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GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

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ClinicalTrials.gov Identifier: NCT04456998
Recruitment Status : Completed
First Posted : July 7, 2020
Results First Posted : November 7, 2023
Last Update Posted : November 7, 2023
Sponsor:
Information provided by (Responsible Party):
Gossamer Bio Inc. ( GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pulmonary Artery Hypertension Drug: GB002 (seralutinib) Drug: Placebo Device: Generic Dry Powder Inhaler Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)
Actual Study Start Date : November 12, 2020
Actual Primary Completion Date : October 17, 2022
Actual Study Completion Date : November 1, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: GB002 (seralutinib)
GB002 (seralutinib) inhaled orally twice per day (BID) for 24 weeks
 Drug: GB002 (seralutinib)
Capsule containing GB002 (seralutinib)

Device: Generic Dry Powder Inhaler
Generic dry powder inhaler for GB002 (seralutinib) or placebo delivery
Placebo Comparator: Placebo
Placebo inhaled orally BID for 24 weeks
 Drug: Placebo
Matching capsule containing placebo

Device: Generic Dry Powder Inhaler
Generic dry powder inhaler for GB002 (seralutinib) or placebo delivery


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline to Week 24 in Pulmonary Vascular Resistance (PVR) [ Time Frame: Baseline, Week 24 ]
    PVR was evaluated using right heart catheterization (RHC).


Secondary Outcome Measures :
  1. Change From Baseline to Week 24 in Distance Achieved on the Six-Minute Walk Test (6MWT) [ Time Frame: Baseline, Week 24 ]
    The 6MWT measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A current diagnosis of symptomatic PAH classified by one of the following:

    1. Idiopathic PAH (IPAH) or heritable pulmonary arterial hypertension (HPAH).
    2. PAH associated with connective tissue disease (CTD-APAH).
    3. PAH associated with anorexigen or methamphetamine use.
    4. Congenital heart disease with simple systemic to pulmonary shunt at least 1 year after surgical repair.
  2. 6MWD ≥ 150 meters and ≤ 550 meters at screening.
  3. WHO FC II or III symptomatology.
  4. Treatment with standard of care PAH background therapies.

  5. 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:

    1. Mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg (at rest), AND
    2. PVR ≥ 400 dyne•sec/cm5, AND
    3. Pulmonary capillary wedge pressure (PCWP) or left ventricular-end diastolic pressure (LVEDP) ≤12 mm Hg if PVR ≥400 to <500 dyne∙sec/cm5 OR
    4. PCWP or LVEDP ≤15 mmHg if PVR ≥500 dyne∙sec/cm5

  6. Pulmonary function tests (PFTs) at screening with the following criteria met:

    1. Forced expiratory volume in 1 second (FEV1) divided by the forced vital capacity (FVC) ≥70%;
    2. Total lung capacity (TLC) or FVC ≥ 70% predicted

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Systolic blood pressure < 90 mm Hg during screening and baseline visits.
  4. WHO Pulmonary Hypertension Group 2-5.
  5. Human immunodeficiency virus (HIV)-associated PAH.
  6. History of left-sided heart disease and/or clinically significant cardiac disease.
  7. Untreated severe obstructive sleep apnea.
  8. History of atrial septostomy within 180 days prior to screening.
  9. Pulmonary venous occlusive disease (PVOD).
  10. 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.
  11. History of malignancy within 5 years prior to screening.
  12. History of a potentially life-threatening cardiac arrhythmia with an ongoing risk.
  13. Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or IP administration (eg; history intracranial hemorrhage).
  14. 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.
  15. Hemoglobin (Hgb) concentration < 8.5 g/dL at screening.
  16. Evidence of active HIV, Hepatitis B or Hepatitis C, or tuberculosis (TB) infections.
  17. Inhaled prostanoids; these drugs may be withdrawn ≥ 4 weeks prior to or at screening, if clinically indicated.
  18. Use of oral anticoagulants (ie, warfarin or NOAC) at randomization.
  19. Requirement of intravenous (IV) inotropes (ie, levosimendan, dopamine, dobutamine, milrinone, norepinephrine) other than an IV prostanoid within 4 weeks of screening.
  20. Prior participation in GB002 studies and/or prior treatment with GB002.
  21. 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.
  22. Current use of inhaled tobacco and/or inhaled marijuana.
  23. Current alcohol use disorder as defined by DSM-5 and/or positive test for drugs of abuse (amphetamines, methamphetamines, cocaine, phencyclidine [PCP]).
  24. 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.
  25. QTcF of > 480 msec recorded on a screening or baseline ECG or receiving concurrent treatment with medications that prolong QT interval.
  26. Have any other condition or reason that, in the opinion of the Investigator or Medical Monitor, would prohibit the subject from participating in the study.

NOTE: Additional inclusion/exclusion criteria may apply, per protocol.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04456998


Locations
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Sponsors and Collaborators
GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Investigators
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Study Director: Richard Aranda Gossamer Bio Inc.
  Study Documents (Full-Text)

Documents provided by Gossamer Bio Inc. ( GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. ):
Study Protocol  [PDF] November 18, 2021
Statistical Analysis Plan  [PDF] October 27, 2022

More Information
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Responsible Party: GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
ClinicalTrials.gov Identifier: NCT04456998    
Other Study ID Numbers: GB002-2101
First Posted: July 7, 2020    Key Record Dates
Results First Posted: November 7, 2023
Last Update Posted: November 7, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Gossamer Bio Inc. ( GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. ):
seralutinib
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
 Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases