GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

NCT04456998 | Completed Phase 2 Results DMC FDA Drug FDA Device

• 1 other identifier: GB002-2101
• Study Type: interventional
• Target: 86
• Locations: 10 countries
• Sites: 59

Brief Summary

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

Keywords

seralutinib

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 24 in Pulmonary Vascular Resistance (PVR)

  PVR was evaluated using right heart catheterization (RHC).

  Baseline, Week 24

Secondary Outcomes (1)

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

  Baseline, Week 24

Study Arms (2)

GB002 (seralutinib)

EXPERIMENTAL

GB002 (seralutinib) inhaled orally twice per day (BID) for 24 weeks

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

Placebo

PLACEBO COMPARATOR

Placebo inhaled orally BID for 24 weeks

Drug: Placebo; Device: Generic Dry Powder Inhaler

Interventions

GB002 (seralutinib) DRUG

Capsule containing GB002 (seralutinib)

GB002 (seralutinib)

Placebo DRUG

Matching capsule containing placebo

Placebo

Generic Dry Powder Inhaler DEVICE

Generic dry powder inhaler for GB002 (seralutinib) or placebo delivery

GB002 (seralutinib); Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• MWD ≥ 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:
• 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%;

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (63)

Pulmonary Associates, PA

Phoenix, Arizona, 85032, United States

Location

Dept of Veterans Affairs Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

The University of California San Francisco

San Francisco, California, 94143, United States

Location

Medical Corporation

Santa Barbara, California, 93105, United States

Location

Stanford Healthcare

Stanford, California, 94305, United States

Location

The Lundquist Institute of Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Central Florida Pulmonary Group, PA

Altamonte Springs, Florida, 32701, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

The Emory Clinic

Atlanta, Georgia, 30322, United States

Location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Kentuckiana Pulmonary Research Center

Louisville, Kentucky, 40202, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, 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

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44124, 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

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Utah Health

Salt Lake City, Utah, 84132, United States

Location

Medical College of Wisconsin - Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

St Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

St Vincent's Hospital Melbourne

Fitzroy, 3065, Australia

Location

Royal Hobart Hospital

Hobart, TAS 7000, Australia

Location

Westmead Hospital

Westmead, NSW 2145, Australia

Location

LKH - Univ. Klinikum Graz - Universitatsklinik fur Innere Medizin

Graz, 8036, Austria

Location

Medizinische Universitat Wien - Universitatsklinik fur Innere Medizin II

Vienna, 1090, Austria

Location

Erasme University Hospital

Brussels, 1070, Belgium

Location

University Hospital of Leuven

Leuven, 3000, Belgium

Location

Sir Mortimer B Davis Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Peter Lougheed Centre

Calgary, T1Y 6J4, Canada

Location

London Health Sciences Centre - Victoria Hospital

London, N6A 5W9, Canada

Location

Všeobecná fakultní nemocnice v Praze

Prague, 128 08, Czechia

Location

AP-HP, Hopital de Bicetre

Le Kremlin-Bicêtre, 94270, France

Location

CHU de Montpellier - Hopital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

Location

DRK Kliniken Berlin - Westend

Berlin, 14050, Germany

Location

Universitätsklinikum Giessen / Marburg

Giessen, 35392, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Zentrum fur Pulmonale Hypertonie Thoraxklinik-Heidelberg gGmbH

Heidelberg, 69126, Germany

Location

Universitatsklinikum Regensburg

Regensburg, 93053, Germany

Location

University Clinical Centre of Serbia

Belgrade, 11000, Serbia

Location

Institute for Pulmonary Diseases of Vojvodina

Kamenitz, 21204, Serbia

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

Location

Royal Papworth Hospital NHS Foundation

Cambridge, CB2 0AY, United Kingdom

Location

Imperial College Healthcare NHS Trust - Hammersmith Medicines Research Limited

London, W12 OHS, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 38705167 DERIVED

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GB002, Inc. Study Director
• Organization: GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

ClinicalTrials@gossamerbio.com

1-866-668-4083

Study Officials

• Richard Aranda

  Gossamer Bio Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Subjects, investigators, other site personnel, and Sponsor (and/or designee) personnel who are directly involved in the conduct of the study, collection of the data, and analysis of the final safety and efficacy results will remain blinded to treatment assignments until after the completion of the study and the database has been locked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 7, 2020
• Study Start: November 12, 2020
• Primary Completion: October 17, 2022
• Study Completion: November 1, 2022
• Last Updated: November 7, 2023
• Results First Posted: November 7, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); CA (3); FR (2); BE (2); CZ (1); DE (6); ES (3); US (36); SE (2); GB (2)