NCT06274801 Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
| NCT ID | NCT06274801 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Gossamer Bio USA, Inc. |
| Condition | Pulmonary Arterial Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 330 participants |
| Start Date | 2024-09-03 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 330 participants in total. It began in 2024-09-03 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility 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.
Contact & Investigator
Richard Aranda, MD
STUDY DIRECTOR
Gossamer Bio USA, Inc.
Frequently Asked Questions
Who can join the NCT06274801 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pulmonary Arterial Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06274801 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 330 participants.
Is NCT06274801 currently recruiting?
Yes, NCT06274801 is actively recruiting participants. Contact the research team at ClinicalTrials@gossamerbio.com for enrollment information.
Where is the NCT06274801 trial being conducted?
This trial is being conducted at Fresno, United States, Los Angeles, United States, Sacramento, United States, Stanford, United States and 11 additional locations.
Who is sponsoring the NCT06274801 clinical trial?
NCT06274801 is sponsored by Gossamer Bio USA, Inc.. The principal investigator is Richard Aranda, MD at Gossamer Bio USA, Inc.. The trial plans to enroll 330 participants.