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NCT04419558 · ClinicalTrials.gov registry record · Phase 3
Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 3 study, sponsored by Kyntra Bio.
- Terminated
- Registry status
- Phase 3
- Development phase
- 372
- Enrollment target
NCT04419558: Clinical Trial Phase 3 study, sponsored by Kyntra Bio.
NCT04419558 is a Phase 3 study that was terminated before completion, run by Kyntra Bio. The registered enrollment target is 372 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04419558, a Phase 3 study, was terminated before completion, sponsored by Kyntra Bio.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 372 participants
- Enrollment target
Study Summary
This is a Phase 3 trial to evaluate the efficacy and safety of 30 milligrams (mg)/kilogram (kg) intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). There is a 48-week randomized treatment phase followed by an optional, open-label extension phase.
Primary Outcome
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Least square (LS) mean and standard error (SE) were analyzed using mixed model repeated measures (MMRM).
Interventions
- DRUG Placebo
- DRUG Pamrevlumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 372 participants |
| Start Date | 2020-09-30 |
| Est. Completion | 2023-09-04 |
| Phase | Phase 3 |
Why NCT04419558 stopped before completion
NCT04419558 is an interventional study that assigns participants to a tested intervention. The registered 372 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04419558 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04419558 about?
NCT04419558 is a clinical study titled "Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)". This is a Phase 3 trial to evaluate the efficacy and safety of 30 milligrams (mg)/kilogram (kg) intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). There is a 48-week randomized treatment phase followed...
What is the current status of trial NCT04419558?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 372 participants. The study started on 2020-09-30. Estimated completion is 2023-09-04.
What interventions are being tested in trial NCT04419558?
The interventions under investigation include: Placebo (DRUG), Pamrevlumab (DRUG).
Who is sponsoring clinical trial NCT04419558?
This trial is sponsored by Kyntra Bio, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04419558's enrollment target sits among peer trials
372 991st of 2000 higher than 1,009 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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