Pulmonary Arterial HypertensionPhase 2NCT04816604
Open-label Extension Study of 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 Arterial Hypertension, run by Gossamer Bio USA, Inc. at 28 sites in 7 countries.
Trial summary
This open-label extension study will evaluate the long-term effects of GB002 (seralutinib) in subjects who previously participated in a GB002 PAH study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Arterial 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?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 28 sitesin 7 countries
- Study dates
- 5 Apr 2021to 9 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type of Subject and Disease Characteristics
- 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.
- Treatment with standard of care PAH disease-specific background therapies (stable dose).
- Informed Consent
- Review and signature of an IRB-approved informed consent form.
Who cannot join
- Medical Conditions
- Persistent and clinically significant systemic hypertension or hypotension.
- Interval history of newly developed left-sided heart disease.
- Potentially life-threatening cardiac arrhythmia with an ongoing risk.
- Uncontrolled bacterial, viral, or fungal infections which require systemic therapy.
- Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or GB002 administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
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- History of portopulmonary hypertension or portal hypertension due to cirrhosis classified as Child-Pugh Class A or higher.
- 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.
- Current use of inhaled tobacco and/or inhaled marijuana. Ingestible or topical marijuana is allowed, per local restrictions and regulations.
- Current alcohol use disorder as defined by DSM-5, and/or history of current utilization of drugs of abuse (amphetamines, methamphetamines, cocaine, phencyclidine [PCP]).
- Have any other condition or reason that, in the opinion of the Investigator and/or the Sponsor's Medical Monitor (or designee), would prohibit the subject from participating in the study.
- Diagnostic Assessments
- Chronic renal insufficiency
- Hemoglobin (Hgb) concentration <8.5 g/dL.
- Absolute neutrophil count (ANC) < 1x 10^9/L.
- Platelet count <50 x 10^9/L.
- Prior Therapy
- Use of inhaled prostanoids.
- Chronic use of oral anticoagulants (ie, vitamin K antagonist such as warfarin or novel oral anticoagulant [NOAC]/direct oral anticoagulant [DOAC]).
- Chronic use of any prohibited medication.
- NOTE: Additional inclusion/exclusion criteria may apply, per protocol.
Trial locations and contacts
28 sites in 7 countries.
28 sites in 7 countries
United States15 sites
Tufts Medical Center
Boston, Massachusetts, 02111
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Houston Methodist Hospital
Houston, Texas, 77030
Mayo Clinic
Jacksonville, Florida, 32224
University of Kansas Medical Center
Kansas City, Kansas, 66160
Norton Pulmonary Specialists
Louisville, Kentucky, 40202
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
University of Rochester Medical Center
Rochester, New York, 14642
University of California, Davis Medical Center
Sacramento, California, 95817
University of Utah Health
Salt Lake City, Utah, 84132
Medical Corporation
Santa Barbara, California, 93105
Cleveland Clinic Florida
Weston, Florida, 33331
Germany5 sites
DRK Kliniken Berlin
Berlin
Universitaetsklinikum Giessen und Marburg GmbH - Medizinische Klinik IV und V
Giessen
Klinik für Pneumologie, Klinisches Studienzentrum Medizinische Hochschule
Hanover, 30625
Thoraxklinik-Heidelberg gGmbH
Heidelberg, 69126
Klinik und Poliklinik f. Innere Medizin II Universitätsklinikum Regensburg
Regensburg, 93053
Australia2 sites
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065
Royal Hobart Hospital
Hobart, Tasmania, 7000
Spain2 sites
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Marqués de Valdecilla
Santander, 39008
United Kingdom2 sites
Royal Papworth Hospital NHS Foundation Trust
Cambridge, CB2 OAY
Imperial College Healthcare NHS Trust - Hammersmith Medicines Research Limited
London
About this study
Official title: An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)
This open-label extension study will evaluate the long-term effects of GB002 (seralutinib) in subjects who previously participated in a GB002 PAH study.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- GB002 (seralutinib), Generic Dry Powder Inhaler
- Keywords
- seralutinib
- Medical subject headings
- Pulmonary Arterial 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)
Generic Dry Powder InhalerDevice
Generic dry powder inhaler for GB002 (seralutinib) delivery
| Study group | Role | What they receive |
|---|---|---|
| GB002 (seralutinib) | Experimental | GB002 (seralutinib) inhaled orally twice per day (BID) Receives: Drug: GB002 (seralutinib); Device: Generic Dry Powder Inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events
Measured: From first dose of study drug up to 80 months or availability of commercial product
Secondary outcomes (1)
Change from Baseline Over Time on the Six-Minute Walk Test (6MWT)
Change in the distance achieved on the 6MWT (Δ6MWT)
Measured: Baseline, up to 80 months or availability of commercial product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start5 Apr 2021
- Primary completion9 Sep 2026
- Study completion9 Sep 2026
Why it stopped: Enrollment has declined and remaining participants have been on study more than three years. Continued study visits/data collection are no longer considered necessary. This is not expected to affect study interpretation or the overall benefit-risk.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gossamer Bio USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Roscigno, Study director, Gossamer Bio USA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816604
- Sponsor's protocol ID
- GB002-2102
- Status last verified
- Oct 2026
- First submitted
- 23 Mar 2021
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sitbon O, Sahay S, Escribano Subias P, Zolty RL, Kingrey JF, Ryan JJ, Sobol I, Sood N, Benza RL, Channick RN, Chin KM, Frantz RP, Ghofrani HA, Hemnes AR, McLaughlin VV, Vachiery JL, Zamanian RT, Ter Veer A, Roscigno RF, Mottola D, Parsley E, Aranda R, Zisman LS, Howard LS; TORREY Study Investigators. Seralutinib for the Treatment of Pulmonary Arterial Hypertension in Adults: TORREY Open-Label Extension Study. Adv Ther. 2025 Oct;42(10):5104-5123. doi: 10.1007/s12325-025-03297-2. Epub 2025 Aug 11.
