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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519081-49 | EudraCT Number |
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This trial is designed to evaluate multiple compounds in participants with moderate to severe atopic dermatitis (AD).
This is a multicenter, randomized, double-blind, placebo-controlled Phase II platform study to investigate the efficacy and safety of several interventions in participants with moderate to severe AD.
The first intervention planned to be evaluated is GHZ339. Participants will be randomly assigned to one of the study arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GHZ339 Dose A | Experimental | Participants who will receive GHZ339 at dose A during Treatment Period 1 will receive GHZ339 at dose A during Treatment Period 2 |
|
| GHZ339 Dose B | Experimental | Participants who will receive GHZ339 at dose B during Treatment Period 1 will receive GHZ339 at dose B during Treatment Period 2 |
|
| GHZ339 Dose C | Experimental | Participants who will receive GHZ339 at dose C during Treatment Period 1 will receive GHZ339 at dose C or A during Treatment Period 2 |
|
| GHZ339 Dose D | Experimental | Participants who will receive GHZ339 at dose D during Treatment Period 1 will receive GHZ339 at dose D or A during Treatment Period 2 |
|
| Placebo | Placebo Comparator | Participants who will receive placebo during Treatment Period 1 will receive GHZ339 at dose A during Treatment Period 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GHZ339 | Drug | GHZ339 administered at dose A, B, C and D |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the Eczema Area and Severity Index (EASI) score at Week 16 | EASI will be used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema. | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| EASI-75 response at Week 16 | EASI will be used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema. EASI-75 response is defined as achieving ≥ 75% improvement (reduction) in EASI score compared to baseline. | Baseline, Week 16 |
| Investigator Global Assessment (IGA) response at Week 16 |
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Key Inclusion Criteria of the master protocol:
Key Exclusion Criteria of the master protocol:
Additional inclusion and exclusion criteria may apply depending on the intervention specific requirements
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | 1-888-669-6682 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact | +41613241111 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Recruiting | Birmingham | Alabama | 35233 | United States | |
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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| Placebo | Drug | Matching placebo |
|
The IGA rating scale will be used to determine the severity of atopic dermatitis symptoms and clinical response to treatment. The IGA score ranges from 0 (clear) to 4 (severe). IGA response is defined as clear or almost clear score with at least a 2 point-reduction from baseline |
| Baseline, Week 16 |
| Novartis Investigative Site |
| Recruiting |
| Birmingham |
| Alabama |
| 35244 |
| United States |
| Novartis Investigative Site | Recruiting | Fort Smith | Arkansas | 72916 | United States |
| Novartis Investigative Site | Recruiting | Fountain Valley | California | 92708 | United States |
| Novartis Investigative Site | Recruiting | Los Angeles | California | 90056 | United States |
| Novartis Investigative Site | Recruiting | Sacramento | California | 95815 | United States |
| Novartis Investigative Site | Recruiting | Santa Ana | California | 92701 | United States |
| Novartis Investigative Site | Recruiting | Santa Monica | California | 90404 | United States |
| Novartis Investigative Site | Recruiting | Washington D.C. | District of Columbia | 20060 | United States |
| Novartis Investigative Site | Recruiting | Miami | Florida | 33144 | United States |
| Novartis Investigative Site | Recruiting | Atlanta | Georgia | 30342 | United States |
| Novartis Investigative Site | Recruiting | Macon | Georgia | 31217 | United States |
| Novartis Investigative Site | Recruiting | Louisville | Kentucky | 40241 | United States |
| Novartis Investigative Site | Recruiting | Brighton | Massachusetts | 02135 | United States |
| Novartis Investigative Site | Recruiting | Troy | Michigan | 48084 | United States |
| Novartis Investigative Site | Recruiting | Saint Joseph | Missouri | 64506 | United States |
| Novartis Investigative Site | Recruiting | Brooklyn | New York | 11203 | United States |
| Novartis Investigative Site | Recruiting | Arlington | Texas | 76011 | United States |
| Novartis Investigative Site | Recruiting | Cypress | Texas | 77433 | United States |
| Novartis Investigative Site | Recruiting | Dallas | Texas | 75235-9069 | United States |
| Novartis Investigative Site | Recruiting | Houston | Texas | 77030 | United States |
| Novartis Investigative Site | Recruiting | San Antonio | Texas | 78218 | United States |
| Novartis Investigative Site | Recruiting | Caba | Buenos Aires | C1119ACN | Argentina |
| Novartis Investigative Site | Recruiting | Caba | Buenos Aires | C1121ABE | Argentina |
| Novartis Investigative Site | Recruiting | Rosario | Santa Fe Province | S2000DBS | Argentina |
| Novartis Investigative Site | Recruiting | Edmonton | Alberta | T5K 1X3 | Canada |
| Novartis Investigative Site | Recruiting | Hamilton | Ontario | L8L 3C3 | Canada |
| Novartis Investigative Site | Recruiting | Markham | Ontario | L3P 1X3 | Canada |
| Novartis Investigative Site | Recruiting | Montreal | Quebec | H1Y 3L1 | Canada |
