Seralutinib for Pulmonary Arterial Hypertension

Recruiting at 122 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the long-term safety and effectiveness of seralutinib, an inhaled treatment for pulmonary arterial hypertension (PAH), a type of high blood pressure affecting the lungs. Participants will use an inhaler twice a day to evaluate the treatment's effectiveness over time. It suits those who have already participated in a previous seralutinib study for PAH. As a Phase 3 trial, this study is the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment for PAH.

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.

Is there any evidence suggesting that seralutinib is likely to be safe for humans?

Research has shown that seralutinib is generally safe for people. Previous studies found that patients tolerated inhaled seralutinib well. In one study, patients experienced a significant drop in lung blood flow resistance, indicating the treatment's effectiveness without serious side effects. Another study demonstrated a reduction in pressure in the heart's right lower chamber, again without major issues.

Moreover, long-term safety data support its use, as other studies have shown consistent results over time. This suggests seralutinib is not only effective but also safe for long-term use in patients with high blood pressure in the lungs. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for pulmonary arterial hypertension, which typically includes oral medications, injectable therapies, and intravenous infusions, Seralutinib is unique because it's delivered via a dry powder inhaler. This inhalation method targets the lungs directly, potentially enhancing the drug's effectiveness and minimizing systemic side effects. Researchers are excited about Seralutinib because it represents a novel approach by focusing on a distinct delivery system that could improve patient convenience and adherence to treatment.

What evidence suggests that seralutinib might be an effective treatment for pulmonary arterial hypertension?

Research has shown that seralutinib, which participants in this trial will receive, may help treat pulmonary arterial hypertension (PAH). In studies, patients taking seralutinib experienced a significant drop in pulmonary vascular resistance (PVR), indicating reduced effort by the heart to pump blood through the lungs. This suggests that seralutinib can improve heart function in people with PAH. It also lowered the pressure on the right side of the heart needed to push blood through the lungs. Additionally, seralutinib reduced levels of NT-proBNP, a marker indicating heart stress. These findings suggest that seralutinib could ease heart function and improve symptoms in PAH patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Richard Aranda, MD

Principal Investigator

Gossamer Bio Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38705167/

Seralutinib in adults with pulmonary arterial hypertension ... Treatment with inhaled seralutinib significantly decreased PVR, meeting the primary endpoint of the study among patients receiving background therapy for PAH.

2. gossamerbio.com gossamerbio.com/wp-content/uploads/2024/08/Poster-233.pdf

Phase 2 Clinical Study to Evaluate the Efficacy and Safety ... Seralutinib treatment led to significant reduction in right ventricular systolic pressure, data shown as mean ± SEM (A), reduced circulating levels of NT-proBNP ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9724289/

Inhaled seralutinib exhibits potent efficacy in models of ... Inhaled seralutinib was an effective treatment of severe PAH in two animal models, with improved cardiopulmonary haemodynamic parameters, a reduction in NT- ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05934526

NCT05934526 | Efficacy and Safety of Seralutinib in Adult ... 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 ...

5. thelancet.com thelancet.com/journals/lanres/article/PIIS2213-2600(24)00072-9/abstract

Seralutinib in adults with pulmonary arterial hypertension ... Treatment with inhaled seralutinib significantly decreased PVR, meeting the primary endpoint of the study among patients receiving background ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12474731/

Seralutinib for the Treatment of Pulmonary Arterial ... These OLE data are consistent with TORREY results and support long-term safety and efficacy of inhaled seralutinib in patients with PAH. A ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07181382

NCT07181382 | Efficacy and Safety of Seralutinib in Adult ... Efficacy and Safety of Seralutinib in Adult Subjects With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) (SERANATA).