drugset / Trial / NCT03929601
Rituximab-pvvr and Abatacept vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes
Phase 2
Active not recruiting
74 enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH) · collab
RandomizedSequentialTriple-blindTreatment
Summary
The study is a two-arm, multicenter, double-blinded clinical trial testing sequential therapy with rituximab-pvvr followed by abatacept versus rituximab-pvvr alone in new onset T1D. The primary objective is to test whether the C-peptide response to a 2-hour mixed meal tolerance test, will be improved in participants with new onset T1D who are treated with Abatacept after Rituximab-pvvr compared to those treated with Rituximab-pvvr and placebo 24 months after enrollment.
Timeline
- Start
- 2023-10-30
- Primary completion
- 2027-03-31
- Completion
- 2029-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Abatacept | Other / unclassified | 50 mg | Subcutaneous |
| Comparator | Abatacept | Other / unclassified | 87.5 mg | Subcutaneous |
| Comparator | Abatacept | Other / unclassified | 125 mg | Subcutaneous |
| Comparator | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |