Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

NCT04816604 | Active Not Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: GB002-2102
• Study Type: interventional
• Target: 74
• Locations: 7 countries
• Sites: 28

Brief 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.

Conditions

Pulmonary Arterial Hypertension

Keywords

seralutinib

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events

  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)

  Baseline, up to 80 months or availability of commercial product

Study Arms (1)

GB002 (seralutinib)

EXPERIMENTAL

GB002 (seralutinib) inhaled orally twice per day (BID)

Drug: GB002 (seralutinib); Device: Generic Dry Powder Inhaler

Interventions

Generic Dry Powder Inhaler DEVICE

Generic dry powder inhaler for GB002 (seralutinib) delivery

GB002 (seralutinib)

GB002 (seralutinib) DRUG

Capsule containing GB002 (seralutinib)

GB002 (seralutinib)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.: lead

Study Sites (28)

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

Medical Corporation

Santa Barbara, California, 93105, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Norton Pulmonary Specialists

Louisville, Kentucky, 40202, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

New York Presbyterian Hospital - Weill Cornell Medicine

New York, New York, 10065, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

INTEGRIS Baptist Medical Center, Inc.

Oklahoma City, Oklahoma, 73112, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Utah Health

Salt Lake City, Utah, 84132, United States

Location

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

Location

Všeobecná fakultní nemocnice v Praze

Prague, 128 08, Czechia

Location

AP-HP Hôpital de Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

DRK Kliniken Berlin

Berlin, Germany

Location

Universitaetsklinikum Giessen und Marburg GmbH - Medizinische Klinik IV und V

Giessen, Germany

Location

Klinik für Pneumologie, Klinisches Studienzentrum Medizinische Hochschule

Hanover, 30625, Germany

Location

Thoraxklinik-Heidelberg gGmbH

Heidelberg, 69126, Germany

Location

Klinik und Poliklinik f. Innere Medizin II Universitätsklinikum Regensburg

Regensburg, 93053, Germany

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

Location

Royal Papworth Hospital NHS Foundation Trust

Cambridge, CB2 OAY, United Kingdom

Location

Imperial College Healthcare NHS Trust - Hammersmith Medicines Research Limited

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40788460 DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Richard Aranda

  Gossamer Bio Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 25, 2021
• Study Start: April 5, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); DE (5); ES (2); GB (2); US (15); FR (1); AU (2)