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ACTIVE NOT RECRUITING Phase 2

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

NCT04816604 · View on ClinicalTrials.gov ↗

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.

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

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GB002, Inc., a wholly owned subsidiary of Gossamer Bio, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04816604 reports 20 study locations spanning 14 distinct geographic areas — top geographies include New York, Other, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04816604?

The interventions under investigation include: GB002 (seralutinib) (DRUG), Generic Dry Powder Inhaler (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04816604?

This trial is sponsored by GB002, Inc., a wholly owned subsidiary of Gossamer Bio, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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