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Condition / disease
Location
Status: Not yet recruiting

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

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

Participants needed: 36
Trial details
Phase: Phase 2Age: 19+Biological sex: AllType: InterventionalSponsor: Paean Biotechnology Inc.Updated: Aug 14, 2025Locations: 5
Eligibility criteria

Adult aged 19 years or more [+13]

A subject with clear muscular damage, with the VAS-based myositis damage index (... [+28]