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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-520771-59-00 | EU Trial (CTIS) Number |
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This study will assess long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with Atopic Dermatitis (AD) who participated in previous afimkibart clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Afimkibart Group I | Experimental | Participants will receive Afimkibart as subcutaneous (SC) injection. |
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| Afimkibart Group II | Experimental | Participants will receive Afimkibart as SC injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Afimkibart | Drug | Afimkibart SC injection will be administered as per the schedule defined in the protocol. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events | From Baseline up to 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (in Parent Study) in Eczema Area and Severity Index (EASI) Score at Each Visit | Baseline, Up to 6 years | |
| Percent Change From Baseline (in Parent Study) in EASI Score at Each Visit | Baseline, Up to 6 years |
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Inclusion Criteria:
Parent Clinical Trial-Specific Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: CS45943 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Research, LLC | Recruiting | Alpharetta | Georgia | 30022 | United States | |
| Revival Research Institute, LLC |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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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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| Percentage of Participants With EASI-50 at Each Visit | Up to 6 years |
| Percentage of Participants with EASI-75 at Each Visit | Up to 6 years |
| Percentage of Participants with EASI-90 at Each Visit | Up to 6 years |
| Percentage of Participants who Achieve Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) of Clear (0) or Almost clear (1) at Each Visit | From Baseline up to 6 years |
| Change from Baseline (in the parent study) in Participant-Oriented Eczema Measure (POEM) at Each Visit | Baseline, Up to 6 years |
| Change from Baseline (in the parent study) in Dermatology Life Quality Index (DLQI) at Each Visit | Baseline, Up to 6 years |
| Serum Concentration of Afimkibart at Specified Timepoints | Pre-dose on Day 1, Weeks 2, 10, 18, 26, 34, 42, 50 74, 98, 122, 146, 170, 194, 218, 242, 266, 290 and 14 weeks after last dose |
| Percentage of Participants with Anti-Drug Antibodies (ADAs) to Afimkibart | From Baseline up to 6 years |
| Percentage of Participants with Neutralizing Antibody (NAb) to Afimkibart | From Baseline up to 6 years |
| Recruiting |
| Troy |
| Michigan |
| 48084 |
| United States |
| Best Skin Research LLC | Recruiting | Camp Hill | Pennsylvania | 17011 | United States |
| Centro de Estudos em Terapias Inovadoras ? CETI | Recruiting | Curitiba | Paraná | 80030-110 | Brazil |
| Irmandade Da Santa Casa de Misericordia de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Hospital de Clnicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu | Recruiting | Botucatu | São Paulo | 18618-686 | Brazil |
| Centro de Pesquisa São Lucas | Recruiting | Campinas | São Paulo | 13060-803 | Brazil |
| HMCG - Hospital e Maternidade Dr. Christovo da Gama | Recruiting | Santo Andr | São Paulo | 09030-010 | Brazil |
| Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS | Recruiting | Sao Jose Rio Preto | São Paulo | 15090-000 | Brazil |
| Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A | Recruiting | Rio de Janeiro | 20241-180 | Brazil |
| DermEffects | Recruiting | London | Ontario | N6H 5L5 | Canada |
| Lynderm Research Inc | Recruiting | Markham | Ontario | L3P 1X3 | Canada |
| DermEdge | Recruiting | Mississauga | Ontario | L4Y4C5 | Canada |
| Ryan Clinical Research Inc | Recruiting | Newmarket | Ontario | L3Y 5G8 | Canada |
| Fachklinik Bad Bentheim | Recruiting | Bad Bentheim | Lower Saxony | 48455 | Germany |
| Dermatologikum Hamburg Gemeinschaftspraxis GbR | Recruiting | Hamburg | 20354 | Germany |
| Centrum Medyczne Pratia Katowice I | Recruiting | Katowice | Silesian Voivodeship | 40-081 | Poland |
| Centrum Medyczne Pratia Gdynia | Recruiting | Gdynia | 81-338 | Poland |
| Specjalistyczny Gabinet Dermatologiczny dr n. med. Pawel Brzewski | Recruiting | Krakow | 30-002 | Poland |
| Centrum Nowoczesnych Terapii "Dobry Lekarz" | Recruiting | Krakow | 31-011 | Poland |
| Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie | Recruiting | Rzeszów | 35-055 | Poland |
| Klinika Ambroziak Dermatologia | Recruiting | Warsaw | 02-953 | Poland |
| Hospital Universitario Reina Sofia | Recruiting | Córdoba | 14004 | 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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