | Texas | 77401 | United States |
| Reveal Research Institute - Dallas- Site Number : 8401219 | Recruiting | Dallas | Texas | 75235 | United States |
| Advanced Research Institute - Odgen (ARI - Ogden)- Site Number : 8401057 | Recruiting | Ogden | Utah | 84405 | United States |
| Virginia Dermatology & Skin Cancer Center- Site Number : 8401047 | Recruiting | Norfolk | Virginia | 23502 | United States |
| North Sound Dermatology- Site Number : 8401280 | Recruiting | Mill Creek | Washington | 98012 | United States |
| Children's Wisconsin- Site Number : 8401246 | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
| Cheyenne Skin Clinic- Site Number : 8401234 | Recruiting | Cheyenne | Wyoming | 82009 | United States |
| Investigational Site Number : 0320007 | Recruiting | Rosario | Santa Fe Province | 2000 | Argentina |
| Investigational Site Number : 0320011 | Recruiting | Buenos Aires | 1035 | Argentina |
| Investigational Site Number : 0320019 | Recruiting | Buenos Aires | 1426 | Argentina |
| Investigational Site Number : 0320014 | Recruiting | Córdoba | 5000 | Argentina |
| Investigational Site Number : 0360008 | Recruiting | Melbourne | Victoria | 3002 | Australia |
| Investigational Site Number : 0360006 | Recruiting | Melbourne | Victoria | 3004 | Australia |
| Centro de Pesquisas da Clínica IBIS- Site Number : 0760002 | Recruiting | Salvador | Estado de Bahia | 41820-020 | Brazil |
| Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005 | Recruiting | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Faculdade de Medicina do ABC- Site Number : 0760001 | Recruiting | Santo André | São Paulo | 09060-650 | Brazil |
| Clinica de Alergia Martti Antila- Site Number : 0760006 | Completed | Sorocaba | São Paulo | 18040-425 | Brazil |
| Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760010 | Recruiting | São Paulo | 01323-020 | Brazil |
| Centro de Desenvolvimento em Estudos ClÌnicos Brasil- Site Number : 0760014 | Recruiting | São Paulo | 04020-060 | Brazil |
| Investigational Site Number : 1240019 | Recruiting | Calgary | Alberta | T2W 4X9 | Canada |
| Investigational Site Number : 1240016 | Recruiting | Edmonton | Alberta | T5J 3S9 | Canada |
| Investigational Site Number : 1240058 | Recruiting | Burlington | Ontario | L7L 6W6 | Canada |
| Investigational Site Number : 1240020 | Recruiting | Hamilton | Ontario | L8L 3C3 | Canada |
| Investigational Site Number : 1240053 | Recruiting | London | Ontario | N6A 5R9 | Canada |
| Investigational Site Number : 1240035 | Recruiting | Toronto | Ontario | M5A 3R6 | Canada |
| Investigational Site Number : 1240054 | Recruiting | Toronto | Ontario | M5m 3z8 | Canada |
| Investigational Site Number : 1240028 | Recruiting | Regina | Saskatchewan | S4V 1R9 | Canada |
| Investigational Site Number : 1520002 | Recruiting | Santiago | Reg Metropolitana de Santiago | 7580206 | Chile |
| Investigational Site Number : 1520003 | Recruiting | Santiago | Reg Metropolitana de Santiago | 7640881 | Chile |
| Investigational Site Number : 1520010 | Recruiting | Santiago | Reg Metropolitana de Santiago | 8330034 | Chile |
| Investigational Site Number : 1520005 | Recruiting | Santiago | Reg Metropolitana de Santiago | 8380465 | Chile |
| Investigational Site Number : 1520001 | Recruiting | Santiago | Reg Metropolitana de Santiago | 8420383 | Chile |
| Investigational Site Number : 1560031 | Recruiting | Changchun | 130021 | China |
| Investigational Site Number : 1560057 | Recruiting | Chongqing | 400016 | China |
| Investigational Site Number : 1560021 | Recruiting | Guangzhou | 510018 | China |
| Investigational Site Number : 1560036 | Recruiting | Guangzhou | 510100 | China |
| Investigational Site Number : 1560044 | Recruiting | Hangzhou | 310003 | China |
| Investigational Site Number : 1560002 | Recruiting | Hangzhou | 310006 | China |
| Investigational Site Number : 1560009 | Recruiting | Hangzhou | 310009 | China |
| Investigational Site Number : 1560034 | Recruiting | Nanyang | 473014 | China |
| Investigational Site Number : 1560024 | Recruiting | Ningbo | 315010 | China |
| Investigational Site Number : 1560035 | Recruiting | Ningbo | 315010 | China |
| Investigational Site Number : 1560001 | Recruiting | Shanghai | 200040 | China |
| Investigational Site Number : 1560005 | Recruiting | Shanghai | 200443 | China |
| Investigational Site Number : 1560041 | Recruiting | Shenyang | 110001 | China |
| Investigational Site Number : 1560038 | Recruiting | Wuhan | 430030 | China |
| Investigational Site Number : 1560032 | Recruiting | Xi'an | 710004 | China |
| Investigational Site Number : 2500011 | Recruiting | Bordeaux | 33000 | France |
| Investigational Site Number : 2500014 | Active, not recruiting | Clermont-Ferrand | 63100 | France |
| Investigational Site Number : 2500004 | Recruiting | Créteil | 94010 | France |
| Investigational Site Number : 2500001 | Recruiting | Lille | 59037 | France |
| Investigational Site Number : 2500017 | Recruiting | Paris | 75010 | France |
| Investigational Site Number : 2500012 | Recruiting | Rouen | 76031 | France |
| Investigational Site Number : 2762203 | Recruiting | Berlin | 10117 | Germany |
| Investigational Site Number : 2762202 | Recruiting | Blankenfelde-Mahlow | 15831 | Germany |
| Investigational Site Number : 2761001 | Recruiting | Dresden | 01307 | Germany |
| Investigational Site Number : 2760022 | Recruiting | Frankfurt | 60590 | Germany |
| Investigational Site Number : 2761002 | Recruiting | Lübeck | 23562 | Germany |
| Investigational Site Number : 2760019 | Recruiting | Witten | 58453 | Germany |
| Investigational Site Number : 3000004 | Recruiting | Athens | 124 62 | Greece |
| Investigational Site Number : 3000001 | Recruiting | Athens | 16121 | Greece |
| Investigational Site Number : 3000005 | Recruiting | Athens | 16121 | Greece |
| Investigational Site Number : 3000002 | Recruiting | Thessaloniki | 54643 | Greece |
| Investigational Site Number : 3760005 | Recruiting | Beersheba | 8457108 | Israel |
| Investigational Site Number : 3760008 | Recruiting | Ramat Gan | 5262100 | Israel |
| Investigational Site Number : 3760007 | Recruiting | Tel Aviv | 6423906 | Israel |
| Investigational Site Number : 3800020 | Recruiting | Turin | Torino | 10126 | Italy |
| Center for Advanced Studies and Technology-Site Number: 3800016 | Recruiting | Chieti | 66100 | Italy |
|
| A.O.U. di Modena -Site Number: 3800021 | Recruiting | Modena | 41125 | Italy |
|
| UOC Clinica Dermatologica - AOU "Luigi Vanvitelli"-Site Number : 3800017 | Recruiting | Naples | 80131 | Italy |
|
| Azienda ospedaliera di Perugia - Ospedale "Santa Maria della Misericordia"-Site Number: 3800015 | Recruiting | Perugia | 06129 | Italy |
|
| Investigational Site Number : 3923113 | Recruiting | Yokohama | Kanagawa | 221-0825 | Japan |
| Investigational Site Number : 3923109 | Recruiting | Habikino | Osaka | 583-8588 | Japan |
| Investigational Site Number : 3923110 | Recruiting | Sakai | Osaka | 593-8324 | Japan |
| Investigational Site Number : 3923106 | Recruiting | Mibu | Tochigi | 321-0293 | Japan |
| Investigational Site Number : 3920001 | Recruiting | Tachikawa | Tokyo | 190-0023 | Japan |
| Investigational Site Number : 3920007 | Recruiting | Hiroshima | 734-8551 | Japan |
| Investigational Site Number : 4840011 | Recruiting | Monterrey | Nuevo León | 64460 | Mexico |
