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Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)

Does the drug Seralutinib improve the exercise capacity of people with Pulmonary Arterial Hypertension (PAH)?

Lead Researcher: R White

Seralutinib is an inhaled medication for PAH. Participants with PAH age 18-75 and a BMI of 17-40 may be eligible to participate. Participants will be randomized to either placebo or drug. The duration of the study is up to a maximum of 48 weeks.

Eligibility:

Inclusion Criteria:

          1. Adult subjects aged 18 to 75 years.

          2. Body mass index (BMI) ≥ 17 kg/m^2 and ≤ 40 kg/m^2.

          3. Diagnosis of PAH classified by one of the following:

               1. Idiopathic PAH (IPAH) or heritable PAH (HPAH).

               2. PAH associated with connective tissue disease (CTD-APAH); PAH associated with
                  anorexigen or PAH associated with methamphetamine use.

               3. Congenital heart disease with simple systemic to pulmonary shunt at least 1 year
                  after surgical repair.

          4. 6MWDs ≥ 150 meters and ≤ 450 meters at Screening.

          5. WHO FC II or III.

          6. US Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) Lite 2
             Risk Score ≥ 5 OR NT-proBNP ≥ 300 ng/L.

          7. Cardiac catheterization within the screening period, or a standard of care right heart
             catheterization (RHC) (with pressure wave forms available for review) up to 24 weeks
             prior to Screening.

               1. Mean pulmonary arterial pressure (mPAP) > 20 mmHg (at rest), AND

               2. Pulmonary vascular resistance (PVR) ≥ 400 dyne·s/cm^5, AND

               3. Pulmonary capillary wedge pressure (PCWP) or left ventricle end-diastolic
                  pressure (LVEDP) ≤ 12 mmHg if PVR ≥ 400 to < 500 dyne·s/cm^5 OR PCWP or LVEDP ≤
                  15 mmHg if PVR ≥ 500 dyne·s/cm^5.

          8. Treatment with at least one allowed background PAH disease-specific medication prior
             to Screening, and on stable regimen and doses for at least 12 weeks.

          9. Pulmonary function tests (PFTs) at Screening or completed no more than 12 weeks prior
             to Screening.

         10. Women of childbearing potential (WOCBP) must have a negative pregnancy test at
             Screening and on Day 1 before first administration of Investigational Product (IP).

         11. 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.

         12. 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.

        

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