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NCT04628936 · ClinicalTrials.gov registry record · Phase 2
Open-label Extension to the Phase 2 Crossover Study (PRESIDIO) Evaluating KZR-616 in Patients With PM and DM.
A Phase 2 study, sponsored by Kezar Life Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT04628936: Completed Phase 2 study, sponsored by Kezar Life Sciences.
NCT04628936 is a Phase 2 study that has completed, run by Kezar Life Sciences. The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04628936, a Phase 2 study, has completed, sponsored by Kezar Life Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study 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.
Primary Outcome
The mean Total Improvement Score (TIS) at OLE Week 48, which ranges from 0 to 100 \[low of 0 to high of 100, where higher scores are better\]. The timeframe of 48 weeks was selected because it represented the maximum timeframe of dosing for the last patient enrolled as the study drug administration ended when the last patient enrolled completed 48 weeks of dosing.
Interventions
- DRUG KZR-616
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2020-11-04 |
| Est. Completion | 2023-06-12 |
| Phase | Phase 2 |
What the finished NCT04628936 record still lists
NCT04628936 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which KZR-616 is the first listed.
NCT04628936 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04628936 about?
NCT04628936 is a clinical study titled "Open-label Extension to the Phase 2 Crossover Study (PRESIDIO) Evaluating KZR-616 in Patients With PM and DM.". 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 K...
What is the current status of trial NCT04628936?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2020-11-04. Estimated completion is 2023-06-12.
What interventions are being tested in trial NCT04628936?
The interventions under investigation include: KZR-616 (DRUG).
Who is sponsoring clinical trial NCT04628936?
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 NCT04628936's enrollment target sits among peer trials
18 1898th of 2000 higher than 98 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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