A Phase 2 Study of KZR-616 to Evaluate Safety and Efficacy in Patients With Active Polymyositis o… (NCT04033926) | Clinical Trial Compass
CompletedPhase 2
A Phase 2 Study of KZR-616 to Evaluate Safety and Efficacy in Patients With Active Polymyositis or Dermatomyositis
United States25 participantsStarted 2020-01-14
Plain-language 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 treatment with KZR-616 in patients with active polymyositis (PM) or dermatomyositis (DM). Patients were evaluated for eligibility during the Screening Period. Eligible patients were stratified by diagnosis of DM or PM and randomized 1:1 to Arm A or Arm B of the study.
During the 32-week treatment period, patients received study drug subcutaneously (SC) once weekly with 2 treatment periods of 16 weeks each.
This study was conducted on an outpatient basis.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
Exclusion criteria
✕
What they're measuring
1
Mean Change in the Total Improvement Score (TIS) From Start to End of Zetomipzomib (KZR-616) Treatment Period
Timeframe: 16 weeks in each Treatment Period (32 weeks total)