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Long-term evaluation of seralutinib for pulmonary arterial hypertension

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

Phase 3 Interventional Gossamer Bio Inc. · NCT06274801

This study is testing how well and safely a new inhaled medication called seralutinib works for adults with pulmonary arterial hypertension who have already tried it before.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorGossamer Bio Inc. Industry-sponsored
Drugs / interventionsseralutinib
Locations53 sites (Los Angeles, California and 52 other locations)
Trial IDNCT06274801 on ClinicalTrials.gov

What this trial studies

This open-label extension study aims to assess the long-term safety, tolerability, and efficacy of orally inhaled seralutinib in adults who have previously participated in a seralutinib study. Participants will continue receiving the treatment until seralutinib receives market approval or the study is terminated. The study focuses on individuals with pulmonary arterial hypertension (PAH) to gather additional data on the medication's performance over an extended period.

Who should consider this trial

Good fit: Ideal candidates are adults who have completed a prior seralutinib study and meet the eligibility criteria.

Not a fit: Patients who have not participated in previous seralutinib studies or do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term management of pulmonary arterial hypertension with seralutinib.

How similar studies have performed: Other studies involving seralutinib have shown promise, indicating potential for success in this extension study.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Los Angeles, California and 52 other locations

+3 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pulmonary Arterial HypertensionseralutinibGB002PROSERAPROSERA-EXT
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.