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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1253-9888 | Registry Identifier | ICTRP | |
| 2023-508879-36-00 | Registry Identifier | CTIS | |
| 2023-508879-36 | Registry Identifier | CTIS | |
| 2021-004315-76 | EudraCT Number |
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The main objective of the study is to assess efficacy and safety of dupilumab given up to 24 weeks in adults with CPUO.
This is a master protocol which includes 2 parallel-treatment, double-blind, 2- arm Phase 3 staggered studies of similar design (Study A and Study B) in male and female participants aged 18 to 90 years with CPUO. Study B design was to be adapted based on the results of Study A.
For both Study A and B, after an up-to-4-week screening period, participants with severe pruritus (worst-itch numerical rating scale [WI-NRS ≥7) will enter a 4-week run-in period and will be treated with a non-sedative antihistamine and an emollient (moisturizer). Participants with severe pruritus (WI-NRS ≥7) at baseline will be randomized (1:1) to be treated for 24 weeks with either dupilumab or matching placebo in addition to their non-sedative antihistamine and emollient regimen. The treatment period for both study A and B will be followed by a 12-week follow-up period.](streamdown:incomplete-link)
Study duration per participant will be up to 44 weeks for both Study A and Study B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dupilumab | Experimental | Loading dose administered subcutaneous (SC), followed by SC once every 2 weeks (Q2W) on top of non-sedative antihistamine and moisturizer |
|
| Placebo | Placebo Comparator | Loading dose administered SC, followed by SC Q2W on top of non-sedative antihistamine and moisturizer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | Injection solution subcutaneous |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Study A: Proportion of participants with improvement (reduction) in weekly average of daily worst-itch numerical rating scale (WI-NRS) by ≥4 from baseline to Week 24 | WI-NRS is a patient reported outcome (PRO) comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch"). | Baseline to Week 24 |
| Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12 | WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch"). | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Study A; Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12 | WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch"). | Baseline to Week 12 |
| Study A: Proportion of participants who scored "none" or "mild" in Patient Global Impression of Severity (PGIS) of pruritus at 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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency email recommended (Toll free number for US & Canada) | Contact | 800-633-1610 | option 6 | Contact-US@sanofi.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kern Allergy and Medical Research- Site Number : 8400016 | Completed | Bakersfield | California | 93301 | United States | |
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| Label | URL |
|---|---|
| EFC16973 Chronic Pruritus of Unknown Origin Website | View source |
| EFC16973 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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| Drug |
Injection solution SC |
|
| Fexofenadine (loratadine if not available) | Drug | Tablet or capsule Oral |
|
The PGIS of pruritus is a one-item categorical scale that asks participants to provide the overall self-assessment of their pruritus severity on a 4-point scale for the past week. Response choices are: "None", "Mild", "Moderate", "Severe". |
| Week 24 |
| Study A: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline over time until Week 24 | WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch"). | Baseline to Week 24 |
| Study A: Time to first response of WI-NRS ≥4 points reduction from baseline by Week 24 | WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch"). | Baseline to Week 24 |
| Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 24 | WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch"). | Baseline to Week 24 |
| Study A: Percent change from baseline in weekly average of daily WI-NRS at Week 24 | WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch"). | Baseline to Week 24 |
