A Phase 2 Study of KZR-616 to Evaluate Safety and Efficacy in Patients With Active Polymyositis or Dermatomyositis
Public ClinicalTrials.gov record NCT04033926. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT04033926
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 25 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 14, 2020 (Actual)
- Primary completion
- Apr 6, 2022 (Actual)
- Completion
- Apr 6, 2022 (Actual)
- Last update posted
- Nov 19, 2025
2020 – 2022
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| KZR Research Site | Beverly Hills | California | 90211 | — |
| KZR Research Site | Orange | California | 92868 | — |
| KZR Research Site | Miami | Florida | 33136 | — |
| KZR Research Site | Atlanta | Georgia | 30322 | — |
| KZR Research Site | Kansas City | Kansas | 66160 | — |
| KZR Research Site | Baltimore | Maryland | 21224 | — |
| KZR Research Site | Ann Arbor | Michigan | 48109 | — |
| KZR Research Site | Great Neck | New York | 11021 | — |
| KZR Research Site | Duncansville | Pennsylvania | 16635 | — |
| KZR Research Site | Pittsburgh | Pennsylvania | 15213 | — |
| KZR Research Site | Austin | Texas | 78756 | — |
| KZR Research Site | Henrico | Virginia | 23233 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04033926, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 19, 2025 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04033926 live on ClinicalTrials.gov.