At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 18 enrolled
Drug / intervention
KZR-616drug
Likely dose
KZR-616 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Extension to the 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 for Polymyositis and Dermatomyositis. Completed, enrolled 18 participants across 10 sites in 2 countries.
Detailed Summary
This was an open-label study to evaluate the long-term efficacy and safety of KZR-616 in patients with active polymyositis (PM) or dermatomyositis (DM) who completed the double-blind treatment period of Study KZR-616-003, up to and including the Week 32 Visit, prior to the first dose of open-label KZR-616.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolymyositis, Dermatomyositis
CountriesCzechia, United States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
Enrollment StartNov 2020
First PostedNov 2020
Primary CompletionMar 2023
Study CompletionJun 2023
TodayJul 2026
First PostedNov 16, 2020
Enrollment StartNov 4, 2020
Primary CompletionMar 10, 2023
Study CompletionJun 12, 2023
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 5.6 years ago
Interventions
KZR-616drug
Subcutaneous 30 mg for 1 week, then 45 mg weekly