Seralutinib for Pulmonary Arterial Hypertension

Recruiting at 48 trial locations

Overseen By GB002 Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: GB002, Inc.

Must be taking: Seralutinib

Disqualifiers: Severe medical abnormality, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 48 months or until market approval

300 Participants Needed

Trial Summary

What is the purpose of this trial?

This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Research Team

Richard Aranda, MD

Principal Investigator

Gossamer Bio Inc.

Eligibility Criteria

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.

Inclusion Criteria

I will use effective birth control during and for 30 days after the trial if I'm sexually active.

I am willing and able to follow the study's schedule and procedures.

Subjects must have completed a prior seralutinib PAH study on investigational product (IP) and in accordance with the protocol

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 medical monitor (MM) (or designee)

Have any other condition or reason that, in the opinion of the Investigator or in the opinion of the Sponsor's MM (or designee) in consultation with the Investigator, would prohibit the subject from participating in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive seralutinib inhaled orally twice per day (BID) until market approval or study termination

Up to 48 months or until market approval

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants continue to receive seralutinib to evaluate long-term safety and efficacy

Long-term

Treatment Details

Interventions

• Gereic Dry Powder Inhaler

Trial Overview 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.

Participant Groups

Group I: Seralutinib 90 mg Experimental Treatment 2 Interventions

Seralutinib inhaled orally twice per day (BID)

Who Is Running the Clinical Trial?

GB002, Inc.

Lead Sponsor

Trials

2

Recruited

650+