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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. )

Tracking Information
First Submitted Date  ICMJE April 22, 2019
First Posted Date  ICMJE April 25, 2019
Last Update Posted Date September 29, 2020
Actual Study Start Date  ICMJE February 4, 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2020)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
Number of participants with Treatment-Related Adverse Events GB002 [ Time Frame: Up to 45 days ]
To evaluate the safety and tolerability of GB002
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2020)
  • Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of GB002 (Main study) [ Time Frame: 14 days ]
  • Pharmacokinetics: Maximum Concentration (Cmax) of GB002 (Main study) [ Time Frame: 14 days ]
  • Pharmacokinetics: Area Under the Concentration Curve (AUC) of GB002 (Main study) [ Time Frame: 14 days ]
  • Changes from baseline in 6-Minute Walk Test (6MWT) (OLE study) [ Time Frame: 169 days ]
  • Changes from baseline in WHO Functional Class (OLE study) [ Time Frame: 197 days ]
  • Changes from baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP) (OLE study) [ Time Frame: 169 days ]
  • Changes from baseline in Pulmonary Arterial Hypertension - Symptoms and Impact (PAH-SYMPACT) Quality of Life questionnaire (OLE study) [ Time Frame: 197 days ]
  • Changes from baseline in Right Ventricular function by imaging (OLE study) [ Time Frame: 169 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
  • Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of GB002 [ Time Frame: 14 days ]
  • Pharmacokinetics: Maximum Concentration (Cmax) of GB002 [ Time Frame: 14 days ]
  • Pharmacokinetics: Area Under the Concentration Curve (AUC) of GB002 [ Time Frame: 14 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study of Inhaled GB002 for Treatment of WHO Group I Pulmonary Arterial Hypertension
Official Title  ICMJE 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)
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE Pulmonary Arterial Hypertension
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Cohort 1
    Patients will be randomized to receive inhaled GB002 or Placebo daily for 14 days
    Interventions:
    • Drug: GB002
    • Drug: Placebo
    • Device: Generic Dry Powder Inhaler
  • Experimental: Cohort 2
    Patients will be randomized to receive inhaled GB002 or Placebo daily for 14 days
    Interventions:
    • Drug: GB002
    • Drug: Placebo
    • Device: Generic Dry Powder Inhaler
  • Experimental: Open Label Extension
    Eligible subjects may participate in the Open Label Extension (OLE) study for a period of 24 weeks.
    Interventions:
    • Drug: GB002
    • Device: Generic Dry Powder Inhaler
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 19, 2020)
16
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2019)
24
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: GB002, Inc. 1-866-668-4083 ClinicalTrials@gossamerbio.com
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03926793
Other Study ID Numbers  ICMJE GB002-1101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gossamer Bio Inc. ( GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. )
Study Sponsor  ICMJE GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Gossamer Bio Inc.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP