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Seralutinib 90 mg for Pulmonary Arterial Hypertension

Phase 3

Waitlist Available

Research Sponsored by GB002, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product)

Awards & highlights

Study Summary

This trial will assess the safety, side effects, and effectiveness of inhaled seralutinib over a long period of time in participants who have already finished a previous seralutinib study

Who is the study for?

This trial is for adults who have completed a previous study with seralutinib and are living with Pulmonary Arterial Hypertension (PAH), a type of high blood pressure that affects the arteries in the lungs. Specific eligibility details aren't provided, but typically participants must meet certain health standards.Check my eligibility

What is being tested?

The trial is testing the long-term safety and effectiveness of an orally inhaled drug called seralutinib, using a device known as Gereic Dry Powder Inhaler. It's an open-label extension, meaning everyone knows they're getting seralutinib and not a placebo.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones for PAH medications can include cough, headache, dizziness, nausea, fatigue or irritation at the inhalation site. Long-term effects will be particularly monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a man who will use a condom if I have sex with a woman who can get pregnant, from now until 90 days after my last treatment dose.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of treatment-emergent adverse events (TEAEs)

Secondary outcome measures

Changes in NT-proBNP

Changes in distance achieved on the Six-Minute Walk Test (6MWT)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Seralutinib 90 mgExperimental Treatment2 Interventions

Seralutinib inhaled orally twice per day (BID)

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

GB002, Inc.Lead Sponsor

1 Previous Clinical Trials

350 Total Patients Enrolled

1 Trials studying Pulmonary Arterial Hypertension

350 Patients Enrolled for Pulmonary Arterial Hypertension

Richard Aranda, MDStudy DirectorGossamer Bio Inc.

1 Previous Clinical Trials

350 Total Patients Enrolled

1 Trials studying Pulmonary Arterial Hypertension

350 Patients Enrolled for Pulmonary Arterial Hypertension

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it feasible for me to participate in this clinical trial?

"Candidates aged between 18 and 75 with a confirmed diagnosis of pulmonary arterial hypertension are eligible for participation in this clinical trial, which aims to enroll approximately 300 individuals."

Answered by AI

Are researchers currently seeking participants for this study?

"As per clinicaltrials.gov, this particular research endeavor is not actively seeking participants. Its initial posting was on June 1st, 2024, with the most recent update made on February 15th of the same year. Although enrollment is currently closed for this study, it's worth noting that there are 740 alternate trials actively pursuing candidates at present."

Answered by AI

Is there an age limit for participation in this study, particularly regarding individuals under 35 years old?

"To be eligible for participation in this study, potential subjects must have reached the age of consent but not exceed 75 years old."

Answered by AI

What risks are associated with the administration of Seralutinib 90 mg to individuals?

"Our evaluation at Power assigns a safety rating of 3 to the administration of Seralutinib 90 mg in this Phase 3 trial. This decision is based on existing evidence demonstrating effectiveness, as well as extensive safety data collected throughout various phases of testing."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)

2024. "Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06274801.

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