RightFit
RecruitingPhase 3

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

An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension (PAH)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the long-term safety of seralutinib, how well people handle it, and how well it works. Seralutinib is breathed in through the mouth. The study is for adults with pulmonary arterial hypertension (PAH), or high blood pressure in the arteries of the lungs, who completed a prior seralutinib study.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Completed the required final visit in a prior seralutinib PAH study while taking the study drug and following that study’s rules.
  • Signed and dated a consent form after learning about the study and before any required study procedures.
  • Willing and able to follow the visit schedule, treatment plan, lab tests, and other study steps.
  • Women who can become pregnant must have a negative pregnancy test at enrollment, before their first study dose.
  • Women who can become pregnant and plan to have sex with a man who has not been sterilized must use highly effective birth control from signing consent until 30 days after the last dose.
  • Men who have not been sterilized and plan to have sex with a woman who can become pregnant must use condoms from signing consent until 90 days after the last dose.

Who can't join

  • A severe short-term or long-term health problem or abnormal lab result that could make the study or drug unsafe. An exception may apply if it is linked to an ongoing health issue reported during the study and discussed with the sponsor’s medical reviewer.
  • Any other condition or reason that the study doctor believes would prevent taking part.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (33)

CA

FL

GA

IL

KS

KY

MI

MO

NC

NE

NM

NY

OH

OK

PA

SC

TX

UT

VA