| Study A: Proportion of participants who scored "none" or "mild" in PGIS of pruritus at Week 12 | The PGIS of pruritus is a one-item categorical scale that asks participants to provide the overall self-assessment of their pruritus severity on a 4-point scale for the past week. Response choices are: "None", "Mild", "Moderate", "Severe". | Week 12 |
| Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 12 | WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch"). | Baseline to Week 12 |
| Study A: Percent change from baseline in weekly average of daily WI-NRS at Week 12 | WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch"). | Baseline to Week 12 |
| Study A: Absolute change from baseline in weekly average of daily sleep disturbance numerical rating scale (NRS) at Week 24 | The sleep disturbance NRS is to be used by the participants to report the degree of their sleep loss related to itch over the past 24 hours. Participants will rate their sleep disturbance from 0 ('no sleep loss related to itch') to 10 ('I cannot sleep at all due to itch') once daily in the morning. | Baseline to Week 24 |
| Study A: Percent change from baseline in weekly average of daily sleep disturbance NRS at Week 24 | The sleep disturbance NRS is to be used by the participants to report the degree of their sleep loss related to itch over the past 24 hours. Participants will rate their sleep disturbance from 0 ('no sleep loss related to itch') to 10 ('I cannot sleep at all due to itch') once daily in the morning. | Baseline to Week 24 |
| Study A: Change from baseline in Dermatology Life Quality Index (DLQI) score at Week 24 | 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 |
| Study A: Change from baseline in the Itchy quality of life (ItchyQoL) score at Week 24 | ItchyQoL is a pruritus-specific QoL instrument that measures specifically disease burden in pruritus patients. | Baseline to Week 24 |
| Study A: Change from baseline in Hospital Anxiety and Depression Scale (HADS) total score at Week 24 | The HADS is a validated questionnaire for screening anxiety and depression in non-psychiatric populations. The total score ranges from 0 to 42. 0 to 7= normal; 8 to 10= borderline abnormal; 11 to 21= abnormal. | Baseline to Week 24 |
| Study A: Absolute change from baseline in weekly average of daily sleep disturbance NRS at Week 12 | The sleep disturbance NRS is to be used by the participants to report the degree of their sleep loss related to itch over the past 24 hours. Participants will rate their sleep disturbance from 0 ('no sleep loss related to itch') to 10 ('I cannot sleep at all due to itch') once daily in the morning. | Baseline to Week 12 |
| Study A: Percent change from baseline in weekly average of daily sleep disturbance NRS at Week 12 | The sleep disturbance NRS is to be used by the participants to report the degree of their sleep loss related to itch over the past 24 hours. Participants will rate their sleep disturbance from 0 ('no sleep loss related to itch') to 10 ('I cannot sleep at all due to itch') once daily in the morning. | Baseline to Week 12 |
| Study A: Change from baseline in DLQI score at Week 12 | 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 12 |
| Study A: Change from baseline in the ItchyQoL score at Week 12 | ItchyQoL is a pruritus-specific QoL instrument that measures specifically disease burden in pruritus patients. It is a 22-item instrument that measures the degree to which pruritus affects quality-of-life for the past week. The overall score is the average of the 22 items ranging from 1 to 5. A higher score corresponds to a more adverse impact on QoL. | Baseline to Week 12 |
| Study A: Change from baseline in HADS total score at Week 12 | The HADS is a validated questionnaire for screening anxiety and depression in non-psychiatric populations. The total score ranges from 0 to 42. 0 to 7= normal; 8 to 10= borderline abnormal; 11 to 21= abnormal. | Baseline to Week 12 |
| Study A: Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) from baseline through end of study (EOS) | Percentage of participants experiencing TEAEs or SAEs from baseline through EOS | Baseline to Week 36 |
| Study A: Incidence of treatment-emergent antidrug antibodies (ADA) against dupilumab | Incidence of treatment-emergent ADA against dupilumab | Baseline to Week 36 |
| Study B: Proportion of participants who scored "none" or "mild" in PGIS of pruritus at Week 24 | The PGIS of pruritus is a one-item categorical scale that asks participants to provide the overall self-assessment of their pruritus severity on a 4-point scale for the past week. Response choices are: "None", "Mild", "Moderate", "Severe". | Week 24 |
