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

Launched by GB002, INC. · Feb 15, 2024

Keywords

ClinConnect Summary

The PROSERA-EXT trial is a research study looking at the long-term effects of a medication called seralutinib for adults with Pulmonary Arterial Hypertension (PAH), a condition that affects the blood vessels in the lungs and can make it hard to breathe. This study is for people who have already participated in an earlier seralutinib study and will help researchers understand how safe and effective the medication is over a longer period.

To join this study, participants must have completed the previous seralutinib study and provide their consent. They should be willing to keep all scheduled appointments and follow the treatment plan. Eligible participants include both men and women, but women who can become pregnant need to take special precautions to avoid pregnancy during the study. Participants can expect regular check-ups and tests to monitor their health while using the medication. This trial is currently recruiting, so there is an opportunity for eligible individuals to take part in this important research.

Gender

ALL

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.