CompletedPhase 3

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

United States, Argentina, Australia390 participantsStarted 2023-12-28

Plain-language summary

The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary objective for this trial is to determine time to clinical worsening.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adult subjects aged 18 to 75 years.
. Body mass index (BMI) ≥ 15 kg/m\^2 and ≤ 40 kg/m\^2.
. Diagnosis of PAH classified by one of the following:
. Idiopathic PAH (IPAH) or heritable PAH (HPAH).
. PAH associated with connective tissue disease (CTD-APAH); PAH associated with anorexigen or PAH associated with methamphetamine use.
. Congenital heart disease with simple systemic to pulmonary shunt at least 1 year after surgical repair.
. 6MWDs ≥ 150 meters and ≤ 475 meters during Screening prior to randomization.
. WHO FC II or III.

Exclusion criteria

. Evidence of chronic thromboembolic disease or acute pulmonary embolism.
. Uncontrolled systemic hypertension as evidenced by systolic blood pressure \> 160 mm Hg or diastolic blood pressure \> 100 mm Hg.
. Systolic blood pressure \< 90 mm Hg during Screening.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in distance achieved on the six-minute walk test (6MWT), six-minute walk distance (Δ6MWD) from baseline to Week 24

Timeframe: Baseline to 24 weeks

Trial details

NCT IDNCT05934526

SponsorGB002, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-27

View on ClinicalTrials.gov More Pulmonary Arterial Hypertension trials