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
Adult aged 19 years or more
Clinical profile: Slowly progressing clinical profile with symmetrical and apparent muscular weakness confirmed at the proximal muscle (in case of dermatomyositis, clinical findings related with characteristic skin symptoms*)
Gottron's papules or sign, erythema purpura, poikiloderma, calcinosis cutis, etc.
Serum test: Serum creatine kinase (CK) elevated (CK ≥ 1.3 × upper limit of normal (ULN)) or serum myositis-specific antibodies (MSA) positive
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
A surgical operation history within 12 weeks of screening
Malignant tumor within 5 years of screening (excluding a subject who passed 3 years or more from complete recovery of cervical cancer or skin squamous cell carcinoma)
Parallel
placebo
Biological/VaccineParticipants will receive a single IV dose of 300 µg of placebo
PN-101
Biological/VaccineParticipants will receive a single IV dose of 300 µg of PN-101
PN-101
Biological/VaccineParticipants will receive a single IV dose of 600 µg of PN-101.
International Myositis And Clinical Studies group-Total Improvement Score (IMACS-TIS)
Assessment of IMACS-TIS at Week 12 (Visit 6) after the IP administration. Total Improvement Score (TIS) based on absolute percentage change is assessed scale 0 to 100. Higher score indicates greater improvement.
International Myositis And Clinical Studies group-Total Improvement Score (IMACS-TIS)
Assessment of IMACS-TIS at week 4, week 8, and week 16 after the IP administration. Total Improvement Score (TIS) based on absolute percentage change is assessed scale 0 to 100. Higher score indicates greater improvement.
Response rate of IMACS-TIS
Proportion of subjects with the IMACS-TIS ≥ 20 at week 4, week 8, week 12, and week 16 after IP administration
Changes of Core Set Activity Measures(CSAM)
Changes in CSAM for the IMACS assessed at week 4, week 8, week 12, and week16 after the IP administration from the baseline (Visit 2). The core set for the IMCS consists of six components: physician global disease activity, patient global disease activity, MMT-8, extramuscular activity, HAQ, and serum muscle enzyme levels.
Changes of Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)
Changes in CDASI assessed at week 4, week 8, week 12 and week 16 after the IP administration from the baseline (Visit 2) for dermatomyositis only.
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