GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

Completed · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Artery Hypertension

In brief

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.

Key facts

Study ID

NCT04456998

Run by

GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

People needed

86

Starts

2020-11-12

Expected to finish

2022-11-01

Last updated by the study team

2023-11-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.
• 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:
• 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%;
• Total lung capacity (TLC) or FVC ≥ 70% predicted

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.
• Evidence of active HIV, Hepatitis B or Hepatitis C, or tuberculosis (TB) infections.
• Inhaled prostanoids; these drugs may be withdrawn ≥ 4 weeks prior to or at screening, if clinically indicated.
• Use of oral anticoagulants (ie, warfarin or NOAC) at randomization.
• Requirement of intravenous (IV) inotropes (ie, levosimendan, dopamine, dobutamine, milrinone, norepinephrine) other than an IV prostanoid within 4 weeks of screening.
• Prior participation in GB002 studies and/or prior treatment with GB002.
• Currently participating in or has participated in a study of an investigational agent or has used an investigational device for the treatment of PAH within 4 weeks prior to screening.
• Current use of inhaled tobacco and/or inhaled marijuana.
• Current alcohol use disorder as defined by DSM-5 and/or positive test for drugs of abuse (amphetamines, methamphetamines, cocaine, phencyclidine [PCP]).
• 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.
• QTcF of > 480 msec recorded on a screening or baseline ECG or receiving concurrent treatment with medications that prolong QT interval.

Where it is running

• Dept of Veterans Affairs Greater Los Angeles Healthcare System — Los Angeles, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• The University of California San Francisco — San Francisco, California, United States
• Medical Corporation — Santa Barbara, California, United States
• Stanford Healthcare — Stanford, California, United States
• The Lundquist Institute of Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States
• Central Florida Pulmonary Group, PA — Altamonte Springs, Florida, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• The Emory Clinic — Atlanta, Georgia, United States
• University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Kentuckiana Pulmonary Research Center — Louisville, Kentucky, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• University of New Mexico Health Sciences Center — Albuquerque, New Mexico, 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
• Pulmonary Associates, PA — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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