Trial Outcomes & Findings for GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH) (NCT NCT04456998)
NCT ID: NCT04456998
Last Updated: 2023-11-07
Results Overview
PVR was evaluated using right heart catheterization (RHC).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
86 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2023-11-07
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo inhaled orally twice per day (BID) for 24 weeks
|
GB002 (Seralutinib)
GB002 (seralutinib) inhaled orally BID for 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
44
|
|
Overall Study
COMPLETED
|
42
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Placebo inhaled orally twice per day (BID) for 24 weeks
|
GB002 (Seralutinib)
GB002 (seralutinib) inhaled orally BID for 24 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
4
|
|
Overall Study
Protocol Deviation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)
Baseline characteristics by cohort
| Measure |
Placebo
n=42 Participants
Placebo inhaled orally BID for 24 weeks
|
GB002 (Seralutinib)
n=44 Participants
GB002 (seralutinib) inhaled orally BID for 24 weeks
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 11.81 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 12.70 • n=7 Participants
|
48.8 years
STANDARD_DEVIATION 12.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
37 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other, Not Specified
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Intent-to-Treat (ITT) Population: all participants who were randomized.
PVR was evaluated using right heart catheterization (RHC).
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo inhaled orally BID for 24 weeks
|
GB002 (Seralutinib)
n=44 Participants
GB002 (seralutinib) inhaled orally BID for 24 weeks
|
|---|---|---|
|
Change From Baseline to Week 24 in Pulmonary Vascular Resistance (PVR)
|
21.2 dyne•s/cm^5
Interval -37.4 to 79.8
|
-74.9 dyne•s/cm^5
Interval -139.7 to -10.2
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: ITT Population: all participants who were randomized. Participants with a baseline and post-baseline value.
The 6MWT measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo inhaled orally BID for 24 weeks
|
GB002 (Seralutinib)
n=38 Participants
GB002 (seralutinib) inhaled orally BID for 24 weeks
|
|---|---|---|
|
Change From Baseline to Week 24 in Distance Achieved on the Six-Minute Walk Test (6MWT)
|
7.4 meters
Interval -11.2 to 25.9
|
13.9 meters
Interval -5.1 to 32.8
|
Adverse Events
Placebo
Serious events: 6 serious events
Other events: 28 other events
Deaths: 0 deaths
GB002 (Seralutinib)
Serious events: 10 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=42 participants at risk
Placebo inhaled orally BID for 24 weeks
|
GB002 (Seralutinib)
n=44 participants at risk
GB002 (seralutinib) inhaled orally BID for 24 weeks
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/42 • From first dose of study drug through Week 28
|
2.3%
1/44 • From first dose of study drug through Week 28
|
|
Infections and infestations
Pneumonia
|
0.00%
0/42 • From first dose of study drug through Week 28
|
2.3%
1/44 • From first dose of study drug through Week 28
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/42 • From first dose of study drug through Week 28
|
2.3%
1/44 • From first dose of study drug through Week 28
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/42 • From first dose of study drug through Week 28
|
2.3%
1/44 • From first dose of study drug through Week 28
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/42 • From first dose of study drug through Week 28
|
2.3%
1/44 • From first dose of study drug through Week 28
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/42 • From first dose of study drug through Week 28
|
2.3%
1/44 • From first dose of study drug through Week 28
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.4%
1/42 • From first dose of study drug through Week 28
|
0.00%
0/44 • From first dose of study drug through Week 28
|
|
Cardiac disorders
Right ventricular failure
|
7.1%
3/42 • From first dose of study drug through Week 28
|
2.3%
1/44 • From first dose of study drug through Week 28
|
|
Cardiac disorders
Pericardial effusion
|
2.4%
1/42 • From first dose of study drug through Week 28
|
0.00%
0/44 • From first dose of study drug through Week 28
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/42 • From first dose of study drug through Week 28
|
2.3%
1/44 • From first dose of study drug through Week 28
|
|
Vascular disorders
Orthostatic hypotension
|
2.4%
1/42 • From first dose of study drug through Week 28
|
0.00%
0/44 • From first dose of study drug through Week 28
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/42 • From first dose of study drug through Week 28
