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NCT04816604 · ClinicalTrials.gov registry record · Phase 2

Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

A Phase 2 study of Pulmonary Arterial Hypertension, sponsored by GB002, Inc., a wholly owned subsidiary of Gossamer Bio.

Active
Registry status
Phase 2
Development phase
74
Enrollment target
20
Study locations

NCT04816604 is a Phase 2 study of Pulmonary Arterial Hypertension that is active but no longer recruiting, run by GB002, Inc., a wholly owned subsidiary of Gossamer Bio. The registered enrollment target is 74 participants, below the 461-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT04816604, a Phase 2 study of Pulmonary Arterial Hypertension, is active but no longer recruiting, sponsored by GB002, Inc., a wholly owned subsidiary of Gossamer Bio.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
74 participants
Enrollment target
20
Study locations

Study Summary

This open-label extension study will evaluate the long-term effects of GB002 (seralutinib) in subjects who previously participated in a GB002 PAH study.

Conditions Studied

Pulmonary Arterial Hypertension

Interventions

  • DRUG GB002 (seralutinib)
  • DEVICE Generic Dry Powder Inhaler

Study Locations (20)

New York

  • NYU Langone Health - New York
  • New York Presbyterian Hospital - Weill Cornell Medicine - New York
  • University of Rochester Medical Center - Rochester

Other

  • Všeobecná fakultní nemocnice v Praze - Prague
  • AP-HP Hôpital de Bicêtre - Le Kremlin-Bicêtre
  • DRK Kliniken Berlin - Berlin

California

  • University of California, Davis Medical Center - Sacramento
  • Medical Corporation - Santa Barbara

Florida

  • Mayo Clinic - Jacksonville
  • Cleveland Clinic Florida - Weston

Kansas

  • University of Kansas Medical Center - Kansas City

Kentucky

  • Norton Pulmonary Specialists - Louisville

Massachusetts

  • Tufts Medical Center - Boston

Nebraska

  • University of Nebraska Medical Center - Omaha

Trial Details

FieldValue
Enrollment Target 74 participants
Start Date 2021-04-05
Est. Completion 2027-12
Phase Phase 2

Sponsor

GB002, Inc., a wholly owned subsidiary of Gossamer Bio

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04816604

The ClinicalTrials.gov registry entry for NCT04816604 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 461-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (84% lower). The listed sponsor is GB002, Inc., a wholly owned subsidiary of Gossamer Bio, which has 4 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 GB002 (seralutinib) is the first listed.

NCT04816604 reports 20 study locations spanning 14 distinct geographic areas - top geographies include New York, Other, California.

Frequently Asked Questions

What is clinical trial NCT04816604 about?

NCT04816604 is a clinical study titled "Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)". This open-label extension study will evaluate the long-term effects of GB002 (seralutinib) in subjects who previously participated in a GB002 PAH study.

What is the current status of trial NCT04816604?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2021-04-05. Estimated completion is 2027-12.

What conditions does trial NCT04816604 study?

This clinical trial studies the following conditions: Pulmonary Arterial Hypertension.

What interventions are being tested in trial NCT04816604?

The interventions under investigation include: GB002 (seralutinib) (DRUG), Generic Dry Powder Inhaler (DEVICE).

Who is sponsoring clinical trial NCT04816604?

This trial is sponsored by GB002, Inc., a wholly owned subsidiary of Gossamer Bio, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04816604 being conducted?

This trial has 20 study locations across California, Florida, Kansas, Kentucky, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.