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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GB002 (seralutinib) | Experimental | GB002 (seralutinib) inhaled orally twice per day (BID) for 24 weeks |
|
| Placebo | Placebo Comparator | Placebo inhaled orally BID for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GB002 (seralutinib) | Drug | Capsule containing GB002 (seralutinib) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 24 in Pulmonary Vascular Resistance (PVR) | PVR was evaluated using right heart catheterization (RHC). | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 24 |
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Inclusion Criteria:
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:
Pulmonary function tests (PFTs) at screening with the following criteria met:
Exclusion Criteria:
NOTE: Additional inclusion/exclusion criteria may apply, per protocol.
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| Name | Affiliation | Role |
|---|---|---|
| Richard Aranda | Gossamer Bio Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates, PA | Phoenix | Arizona | 85032 | United States | ||
| Dept of Veterans Affairs Greater Los Angeles Healthcare System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38705167 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo inhaled orally twice per day (BID) for 24 weeks |
| FG001 | GB002 (Seralutinib) | GB002 (seralutinib) inhaled orally BID for 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 18, 2021 | Oct 13, 2023 |
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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.
| Placebo |
| Drug |
Matching capsule containing placebo |
|
| Generic Dry Powder Inhaler | Device | Generic dry powder inhaler for GB002 (seralutinib) or placebo delivery |
|
| Los Angeles |
| California |
| 90073 |
| United States |
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
| The University of California San Francisco | San Francisco | California | 94143 | United States |
| Medical Corporation | Santa Barbara | California | 93105 | United States |
| Stanford Healthcare | Stanford | California | 94305 | United States |
| The Lundquist Institute of Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| Central Florida Pulmonary Group, PA | Altamonte Springs | Florida | 32701 | United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States |
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
| The Emory Clinic | Atlanta | Georgia | 30322 | United States |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Kentuckiana Pulmonary Research Center | Louisville | Kentucky | 40202 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| University of New Mexico Health Sciences Center | Albuquerque | New Mexico | 87131 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| New York Presbyterian Hospital - Weill Cornell Medicine | New York | New York | 10065 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44124 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| INTEGRIS Baptist Medical Center, Inc. | Oklahoma City | Oklahoma | 73112 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| University of Utah Health | Salt Lake City | Utah | 84132 | United States |
| Medical College of Wisconsin - Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
| St Vincent's Hospital | Darlinghurst | New South Wales | 2010 | Australia |
| St Vincent's Hospital Melbourne | Fitzroy | 3065 | Australia |
| Royal Hobart Hospital | Hobart | TAS 7000 | Australia |
| Westmead Hospital | Westmead | NSW 2145 | Australia |
| LKH - Univ. Klinikum Graz - Universitatsklinik fur Innere Medizin | Graz | 8036 | Austria |
| Medizinische Universitat Wien - Universitatsklinik fur Innere Medizin II | Vienna | 1090 | Austria |
| Erasme University Hospital | Brussels | 1070 | Belgium |
| University Hospital of Leuven | Leuven | 3000 | Belgium |
| Sir Mortimer B Davis Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| Peter Lougheed Centre | Calgary | T1Y 6J4 | Canada |
| London Health Sciences Centre - Victoria Hospital | London | N6A 5W9 | Canada |
| Všeobecná fakultnà nemocnice v Praze | Prague | 128 08 | Czechia |
| AP-HP, Hopital de Bicetre | Le Kremlin-Bicêtre | 94270 | France |
| CHU de Montpellier - Hopital Arnaud de Villeneuve | Montpellier | 34295 | France |
| Herz- und Diabeteszentrum NRW | Bad Oeynhausen | 32545 | Germany |
| DRK Kliniken Berlin - Westend | Berlin | 14050 | Germany |
| Universitätsklinikum Giessen / Marburg | Giessen | 35392 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Zentrum fur Pulmonale Hypertonie Thoraxklinik-Heidelberg gGmbH | Heidelberg | 69126 | Germany |
| Universitatsklinikum Regensburg | Regensburg | 93053 | Germany |
| University Clinical Centre of Serbia | Belgrade | 11000 | Serbia |
| Institute for Pulmonary Diseases of Vojvodina | Kamenitz | 21204 | Serbia |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | 39008 | Spain |
| Royal Papworth Hospital NHS Foundation | Cambridge | CB2 0AY | United Kingdom |
| Imperial College Healthcare NHS Trust - Hammersmith Medicines Research Limited | London | W12 OHS | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo inhaled orally BID for 24 weeks |
| BG001 | GB002 (Seralutinib) | GB002 (seralutinib) inhaled orally BID for 24 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Week 24 in Pulmonary Vascular Resistance (PVR) | PVR was evaluated using right heart catheterization (RHC). | Intent-to-Treat (ITT) Population: all participants who were randomized. | Posted | Least Squares Mean | 95% Confidence Interval | dyne•s/cm^5 | Baseline, Week 24 |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population: all participants who were randomized. Participants with a baseline and post-baseline value. | Posted | Least Squares Mean | 95% Confidence Interval | meters | Baseline, Week 24 |
|
|
From first dose of study drug through Week 28
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo inhaled orally BID for 24 weeks | 0 | 42 | 6 | 42 | 28 | 42 |
| EG001 | GB002 (Seralutinib) | GB002 (seralutinib) inhaled orally BID for 24 weeks | 0 | 44 | 10 | 44 | 31 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Device malfunction | Product Issues | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 24.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GB002, Inc. Study Director | GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. | 1-866-668-4083 | ClinicalTrials@gossamerbio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 27, 2022 | Oct 13, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D065627 | Familial Primary Pulmonary Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Male |
|
| Black or African American |
|
| Asian |
|
| Other, Not Specified |
|
| Not Hispanic or Latino |
|
| Not Reported |
|
|
|