Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)
NCT ID: NCT04816604
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
74 participants
INTERVENTIONAL
2021-04-05
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GB002 (seralutinib)
GB002 (seralutinib) inhaled orally twice per day (BID)
GB002 (seralutinib)
Capsule containing GB002 (seralutinib)
Generic Dry Powder Inhaler
Generic dry powder inhaler for GB002 (seralutinib) delivery
Interventions
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GB002 (seralutinib)
Capsule containing GB002 (seralutinib)
Generic Dry Powder Inhaler
Generic dry powder inhaler for GB002 (seralutinib) delivery
Eligibility Criteria
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Inclusion Criteria
1. 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.
2. Treatment with standard of care PAH disease-specific background therapies (stable dose).
Informed Consent
3. Review and signature of an IRB-approved informed consent form.
Exclusion Criteria
1. Persistent and clinically significant systemic hypertension or hypotension.
2. Interval history of newly developed left-sided heart disease.
3. Potentially life-threatening cardiac arrhythmia with an ongoing risk.
4. Uncontrolled bacterial, viral, or fungal infections which require systemic therapy.
5. 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.
6. History of portopulmonary hypertension or portal hypertension due to cirrhosis classified as Child-Pugh Class A or higher.
7. 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.
8. Current use of inhaled tobacco and/or inhaled marijuana. Ingestible or topical marijuana is allowed, per local restrictions and regulations.
9. Current alcohol use disorder as defined by DSM-5, and/or history of current utilization of drugs of abuse (amphetamines, methamphetamines, cocaine, phencyclidine \[PCP\]).
10. 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
11. Chronic renal insufficiency
12. Hemoglobin (Hgb) concentration \<8.5 g/dL.
13. Absolute neutrophil count (ANC) \< 1x 10\^9/L.
14. Platelet count \<50 x 10\^9/L.
Prior Therapy
15. Use of inhaled prostanoids.
16. Chronic use of oral anticoagulants (ie, vitamin K antagonist such as warfarin or novel oral anticoagulant \[NOAC\]/direct oral anticoagulant \[DOAC\]).
17. Chronic use of any prohibited medication.
18 Years
80 Years
ALL
No
Sponsors
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GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Richard Aranda
Role: STUDY_DIRECTOR
Gossamer Bio Inc.
Locations
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University of California, Davis Medical Center
Sacramento, California, United States
Medical Corporation
Santa Barbara, California, United States
Mayo Clinic
Jacksonville, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Norton Pulmonary Specialists
Louisville, Kentucky, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
NYU Langone Health
New York, New York, United States
New York Presbyterian Hospital - Weill Cornell Medicine
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
INTEGRIS Baptist Medical Center, Inc.
Oklahoma City, Oklahoma, United States
Houston Methodist Hospital
Houston, Texas, United States
University of Utah Health
Salt Lake City, Utah, United States
Royal Hobart Hospital
Hobart, Tasmania, Australia
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Všeobecná fakultní nemocnice v Praze
Prague, , Czechia
AP-HP Hôpital de Bicêtre
Le Kremlin-Bicêtre, , France
DRK Kliniken Berlin
Berlin, , Germany
Universitaetsklinikum Giessen und Marburg GmbH - Medizinische Klinik IV und V
Giessen, , Germany
Klinik für Pneumologie, Klinisches Studienzentrum Medizinische Hochschule
Hanover, , Germany
Thoraxklinik-Heidelberg gGmbH
Heidelberg, , Germany
Klinik und Poliklinik f. Innere Medizin II Universitätsklinikum Regensburg
Regensburg, , Germany
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Royal Papworth Hospital NHS Foundation Trust
Cambridge, , United Kingdom
Imperial College Healthcare NHS Trust - Hammersmith Medicines Research Limited
London, , United Kingdom
Countries
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References
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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.
Other Identifiers
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GB002-2102
Identifier Type: -
Identifier Source: org_study_id
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