| Study B: Proportion of participants who scored "none" or "mild" in PGIS of pruritus at Week 12 | The PGIS of pruritus is a one-item categorical scale that asks participants to provide the overall self-assessment of their pruritus severity on a 4-point scale for the past week. Response choices are: "None", "Mild", "Moderate", "Severe". | Week 12 |
| Study B: Absolute change from baseline in weekly average of daily WI-NRS at Week 12 | WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch"). | Baseline to Week 12 |
| Study B: Percent change from baseline in weekly average of daily WI-NRS at Week 12 | WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch"). | Baseline to Week 12 |
| Study B: Absolute change from baseline in weekly average of daily WI-NRS at Week 24 | WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch"). | Baseline to Week 24 |
| Study B: Percentage change from baseline in weekly average of daily WI-NRS at Week 24 | WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch"). | Baseline to Week 24 |
| Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline, sustained from Week 19 through Week 24 | WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch"). | Baseline to Week 19 through Week 24 |
| Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥5 from baseline to Week 24 | WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch"). | Baseline to Week 24 |
| Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24 | WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch"). | Baseline to Week 24 |
| Study B: Proportion of participants with weekly average of daily WI-NRS <2 at Week 24 | WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch"). | Week 24 |
| Study B: Time to first response of WI-NRS ≥4 points reduction from baseline by Week 24 | WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch"). | Baseline to Week 24 |
| Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥5 from baseline to Week 12 | WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch"). | Baseline to Week 12 |
| Study B: Proportion of participants with weekly average of daily WI-NRS <2 at Week 12 | WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch"). | Week 12 |
| Study B: Absolute change from baseline in weekly average of daily itch-related sleep disturbance NRS at Week 12 and Week 24 | The sleep disturbance NRS is to be used by the participants to report the degree of their sleep loss related to itch over the past 24 hours. Participants will rate their sleep disturbance from 0 ('no sleep loss related to itch') to 10 ('I cannot sleep at all due to itch') once daily in the morning. | Baseline to Week 12 and Week 24 |
| Study B: Percent change from baseline in weekly average of daily itch-related sleep disturbance NRS at Week 12 and Week 24 | The sleep disturbance NRS is to be used by the participants to report the degree of their sleep loss related to itch over the past 24 hours. Participants will rate their sleep disturbance from 0 ('no sleep loss related to itch') to 10 ('I cannot sleep at all due to itch') once daily in the morning. | Baseline to Week 12 and Week 24 |
| Study B: Change from baseline in DLQI score at Week 12 and Week 24 | 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 12 and Week 24 |
| Study B: Change from baseline in the ItchyQoL score at Week 12 and Week 24 | ItchyQoL is a pruritus-specific QoL instrument that measures specifically disease burden in pruritus patients. It is a 22-item instrument that measures the degree to which pruritus affects quality-of-life for the past week. The overall score is the average of the 22 items ranging from 1 to 5. A higher score corresponds to a more adverse impact on QoL. | Baseline to Week 12 and Week 24 |
| Study B: Change from baseline in HADS total score at Week 12 and Week 24 | The HADS is a validated questionnaire for screening anxiety and depression in non-psychiatric populations. The total score ranges from 0 to 42. 0 to 7= normal; 8 to 10= borderline abnormal; 11 to 21= abnormal. | Baseline to Week 12 and Week 24 |
| Study B: Percentage of participants experiencing TEAEs or SAEs from baseline through EOS | Percentage of participants experiencing TEAEs or SAEs from baseline through EOS | Baseline to Week 36 |
| Study B: Incidence of treatment-emergent ADA against dupilumab | Incidence of treatment-emergent ADA against dupilumab | Baseline to Week 36 |
| Modena Allergy + Asthma- Site Number : 8400038 |
| Recruiting |
| La Jolla |
| California |
| 92037 |
| United States |
