Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04816604




Registration number
NCT04816604
Ethics application status
Date submitted
23/03/2021
Date registered
25/03/2021
Date last updated
18/04/2024

Titles & IDs
Public title
Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)
Scientific title
An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)
Secondary ID [1] 0 0
GB002-2102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cardiovascular 0 0 0 0
Hypertension

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

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


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

Treatment: Devices: Generic Dry Powder Inhaler
Generic dry powder inhaler for GB002 (seralutinib) 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
Number of Participants With Treatment Emergent Adverse Events
Timepoint [1] 0 0
From first dose of study drug up to 80 months or availability of commercial product
Secondary outcome [1] 0 0
Change from Baseline Over Time on the Six-Minute Walk Test (6MWT)
Timepoint [1] 0 0
Baseline, up to 80 months or availability of commercial product

Eligibility
Key inclusion criteria
Type of Subject and Disease Characteristics

1. Subjects must have completed a prior GB002 PAH study and, in the opinion of the
Investigator and Sponsor, have been compliant with study procedures and have completed
treatment with IP through parent study end-of-treatment (EOT) visit.

2. Treatment with standard of care PAH disease-specific background therapies (stable
dose).

Informed Consent

3. Review and signature of an IRB-approved informed consent form.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medical Conditions

1. Persistent and clinically significant systemic hypertension or hypotension.

2. Interval history of newly developed left-sided heart disease.

3. Potentially life-threatening cardiac arrhythmia with an ongoing risk.

4. Uncontrolled bacterial, viral, or fungal infections which require systemic therapy.

5. Other severe acute or chronic medical or laboratory abnormality that may increase the
risk associated with study participation or GB002 administration or may interfere with
the interpretation of study results and, in the judgment of the Investigator, would
make the subject inappropriate for entry into this study.

6. History of portopulmonary hypertension or portal hypertension due to cirrhosis
classified as Child-Pugh Class A or higher.

7. 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.

8. Current use of inhaled tobacco and/or inhaled marijuana. Ingestible or topical
marijuana is allowed, per local restrictions and regulations.

9. Current alcohol use disorder as defined by DSM-5, and/or history of current
utilization of drugs of abuse (amphetamines, methamphetamines, cocaine, phencyclidine
[PCP]).

10. Have any other condition or reason that, in the opinion of the Investigator and/or the
Sponsor's Medical Monitor (or designee), would prohibit the subject from participating
in the study.

Diagnostic Assessments

11. Chronic renal insufficiency

12. Hemoglobin (Hgb) concentration <8.5 g/dL.

13. Absolute neutrophil count (ANC) < 1x 10^9/L.

14. Platelet count <50 x 10^9/L.

Prior Therapy

15. Use of inhaled prostanoids.

16. Chronic use of oral anticoagulants (ie, vitamin K antagonist such as warfarin or novel
oral anticoagulant [NOAC]/direct oral anticoagulant [DOAC]).

17. Chronic use of any prohibited medication.

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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital, Heart & Lung Transplant Unit - Darlinghurst
Recruitment hospital [2] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [3] 0 0
St. Vincent's Hospital Melbourne - Fitzroy
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
7000 - Hobart
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Kansas
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Utah
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Czechia
State/province [15] 0 0
Praha
Country [16] 0 0
France
State/province [16] 0 0
Le Kremlin-Bicêtre
Country [17] 0 0
Germany
State/province [17] 0 0
Gießen
Country [18] 0 0
Germany
State/province [18] 0 0
Hannover
Country [19] 0 0
Germany
State/province [19] 0 0
Heidelberg
Country [20] 0 0
Germany
State/province [20] 0 0
Regensburg
Country [21] 0 0
Spain
State/province [21] 0 0
Madrid
Country [22] 0 0
Spain
State/province [22] 0 0
Santander
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Cambridge
Country [24] 0 0
United Kingdom
State/province [24] 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
This open-label extension study will evaluate the long-term effects of GB002 (seralutinib) in
subjects who previously participated in a GB002 PAH study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04816604
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
GB002, Inc.
Address 0 0
Country 0 0
Phone 0 0
1-866-668-4083
Fax 0 0
Email 0 0
ClinicalTrials@gossamerbio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04816604