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Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)

NCT06274801 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2026-05-19

No results posted yet for this 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

Interventions

DRUG

Seralutinib

Capsule containing seralutinib

DEVICE

Gereic Dry Powder Inhaler

Generic dry powder inhaler for seralutinib delivery

Sponsors & Collaborators

  • GB002, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Aranda, MD · Gossamer Bio Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-03
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Ireland
  • Israel
  • Italy
  • Japan
  • Latvia
  • Lithuania
  • Mexico
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Saudi Arabia
  • Serbia
  • Singapore
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06274801 on ClinicalTrials.gov