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Tyrosine Kinase Inhibitor

GB002 (seralutinib) for Pulmonary Arterial Hypertension

Phase 2
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 24
Awards & highlights

Study Summary

This trial is testing a drug to see if it can improve lung function and exercise capacity in people with PAH.

Eligible Conditions
  • Pulmonary Arterial Hypertension

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline to Week 24 in Pulmonary Vascular Resistance (PVR)
Secondary outcome measures
Change From Baseline to Week 24 in Distance Achieved 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
9%
Nightmare
9%
Dyspnoea
7%
Nasopharyngitis
7%
Back pain
7%
Throat irritation
7%
Rash
7%
Nasal congestion
7%
Arthralgia
7%
Abdominal pain lower
7%
Chest discomfort
5%
Vomiting
2%
Staphylococcal bacteraemia
2%
Pulmonary arterial hypertension
2%
Pneumonia
2%
Upper respiratory tract infection
2%
Squamous cell carcinoma
2%
Pleural effusion
2%
Enteritis
2%
Appendicitis
2%
Lymphoma
2%
Right ventricular failure
2%
Device malfunction
2%
Haemoptysis
2%
Vascular device infection
2%
Jugular vein thrombosis
2%
Obstructive pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
GB002 (Seralutinib)
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: GB002 (seralutinib)Experimental Treatment2 Interventions
GB002 (seralutinib) inhaled orally twice per day (BID) for 24 weeks
Group II: PlaceboPlacebo Group2 Interventions
Placebo inhaled orally BID for 24 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GB002 (seralutinib)
2020
Completed Phase 2
~90
Generic Dry Powder Inhaler
2020
Completed Phase 2
~160

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
174 Total Patients Enrolled
2 Trials studying Pulmonary Arterial Hypertension
108 Patients Enrolled for Pulmonary Arterial Hypertension
Richard ArandaStudy DirectorGossamer Bio Inc.
1 Previous Clinical Trials
100 Total Patients Enrolled
1 Trials studying Pulmonary Arterial Hypertension
100 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.
Recent research and studies
clinicaltrials.govStudy
GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)
2020. "GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04456998.
~19 spots leftby Apr 2025
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