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Clinical Study of Inhaled GB002 for Treatment of WHO Group I Pulmonary Arterial Hypertension (PAH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03926793
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : September 29, 2020
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:
This is a Phase 1B, randomized, participant- and investigator-blinded, placebo-controlled, multi-center clinical trial to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and biomarkers of inhaled GB002 in adults with World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH).

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: GB002 Drug: Placebo Device: Generic Dry Powder Inhaler Phase 1

Detailed Description:

The primary objective for this trial is to evaluate the safety and tolerability of GB002. The secondary objective for this trial is to evaluate the PK parameters of GB002. Exploratory objectives are to evaluate the PD readouts, change in WHO Group I functional class, and change in quality of life associated with GB002 treatment.

In this Phase 1B study, two dose levels of GB002 will be tested in adult participants with PAH. Four participants in cohort 1 will be randomized to receive up to two daily doses of either active drug or placebo, with 3 subjects receiving GB002 and 1 subject receiving placebo. An additional 4 participants (3 active and 1 placebo) may be added to cohort 1 at the discretion of the Data Review Committee (DRC). The dose and dosing interval (i.e., once daily or twice daily) for the second cohort will be determined by review of the safety, tolerability, and drug levels in the blood from cohort 1. Cohort 2 participants will also be randomized such that 6 subjects receive GB002 and 2 subjects receive placebo.

Eligible subjects who have completed the 2 week treatment period have the option to participate in a 24 week open label extension.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Clinical site investigators, study personnel, and study subjects will be blinded to treatment assignment; however, the Sponsor will be unblinded.
Primary Purpose: Treatment
Official Title: A Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB002 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension (PAH)
Actual Study Start Date : February 4, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
Patients will be randomized to receive inhaled GB002 or Placebo daily for 14 days
 Drug: GB002
GB002 low dose or high dose for inhalation

Drug: Placebo
Placebo for inhalation

Device: Generic Dry Powder Inhaler
Generic dry powder inhaler for GB002 or Placebo delivery
Experimental: Cohort 2
Patients will be randomized to receive inhaled GB002 or Placebo daily for 14 days
 Drug: GB002
GB002 low dose or high dose for inhalation

Drug: Placebo
Placebo for inhalation

Device: Generic Dry Powder Inhaler
Generic dry powder inhaler for GB002 or Placebo delivery
Experimental: Open Label Extension
Eligible subjects may participate in the Open Label Extension (OLE) study for a period of 24 weeks.
 Drug: GB002
GB002 low dose or high dose for inhalation

Device: Generic Dry Powder Inhaler
Generic dry powder inhaler for GB002 or Placebo delivery


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with Treatment-Related Adverse Events GB002 (Main study) [ Time Frame: Up to 45 days ]
    To evaluate the safety and tolerability of GB002

  2. Number of participants with Treatment-Related Adverse Events GB002 (OLE study) [ Time Frame: Up to 200 days ]
    To evaluate the long-term safety and tolerability and efficacy of GB002


Secondary Outcome Measures :
  1. Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of GB002 (Main study) [ Time Frame: 14 days ]
  2. Pharmacokinetics: Maximum Concentration (Cmax) of GB002 (Main study) [ Time Frame: 14 days ]
  3. Pharmacokinetics: Area Under the Concentration Curve (AUC) of GB002 (Main study) [ Time Frame: 14 days ]
  4. Changes from baseline in 6-Minute Walk Test (6MWT) (OLE study) [ Time Frame: 169 days ]
  5. Changes from baseline in WHO Functional Class (OLE study) [ Time Frame: 197 days ]
  6. Changes from baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP) (OLE study) [ Time Frame: 169 days ]
  7. Changes from baseline in Pulmonary Arterial Hypertension - Symptoms and Impact (PAH-SYMPACT) Quality of Life questionnaire (OLE study) [ Time Frame: 197 days ]
  8. Changes from baseline in Right Ventricular function by imaging (OLE study) [ Time Frame: 169 days ]

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. Adult (males and females) aged 18 to 75 years (inclusive) with pulmonary arterial hypertension (PAH) (Main study)

  2. A current diagnosis of symptomatic PAH classified by one of the following (Main and OLE study):

    1. Idiopathic (IPAH) or heritable pulmonary arterial hypertension (HPAH)

    2. PAH associated with one of the following connective tissue diseases (CTDs):

      systemic sclerosis, rheumatoid arthritis, mixed CTD or overlap syndrome, or systemic lupus erythematosus

    3. PAH associated with anorexigen or methamphetamine use
  3. World Health Organization (WHO)/New York Heart Association (NYHA) functional class II-IV symptomatology (Main study)

Exclusion Criteria:

  1. Clinically significant systemic hypertension or hypotension (Main and OLE study)
  2. History of left-sided heart disease and/or clinically significant cardiac disease (Main and OLE study)
  3. History of decompensated right heart failure within 30 days of screening (e.g., hospitalization for PAH or the need to add an additional PAH medication) (Main 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): NCT03926793


Contacts
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Contact: GB002, Inc. 1-866-668-4083 ClinicalTrials@gossamerbio.com

Locations
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United States, California
UCSD Medical Center Recruiting
La Jolla, California, United States, 92037
University of California Davis Medical Center Recruiting
Sacramento, California, United States, 95817
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
United States, Florida
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
United States, Kentucky
Kentuckiana Pulmonary Research Center Recruiting
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, North Carolina
Duke Early Phase Research Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pittsburgh Medical Center Montefiore University Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
VitaLink Research - Anderson Recruiting
Anderson, South Carolina, United States, 29621
United Kingdom
Golden Jubilee National Hospital Recruiting
Glasgow, United Kingdom, G814DY
Hammersmith Hospital, Imperial Healthcare NHS Trust Recruiting
London, United Kingdom, W12 0HS
Sponsors and Collaborators
GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
More Information
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Responsible Party: GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
ClinicalTrials.gov Identifier: NCT03926793    
Other Study ID Numbers: GB002-1101
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
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
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
 Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases