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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03926793

Recruitment Status Completed

First Posted April 25, 2019

Last update posted May 18, 2021

Study Description

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:Pulmonary Arterial Hypertension
  • Intervention/Treatment: Drug: GB002
    Drug: Placebo
    Device: Generic Dry Powder Inhaler
  • Phase: 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
  • Study Type: Interventional
  • Actual Enrollment: 8 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • 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 2020
  • Actual Primary Completion Date: May 2021
  • Actual Study Completion Date: May 2021
Arms and interventions
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
  • Primary Outcome Measures: 1. 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
  • 2. 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
  • Secondary Outcome Measures: 1. Pharmacokinetics: Maximum Concentration (Cmax) of GB002 (Main study) [ Time Frame: 14 days ]
  • 2. Pharmacokinetics: Area Under the Concentration Curve (AUC) of GB002 (Main study) [ Time Frame: 14 days ]
  • 3. Changes from baseline in 6-Minute Walk Test (6MWT) (OLE study) [ Time Frame: 169 days ]
  • 4. Changes from baseline in WHO Functional Class (OLE study) [ Time Frame: 197 days ]
  • 5. Changes from baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP) (OLE study) [ Time Frame: 169 days ]
  • 6. Changes from baseline in Pulmonary Arterial Hypertension - Symptoms and Impact (PAH-SYMPACT) Quality of Life questionnaire (OLE study) [ Time Frame: 197 days ]
  • 7. Changes from baseline in Right Ventricular function by imaging (OLE study) [ Time Frame: 169 days ]
  • 8. Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of GB002 (Main study) [ Time Frame: 14 days ]
Eligibility Criteria
  • Ages Eligible for Study: 18 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
Contacts
Locations
Show 14 Study Locations
Sponsors and Collaborators

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

More Information
  • Responsible Party: GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
  • ClinicalTrials.gov Identifier: NCT03926793 History of Changes
  • Other Study ID Numbers: GB002-1101
  • First Posted: April 25, 2019 Key Record Dates
  • Last Update Posted: May 18, 2021
  • Last Verified: May 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Additional relevant MeSH terms: Familial Primary Pulmonary Hypertension Hypertension