Pulmonary Artery HypertensionPhase 2NCT04456998

GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

A Phase 2 study testing GB002 (seralutinib) and Generic Dry Powder Inhaler in people with Pulmonary Artery Hypertension, run by GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. at 63 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Pulmonary Artery Hypertension
What is being tested?: GB002 (seralutinib) and Generic Dry Powder Inhaler
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 86 participants
Where: 63 sitesin 11 countries
Study dates: 12 Nov 2020to 1 Nov 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

A current diagnosis of symptomatic PAH classified by one of the following:
Idiopathic PAH (IPAH) or heritable pulmonary arterial hypertension (HPAH).
PAH associated with connective tissue disease (CTD-APAH).
PAH associated with anorexigen or methamphetamine use.
Congenital heart disease with simple systemic to pulmonary shunt at least 1 year after surgical repair.
6MWD ≥ 150 meters and ≤ 550 meters at screening.

Show all 16Show fewer

WHO FC II or III symptomatology.
Treatment with standard of care PAH background therapies.
Documentation of cardiac catheterization within the screening period that is consistent with the diagnosis of PAH and meeting all the following criteria, to be confirmed by a central hemodynamic core laboratory:
Mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg (at rest), AND
PVR ≥ 400 dyne•sec/cm5, AND
Pulmonary capillary wedge pressure (PCWP) or left ventricular-end diastolic pressure (LVEDP) ≤12 mm Hg if PVR ≥400 to <500 dyne∙sec/cm5 OR
PCWP or LVEDP ≤15 mmHg if PVR ≥500 dyne∙sec/cm5
Pulmonary function tests (PFTs) at screening with the following criteria met:
Forced expiratory volume in 1 second (FEV1) divided by the forced vital capacity (FVC) ≥70%;
Total lung capacity (TLC) or FVC ≥ 70% predicted

Who cannot join

Evidence of chronic thromboembolic disease or acute pulmonary embolism as assessed by ventilation-perfusion (V/Q) scan, computed tomography (CT)-angiogram, or pulmonary angiogram prior to screening.
Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure > 160 mm Hg or sitting diastolic blood pressure > 100 mm Hg during screening visit after a period of rest.
Systolic blood pressure < 90 mm Hg during screening and baseline visits.
WHO Pulmonary Hypertension Group 2-5.
Human immunodeficiency virus (HIV)-associated PAH.
History of left-sided heart disease and/or clinically significant cardiac disease.

Show all 27Show fewer

Untreated severe obstructive sleep apnea.
History of atrial septostomy within 180 days prior to screening.
Pulmonary venous occlusive disease (PVOD).
Subjects with a history of portopulmonary hypertension or portal hypertension due to cirrhosis classified as Child-Pugh Class A or higher; or baseline ALT or AST > 2 x ULN or Total Bilirubin ≥ 2 x ULN.
History of malignancy within 5 years prior to screening.
History of a potentially life-threatening cardiac arrhythmia with an ongoing risk.
Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or IP administration (eg; history intracranial hemorrhage).
Chronic renal insufficiency as defined by an estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73m2 via Chronic Kidney Disease Epidemiology Collaboration (CKD-epi) at screening or requires dialytic therapy or hemofiltration.
Hemoglobin (Hgb) concentration < 8.5 g/dL at screening.
Evidence of active HIV, Hepatitis B or Hepatitis C, or tuberculosis (TB) infections.
Inhaled prostanoids; these drugs may be withdrawn ≥ 4 weeks prior to or at screening, if clinically indicated.
Use of oral anticoagulants (ie, warfarin or NOAC) at randomization.
Requirement of intravenous (IV) inotropes (ie, levosimendan, dopamine, dobutamine, milrinone, norepinephrine) other than an IV prostanoid within 4 weeks of screening.
Prior participation in GB002 studies and/or prior treatment with GB002.
Currently participating in or has participated in a study of an investigational agent or has used an investigational device for the treatment of PAH within 4 weeks prior to screening.
Current use of inhaled tobacco and/or inhaled marijuana.
Current alcohol use disorder as defined by DSM-5 and/or positive test for drugs of abuse (amphetamines, methamphetamines, cocaine, phencyclidine [PCP]).
Subjects with a history of severe milk protein allergy. In addition, subjects with known intolerance or hypersensitivity to lactose who, in the opinion of the investigator, may experience severe symptoms following the ingestion of lactose.
QTcF of > 480 msec recorded on a screening or baseline ECG or receiving concurrent treatment with medications that prolong QT interval.
Have any other condition or reason that, in the opinion of the Investigator or Medical Monitor, would prohibit the subject from participating in the study.
NOTE: Additional inclusion/exclusion criteria may apply, per protocol.

