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NCT05934526 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)

A Phase 3 study, sponsored by GB002.

Completed
Registry status
Phase 3
Development phase
390
Enrollment target

NCT05934526 is a Phase 3 study that has completed, run by GB002. The registered enrollment target is 390 participants.

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The verdict

NCT05934526, a Phase 3 study, has completed, sponsored by GB002.

COMPLETED
Registry status
Phase 3
Development phase
390 participants
Enrollment target

Study Summary

The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary objective for this trial is to determine time to clinical worsening.

Interventions

  • DRUG Placebo
  • DEVICE Generic Dry Powder Inhaler
  • DRUG Seralutinib

Trial Details

FieldValue
Enrollment Target 390 participants
Start Date 2023-12-28
Est. Completion 2025-12-22
Phase Phase 3

Sponsor

GB002

2 total trials

What the Registry Record Tells You About NCT05934526

The ClinicalTrials.gov registry entry for NCT05934526 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 390 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GB002, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT05934526 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05934526 about?

NCT05934526 is a clinical study titled "Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)". The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary objective for this trial is to determine time to clinical worsening.

What is the current status of trial NCT05934526?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 390 participants. The study started on 2023-12-28. Estimated completion is 2025-12-22.

What interventions are being tested in trial NCT05934526?

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

Who is sponsoring clinical trial NCT05934526?

This trial is sponsored by GB002, which has 2 total clinical trials registered on ClinicalTrials.gov.

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.