Phase 2 Trial to Evaluate the Efficacy, Safety of Allogeneic Mitochondria (PN-101) in Patients Wi… (NCT07122648) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phase 2 Trial to Evaluate the Efficacy, Safety of Allogeneic Mitochondria (PN-101) in Patients With Refractory Polymyositis or Dermatomyositis
South Korea36 participantsStarted 2025-12
Plain-language 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
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Adult aged 19 years or more
✓. A subject who is diagnosed with polymyositis or dermatomyositis and satisfies all of the followings:
✓. Baseline (prior to the investigational product administration) manual muscle testing-8 (MMT-8) result \< 125/150 (bilaterally), and at least 2 of the following International Myositis and Clinical Studies Group (IMACS) core set results
✓. Individuals who are currently receiving glucocorticosteroids and/or steroid-sparing drugs such as immunosuppressants or immunomodulators for the treatment of polymyositis or dermatomyositis but are deemed to have an inadequate response to treatment, or who are unable to continue existing treatment due to drug-related adverse events or side effects (however, during the clinical trial, the dosage of steroids and immunosuppressants may be adjusted within 20% of the dose prior to the study participation)
✓. Individuals who are receiving exercise or physical therapy and have agreed to maintain the same intensity and frequency of their current therapy
✓. A subject who fully understands the trial and provided voluntary written consent to take part in the trial
Exclusion criteria
✕. A subject with clear muscular damage, with the VAS-based myositis damage index (MDI) of ≥ 5 at screening
✕. A subject with the following medical history or surgical history
✕. Patients diagnosed with polymyositis or dermatomyositis before the age of 10 (Juvenile PM or Juvenile DM)
What they're measuring
1
International Myositis And Clinical Studies group-Total Improvement Score (IMACS-TIS)
. A patient with severe respiratory muscular weakening or interstitial pulmonary disease (a patient who has no moderate or severe dyspnea and has stable interstitial pneumonia may participate)
✕. A patient with the following comorbidity at screening
✕. Hematological, renal and hepatic dysfunction based on the following laboratory findings at screening
✕. A subject with a difficulty in the efficacy assessment including the muscular strength assessment during the trial
✕. A subject who is determined to require prohibited concomitant treatment during the trial