2023-506334-75-00RecruitingPhase 3
An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension (PAH)
GB002 Inc.64 sites in 15 countries128 target enrollmentStarted: June 18, 2024Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 128
- Locations
- 64
- Primary Endpoint
- Incidence of treatment-emergent adverse events (TEAEs)
Study Overview
Brief Summary
To evaluate the long-term safety and tolerability of seralutinib in subjects with PAH
Study Design
- Allocation
- Not Applicable
- Primary Purpose
- Phase 3 study
- Masking
- None
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- 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.
- •Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) at Enrollment visit before first administration of seralutinib. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required, and results must be negative.
- •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 seralutinib; acceptable methods include hormonal contraception (oral contraceptives – provided stable dose, patch, implant, or injection), intrauterine devices, or other form of highly effective contraception. Female subjects must refrain from egg donation throughout this period.
- •Women of nonchildbearing potential (WONCBP), classified by one of the following: a. Surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, tubal ligation, Falope® rings, clips, or bands; segmental destruction of the fallopian tubes with electrocoagulation; suture ligation, a microinsert such as the Essure® system, or hysterectomy). b. Evidence of post-menopausal status. Women will be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and have luteinizing hormone (LH), follicle stimulating hormone (FSH), and estradiol levels in the post-menopausal range at the Enrollment visit.
- •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 seralutinib. Male subjects must refrain from sperm donation throughout this period.
- •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. "
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 MM (or designee).
- •Have any other condition or reason that, in the opinion of the Investigator would prohibit the subject from participating in the study.
Outcomes
Primary Outcomes
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events (TEAEs)
Secondary Outcomes
- 1. Changes in distance achieved on the six-minute walk test (6MWT), (Δ6MWD)
- 2. Changes in NT-proBNP
Investigators
Conor O'Donovan
Scientific
GB002 Inc.
Study Sites (64)
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