Clinical Trial

Phase 2 Trial to Evaluate the Efficacy, Safety of Allogeneic Mitochondria (PN-101) in Patients With Refractory Polymyositis or Dermatomyositis

Not Yet Recruiting Phase 2
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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
Trial Details
NCT Number NCT07122648
Lead Sponsor Paean Biotechnology Inc.
Conditions Polymyositis, Dermatomyositis
Enrollment 36 participants
Start Date 2025-12
Primary Completion 2027-04 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2025-08-14