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

UCI Specialty Area: Pulmonology

Principal Investigator: Bassam Yaghmour

Official Title: A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Arterial Hypertension (PAH)

A Study On:

Lung - Pulmonary

Study Description

Eligibility

Adult subjects aged 18 to 75 years.
Body mass index (BMI) greater than or equal to 17 kg/m2 and less than or equal to 40 kg/m2.
Diagnosis of PAH classified by one of the following:

3a. Idiopathic PAH (IPAH) or heritable PAH (HPAH).

3b. PAH associated with connective tissue disease (CTD-APAH); PAH associated with anorexigen or PAH associated with methamphetamine use.

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

6MWDs greater than or equal to 150 meters and less than or equal to 450 meters at Screening.
WHO FC II or III.
US Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) Lite 2 Risk Score greater than or equal to 5 OR NT-proBNP greater than or equal to 300 ng/L.
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.

7a. Mean pulmonary arterial pressure (mPAP) > 20 mmHg (at rest), AND

7b. Pulmonary vascular resistance (PVR) greater than or equal to 400 dyne-s/cm5, AND

7c. Pulmonary capillary wedge pressure (PCWP) or left ventricle end-diastolic pressure (LVEDP) less than or equal to 12 mmHg if PVR ≥ 400 to < 500 dyne-s/cm5 OR PCWP or LVEDP less than or equal to 15 mmHg if PVR greater than or equal to 500 dyne-s/cm5.

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.
Pulmonary function tests (PFTs) at Screening or completed no more than 12 weeks prior to Screening.
Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and on Day 1 before first administration of Investigational Product (IP).
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.
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.

Evidence of chronic thromboembolic disease or acute pulmonary embolism.
Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure > 160 mm Hg or sitting diastolic blood pressure > 100 mm Hg.
Systolic blood pressure < 90 mm Hg during Screening.
WHO Pulmonary Hypertension Group 2 - 5.

Other Protocol defined inclusion/ exclusion criteria may apply.

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

Please read the information below and ask questions about anything that you do not understand. A
researcher listed above will be available to answer your questions.

You are being asked to participate in a clinical research potential participant database to identify
potential clinical research studies you may be eligible for. Participation in this database is voluntary.
You may choose to skip any question. You may refuse to participate or discontinue your involvement
at any time without penalty or loss of benefits. You are free to withdraw from this database at any
time. If you decide to withdraw from this database you should notify the research team
immediately.

You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health

We would like to interview you to learn more about your eligibility for current clinical research studies at UCI. The interview will last about 5-30 minutes, depending on the extent of your medical history.

Possible risks/discomforts associated with the database are hearing about potential clinical research studies that may not be of interest to you, invasion of your privacy, or a potential breach of confidentiality.

There are no direct benefits from participation in the database. However, this database may help inform you on clinical research studies that you may be eligible for. Participation in UCI clinical research studies help us gain important data and knowledge that may lead to improved treatment options for people with similar conditions to you in the future.

There are no alternative procedures available. The only alternative is not to participate in this study.

There is no compensation for your participation in this database.

There is no cost to you for participation in this database.

All information collected will be stored confidentially in a world-class securely-hosted application, “RealTime CTMS,” with robust data protections and encryption. This application has HIPAA compliant architecture and application rules to ensure data privacy and regulatory compliance.

Researchers will use your information to assess your eligibility for current and future clinical research studies at UCI. You may opt out at any time.

The research team, authorized UCI personnel, and regulatory entities, may have access to your study records to protect your safety and welfare.

While the research team will make every effort to keep your personal information confidential, it is possible that an unauthorized person might see it. We cannot guarantee total privacy.

Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information

Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.

If, during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the research team listed at the top of the form.

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Please contact the UCI Institutional Review Board by phone, (949) 824-8170, by e-mail at IRB@research.uci.edu or at 160 Aldrich Hall, Irvine, CA 92697-7600 if you are unable to reach the researchers listed at the top of the form and have general questions; have concerns or complaints about the research; have questions about your rights as a research subject; or have general comments or suggestions.

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