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

  • STATUS
    Recruiting
  • End date
    Apr 25, 2022
  • participants needed
    24
  • sponsor
    Kezar Life Sciences, Inc.
Updated on 26 January 2021
cancer
MRI
weakness
body mass index (bmi)
muscle biopsy
creatine kinase
dermatomyositis
polymyositis
muscle enzyme
mdga

Summary

"This is a Phase 2 randomized, double-blind, placebo-controlled, crossover, multicenter study to evaluate the safety, tolerability, efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of treatment with KZR-616 in patients with active Polymyositis (PM) or Dermatomyositis (DM). Patients will be evaluated for eligibility during the Screening Period. Eligible patients will be randomized 1:1 to Arm A or Arm B of the study.

During the 32-week treatment period, patients will receive study drug subcutaneously (SC) once weekly with 2 treatment periods of 16 weeks each.

This study will be conducted on an outpatient basis.

Details
Condition Dermatomyositis, CONNECTIVE TISSUE DISEASE, Myositis, Dermatosis, Polymyositis, Dermatomyositis (Connective Tissue Disease), Congenital Skin Diseases, Polymyositis (Inflammatory Muscle Disease), Skin Conditions, Connective Tissue Diseases, Idiopathic Inflammatory Myopathies
Treatment Placebo, KZR-616
Clinical Study IdentifierNCT04033926
SponsorKezar Life Sciences, Inc.
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult patients at least 18 years of age
Body Mass Index (BMI) of 18 to 40 kg/m2
Diagnosis of probable or definite DM or PM
Must confirm eligibility unless at least 1 of the following is present
Muscle biopsy with evidence of active myositis within the last 6 months prior to or at Screening
Electromyography or magnetic resonance imaging with evidence of active myositis within the last 6 months prior to Screening
A creatine kinase (CK) 4 upper limit of normal (ULN)
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
Physician Global Assessment (MDGA) visual analog scale (VAS) 2 cm
Patient Global Assessment of Disease Activity (PtGADA) VAS 2 cm
At least one muscle enzyme laboratory measurement 1.3 ULN
Myositis Disease Activity Assessment Tool (MDAAT) Extramuscular Global Activity VAS 1 cm
Documented inadequate response OR have demonstrated documented toxicity or intolerance to prior standard of care therapies
Has had age-appropriate cancer screening that is up to date and negative for evidence of malignancy as per local standard of care

Exclusion Criteria

Has significant muscle damage or has a muscle damage VAS score 5 cm on the MDI
Any other form of myositis or myopathy other than PM or DM
Any condition that precludes the ability to quantitate muscle strength
Has severe interstitial lung disease or has a pulmonary damage VAS score 5 cm on the Myositis Damage Index (MDI)
Presence of autoinflammatory disease
Use of nonpermitted medications or treatments within the specified washout periods prior to screening
Patient has had recent serious or ongoing infection, or risk for serious infection
Any of the following laboratory values at Screening
Estimated glomerular filtration rate <45 mL/min
Hemoglobin <10 g/dL
White blood cell (WBC) count <3.0 109/L
Absolute neutrophil count (ANC) <1.5 109/L (1500/mm3)
Platelet count <100 109/L
Serum AST or serum ALT >2.5 ULN (unless considered consistent with muscle origin)
Serum alkaline phosphatase >2.5 ULN
Total bilirubin >1.5 ULN (3 ULN for patients with documented Gilbert's syndrome)
Thyroid stimulating hormone outside of the central laboratory normal range
Immunoglobulin G (IgG) <500 mg/dL
Presence of New York Heart Association Class III or IV heart failure, or uncontrolled blood pressure, or prolonged QT interval
Major surgery within 12 weeks before Screening or planned during the study period
Clinical evidence of significant unstable or uncontrolled diseases
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
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