| Novartis Investigative Site | Recruiting | Verdun | Quebec | H4G 3E7 | Canada |
| Novartis Investigative Site | Recruiting | Guangzhou | Guangdong | 510091 | China |
| Novartis Investigative Site | Recruiting | Shantou | Guangdong | 515000 | China |
| Novartis Investigative Site | Recruiting | Changsha | Hunan | 410008 | China |
| Novartis Investigative Site | Recruiting | Changchun | Jilin | 130021 | China |
| Novartis Investigative Site | Recruiting | Hangzhou | Zhejiang | 310001 | China |
| Novartis Investigative Site | Recruiting | Beijing | 100029 | China |
| Novartis Investigative Site | Recruiting | Beijing | 100050 | China |
| Novartis Investigative Site | Recruiting | Shanghai | 200040 | China |
| Novartis Investigative Site | Recruiting | Plzen Bory | 301 00 | Czechia |
| Novartis Investigative Site | Recruiting | Prague | 100 34 | Czechia |
| Novartis Investigative Site | Recruiting | Prague | 130 00 | Czechia |
| Novartis Investigative Site | Recruiting | Prague | 150 06 | Czechia |
| Novartis Investigative Site | Recruiting | Brest | 29609 | France |
| Novartis Investigative Site | Recruiting | Lille | 59037 | France |
| Novartis Investigative Site | Recruiting | Lorient | 56322 | France |
| Novartis Investigative Site | Recruiting | Paris | 75475 | France |
| Novartis Investigative Site | Recruiting | Pierre-Bénite | 69495 | France |
| Novartis Investigative Site | Recruiting | Reims | 51100 | France |
| Novartis Investigative Site | Recruiting | Rouen | 76031 | France |
| Novartis Investigative Site | Recruiting | Frankfurt am Main | Hesse | 60590 | Germany |
| Novartis Investigative Site | Recruiting | Mainz | Rhineland-Palatinate | 55128 | Germany |
| Novartis Investigative Site | Recruiting | Bad Bentheim | 48455 | Germany |
| Novartis Investigative Site | Recruiting | Dresden | 01097 | Germany |
| Novartis Investigative Site | Recruiting | Hamburg | 20246 | Germany |
| Novartis Investigative Site | Recruiting | Heidelberg | 69120 | Germany |
| Novartis Investigative Site | Recruiting | Magdeburg | 39120 | Germany |
| Novartis Investigative Site | Recruiting | Münster | 48149 | Germany |
| Novartis Investigative Site | Recruiting | Oldenburg | 26133 | Germany |
| Novartis Investigative Site | Recruiting | Pécs | Baranya | 7623 | Hungary |
| Novartis Investigative Site | Recruiting | Debrecen | Hajdu Bihar Megye | 4032 | Hungary |
| Novartis Investigative Site | Recruiting | Budapest | 1033 | Hungary |
| Novartis Investigative Site | Recruiting | Budapest | H-1083 | Hungary |
| Novartis Investigative Site | Recruiting | Szeged | 6725 | Hungary |
| Novartis Investigative Site | Recruiting | Ancona | AN | 60126 | Italy |
| Novartis Investigative Site | Recruiting | Cona | FE | 44124 | Italy |
| Novartis Investigative Site | Recruiting | Nagoya | Aichi-ken | 4678602 | Japan |
| Novartis Investigative Site | Recruiting | Matsudo | Chiba | 2710092 | Japan |
| Novartis Investigative Site | Recruiting | Kawasaki | Kanagawa | 211-0063 | Japan |
| Novartis Investigative Site | Recruiting | Yokohama | Kanagawa | 220-6208 | Japan |
| Novartis Investigative Site | Recruiting | Habikino | Osaka | 583 8588 | Japan |
| Novartis Investigative Site | Recruiting | Shinagawa Ku | Tokyo | 141 8625 | Japan |
| Novartis Investigative Site | Active, not recruiting | Fukuoka | 8128582 | Japan |
| Novartis Investigative Site | Recruiting | Kyoto | 6078062 | Japan |
| Novartis Investigative Site | Recruiting | Rotterdam | South Holland | 3015 GD | Netherlands |
| Novartis Investigative Site | Recruiting | Utrecht | 3584 CX | Netherlands |
| Novartis Investigative Site | Recruiting | Warsaw | Masovian Voivodeship | 02-953 | Poland |
| Novartis Investigative Site | Recruiting | Katowice | 40-611 | Poland |
| Novartis Investigative Site | Recruiting | Lodz | 90-436 | Poland |
| Novartis Investigative Site | Recruiting | Lublin | 20-573 | Poland |
| Novartis Investigative Site | Recruiting | Warsaw | 02-962 | Poland |
| Novartis Investigative Site | Recruiting | Bardejov | 085 01 | Slovakia |
| Novartis Investigative Site | Recruiting | Komárno | 945 01 | Slovakia |
| Novartis Investigative Site | Recruiting | Košice | 040 22 | Slovakia |
| Novartis Investigative Site | Recruiting | Košice | 041 90 | Slovakia |
| Novartis Investigative Site | Recruiting | Prešov | 080 01 | Slovakia |
| Novartis Investigative Site | Recruiting | Ansan | Gyeonggi-do | 425-801 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 03722 | South Korea |
| Novartis Investigative Site | Recruiting | Badalona | Barcelona | 08916 | Spain |
| Novartis Investigative Site | Recruiting | Alicante | 03010 | Spain |
| Novartis Investigative Site | Recruiting | Granada | 18016 | Spain |
| Novartis Investigative Site | Recruiting | Las Palmas GC | 35010 | Spain |
| Novartis Investigative Site | Recruiting | Madrid | 28006 | Spain |
| Novartis Investigative Site | Recruiting | Madrid | 28041 | Spain |
| Novartis Investigative Site | Recruiting | Pontevedra | 36003 | Spain |
| Novartis Investigative Site | Recruiting | Kaohsiung City | 83301 | Taiwan |
| Novartis Investigative Site | Recruiting | Taipei | 10002 | Taiwan |
| Novartis Investigative Site | Recruiting | Taipei | 11217 | Taiwan |
| Novartis Investigative Site | Recruiting | Dudley | West Midlands | DY1 2HQ | United Kingdom |
| Novartis Investigative Site | Recruiting | Liverpool | L7 8XP | United Kingdom |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D003872 | Dermatitis |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| 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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