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

NCT05934526 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2026-05-19

No results posted yet for this 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.

Conditions

Interventions

DRUG

Placebo

Matching capsule containing placebo

DRUG

Seralutinib

Capsule containing seralutinib

DEVICE

Generic Dry Powder Inhaler

Generic dry powder inhaler for seralutinib or placebo delivery

Sponsors & Collaborators

  • GB002, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Aranda, MD · Gossamer Bio Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-12-28
Primary Completion
2025-11-27
Completion
2025-12-22
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • 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 NCT05934526 on ClinicalTrials.gov