drugset / Trial / NCT04118153
Early Markers of Disease and Response to Therapy
Phase 0
Completed
60 enrolled
Sandra Lord, MD
Juvenile Diabetes Research Foundation · collabMedical College of Wisconsin · collab
NaSingle-groupOpen-labelBasic science
Summary
The purpose of this study is to identify early immune markers associated with response to treatment with abatacept in individuals with Type 1 diabetes (T1D). In this open label mechanistic study, participants who were recently diagnosed with T1D (males or females, ages 6-45 and \<7months from T1D diagnosis) will be treated with a short-course of abatacept (weekly subcutaneous injections for 3 months). Participants will undergo baseline and repeated mixed meal tolerance testing (MMTT) to assess disease progression and blood samples will be obtained at frequent intervals to measure changes in immune markers.
Timeline
- Start
- 2021-03-05
- Primary completion
- 2024-05-24
- Completion
- 2024-05-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abatacept | Other / unclassified | 50 mg | Subcutaneous |
| Subject | Abatacept | Other / unclassified | 87.5 mg | Subcutaneous |
| Subject | Abatacept | Other / unclassified | 125 mg | Subcutaneous |