| FoxHall Dermatology- Site Number : 8400042 | Recruiting | Washington D.C. | District of Columbia | 20016 | United States |
| Palm Harbor Dermatology- Site Number : 8400024 | Recruiting | Belleair | Florida | 32756 | United States |
| University of Miami Hospital- Site Number : 8400011 | Recruiting | Miami | Florida | 33136 | United States |
| Skin Care Physicians of Georgia - Macon- Site Number : 8400030 | Recruiting | Macon | Georgia | 31217 | United States |
| Aeroallergy Research Laboratory- Site Number : 8400036 | Recruiting | Savannah | Georgia | 31406 | United States |
| Dawes Fretzin Clinical Research- Site Number : 8400007 | Recruiting | Indianapolis | Indiana | 46256 | United States |
| Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400031 | Recruiting | Louisville | Kentucky | 40241 | United States |
| Tulane University School of Medicine- Site Number : 8400045 | Recruiting | New Orleans | Louisiana | 70112 | United States |
| Johns Hopkins Hospital- Site Number : 8400020 | Recruiting | Baltimore | Maryland | 21287 | United States |
| The Asthma and Allergy Center- Site Number : 8400014 | Recruiting | Bellevue | Nebraska | 68123 | United States |
| Mount Sinai - Union Square- Site Number : 8400034 | Recruiting | New York | New York | 10003 | United States |
| AXIS Clinicals - Fargo- Site Number : 8400037 | Recruiting | Fargo | North Dakota | 58103 | United States |
| Optima Research - Boardman- Site Number : 8400039 | Recruiting | Boardman | Ohio | 44512 | United States |
| Columbia Dermatology & Aesthetics- Site Number : 8400047 | Recruiting | Columbia | South Carolina | 29212 | United States |
| National Allergy and Asthma - North Charleston - Northside Drive- Site Number : 8400032 | Recruiting | North Charleston | South Carolina | 29420 | United States |
| Complete Dermatology - Sugar Land- Site Number : 8400046 | Recruiting | Sugar Land | Texas | 77479 | United States |
| Investigational Site Number : 0320004 | Completed | Rosario | Santa Fe Province | 2000 | Argentina |
| Investigational Site Number : 0320008 | Recruiting | Rosario | Santa Fe Province | 2000 | Argentina |
| Investigational Site Number : 0320005 | Recruiting | Buenos Aires | 1012 | Argentina |
| Investigational Site Number : 0320001 | Completed | Buenos Aires | 1023 | Argentina |
| Investigational Site Number : 0320006 | Recruiting | Buenos Aires | 1055 | Argentina |
| Investigational Site Number : 0320007 | Recruiting | Buenos Aires | 1061 | Argentina |
| Investigational Site Number : 0320002 | Recruiting | Buenos Aires | 1121 | Argentina |
| Investigational Site Number : 0320003 | Recruiting | Buenos Aires | 1414 | Argentina |
| Investigational Site Number : 1240001 | Recruiting | Calgary | Alberta | T2G 1B1 | Canada |
| Investigational Site Number : 1240008 | Completed | Edmonton | Alberta | T6G 1C3 | Canada |
| Investigational Site Number : 1240002 | Recruiting | London | Ontario | L6A 2C2 | Canada |
| Investigational Site Number : 1240003 | Completed | Markham | Ontario | L3P 1X2 | Canada |
| Investigational Site Number : 1240006 | Recruiting | Toronto | Ontario | M4C 1L1 | Canada |
| Investigational Site Number : 1240005 | Completed | Montreal | Quebec | H4A 3T2 | Canada |
| Investigational Site Number : 1240004 | Recruiting | Verdun | Quebec | H4G 2L8 | Canada |
| Investigational Site Number : 1560003 | Recruiting | Beijing | 100191 | China |
| Investigational Site Number : 1560004 | Recruiting | Chengdu | 610041 | China |
| Investigational Site Number : 1560009 | Recruiting | Chongqing | 400016 | China |
| Investigational Site Number : 1560006 | Recruiting | Guangzhou | 510018 | China |
| Investigational Site Number : 1560005 | Recruiting | Guangzhou | 510080 | China |
| Investigational Site Number : 1560002 | Recruiting | Hangzhou | 310006 | China |
| Investigational Site Number : 1560001 | Recruiting | Shanghai | 200040 | China |
| Investigational Site Number : 1560011 | Recruiting | Suzhou | 215006 | China |
| Investigational Site Number : 1560008 | Recruiting | Wuhan | 430022 | China |
| Investigational Site Number : 2500001 | Recruiting | Brest | 29200 | France |
| Investigational Site Number : 2500003 | Recruiting | Nice | 06202 | France |
| Investigational Site Number : 2500004 | Recruiting | Reims | 51100 | France |
| Investigational Site Number : 2760005 | Recruiting | Bad Bentheim | 48455 | Germany |
| Investigational Site Number : 2760002 | Recruiting | Berlin | 12203 | Germany |
| Investigational Site Number : 2760004 | Recruiting | Frankfurt | 60590 | Germany |
