drugset / Trial / NCT07122648
Phase 2 Trial to Evaluate the Efficacy, Safety of Allogeneic Mitochondria (PN-101) in Patients With Refractory Polymyositis or Dermatomyositis
RandomizedParallel-groupDouble-blindTreatment
Summary
The efficacy of PN-101 in subjects with polymyositis or dermatomyositis will be evaluated at Week 12 using IMACS-TIS in comparison with the placebo control group. The safety and efficacy will be evaluated following administration of PN-101 to subjects with polymyositis or dermatomyositis, in comparison with the placebo group
Timeline
- Start
- 2025-12
- Primary completion
- 2027-04
- Completion
- 2027-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PN-101 | Unknown | 300 ug | Intravenous |
| Subject | PN-101 | Unknown | 600 ug | Intravenous |