PubMed 40788460
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)
- ClinicalTrials.gov ID
- NCT04816604
- Acronym / sponsor ID
- GB002-2102
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- seralutinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment has declined and remaining participants have been on study more than three years. Continued study visits/data collection are no longer considered necessary. This is not expected to affect study interpretation or the overall benefit-risk.
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Gossamer Bio USA, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 9 Sep 2026 (actual)
- Study completion
- 9 Sep 2026 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open-label extension study will evaluate the long-term effects of GB002 (seralutinib) in subjects who previously participated in a GB002 PAH study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GB002 (seralutinib) | Experimental | Drug: GB002 (seralutinib), Device: Generic Dry Powder InhalerGB002 (seralutinib) inhaled orally twice per day (BID) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type of Subject and Disease Characteristics
- 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.
- Treatment with standard of care PAH disease-specific background therapies (stable dose).
- Informed Consent
- Review and signature of an IRB-approved informed consent form.
Key exclusion criteria (21 listed)
- Medical Conditions
- Persistent and clinically significant systemic hypertension or hypotension.
- Interval history of newly developed left-sided heart disease.
- Potentially life-threatening cardiac arrhythmia with an ongoing risk.
- Uncontrolled bacterial, viral, or fungal infections which require systemic therapy.
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) |
| Generic Dry Powder InhalerGeneric dry powder inhaler for GB002 (seralutinib) delivery | Device | GB002 (seralutinib) |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events
Time frame: From first dose of study drug up to 80 months or availability of commercial product
1 secondary outcome
Change from Baseline Over Time on the Six-Minute Walk Test (6MWT)
Time frame: Baseline, up to 80 months or availability of commercial product
Results and safety
The study was stopped early (reason given: Enrollment has declined and remaining participants have been on study more than three years. Continued study visits/data collection are no longer considered necessary. This is not expected to affect study interpretation or the overall benefit-risk.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Derived from this study: PubMed 40788460Sitbon O, Sahay S, Escribano Subias P, Zolty RL, Kingrey JF, Ryan JJ, Sobol I, Sood N, Benza RL, Channick RN, Chin KM, Frantz RP, Ghofrani HA, Hemnes AR, McLaughlin VV, Vachiery JL, Zamanian RT, Ter Veer A, Roscigno RF, Mottola D, Parsley E, Aranda R, Zisman LS, Howard LS; TORREY Study Investigators. Seralutinib for the Treatment of Pulmonary Arterial Hypertension in Adults: TORREY Open-Label Extension Study. Adv Ther. 2025 Oct;42(10):5104-5123. doi: 10.1007/s12325-025-03297-2. Epub 2025 Aug 11.
- Individual participant dataSharing planned: No
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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.
Robert Roscigno study director
Gossamer Bio USA, Inc.
28 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GB002 (seralutinib) and Generic Dry Powder Inhaler in people with Pulmonary Arterial Hypertension, run by Gossamer Bio USA, Inc. at 28 sites in 7 countries.
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 5 inclusion and 21 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: stopped early, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Germany, Australia, Spain, United Kingdom and 2 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. 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?
The study was stopped early (reason given: Enrollment has declined and remaining participants have been on study more than three years. Continued study visits/data collection are no longer considered necessary. This is not expected to affect study interpretation or the overall benefit-risk.). Results are not available in the source record.
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?
Number of Participants With Treatment Emergent Adverse Events (time frame: From first dose of study drug up to 80 months or availability of commercial product). 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 NCT04816604, 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 5 Nov 2026.