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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515494-95-00 | Other Identifier | EU CT Number |
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The purpose of this study is to assess the efficacy and safety of Afimkibart (also known as RO7790121) in participants with moderate to severe atopic dermatitis (AD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Afimkibart Group I | Experimental | Participants will receive afimkibart via subcutaneous (SC) injection. |
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| Afimkibart Group II | Experimental | Participants will receive afimkibart via SC injection. |
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| Afimkibart Group III | Experimental | Participants will receive afimkibart via SC injection. |
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| Placebo | Placebo Comparator | Participants will receive placebo via SC injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Afimkibart | Drug | Afimkibart will be administered as SC injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who Achieve Eczema Area and Severity Index-75 (EASI-75) Response (>= 75% Improvement from Baseline) at Week 16 | Baseline and Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who Achieve Investigator Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) with >= 2-Grade Improvement at Week 16 and Week 32 | At Week 16 and Week 32 | |
| Percentage of Participants who Achieve EASI-75 Response at Week 32 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First OC Dermatology | Fountain Valley | California | 92708 | United States | ||
| The Center for Dermatology Clinical Research |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Placebo | Drug | Placebo will be administered as SC injection. |
|
| At Week 32 |
| Percentage of Participants who Achieve EASI-90 Response at Week 16 and Week 32 | At Week 16 and Week 32 |
| Percent Change from Baseline in EASI by Visit | Baseline up to end of study (approximately 1 year) |
| Percent Change from Baseline in Peak Pruritus Numerical Rating Scale (NRS) Score by Visit | Baseline up to end of study (approximately 1 year) |
| Change from Baseline in Dermatology Quality of Life Index at Week 16, Week 32 and by Visit | Baseline, weeks 4, 10, 16, 22 and 32 |
| Percentage of EASI-75 Responders at Week 16 | At Week 16 |
| Percentage of Participants with Adverse Events | Baseline up to end of study (approximately 1 year) |
| Serum Concentration of Afimkibart at Specified Timepoints | Weeks 0, 2, 4, 6, 10, 14, 16, 18, 22, 26, 30, 32 and monthly at weeks 4, 8 and 12 after treatment discontinuation. |
| Fremont |
| California |
| 94538 |
| United States |
| University of California Los Angeles | Los Angeles | California | 90024 | United States |
| Dermatology Research Associate | Los Angeles | California | 90045 | United States |
| Suncoast Research Associates LLC - ERN - PPDS | Doral | Florida | 33172 | United States |
| Olympian Clinical Research | Tampa | Florida | 33615 | United States |
| Hamilton Research, LLC | Alpharetta | Georgia | 30022 | United States |
| Dermatology Affiliates Research Institute, LLC | Atlanta | Georgia | 30305 | United States |
| Dawes Fretzin Clinical Res LLC | Indianapolis | Indiana | 46250 | United States |
| Southern Indiana Clinical Trials | New Albany | Indiana | 47150 | United States |
| Revival Research Institute, LLC | Troy | Michigan | 48084 | United States |
| Regents of the University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Care Access Research - Hoboken | Hoboken | New Jersey | 07030 | United States |
| Forest Hill Dermatology Group | Kew Gardens | New York | 11415 | United States |
| Weill Cornell Medicine | New York | New York | 10075 | United States |
| Centricity Research Dublin | Columbus | Ohio | 43213 | United States |
| DOCS Clinical Research - Springfield | Springfield | Ohio | 45505 | United States |
