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Kinase Inhibitor
Seralutinib for Pulmonary Arterial Hypertension
Phase 3
Recruiting
Research Sponsored by GB002, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult subjects aged 18 to 75 years
Diagnosis of PAH classified by one of the following: Idiopathic PAH (IPAH) or heritable PAH (HPAH), PAH associated with connective tissue disease (CTD-APAH) or anorexigen or methamphetamine use, Congenital heart disease with simple systemic to pulmonary shunt at least 1 year after surgical repair
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 52 weeks
Awards & highlights
Study Summary
This trial will study if a drug can help improve exercise capacity and delay worsening in people with PAH.
Who is the study for?
Adults aged 18-75 with Pulmonary Arterial Hypertension (PAH) who can walk between 150 and 450 meters in a six-minute test. They must have been on stable PAH medication for at least three months, have specific heart catheterization results, and not be pregnant or nursing. Participants need to use effective contraception if of childbearing potential.Check my eligibility
What is being tested?
The trial is testing Seralutinib's effectiveness in improving exercise capacity for those with WHO Group 1 PAH who are classified as Functional Class II or III. It involves comparing Seralutinib against a placebo using a generic dry powder inhaler to see which is better at preventing clinical worsening.See study design
What are the potential side effects?
While the side effects of Seralutinib are not detailed here, common side effects from similar treatments include breathlessness, headache, dizziness, nausea, diarrhea, rash and fatigue. The severity varies among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
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My PAH is due to genetics, connective tissue disease, drug use, or heart defect repair.
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.
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I have been on a stable PAH medication for at least 12 weeks.
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I can walk between 150 and 450 meters without stopping.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in distance achieved on the six-minute walk test (6MWT), six-minute walk distance (Δ6MWD) from baseline to Week 24
Secondary outcome measures
Change in Euro-QoL - 5 Dimensions - 5 Levels (EQ-5D-5L) from baseline to Week 24
Change in NT-proBNP from baseline to Week 24
Change in PAH-SYMPACT™ from baseline to Week 24
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Seralutinib 90 mgExperimental Treatment2 Interventions
Seralutinib inhaled orally BID up to 48 weeks
Group II: PlaceboPlacebo Group2 Interventions
Placebo inhaled orally twice daily (BID) up to 48 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Generic Dry Powder Inhaler
2020
Completed Phase 2
~160
Find a Location
Who is running the clinical trial?
GB002, Inc.Lead Sponsor
1 Previous Clinical Trials
300 Total Patients Enrolled
1 Trials studying Pulmonary Arterial Hypertension
300 Patients Enrolled for Pulmonary Arterial Hypertension
Richard Aranda, MDStudy DirectorGossamer Bio Inc.
1 Previous Clinical Trials
300 Total Patients Enrolled
1 Trials studying Pulmonary Arterial Hypertension
300 Patients Enrolled for Pulmonary Arterial Hypertension
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have needed strong heart or fluid medication through an IV for more than a day in the last month.Your blood pressure is too high and not well controlled.Your heart and lung pressures are higher than normal at rest.You need to have had a lung function test within the last 12 weeks or have one during the screening.You have a severe medical condition that could make participating in the study risky, such as a history of repeated fainting or bleeding inside the skull.My body weight is less than 40 kg.I am between 18 and 75 years old.My PAH is due to genetics, connective tissue disease, drug use, or heart defect repair.You have a problem with drinking too much alcohol or have tested positive for illegal drugs.I will use effective birth control during and for 30 days after the trial if I'm sexually active.I am taking blood thinners and have had serious bleeding or other listed issues.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.My PAH is related to HIV, schistosomiasis, portal hypertension, or POVD.I have had heart disease or significant heart issues in the last year.I don't have any conditions that would affect my ability to perform a walking test.My kidney function is low and my blood count is below normal.I had a heart catheter test recently or within the last 24 weeks.I have a serious heart valve problem.I have previously participated in studies or been treated with seralutinib.I currently use inhaled tobacco, nicotine products, or marijuana.I haven't taken any tyrosine kinase inhibitors in the last 12 weeks.I have severe sleep apnea that hasn't been treated.You have had a serious allergy to milk protein or have trouble digesting lactose.You have a World Health Organization Functional Class (WHO FC) of II or III.My condition is classified under WHO Pulmonary Hypertension Groups 2 to 5.I have irregular heartbeats that doctors haven't been able to control.I have had blood clots in my lungs.My liver function is not normal, with specific test results above the usual range.You started a new exercise program for heart and lung rehabilitation within the last 12 weeks, or you plan to start one during the study.I have had a procedure to create a hole in the wall between the upper chambers of my heart.Your body mass index (BMI) needs to be between 17 and 40.Your blood pressure is lower than 90 mm Hg when checked during the screening.I have been on a stable PAH medication for at least 12 weeks.You have an active or hidden infection of HIV, Hepatitis B, Hepatitis C, or tuberculosis when you are screened for the trial.Your heart's pumping ability is less than 50% within 24 weeks of the screening.Your heart's electrical activity takes longer than usual to recharge between beats.I can walk between 150 and 450 meters without stopping.You have a risk score of 5 or higher on the US Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) Lite 2 or your NT-proBNP level is 300 ng/L or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Seralutinib 90 mg
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research study accept participants who are younger than 80 years old?
"Eligible candidates for this clinical trial must be aged 18 to 75 years old. There are 49 trials available for minors and 660 studies accessible to those over 65."
Answered by AI
Would I be a suitable candidate for enrollment in this trial?
"To be eligible for this research study, participants must have pulmonary arterial hypertension and lie within the age range 18 to 75. The recruitment phase is estimated to involve 350 individuals."
Answered by AI
Has Seralutinib 90 mg received sanction from the FDA?
"There is evidence to suggest that Seralutinib 90 mg falls into a level 3 safety risk category, due to the efficacy and safety data collected from Phase 3 trials."
Answered by AI
Does this clinical trial still have open slots for participants?
"Contrary to expectation, the information on clinicaltrials.gov reveals that this trial is not presently recruiting patients. Originally posted on September 30th 2023 and last edited June 28th 2023, it appears as though no further enrolment is required for now; however there are a plethora of other trials actively seeking participants at present."
Answered by AI
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