Status:
COMPLETED
A Phase 2 Study of KZR-616 to Evaluate Safety and Efficacy in Patients With Active Polymyositis or Dermatomyositis
Lead Sponsor:
Kezar Life Sciences, Inc.
Conditions:
Polymyositis
Dermatomyositis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This was a Phase 2 randomized, double-blind, placebo-controlled, crossover, multicenter study to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of treatme...
Eligibility Criteria
Inclusion
- Adult patients at least 18 years of age
- Body Mass Index (BMI) of 18 to 40 kg/m\^2
- Diagnosis of probable or definite DM or PM by the 2017 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria
- Must have their data reviewed by an adjudication committee to 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
- 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 × 10\^9/L
- Absolute neutrophil count (ANC) \<1.5 × 10\^9/L (1500/mm\^3)
- Platelet count \<100 × 10\^9/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
Key Trial Info
Start Date :
January 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04033926
Start Date
January 14 2020
End Date
April 6 2022
Last Update
November 19 2025
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
KZR Research Site
Beverly Hills, California, United States, 90211
2
KZR Research Site
Orange, California, United States, 92868
3
KZR Research Site
Miami, Florida, United States, 33136
4
KZR Research Site
Atlanta, Georgia, United States, 30322