|
2.3%
1/44 • From first dose of study drug through Week 28
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/42 • From first dose of study drug through Week 28
|
2.3%
1/44 • From first dose of study drug through Week 28
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.00%
0/42 • From first dose of study drug through Week 28
|
2.3%
1/44 • From first dose of study drug through Week 28
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
1/42 • From first dose of study drug through Week 28
|
0.00%
0/44 • From first dose of study drug through Week 28
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/42 • From first dose of study drug through Week 28
|
2.3%
1/44 • From first dose of study drug through Week 28
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/42 • From first dose of study drug through Week 28
|
2.3%
1/44 • From first dose of study drug through Week 28
|
|
Product Issues
Device malfunction
|
0.00%
0/42 • From first dose of study drug through Week 28
|
2.3%
1/44 • From first dose of study drug through Week 28
|
Other adverse events
| Measure |
Placebo
n=42 participants at risk
Placebo inhaled orally BID for 24 weeks
|
GB002 (Seralutinib)
n=44 participants at risk
GB002 (seralutinib) inhaled orally BID for 24 weeks
|
|---|---|---|
|
Infections and infestations
COVID-19
|
16.7%
7/42 • From first dose of study drug through Week 28
|
13.6%
6/44 • From first dose of study drug through Week 28
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/42 • From first dose of study drug through Week 28
|
6.8%
3/44 • From first dose of study drug through Week 28
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
3/42 • From first dose of study drug through Week 28
|
2.3%
1/44 • From first dose of study drug through Week 28
|
|
Psychiatric disorders
Nightmare
|
2.4%
1/42 • From first dose of study drug through Week 28
|
9.1%
4/44 • From first dose of study drug through Week 28
|
|
Nervous system disorders
Headache
|
19.0%
8/42 • From first dose of study drug through Week 28
|
13.6%
6/44 • From first dose of study drug through Week 28
|
|
Nervous system disorders
Dizziness
|
4.8%
2/42 • From first dose of study drug through Week 28
|
11.4%
5/44 • From first dose of study drug through Week 28
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
38.1%
16/42 • From first dose of study drug through Week 28
|
43.2%
19/44 • From first dose of study drug through Week 28
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.5%
4/42 • From first dose of study drug through Week 28
|
9.1%
4/44 • From first dose of study drug through Week 28
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.4%
1/42 • From first dose of study drug through Week 28
|
6.8%
3/44 • From first dose of study drug through Week 28
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/42 • From first dose of study drug through Week 28
|
6.8%
3/44 • From first dose of study drug through Week 28
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
3/42 • From first dose of study drug through Week 28
|
13.6%
6/44 • From first dose of study drug through Week 28
|
|
Gastrointestinal disorders
Nausea
|
14.3%
6/42 • From first dose of study drug through Week 28
|
11.4%
5/44 • From first dose of study drug through Week 28
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/42 • From first dose of study drug through Week 28
|
6.8%
3/44 • From first dose of study drug through Week 28
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
3/42 • From first dose of study drug through Week 28
|
4.5%
2/44 • From first dose of study drug through Week 28
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.4%
1/42 • From first dose of study drug through Week 28
|
6.8%
3/44 • From first dose of study drug through Week 28
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
1/42 • From first dose of study drug through Week 28
|
6.8%
3/44 • From first dose of study drug through Week 28
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
2/42 • From first dose of study drug through Week 28
|
6.8%
3/44 • From first dose of study drug through Week 28
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
3/42 • From first dose of study drug through Week 28
|
0.00%
0/44 • From first dose of study drug through Week 28
|
|
General disorders
Fatigue
|
7.1%
3/42 • From first dose of study drug through Week 28
|
11.4%
5/44 • From first dose of study drug through Week 28
|
|
General disorders
Chest discomfort
|
2.4%
1/42 • From first dose of study drug through Week 28
|
6.8%
3/44 • From first dose of study drug through Week 28
|
Additional Information
GB002, Inc. Study Director
GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Phone: 1-866-668-4083
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER