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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523318-96-00 | EU Trial (CTIS) Number |
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This phase III, double-blind, multi-center treat-through study will evaluate the efficacy and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).
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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 per Pediatric Crohn's Disease Activity Index (PCDAI) | At Week 52 | |
| Percentage of Participants With Endoscopic Response | At Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Remission | At Week 12 and Week 52 | |
| Percentage of Participants With Clinical Response | At Week 12 and Week 52 | |
| Percentage of Participants With CDAI Remission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: CP45906 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 |
|---|---|---|---|---|---|---|
| Royal Children's Hospital | Recruiting | Parkville | Victoria | 3052 | Australia | |
| Perth Children's Hospital |
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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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|
| At Week 12 and Week 52 |
| Change From Baseline in Fecal Calprotectin | Baseline, Week 12 and Week 52 |
| Change From Baseline in Mucosal Inflammation Noninvasive Index (MINI) Score | Baseline, Week 12 and Week 52 |
| Percentage of Participants With Endoscopic Remission | At Week 52 |
| Percentage of Participants With Corticosteroid-Free Clinical Remission | At Week 52 |
| Percentage of Participants with Maintenance of Remission | At Week 12 and Week 52 |
| Percentage of Participants With Histologic Improvement | At Week 52 |
| Percentage of Participants With Ulcer-Free Endoscopy | At Week 52 |
| Incidence and Severity of Adverse Events (AEs) | Up to Approximately 5.5 Years |
| Serum Concentration of Afimkibart | Up to Approximately 5.5 Years |
| Recruiting |
| Nedlands |
| Western Australia |
| 6009 |
| Australia |
| National Taiwan University Hospital | Recruiting | Taipei | 100 | Taiwan |
| Chulalongkorn University | Recruiting | Bangkok | 10330 | Thailand |
| Ramathibodi Hospital | Recruiting | Bangkok | Thailand |