Long-term evaluation of seralutinib for pulmonary arterial hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Valley Advanced Lung Diseases Institute
  Fresno, California, United States Recruiting
• Department of Veterans Affairs Greater Los Angeles Healthcare System
  Los Angeles, California, United States Recruiting
• UC Davis Health Medical Center
  Sacramento, California, United States Recruiting
• Stanford Healthcare
  Stanford, California, United States Recruiting
• University of Florida Health
  Gainesville, Florida, United States Recruiting
• Mayo Clinic Jacksonville
  Jacksonville, Florida, United States Recruiting

+70 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: GB002 Inc.
• Email: ClinicalTrials@gossamerbio.com
• Phone: 1-866-668-4083

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Understanding how low-load leg exercises affect muscle and blood flow in PAH patients

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• Sotatercept in Japanese children with pulmonary arterial hypertension

  This study tests whether sotatercept is safe and well tolerated in Japanese children with PAH when added to standard PAH treatment.

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• DIAG723 in Adults With HHT

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  Recruiting at 3 sites Phase 1/2 Diagonal Therapeutics, Inc. · Camperdown, New South Wales and 10 other locations · NCT07623525

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  Recruiting Phase 3 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07613099

• Sotatercept in Indian adults with pulmonary arterial hypertension on standard therapy

  This study tests whether adding sotatercept to current PAH medicines is safe and tolerable for adults with PAH in India.

  Recruiting at 3 sites Phase 4 Merck Sharp & Dohme LLC · Hyderabad, Andhra Pradesh and 2 other locations · NCT07600723

• Once-daily treprostinil palmitil inhalation powder for PAH

  This study tests whether taking a daily inhaled treprostinil palmitil powder for 24 weeks improves exercise ability in adults with pulmonary arterial hypertension compared to a placebo.

  Recruiting at 39 sites Phase 3 Insmed Incorporated · Los Angeles, California and 38 other locations · NCT07481981

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.