GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

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ClinicalTrials.gov Identifier: NCT04456998

Recruitment Status : Completed

First Posted : July 7, 2020

Results First Posted : November 7, 2023

Last Update Posted : November 7, 2023

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Sponsor:

Information provided by (Responsible Party):

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

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition	Pulmonary Artery Hypertension
Interventions	Drug: GB002 (seralutinib) Drug: Placebo Device: Generic Dry Powder Inhaler
Enrollment	86

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Placebo	GB002 (Seralutinib)
Arm/Group Description	Placebo inhaled orally twice per da...	GB002 (seralutinib) inhaled orally ...
Arm/Group Description	Placebo inhaled orally twice per day (BID) for 24 weeks	GB002 (seralutinib) inhaled orally BID for 24 weeks
Period Title: Overall Study
Started	42	44
Completed	42	38
Not Completed	0	6
Reason Not Completed
Adverse Event	0	4
Protocol Deviation	0	1
Withdrawal by Subject	0	1

Baseline Characteristics

Arm/Group Title		Placebo	GB002 (Seralutinib)	Total
Arm/Group Description		Placebo inhaled orally BID for 24 w...	GB002 (seralutinib) inhaled orally ...	Total of all reporting groups
Arm/Group Description		Placebo inhaled orally BID for 24 weeks	GB002 (seralutinib) inhaled orally BID for 24 weeks	Total of all reporting groups
Overall Number of Baseline Participants		42	44	86
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	42 participants	44 participants	86 participants
		49.5 (11.81)	48.3 (12.70)	48.8 (12.22)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	42 participants	44 participants	86 participants
	Female	38	40	78
	Male	4	4	8
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	42 participants	44 participants	86 participants
	White	37	37	74
	Black or African American	1	0	1
	Asian	2	4	6
	Other, Not Specified	2	3	5
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	42 participants	44 participants	86 participants
	Hispanic or Latino	6	8	14
	Not Hispanic or Latino	34	36	70
	Not Reported	2	0	2

Outcome Measures

1.Primary Outcome


Title	Change From Baseline to Week 24 in Pulmonary Vascular Resistance (PVR)
Description	PVR was evaluated using right heart catheterization (RHC).
Description	PVR was evaluated using right heart catheterization (RHC).
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: all participants who were randomized.


Arm/Group Title	Placebo	GB002 (Seralutinib)
Arm/Group Description:	Placebo inhaled orally BID for 24 w...	GB002 (seralutinib) inhaled orally ...
Arm/Group Description:	Placebo inhaled orally BID for 24 weeks	GB002 (seralutinib) inhaled orally BID for 24 weeks
Overall Number of Participants Analyzed	42	44
Least Squares Mean (95% Confidence Interval) Unit of Measure: dyne•s/cm^5
	21.2 (-37.4 to 79.8)	-74.9 (-139.7 to -10.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, GB002 (Seralutinib)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0310
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-96.1
	Confidence Interval	(2-Sided) 95% -183.5 to -8.8
	Estimation Comments	GB002 vs. Placebo

2.Secondary Outcome


Title	Change From Baseline to Week 24 in Distance Achieved on the Six-Minute Walk Test (6MWT)
Description	The 6MWT measures the distance a participant is able to walk quickly o...
Description	The 6MWT measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

ITT Population: all participants who were randomized. Participants with a baseline and post-baseline value.


Arm/Group Title	Placebo	GB002 (Seralutinib)
Arm/Group Description:	Placebo inhaled orally BID for 24 w...	GB002 (seralutinib) inhaled orally ...
Arm/Group Description:	Placebo inhaled orally BID for 24 weeks	GB002 (seralutinib) inhaled orally BID for 24 weeks
Overall Number of Participants Analyzed	42	38
Least Squares Mean (95% Confidence Interval) Unit of Measure: meters
	7.4 (-11.2 to 25.9)	13.9 (-5.1 to 32.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, GB002 (Seralutinib)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.5972
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	6.5
	Confidence Interval	(2-Sided) 95% -17.9 to 30.9
	Estimation Comments	GB002 vs. Placebo