Trial locations and contacts

63 sites in 11 countries.

Country

City, postcode or hospital

63 sites in 11 countries

United States36 sites

University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
Central Florida Pulmonary Group, PA
Altamonte Springs, Florida, 32701
University of Michigan
Ann Arbor, Michigan, 48109
The Emory Clinic
Atlanta, Georgia, 30322
Tufts Medical Center
Boston, Massachusetts, 02111
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Cleveland Clinic Foundation
Cleveland, Ohio, 44124
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
UT Southwestern Medical Center
Dallas, Texas, 75390
Houston Methodist Hospital
Houston, Texas, 77030
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
University of Kansas Medical Center
Kansas City, Kansas, 66160
Dept of Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Kentuckiana Pulmonary Research Center
Louisville, Kentucky, 40202
Medical College of Wisconsin - Froedtert Hospital
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
NYU Langone Health
New York, New York, 10016
New York Presbyterian Hospital - Weill Cornell Medicine
New York, New York, 10065
INTEGRIS Baptist Medical Center, Inc.
Oklahoma City, Oklahoma, 73112
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
Pulmonary Associates, PA
Phoenix, Arizona, 85032
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Oregon Health & Science University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester Medical Center
Rochester, New York, 14642
UC Davis Medical Center
Sacramento, California, 95817
University of Utah Health
Salt Lake City, Utah, 84132
The University of California San Francisco
San Francisco, California, 94143
Medical Corporation
Santa Barbara, California, 93105
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford Healthcare
Stanford, California, 94305
The Lundquist Institute of Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
Cleveland Clinic Florida
Weston, Florida, 33331

Other trials in United States

Germany6 sites

Herz- und Diabeteszentrum NRW
Bad Oeynhausen, 32545
DRK Kliniken Berlin - Westend
Berlin, 14050
Universitätsklinikum Giessen / Marburg
Giessen, 35392
Medizinische Hochschule Hannover
Hanover, 30625
Zentrum fur Pulmonale Hypertonie Thoraxklinik-Heidelberg gGmbH
Heidelberg, 69126
Universitatsklinikum Regensburg
Regensburg, 93053

Other trials in Germany

Australia4 sites

St Vincent's Hospital
Darlinghurst, New South Wales, 2010
St Vincent's Hospital Melbourne
Fitzroy, 3065
Royal Hobart Hospital
Hobart, TAS 7000
Westmead Hospital
Westmead, NSW 2145

Other trials in Australia

Canada3 sites

Peter Lougheed Centre
Calgary, T1Y 6J4
London Health Sciences Centre - Victoria Hospital
London, N6A 5W9
Sir Mortimer B Davis Jewish General Hospital
Montreal, Quebec, H3T 1E2

Other trials in Canada

Spain3 sites

Hospital Universitario Vall d'Hebron
Barcelona, 08035
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Marqués de Valdecilla
Santander, 39008

Other trials in Spain

Austria2 sites

LKH - Univ. Klinikum Graz - Universitatsklinik fur Innere Medizin
Graz, 8036
Medizinische Universitat Wien - Universitatsklinik fur Innere Medizin II
Vienna, 1090

Other trials in Austria

Belgium2 sites

Erasme University Hospital
Brussels, 1070
University Hospital of Leuven
Leuven, 3000

