Brentuximab Vedotin for Systemic Sclerosis
Summary
There is significant unmet need for effective treatment options for Diffuse Cutaneous Systemic Sclerosis (dcSSc). The present study will be a dose-escalation safety trial of brentuximab vedotin, a drug-antibody conjugate approved for the treatment of lymphoma and targeted to the protein CD30 molecule expressed on activated immune cells There is evidence for CD30 involvement in SSc. This study represents the first step in determining safety and tolerability of brentuximab vedotin in SSc.
Timeline
- Start
- 2017-09-20
- Primary completion
- 2023-04-10
- Completion
- 2023-04-10
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
registry analysis (superiority test); 0.6 mg/kg Brentuximab Vedotin vs 0.6 mg/kg Placebo; p = 1.000; Fisher Exact; NCT03222492 ↗
registry analysis (superiority test); 1.2 mg/kg Brentuximab Vedotin vs 1.2 mg/kg Placebo; p = 0.444; Fisher Exact; NCT03222492 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brentuximab Vedotin | Monoclonal antibody | 0.6 mg/kg | Intravenous |
| Subject | Brentuximab Vedotin | Monoclonal antibody | 1.2 mg/kg | Intravenous |
| Subject | Brentuximab Vedotin | Monoclonal antibody | 1.8 mg/kg | Intravenous |