| Investigational Site Number : 2760003 | Recruiting | Mainz | 55131 | Germany |
| Investigational Site Number : 2760001 | Recruiting | Münster | 48149 | Germany |
| Investigational Site Number : 3480001 | Recruiting | Budapest | 1036 | Hungary |
| Investigational Site Number : 3480009 | Recruiting | Budapest | 1066 | Hungary |
| Investigational Site Number : 3480005 | Recruiting | Debrecen | 4031 | Hungary |
| Investigational Site Number : 3480010 | Recruiting | Gyula | 5700 | Hungary |
| Investigational Site Number : 3480003 | Recruiting | Szeged | 6720 | Hungary |
| Investigational Site Number : 3480011 | Recruiting | Székesfehérvár | 8000 | Hungary |
| Investigational Site Number : 3480002 | Recruiting | Zalaegerszeg | 8900 | Hungary |
| Azienda Ospedaliero-Universitaria di Ferrara-Site Number : 3800007 | Recruiting | Cona | Ferrara | 44124 | Italy |
|
| AUSL Toscana Centro - Presidio Ospedaliero "Piero Palagi-"Site Number : 3800005 | Recruiting | Florence | Firenze | 50125 | Italy |
|
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-Site Number : 3800003 | Recruiting | Milan | Milano | 20122 | Italy |
|
| Investigational Site Number : 3800002 | Recruiting | Rozzano | Milano | 20089 | Italy |
| Investigational Site Number : 3800006 | Recruiting | Naples | Napoli | 80131 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Site Number : 3800001 | Recruiting | Rome | Roma | 00168 | Italy |
|
| Azienda Ospedaliero Universitaria delle Marche-Site Number : 3800004 | Recruiting | Ancona | 60126 | Italy |
|
| Investigational Site Number : 3920007 | Recruiting | Urayasu | Chiba | 279-0011 | Japan |
| Investigational Site Number : 3920003 | Recruiting | Obihiro | Hokkaido | 080-0013 | Japan |
| Investigational Site Number : 3920006 | Recruiting | Sapporo | Hokkaido | 060-0063 | Japan |
| Investigational Site Number : 3920004 | Recruiting | Habikino | Osaka | 583-8588 | Japan |
| Investigational Site Number : 3920002 | Recruiting | Sakai | Osaka | 593-8324 | Japan |
| Investigational Site Number : 3920005 | Recruiting | Izumo | Shimane | 693-8501 | Japan |
| Investigational Site Number : 3920001 | Recruiting | Tachikawa | Tokyo | 190-0023 | Japan |
| Investigational Site Number : 6160001 | Recruiting | Krakow | Lesser Poland Voivodeship | 30-033 | Poland |
| Investigational Site Number : 6160007 | Recruiting | Wroclaw | Lower Silesian Voivodeship | 50-566 | Poland |
| Investigational Site Number : 6160003 | Active, not recruiting | Wroclaw | Lower Silesian Voivodeship | 51-318 | Poland |
| Investigational Site Number : 6160003 | Recruiting | Wroclaw | Lower Silesian Voivodeship | 51-503 | Poland |
| Investigational Site Number : 6160008 | Recruiting | Warsaw | Masovian Voivodeship | 01-142 | Poland |
| Investigational Site Number : 6160005 | Recruiting | Warsaw | Masovian Voivodeship | 02-172 | Poland |
| Investigational Site Number : 4100003 | Completed | Busan | Busan | 49241 | South Korea |
| Investigational Site Number : 4100004 | Completed | Ansan-si | Gyeonggi-do | 15355 | South Korea |
| Investigational Site Number : 4100005 | Completed | Seoul | Seoul-teukbyeolsi | 03080 | South Korea |
| Investigational Site Number : 4100002 | Completed | Seoul | Seoul-teukbyeolsi | 03722 | South Korea |
| Investigational Site Number : 4100006 | Recruiting | Seoul | Seoul-teukbyeolsi | 05030 | South Korea |
| Investigational Site Number : 4100001 | Completed | Seoul | Seoul-teukbyeolsi | 07441 | South Korea |
| Investigational Site Number : 4100007 | Recruiting | Seoul | Seoul-teukbyeolsi | 07804 | South Korea |
| Investigational Site Number : 7240003 | Recruiting | Barcelona | Barcelona [Barcelona] | 08003 | Spain |
| Investigational Site Number : 7240006 | Recruiting | Barcelona | Catalunya [Cataluña] | 08041 | Spain |
| Investigational Site Number : 7240001 | Recruiting | Pontevedra | Pontevedra [Pontevedra] | 36002 | Spain |
| Investigational Site Number : 7240005 | Recruiting | Alicante | 03010 | Spain |
| Investigational Site Number : 7240004 | Recruiting | Córdoba | 14004 | Spain |
| Investigational Site Number : 1580003 | Recruiting | Kaohsiung City | 833 | Taiwan |
| Investigational Site Number : 1580004 | Recruiting | New Taipei City | 235 | Taiwan |
| Investigational Site Number : 1580001 | Recruiting | Taipei | 100 | Taiwan |
| Investigational Site Number : 1580002 | Recruiting | Taoyuan City | 333 | Taiwan |
| ID | Term |
|---|---|
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
| C093230 | fexofenadine |
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