Clinical trial for Pulmonary Arterial Hypertension
Official title Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
ClinicalTrials.gov ID: NCT06274801
What this study is testing
What is Seralutinib?
Seralutinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for pulmonary arterial hypertension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- people must have completed a qualifying last visit in a prior seralutinib PAH study on investigational product (IP) and in accordance with the...
- Evidence of an informed consent document, signed and dated by the subject, indicating that the subject has been informed of all pertinent aspects of...
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at enrollment visit before first administration of...
- 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...
You likely can't join if
- Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or seralutinib...
- Have any other condition or reason that, in the opinion of the Investigator, would prohibit the subject from participating in the study.
See the full eligibility criteria
- people must have completed a qualifying last visit in a prior seralutinib PAH study on investigational product (IP) and in accordance with the protocol.
- 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.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- 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.
- 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...
- Male people: Non-sterilized male people 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...
- 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...
- Have any other condition or reason that, in the opinion of the Investigator, would prohibit the subject from participating in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Fresno, California, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- Stanford, California, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Kansas City, Kansas, United States
- Louisville, Kentucky, United States
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Albuquerque, New Mexico, United States
- New York, New York, United States
- Rochester, New York, United States
- Chapel Hill, North Carolina, United States
- Cincinnati, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Philadelphia, Pennsylvania, United States
+ 84 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fresno, California, United States; Los Angeles, California, United States; Sacramento, California, United States; Stanford, California, United States; Gainesville, Florida, United States; Jacksonville, Florida, United States and 98 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.