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Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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

An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension (PAH)

NCT06274801•GB002, Inc.

View on ClinicalTrials.gov

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

Detailed Description

The treatment period is planned to run until the market approval of seralutinib or until the study is terminated.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects must have completed a qualifying last visit in a prior seralutinib PAH study on investigational product (IP) and in accordance with the protocol.
•2. Evidence of an informed consent document, signed and dated by the subject, indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any subject-mandated procedures.
•3. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
•4. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at enrollment visit before first administration of Investigational Product (IP) in this study.
•5. WOCBP who are not abstinent and intend to be sexually active with a non-sterilized male partner must be willing to use a highly effective method of contraception from consent through 30 days following the last administration of IP.
•6. Male subjects: Non-sterilized male subjects who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom from consent through 90 days after the last dose of IP.

Exclusion Criteria

•1. Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or seralutinib administration, unless associated with an ongoing AE and discussed with the Sponsor's medical monitor (MM) (or designee).
•2. Have any other condition or reason that, in the opinion of the Investigator, would prohibit the subject from participating in the study.

Locations (115)

Valley Advanced Lung Diseases Institute

Fresno, California, United States

Department of Veterans Affairs Greater Los Angeles Healthcare System

Los Angeles, California, United States

UC Davis Health Medical Center

Sacramento, California, United States

Stanford Healthcare

Stanford, California, United States

University of Florida Health

Gainesville, Florida, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead

Atlanta, Georgia, United States

The Emory Clinic

Atlanta, Georgia, United States

Northside Hospital - Atlanta

Atlanta, Georgia, United States

UI Health Hospital

Chicago, Illinois, United States

Key Dates

Start Date

September 3, 2024

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

February 9, 2026

Enrollment

316

ACTUAL participants

Conditions

Pulmonary Arterial Hypertension

Interventions

Seralutinib

DRUG

Gereic Dry Powder Inhaler

DEVICE

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

NCT06649110

Healthy Volunteers, Pulmonary Arterial Hypertension

View study

RECRUITINGPHASE3

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

NCT07218029

Pulmonary Arterial Hypertension

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RECRUITINGPHASE1

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

COMPERA / COMPERA-KIDS

The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study

China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-right Heart Catheterization