Adverse Events

Time Frame	From first dose of study drug through Week 28
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Placebo	GB002 (Seralutinib)
Arm/Group Description	Placebo inhaled orally BID for 24 w...	GB002 (seralutinib) inhaled orally ...
Arm/Group Description	Placebo inhaled orally BID for 24 weeks	GB002 (seralutinib) inhaled orally BID for 24 weeks
All-Cause Mortality
	Placebo	GB002 (Seralutinib)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/42 (0.00%)	0/44 (0.00%)
Serious Adverse Events Serious Adverse Events
	Placebo	GB002 (Seralutinib)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	6/42 (14.29%)	10/44 (22.73%)
Cardiac disorders
Right ventricular failure ^† 1	3/42 (7.14%)	1/44 (2.27%)
Pericardial effusion ^† 1	1/42 (2.38%)	0/44 (0.00%)
Gastrointestinal disorders
Enteritis ^† 1	0/42 (0.00%)	1/44 (2.27%)
Obstructive pancreatitis ^† 1	0/42 (0.00%)	1/44 (2.27%)
Infections and infestations
Appendicitis ^† 1	0/42 (0.00%)	1/44 (2.27%)
Pneumonia ^† 1	0/42 (0.00%)	1/44 (2.27%)
Staphylococcal bacteraemia ^† 1	0/42 (0.00%)	1/44 (2.27%)
Vascular device infection ^† 1	0/42 (0.00%)	1/44 (2.27%)
Metabolism and nutrition disorders
Hypokalaemia ^† 1	1/42 (2.38%)	0/44 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma ^† 1	0/42 (0.00%)	1/44 (2.27%)
Squamous cell carcinoma ^† 1	0/42 (0.00%)	1/44 (2.27%)
Product Issues
Device malfunction ^† 1	0/42 (0.00%)	1/44 (2.27%)
Respiratory, thoracic and mediastinal disorders
Haemoptysis ^† 1	0/42 (0.00%)	1/44 (2.27%)
Pleural effusion ^† 1	0/42 (0.00%)	1/44 (2.27%)
Pulmonary arterial hypertension ^† 1	0/42 (0.00%)	1/44 (2.27%)
Dyspnoea ^† 1	1/42 (2.38%)	0/44 (0.00%)
Vascular disorders
Jugular vein thrombosis ^† 1	0/42 (0.00%)	1/44 (2.27%)
Orthostatic hypotension ^† 1	1/42 (2.38%)	0/44 (0.00%)
1 Term from vocabulary, MedDRA 24.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Placebo	GB002 (Seralutinib)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	28/42 (66.67%)	31/44 (70.45%)
Gastrointestinal disorders
Diarrhoea ^† 1	3/42 (7.14%)	6/44 (13.64%)
Nausea ^† 1	6/42 (14.29%)	5/44 (11.36%)
Abdominal pain lower ^† 1	0/42 (0.00%)	3/44 (6.82%)
Vomiting ^† 1	3/42 (7.14%)	2/44 (4.55%)
General disorders
Fatigue ^† 1	3/42 (7.14%)	5/44 (11.36%)
Chest discomfort ^† 1	1/42 (2.38%)	3/44 (6.82%)
Infections and infestations
COVID-19 ^† 1	7/42 (16.67%)	6/44 (13.64%)
Nasopharyngitis ^† 1	0/42 (0.00%)	3/44 (6.82%)
Upper respiratory tract infection ^† 1	3/42 (7.14%)	1/44 (2.27%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	1/42 (2.38%)	3/44 (6.82%)
Back pain ^† 1	2/42 (4.76%)	3/44 (6.82%)
Pain in extremity ^† 1	3/42 (7.14%)	0/44 (0.00%)
Nervous system disorders
Headache ^† 1	8/42 (19.05%)	6/44 (13.64%)
Dizziness ^† 1	2/42 (4.76%)	5/44 (11.36%)
Psychiatric disorders
Nightmare ^† 1	1/42 (2.38%)	4/44 (9.09%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	16/42 (38.10%)	19/44 (43.18%)
Dyspnoea ^† 1	4/42 (9.52%)	4/44 (9.09%)
Nasal congestion ^† 1	1/42 (2.38%)	3/44 (6.82%)
Throat irritation ^† 1	0/42 (0.00%)	3/44 (6.82%)
Skin and subcutaneous tissue disorders
Rash ^† 1	1/42 (2.38%)	3/44 (6.82%)
1 Term from vocabulary, MedDRA 24.0 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	GB002, Inc. Study Director
Organization:	GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Phone:	1-866-668-4083
EMail:	ClinicalTrials@gossamerbio.com

Layout table for additonal information

Responsible Party:	Gossamer Bio Inc. ( GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. )
ClinicalTrials.gov Identifier:	NCT04456998
Other Study ID Numbers:	GB002-2101
First Submitted:	June 30, 2020
First Posted:	July 7, 2020
Results First Submitted:	October 16, 2023
Results First Posted:	November 7, 2023
Last Update Posted:	November 7, 2023

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