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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04456998




Registration number
NCT04456998
Ethics application status
Date submitted
30/06/2020
Date registered
7/07/2020

Titles & IDs
Public title
GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)
Scientific 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)
Secondary ID [1] 0 0
GB002-2101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Artery Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GB002 (seralutinib)
Treatment: Drugs - Placebo
Treatment: Devices - Generic Dry Powder Inhaler

Experimental: GB002 (seralutinib) - GB002 (seralutinib) inhaled orally twice per day (BID) for 24 weeks

Placebo comparator: Placebo - Placebo inhaled orally BID for 24 weeks


Treatment: Drugs: GB002 (seralutinib)
Capsule containing GB002 (seralutinib)

Treatment: Drugs: Placebo
Matching capsule containing placebo

Treatment: Devices: Generic Dry Powder Inhaler
Generic dry powder inhaler for GB002 (seralutinib) or placebo delivery
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to Week 24 in Pulmonary Vascular Resistance (PVR)
Timepoint [1] 0 0
Baseline, Week 24
Secondary outcome [1] 0 0
Change From Baseline to Week 24 in Distance Achieved on the Six-Minute Walk Test (6MWT)
Timepoint [1] 0 0
Baseline, Week 24

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2022
Sample size
Target
Accrual to date
Final
86
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [3] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
TAS 7000 - Hobart
Recruitment postcode(s) [4] 0 0
NSW 2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
New Mexico
Country [14] 0 0
United States of America
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New York
Country [15] 0 0
United States of America
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Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
Wisconsin
Country [22] 0 0
Austria
State/province [22] 0 0
Graz
Country [23] 0 0
Austria
State/province [23] 0 0
Wien
Country [24] 0 0
Belgium
State/province [24] 0 0
Bruxelles
Country [25] 0 0
Belgium
State/province [25] 0 0
Leuven
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
Canada
State/province [27] 0 0
Calgary
Country [28] 0 0
Canada
State/province [28] 0 0
London
Country [29] 0 0
Czechia
State/province [29] 0 0
Praha
Country [30] 0 0
France
State/province [30] 0 0
Le Kremlin-Bicetre
Country [31] 0 0
France
State/province [31] 0 0
Montpellier
Country [32] 0 0
Germany
State/province [32] 0 0
Bad Oeynhausen
Country [33] 0 0
Germany
State/province [33] 0 0
Berlin
Country [34] 0 0
Germany
State/province [34] 0 0
Gießen
Country [35] 0 0
Germany
State/province [35] 0 0
Hannover
Country [36] 0 0
Germany
State/province [36] 0 0
Heidelberg
Country [37] 0 0
Germany
State/province [37] 0 0
Regensburg
Country [38] 0 0
Serbia
State/province [38] 0 0
Belgrade
Country [39] 0 0
Serbia
State/province [39] 0 0
Sremska Kamenica
Country [40] 0 0
Spain
State/province [40] 0 0
Barcelona
Country [41] 0 0
Spain
State/province [41] 0 0
Madrid
Country [42] 0 0
Spain
State/province [42] 0 0
Santander
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Cambridge
Country [44] 0 0
United Kingdom
State/province [44] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Richard Aranda
Address 0 0
Gossamer Bio Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04456998