Other trials in Belgium

France2 sites

AP-HP, Hopital de Bicetre
Le Kremlin-Bicêtre, 94270
CHU de Montpellier - Hopital Arnaud de Villeneuve
Montpellier, 34295

Other trials in France

Serbia2 sites

University Clinical Centre of Serbia
Belgrade, 11000
Institute for Pulmonary Diseases of Vojvodina
Kamenitz, 21204

Other trials in Serbia

United Kingdom2 sites

Royal Papworth Hospital NHS Foundation
Cambridge, CB2 0AY
Imperial College Healthcare NHS Trust - Hammersmith Medicines Research Limited
London, W12 OHS

Other trials in United Kingdom

Czechia1 site

Všeobecná fakultní nemocnice v Praze
Prague, 128 08

Other trials in Czechia

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)

The primary objective for this trial is to determine the effect of GB002 (seralutinib) on improving pulmonary hemodynamics in subjects with World Health Organization (WHO) Group 1 PAH who are Functional Class (FC) II and III. The secondary objective for this trial is to determine the effect of GB002 (seralutinib) on improving exercise capacity in this population.

Conditions: Pulmonary Artery Hypertension
Being tested: GB002 (seralutinib), Placebo, Generic Dry Powder Inhaler
Keywords: seralutinib
Medical subject headings: Familial Primary Pulmonary Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GB002 (seralutinib)Drug
Capsule containing GB002 (seralutinib)
PlaceboDrug
Matching capsule containing placebo
Generic Dry Powder InhalerDevice
Generic dry powder inhaler for GB002 (seralutinib) or placebo delivery

Study groups in NCT04456998
Study group	Role	What they receive
GB002 (seralutinib)	Experimental	GB002 (seralutinib) inhaled orally twice per day (BID) for 24 weeks Receives: Drug: GB002 (seralutinib); Device: Generic Dry Powder Inhaler
Placebo	Placebo comparator	Placebo inhaled orally BID for 24 weeks Receives: Drug: Placebo; Device: Generic Dry Powder Inhaler

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to Week 24 in Pulmonary Vascular Resistance (PVR)
PVR was evaluated using right heart catheterization (RHC).
Measured: Baseline, Week 24

Secondary outcomes (1)

Change From Baseline to Week 24 in Distance Achieved on the Six-Minute Walk Test (6MWT)
The 6MWT measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes.
Measured: Baseline, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Nov 20201 Nov 2022

First posted7 Jul 2020
Study start12 Nov 2020
Primary completion17 Oct 2022
Study completion1 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pulmonary Artery HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04456998
Sponsor's protocol ID: GB002-2101
Status last verified: Oct 2023
First submitted: 30 Jun 2020
Last updated: 7 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Publications

Frantz RP, McLaughlin VV, Sahay S, Escribano Subias P, Zolty RL, Benza RL, Channick RN, Chin KM, Hemnes AR, Howard LS, Sitbon O, Vachiery JL, Zamanian RT, Cravets M, Roscigno RF, Mottola D, Osterhout R, Bruey JM, Elman E, Tompkins CA, Parsley E, Aranda R, Zisman LS, Ghofrani HA; TORREY Study Investigators. Seralutinib in adults with pulmonary arterial hypertension (TORREY): a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Respir Med. 2024 Jul;12(7):523-534. doi: 10.1016/S2213-2600(24)00072-9. Epub 2024 May 2.
PubMed 38705167

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)
ClinicalTrials.gov ID: NCT04456998
Acronym / sponsor ID: GB002-2101
Conditions: Pulmonary Artery Hypertension
Keywords: seralutinib
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 86 participants (actual)
Lead sponsor: GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.Industry (pharma, biotech, devices)
Study start: 12 Nov 2020 (actual)
Primary completion: 17 Oct 2022 (actual)
Study completion: 1 Nov 2022 (actual)
First posted: 7 Jul 2020 (actual)
Results: Posted 7 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
GB002 (seralutinib)	Experimental	Drug: GB002 (seralutinib), Device: Generic Dry Powder InhalerGB002 (seralutinib) inhaled orally twice per day (BID) for 24 weeks
Placebo	Placebo comparator	Drug: Placebo, Device: Generic Dry Powder InhalerPlacebo inhaled orally BID for 24 weeks

