Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
Purpose
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
Condition
- Pulmonary Arterial Hypertension
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Subjects must have completed 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 or his/her legal representative, 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 pregnancy test at Screening and on Day 1 before first administration of Investigational Product (IP). 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
- 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 or in the opinion of the Sponsor's MM (or designee) in consultation with the Investigator, would prohibit the subject from participating in the study.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Seralutinib 90 mg |
Seralutinib inhaled orally twice per day (BID) |
|
Recruiting Locations
University of Kansas Medical Center
Kansas City, Kansas 66160
Kansas City, Kansas 66160
More Details
- Status
- Recruiting
- Sponsor
- GB002, Inc.
Detailed Description
The treatment period is planned to run until the market approval of seralutinib or until the study is terminated.