At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Randomized, Double-blind, Placebo-controlled, Crossover Multicenter Study to Evaluate the Safety and Efficacy of KZR-616 in the Treatment of Patients With Active Polymyositis or Dermatomyositis
In Brief
A Phase 2 clinical trial evaluating KZR-616 and Placebo for Polymyositis and Dermatomyositis. Completed, enrolled 25 participants across 14 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Interventions
Subcutaneous 30 mg weekly for 2 weeks, then 45 mg weekly for 14 weeks
Subcutaneous injection for 16 weeks