ClinicaliQ Trial Snapshot
- Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT) — Recruiting • Phase III • Respiratory / COPD / Asthma • NCT06274801.
- What is being tested: Long-term safety, tolerability, and efficacy of seralutinib, an orally inhaled therapeutic agent, in patients with pulmonary arterial hypertension (PAH) who have completed a preceding seralutinib trial.
- Patient eligibility overview: Adult subjects with PAH who have successfully completed a previous seralutinib clinical study and meet the open-label extension criteria are eligible to participate in this continuation study.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.