A Phase 2 Study of KZR-616 to Evaluate Safety and Efficacy in Patients With Active Polymyositis or Dermatomyositis

Exclusion Criteria

• •1. Has significant muscle damage or has a muscle damage VAS score ≥5 cm on the MDI
• •2. Any other form of myositis or myopathy other than PM or DM
• •3. Any condition that precludes the ability to quantitate muscle strength
• •4. Has severe interstitial lung disease or has a pulmonary damage VAS score ≥5 cm on the Myositis Damage Index (MDI)
• •5. Presence of autoinflammatory disease
• •6. Use of nonpermitted medications or treatments within the specified washout periods prior to screening
• •7. Patient has had recent serious or ongoing infection, or risk for serious infection
• •8. Any of the following laboratory values at Screening:
• •1. Estimated glomerular filtration rate \<45 mL/min
• •2. Hemoglobin \<10 g/dL
• •3. White blood cell (WBC) count \<3.0 × 10\^9/L
• •4. Absolute neutrophil count (ANC) \<1.5 × 10\^9/L (1500/mm\^3)
• •5. Platelet count \<100 × 10\^9/L
• •6. Serum AST or serum ALT \>2.5 × ULN (unless considered consistent with muscle origin)
• •7. Serum alkaline phosphatase \>2.5 × ULN
• •8. Total bilirubin \>1.5 × ULN (3 × ULN for patients with documented Gilbert's syndrome)
• •9. Thyroid stimulating hormone outside of the central laboratory normal range
• •10. Immunoglobulin G (IgG) \<500 mg/dL.
• •9. Presence of New York Heart Association Class III or IV heart failure, or uncontrolled blood pressure, or prolonged QT interval
• •10. Major surgery within 12 weeks before Screening or planned during the study period
• •11. Clinical evidence of significant unstable or uncontrolled diseases
• •12. Any active or suspected malignancy, including myeloproliferative or lymphoproliferative disorder, or history of documented malignancy within the last 5 years before Screening or within 3 years of diagnosis of myositis, except appropriately excised and cured cervical carcinoma in situ or basal or squamous cell carcinoma of the skin