| Investigational Site Number : 4840003 | Recruiting | Veracruz | 91900 | Mexico |
| Investigational Site Number : 6162417 | Recruiting | Wroclaw | Lower Silesian Voivodeship | 51-685 | Poland |
| Investigational Site Number : 6160002 | Recruiting | Lublin | Lublin Voivodeship | 20-363 | Poland |
| Investigational Site Number : 6162411 | Recruiting | Warsaw | Masovian Voivodeship | 01-142 | Poland |
| Investigational Site Number : 6160001 | Recruiting | Warsaw | Masovian Voivodeship | 02-507 | Poland |
| Investigational Site Number : 6160006 | Recruiting | Gdansk | Pomeranian Voivodeship | 80-546 | Poland |
| Investigational Site Number : 2500016 | Recruiting | Saint-Pierre | 97448 | Reunion |
| Investigational Site Number : 6820001 | Recruiting | Riyadh | 12713 | Saudi Arabia |
| Investigational Site Number : 4100002 | Recruiting | Ansan-si | Gyeonggi-do | 15355 | South Korea |
| Investigational Site Number : 4100014 | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Investigational Site Number : 4100015 | Recruiting | Bupyeong-Gu | Incheon-gwangyeoksi | 21431 | South Korea |
| Investigational Site Number : 4100007 | Recruiting | Seoul | Seoul-teukbyeolsi | 03722 | South Korea |
| Investigational Site Number : 4100001 | Recruiting | Seoul | Seoul-teukbyeolsi | 07441 | South Korea |
| Investigational Site Number : 7240002 | Recruiting | Badalona | Barcelona [Barcelona] | 08916 | Spain |
| Investigational Site Number : 7240017 | Recruiting | Majadahonda | Madrid | 28222 | Spain |
| Investigational Site Number : 7240020 | Recruiting | Seville | Sevilla | 41013 | Spain |
| Investigational Site Number : 7242505 | Recruiting | Alicante | 03010 | Spain |
| Investigational Site Number : 7242503 | Recruiting | Madrid | 28046 | Spain |
| Investigational Site Number : 1583201 | Active, not recruiting | Kaohsiung City | 833 | Taiwan |
| Investigational Site Number : 1580001 | Recruiting | Taipei | 100 | Taiwan |
| Investigational Site Number : 1580003 | Recruiting | Taipei | Taiwan |
| Investigational Site Number : 1583203 | Recruiting | Taoyuan City | 333 | Taiwan |
| Investigational Site Number : 7920008 | Recruiting | Gaziantep | 27310 | Turkey (Türkiye) |
| Investigational Site Number : 7920005 | Recruiting | Istanbul | 34093 | Turkey (Türkiye) |
| Investigational Site Number : 7920002 | Recruiting | Istanbul | 34098 | Turkey (Türkiye) |
| Investigational Site Number : 7841002 | Recruiting | Abu Dhabi | 51900 | United Arab Emirates |
| Investigational Site Number : 7840001 | Recruiting | Abu Dhabi | 6222 | United Arab Emirates |
| Investigational Site Number : 7840002 | Recruiting | Abu Dhabi | United Arab Emirates |
| Investigational Site Number : 8260013 | Recruiting | Bristol | Bristol, City of | BS2 8HW | United Kingdom |
| Investigational Site Number : 8260012 | Recruiting | Plymouth | Devon | PL6 8DH | United Kingdom |
| Investigational Site Number : 8262603 | Recruiting | London | England | E11 1NR | United Kingdom |
| Investigational Site Number : 8260015 | Recruiting | London | England | SW10 9NH | United Kingdom |
| Investigational Site Number : 8260003 | Recruiting | Portsmouth | Hampshire | PO3 6DW | United Kingdom |
| Investigational Site Number : 8260009 | Recruiting | Leeds | North Yorkshire | Ls7 4sa | United Kingdom |
| Investigational Site Number : 8260010 | Recruiting | Nottingham | Nottinghamshire | NG17 4JL | United Kingdom |
| Investigational Site Number : 8260008 | Recruiting | Liverpool | L7 8XP | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D016559 | Tacrolimus |
| C117268 | pimecrolimus |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided