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NCT06274801 · ClinicalTrials.gov registry record · Phase 3
Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
A Phase 3 study of Pulmonary Arterial Hypertension, sponsored by GB002.
- Active
- Registry status
- Phase 3
- Development phase
- 316
- Enrollment target
- 20
- Study locations
NCT06274801 is a Phase 3 study of Pulmonary Arterial Hypertension that is active but no longer recruiting, run by GB002. The registered enrollment target is 316 participants, below the 457-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT06274801, a Phase 3 study of Pulmonary Arterial Hypertension, is active but no longer recruiting, sponsored by GB002.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 316 participants
- Enrollment target
- 20
- Study locations
Study Summary
This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study
Conditions Studied
Interventions
- DRUG Seralutinib
- DEVICE Gereic Dry Powder Inhaler
Study Locations (20)
California
- Valley Advanced Lung Diseases Institute - Fresno
- Department of Veterans Affairs Greater Los Angeles Healthcare System - Los Angeles
- UC Davis Health Medical Center - Sacramento
- Stanford Healthcare - Stanford
Georgia
- Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead - Atlanta
- The Emory Clinic - Atlanta
- Northside Hospital - Atlanta - Atlanta
Florida
- University of Florida Health - Gainesville
- Mayo Clinic Jacksonville - Jacksonville
New York
- NYU Langone Health - New York
- University of Rochester Medical Center - Rochester
Illinois
- UI Health Hospital - Chicago
Kansas
- University of Kansas Medical Center - Kansas City
Kentucky
- Norton Pulmonary Specialists - Louisville
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 316 participants |
| Start Date | 2024-09-03 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06274801
The ClinicalTrials.gov registry entry for NCT06274801 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 316 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 457-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (31% lower). The listed sponsor is GB002, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pulmonary Arterial Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Seralutinib is the first listed.
NCT06274801 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Georgia, Florida.
Frequently Asked Questions
What is clinical trial NCT06274801 about?
NCT06274801 is a clinical study titled "Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)". This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study
What is the current status of trial NCT06274801?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 316 participants. The study started on 2024-09-03. Estimated completion is 2026-12.
What conditions does trial NCT06274801 study?
This clinical trial studies the following conditions: Pulmonary Arterial Hypertension.
What interventions are being tested in trial NCT06274801?
The interventions under investigation include: Seralutinib (DRUG), Gereic Dry Powder Inhaler (DEVICE).
Who is sponsoring clinical trial NCT06274801?
This trial is sponsored by GB002, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06274801 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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