Phase 2Not yet recruiting
Phase 2 Trial to Evaluate the Efficacy, Safety of Allogeneic Mitochondria (PN-101) in Patients With Refractory Polymyositis or Dermatomyositis
A Prospective, Multi-center, Randomized, Double-blinded, Placebo-controlled, Parallel, Phase 2 Trial to Evaluate the Efficacy, Safety of PN-101(Mitochondria Isolated From Allogeneic Umbilical Cord-derived Mesenchymal Stem Cells) Single Dose in Patients With Refractory Polymyositis or Dermatomyositis
- Sponsor
- Paean Biotechnology Inc. (Industry)
- Enrolment
- 36 planned
- Conditions
- Polymyositis; Dermatomyositis
- Interventions
- placebo; PN-101; PN-101
- Ages
- adults, older adults
- Registry
- NCT07122648
From the registry
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
Primary outcomes
- International Myositis And Clinical Studies group-Total Improvement Score (IMACS-TIS)