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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 is a Phase 2 study that has completed, run by Kezar Life Sciences. The registered enrollment target is 25 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04033926
The ClinicalTrials.gov registry entry for NCT04033926 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kezar Life Sciences, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04033926 reports 0 study locations.
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.
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