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Tyrosine Kinase Inhibitor

GB002 for Pulmonary Arterial Hypertension

Phase 2

Recruiting

Research Sponsored by GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

Eligibility Criteria Checklist

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

Must have

Treatment with standard of care PAH disease-specific background therapies (stable dose).

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, up to 80 months or availability of commercial product

Awards & highlights

Study Summary

This trial will study the long-term effects of a drug called GB002 in people who have previously taken it for PAH.

Who is the study for?

This trial is for adults who've completed a previous GB002 study for Pulmonary Arterial Hypertension (PAH) and were compliant. They must be on stable PAH medications, not have life-threatening heart issues, severe hypertension or hypotension, new left-sided heart disease, substance abuse problems, certain blood disorders or infections. They can't use inhaled tobacco/marijuana but may use ingestible/topical marijuana.Check my eligibility

What is being tested?

The trial tests the long-term effects of an inhaler drug called GB002 (seralutinib) in patients with PAH who participated in earlier GB002 studies. It's an open-label extension which means everyone knows they're getting the actual drug and there's no placebo.See study design

What are the potential side effects?

While specific side effects of GB002 are not listed here, common ones for PAH treatments include breathlessness, headache, dizziness, nausea and potential risks to liver function. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am on a stable dose of standard treatment for PAH.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, up to 80 months or availability of commercial product

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, up to 80 months or availability of commercial product

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to 80 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

Number of Participants With Treatment Emergent Adverse Events

Secondary outcome measures

Change from Baseline Over Time on the Six-Minute Walk Test (6MWT)

Side effects data

From 2022 Phase 2 trial • 86 Patients • NCT04456998

43%

Cough

14%

Diarrhoea

14%

COVID-19

14%

Headache

11%

Fatigue

11%

Dizziness

11%

Nausea

Nightmare

Dyspnoea

Nasopharyngitis

Back pain

Throat irritation

Rash

Nasal congestion

Arthralgia

Abdominal pain lower

Chest discomfort

Vomiting

Staphylococcal bacteraemia

Pulmonary arterial hypertension

Pneumonia

Upper respiratory tract infection

Squamous cell carcinoma

Pleural effusion

Enteritis

Appendicitis

Lymphoma

Right ventricular failure

Device malfunction

Haemoptysis

Vascular device infection

Jugular vein thrombosis

Obstructive pancreatitis

100%

80%

60%

40%

20%

Study treatment Arm

GB002 (Seralutinib)

Placebo

Trial Design

1Treatment groups

Experimental Treatment

Group I: GB002 (seralutinib)Experimental Treatment2 Interventions

GB002 (seralutinib) inhaled orally twice per day (BID)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Generic Dry Powder Inhaler

2020

Completed Phase 2

~160

GB002 (seralutinib)

2020

Completed Phase 2

~90

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.Lead Sponsor

3 Previous Clinical Trials

160 Total Patients Enrolled

2 Trials studying Pulmonary Arterial Hypertension

94 Patients Enrolled for Pulmonary Arterial Hypertension

Richard ArandaStudy DirectorGossamer Bio Inc.

1 Previous Clinical Trials

86 Total Patients Enrolled

1 Trials studying Pulmonary Arterial Hypertension

86 Patients Enrolled for Pulmonary Arterial Hypertension

Media Library

GB002 (seralutinib) (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04816604 — Phase 2

Pulmonary Arterial Hypertension Research Study Groups: GB002 (seralutinib)

Pulmonary Arterial Hypertension Clinical Trial 2023: GB002 (seralutinib) Highlights & Side Effects. Trial Name: NCT04816604 — Phase 2

GB002 (seralutinib) (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04816604 — Phase 2

Frequently Asked Questions

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

Does this study include middle-aged or elderly participants?

"This particular clinical trial is seeking patients aged 18 to 80. In contrast, there are other ongoing medical trials that focus on those under the age of 18 (56 in total) and another 696 for patients over 65 years old."

Answered by AI

How many test subjects are enrolled in this clinical trial?

"100 patients that meet the required inclusion criteria will be involved in this sponsored trial. GB002, Inc., a subsidiary of Gossamer Bio, Inc., is organising the study from multiple locations; two notable sites are NYU Langone Health located in New york City and The Ohio State University Wexner Medical Center situated in Columbus, Ohio."

Answered by AI

Are there a lot of these kinds of trials happening in metropolitan areas?

"There are 17 sites that are participating in this trial, which include NYU Langone Health in New york, The Ohio State University Wexner Medical Center in Columbus, and Stanford Health Care in Stanford."

Answered by AI

Has GB002 (seralutinib) received FDA authorization?

"GB002 (seralutinib) is still being tested for efficacy in clinical trials, however there is some data that suggests it is safe. Our team at Power gave it a safety rating of 2."

Answered by AI

Are there any available openings for volunteers in this experiment?

"This clinical trial is actively looking for candidates. The clinical trial was initially posted on 4/5/2021 and was last edited on 10/14/2022."

Answered by AI

What are the requirements for participants in this trial?

"This clinical trial is recruiting 100 participants with pulmonary arterial hypertension. Applicants must be aged 18 and 80, and must meet the following criteria: Type of Subject and Disease Characteristics, Informed Consent, Review and signature of an IRB-approved informed consent form., Treatment with standard of care PAH disease-specific background therapies (stable dose). Subjects must have completed a prior GB002 PAH study and, in the opinion of the Investigator and Sponsor, have been compliant with study procedures and have completed treatment with IP through parent study end-of-treatment (EOT) visit."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

2021. "Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04816604.

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