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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522518-22-00 | EU Trial (CTIS) Number |
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This Phase III, randomized, double-blind, multicenter, induction and maintenance study will evaluate the safety and efficacy of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis (UC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Afimkibart Dose A | Experimental | Participants will receive Afimkibart intravenously (IV) followed by Afimkibart subcutaneous (SC) injection. |
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| Afimkibart Dose B | Experimental | Participants will receive Afimkibart IV followed by Afimkibart SC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Afimkibart | Drug | Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Clinical Remission at Week 12 | At Week 12 | |
| Percentage of Participants with Clinical Remission at Week 52 | At Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Pediatric Ulcerative Colitis Activity Index (PUCAI) Response | From Baseline, at Week 12 | |
| Percentage of Participants with PUCAI Remission | At Week 12 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: CA45905 https://forpatients.roche.com/ | Contact | 888-662-6728 (U.S. and Canada) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. No email attachments. 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 |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta | Recruiting | Atlanta | Georgia | 30342 | United States | |
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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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|
| Change from Baseline in Tummy Ulcerative Colitis (TUMMY-UC) Scores |
| From Baseline to Week 12 |
| Percentage of Participants with Endoscopic Improvement | At Week 12 |
| Percentage of Participants with Histologic Improvement | At Week 12 |
| Percentage of Participants with Histologic-endoscopic Mucosal Improvement | At Week 12 |
| Percentage of Participants with Histologic-endoscopic Mucosal Remission | At Week 12 |
| Change from Baseline in PUCAI Response at Week 52 | From Baseline, at Week 52 |
| Percentage of Participants with PUCAI Remission at Week 52 | At Week 52 |
| Change from Baseline in TUMMY-UC Scores | From Baseline to Week 52 |
| Percentage of Participants with Endoscopic Improvement | At Week 52 |
| Percentage of Participants with Histologic Improvement | At Week 52 |
| Percentage of Participants with Histologic-endoscopic Mucosal Improvement | At Week 52 |
| Percentage of Participants with Histologic-endoscopic Mucosal Remission | At Week 52 |
| Percentage of Participants with Clinical Remission without the use of Corticosteriods | At Week 52 |
| Percetage of Participants with Adverse Events (AEs) | From Baseline up to approximately 4 years |
| Serum Concentartion of Afimkibart | Up to approximately 4 years |
| NYU Langone Health |
| Recruiting |
| New York |
| New York |
| 10016 |
| United States |
| Royal Children's Hospital | Recruiting | Parkville | Victoria | 3052 | Australia |
| Perth Children's Hospital | Recruiting | Nedlands | Western Australia | 6009 | Australia |
| Children's Hospital ZheJiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310052 | China |
| National Taiwan University Hospital | Recruiting | Taipei | 100 | Taiwan |
| Chulalongkorn University | Recruiting | Bangkok | 10330 | Thailand |
| Siriraj Hospital | Recruiting | Bangkok | 10700 | Thailand |
| Ramathibodi Hospital | Recruiting | Bangkok | Thailand |
| Birmingham Children's Hospital | Recruiting | Birmingham | B4 6NH | United Kingdom |
| Addenbrooke's Hospital | Recruiting | Cambridge | CB2 0QQ | United Kingdom |
| Sheffield Childrens Hospital | Recruiting | Sheffield | S10 2TH | United Kingdom |