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

A current diagnosis of symptomatic PAH classified by one of the following:
6MWD ≥ 150 meters and ≤ 550 meters at screening.
WHO FC II or III symptomatology.
Treatment with standard of care PAH background therapies.
Documentation of cardiac catheterization within the screening period that is consistent with the diagnosis of PAH and meeting all the following criteria, to be confirmed by a central hemodynamic core laboratory:

Key exclusion criteria (27 listed)

Evidence of chronic thromboembolic disease or acute pulmonary embolism as assessed by ventilation-perfusion (V/Q) scan, computed tomography (CT)-angiogram, or pulmonary angiogram prior to screening.
Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure > 160 mm Hg or sitting diastolic blood pressure > 100 mm Hg during screening visit after a period of rest.
Systolic blood pressure < 90 mm Hg during screening and baseline visits.
WHO Pulmonary Hypertension Group 2-5.
Human immunodeficiency virus (HIV)-associated PAH.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GB002 (seralutinib)Capsule containing GB002 (seralutinib)	Drug	GB002 (seralutinib)
PlaceboMatching capsule containing placebo	Drug	Placebo
Generic Dry Powder InhalerGeneric dry powder inhaler for GB002 (seralutinib) or placebo delivery	Device	GB002 (seralutinib), Placebo

Primary outcome

Change From Baseline to Week 24 in Pulmonary Vascular Resistance (PVR)
Time frame: Baseline, Week 24
PVR was evaluated using right heart catheterization (RHC).

1 secondary outcome

Change From Baseline to Week 24 in Distance Achieved on the Six-Minute Walk Test (6MWT)
Time frame: Baseline, Week 24

Results and safety

Results posted to the registry on 7 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	42	42
GB002 (Seralutinib)	44	38

Primary outcome: Change From Baseline to Week 24 in Pulmonary Vascular Resistance (PVR)

Time frame: Baseline, Week 24. Least squares mean (95% Confidence Interval). Unit: dyne•s/cm^5

Measure	Placebo n = 42	GB002 (Seralutinib) n = 44
Value	21.2 (-37.4 to 79.8)	-74.9 (-139.7 to -10.2)

Placebo vs GB002 (Seralutinib): Mean Difference (Net): -96.1 (95% CI -183.5 to -8.8), p = 0.0310, ANCOVA

Population analysed: Intent-to-Treat (ITT) Population: all participants who were randomized.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From first dose of study drug through Week 28. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	6 of 42 (14.3%)	28 of 42 (66.7%)	0 of 42
GB002 (Seralutinib)	10 of 44 (22.7%)	31 of 44 (70.5%)	0 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38705167Frantz RP, McLaughlin VV, Sahay S, Escribano Subias P, Zolty RL, Benza RL, Channick RN, Chin KM, Hemnes AR, Howard LS, Sitbon O, Vachiery JL, Zamanian RT, Cravets M, Roscigno RF, Mottola D, Osterhout R, Bruey JM, Elman E, Tompkins CA, Parsley E, Aranda R, Zisman LS, Ghofrani HA; TORREY Study Investigators. Seralutinib in adults with pulmonary arterial hypertension (TORREY): a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Respir Med. 2024 Jul;12(7):523-534. doi: 10.1016/S2213-2600(24)00072-9. Epub 2024 May 2.
Individual participant dataSharing planned: No

Related trials for Pulmonary Artery Hypertension

Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Richard Aranda study director

Gossamer Bio USA, Inc.

63 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States, Germany, Australia, Canada, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 24 in Pulmonary Vascular Resistance (PVR) (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04456998, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.