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NCT04033926 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study of KZR-616 to Evaluate Safety and Efficacy in Patients With Active Polymyositis or Dermatomyositis
A Phase 2 study, sponsored by Kezar Life Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT04033926: Completed Phase 2 study, sponsored by Kezar Life Sciences.
NCT04033926 is a Phase 2 study that has completed, run by Kezar Life Sciences. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04033926, a Phase 2 study, has completed, sponsored by Kezar Life Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study 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.
Primary Outcome
The primary efficacy endpoint was mean change from start to end of zetomipzomib (KZR-616) Treatment Periods in the Total Improvement Score (TIS), which ranges from 0 to 100 \[low of 0 to high of 100, where higher scores are better\]. Mean change in TIS was calculated by comparing the Baseline and post Baseline observations for patients in both KZR-616 treatment periods combined. Note: TIS scores for placebo treatment periods are presented in this outcome measure but were not included in the pri
Interventions
- DRUG Placebo
- DRUG KZR-616
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2020-01-14 |
| Est. Completion | 2022-04-06 |
| Phase | Phase 2 |
What the finished NCT04033926 record still lists
NCT04033926 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04033926 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04033926 about?
NCT04033926 is a clinical study titled "A Phase 2 Study of KZR-616 to Evaluate Safety and Efficacy in Patients With Active Polymyositis or Dermatomyositis". 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 eva...
What is the current status of trial NCT04033926?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2020-01-14. Estimated completion is 2022-04-06.
What interventions are being tested in trial NCT04033926?
The interventions under investigation include: Placebo (DRUG), KZR-616 (DRUG).
Who is sponsoring clinical trial NCT04033926?
This trial is sponsored by Kezar Life Sciences, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04033926's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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