| Central Sooner Research | Oklahoma City | Oklahoma | 73170 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Best Skin Research LLC | Camp Hill | Pennsylvania | 17011 | United States |
| Arlington Research Center | Arlington | Texas | 76011 | United States |
| Modern Research Associates | Dallas | Texas | 75231 | United States |
| Reveal Research Institute | Dallas | Texas | 75235 | United States |
| Rainey & Finklea Dermatology d/b/a RFSA Dermatology, PLLC | San Antonio | Texas | 78213 | United States |
| Care Access Research - Arlington | Arlington | Virginia | 22206 | United States |
| Centro de Pesquisas da Clínica IBIS | Salvador | Estado de Bahia | 41820-020 | Brazil |
| Centro de Estudos em Terapias Inovadoras ? CETI | Curitiba | Paraná | 80030-110 | Brazil |
| Hospital de Clnicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Santa Casa de Misericordia de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90050-170 | Brazil |
| UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu | Botucatu | São Paulo | 18618-686 | Brazil |
| Centro de Pesquisa São Lucas | Campinas | São Paulo | 13034-685 | Brazil |
| HMCG - Hospital e Maternidade Dr. Christovo da Gama | Santo Andr | São Paulo | 09030-010 | Brazil |
| Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A | Rio de Janeiro | 20241-180 | Brazil |
| Dermatology Research Institute Inc. | Calgary | Alberta | T2J 7E1 | Canada |
| CARe Clinic | Red Deer | Alberta | T4P-1K4 | Canada |
| Centricity Research | London | Ontario | N6A 2C2 | Canada |
| DermEffects | London | Ontario | N6H 5L5 | Canada |
| Lynderm Research Inc | Markham | Ontario | L3P 1X3 | Canada |
| DermEdge | Mississauga | Ontario | L4Y4C5 | Canada |
| Ryan Clinical Research Inc | Newmarket | Ontario | L3Y 5G8 | Canada |
| Centre de Recherche Saint-Louis | Québec | G1W 4R4 | Canada |
| Hopital Charles Nicolle | Rouen | Nord | 76031 | France |
| Hopital Saint Louis | Cedex 10 | Paris | 75010 | France |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | 79104 | Germany |
| Klinisches Studienzentrum | Bad Bentheim | Lower Saxony | 48455 | Germany |
| Hautmedizin Saar | Merzig | Saarland | 66663 | Germany |
| DRK Krankenhaus Chemnitz-Rabenstein | Chemnitz | Saxony | 09117 | Germany |
| Harzklinikum Dorothea Christiane Erxleben GmbH | Quedlinburg | Saxony-Anhalt | 06484 | Germany |
| Dermatologikum Hamburg GmbH | Hamburg | 20354 | Germany |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | Emilia-Romagna | 00168 | Italy |
| Fondazione IRCCS CA? Granda Ospedale Maggiore Policlinico | Milan | Lombardy | 20144 | Italy |
| Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco (Presidio G. Rodolico) | Catania | Sicily | 95123 | Italy |
| Azienda Ospedaliero Universitaria delle Marche | Ancona | The Marches | 60126 | Italy |
| Centrum Medyczne Pratia Gdynia | Gdynia | 81-338 | Poland |
| Centrum Medyczne Pratia Katowice I | Katowice | 40-081 | Poland |
| Specjalistyczny Gabinet Dermatologiczny dr n. med. Pawel Brzewski | Krakow | 30-002 | Poland |
| Centrum Nowoczesnych Terapii "Dobry Lekarz" | Krakow | 31-011 | Poland |
| Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie | Rzeszów | 35-055 | Poland |
| LASER CLINIC S.C. Dr Tomasz Kochanowski Dr Andrzej Krolicki | Szczecin | 70-332 | Poland |
| MICS Centrum Medyczne Warszawa | Warsaw | 00-872 | Poland |
| Klinika Ambroziak Dermatologia | Warsaw | 02-953 | Poland |
| Royalderm | Warsaw | 02-962 | Poland |
| WIP Warsaw IBD Point Profesor Kierkus | Warsaw | 04-501 | Poland |
| Complejo Hospitalario Universitario de Santiago. | Santiago de Compostela | LA Coruna | 15706 | Spain |
| Clinica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Clinica Universidad de Navarra-Madrid | Madrid | 28027 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| 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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