Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Kezar Life Sciences, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Adult patients at least 18 years of age
2. Body Mass Index (BMI) of 18 to 40 kg/m\^2
3. Diagnosis of probable or definite DM or PM by the 2017 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria
4. Must have their data reviewed by an adjudication committee to confirm eligibility unless at least 1 of the following is present:
1. Muscle biopsy with evidence of active myositis within the last 6 months prior to or at Screening
2. Electromyography or magnetic resonance imaging with evidence of active myositis within the last 6 months prior to Screening
3. A creatine kinase (CK) ≥4 × upper limit of normal (ULN).
5. Must have demonstrable muscle weakness as measured by the Manual Muscle Testing-8 muscle Groups (MMT-8) with a score ≥80/150 but ≤136/150 units and any 2 of the following:
1. Physician Global Assessment (MDGA) visual analog scale (VAS) ≥2 cm
2. Patient Global Assessment of Disease Activity (PtGADA) VAS ≥2 cm
3. At least one muscle enzyme laboratory measurement ≥1.3 × ULN
4. Myositis Disease Activity Assessment Tool (MDAAT) Extramuscular Global Activity VAS ≥1 cm.
6. Documented inadequate response OR have demonstrated documented toxicity or intolerance to prior standard of care therapies
7. Has had age-appropriate cancer screening that is up to date and negative for evidence of malignancy as per local standard of care
You may not be if
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:
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
Clareo Health | A Phase 2 Study of KZR-616 to Evaluate Safety and Efficacy in Patients With Active Polymyositis or Dermatomyositis
