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GB001 in Adult Subjects With Moderate to Severe Asthma

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03683576
Recruitment Status : Completed
First Posted : September 25, 2018
Results First Posted : August 23, 2021
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Gossamer Bio Inc. ( GB001, 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 Asthma
Interventions Drug: GB001
Drug: Placebo
Enrollment 481
Recruitment Details  
Pre-assignment Details The study included a run-in period, during which eligibility for randomization was determined. 731 participants entered the run-in period, 481 of whom were randomized.
Arm/Group Title Placebo GB001 20 mg GB001 40 mg GB001 60 mg
Hide Arm/Group Description Placebo once per day (QD) for 24 weeks GB001 20 mg QD for 24 weeks GB001 40 mg QD for 24 weeks GB001 60 mg QD for 24 weeks
Period Title: Overall Study
Started [1] 120 120 118 122
Completed 114 116 106 114
Not Completed 6 4 12 8
Reason Not Completed
Withdrawal by Subject             2             0             8             3
Adverse Event             3             0             0             4
Lack of Efficacy             1             0             1             1
Lost to Follow-up             0             1             2             0
Other, Not Specified             0             2             0             0
Protocol Violation             0             1             1             0
[1]
Randomized and treated. One participant randomized to GB001 40 mg was never treated and was therefore excluded from the Intent-to-Treat (ITT) and Safety Analysis Populations.
Arm/Group Title Placebo GB001 20 mg GB001 40 mg GB001 60 mg Total
Hide Arm/Group Description Placebo QD for 24 weeks GB001 20 mg QD for 24 weeks GB001 40 mg QD for 24 weeks GB001 60 mg QD for 24 weeks Total of all reporting groups
Overall Number of Baseline Participants 120 120 118 122 480
Hide Baseline Analysis Population Description
Intent to Treat (ITT) Population: all participants who were randomized and received at least 1 dose of study treatment
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants 120 participants 118 participants 122 participants 480 participants
51.5  (11.91) 52.8  (11.81) 52.9  (13.32) 49.9  (14.37) 51.8  (12.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 120 participants 118 participants 122 participants 480 participants
Female 76 86 74 72 308
Male 44 34 44 50 172
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 120 participants 118 participants 122 participants 480 participants
White 108 109 109 112 438
Black or African American 6 7 8 6 27
Asian 4 3 0 1 8
Other, Not Specified 1 1 1 3 6
Native Hawaiian or Other Pacific Islander 1 0 0 0 1
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 120 participants 118 participants 122 participants 480 participants
Not Hispanic or Latino 107 113 112 116 448
Hispanic or Latino 11 2 5 5 23
Unknown or Not Reported 2 5 1 1 9
1.Primary Outcome
Title Proportion of Participants Who Experience Worsening of Asthma by Week 24
Hide Description

Proportion of participants who experience worsening of asthma by Week 24 as defined by at least 1 of the following:

  • On 2 consecutive days, morning (AM) peak expiratory flow (PEF) ≤ 75% of mean AM PEF measured over the last 7 days of the Run-in
  • Forced expiratory volume in 1 second (FEV1) < 80% of baseline
  • Increase in rescue medication use of ≥ 6 puffs/day on 2 consecutive days compared to mean use over the last 7 days of the Run-in
  • Increase in Asthma Control Questionnaire 5 (ACQ-5; see Outcome Measure 2 for description) score of ≥ 0.5 compared to baseline
  • The occurrence of a severe asthma exacerbation (asthma attack) defined as deterioration of asthma that leads to the use of systemic corticosteroids for at least 3 days, hospitalization, or an Emergency Department visit.
Time Frame up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants who were randomized and received at least 1 dose of study treatment.
Arm/Group Title Placebo GB001 20 mg GB001 40 mg GB001 60 mg
Hide Arm/Group Description:
Placebo QD for 24 weeks
GB001 20 mg QD for 24 weeks
GB001 40 mg QD for 24 weeks
GB001 60 mg QD for 24 weeks
Overall Number of Participants Analyzed 120 120 118 122
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.658
(0.570 to 0.737)
0.567
(0.477 to 0.652)
0.568
(0.478 to 0.654)
0.557
(0.469 to 0.642)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GB001 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1425
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.674
Confidence Interval (2-Sided) 95%
0.398 to 1.142
Estimation Comments GB001 20 mg vs. Placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GB001 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1482
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.677
Confidence Interval (2-Sided) 95%
0.399 to 1.149
Estimation Comments GB001 40 mg vs. Placebo
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GB001 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1086
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.651
Confidence Interval (2-Sided) 95%
0.385 to 1.100
Estimation Comments GB001 60 mg vs. Placebo
2.Secondary Outcome
Title Change From Baseline to Week 24 in Asthma Control Questionnaire - 5 (ACQ-5) Score
Hide Description The ACQ-5 is a 5-item questionnaire which has been developed as a measure of the participant's asthma control that can be quickly and easily completed. The questions are designed to be self-completed by the participant. The 5 questions enquire about the frequency and/or severity of symptoms in the prior week (nocturnal awakening, activity limitation, shortness of breath, wheeze). The response options for each of these questions consists of a zero (no impairment/limitation) to 6 (total impairment/limitation) scale.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants who were randomized and received at least 1 dose of study treatment.
Arm/Group Title Placebo GB001 20 mg GB001 40 mg GB001 60 mg
Hide Arm/Group Description:
Placebo QD for 24 weeks
GB001 20 mg QD for 24 weeks
GB001 40 mg QD for 24 weeks
GB001 60 mg QD for 24 weeks
Overall Number of Participants Analyzed 120 120 118 122
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
-0.89
(-1.05 to -0.73)
-1.04
(-1.20 to -0.89)
-1.04
(-1.20 to -0.88)
-1.08
(-1.24 to -0.92)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GB001 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1647
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-0.36 to 0.06
Estimation Comments GB001 20 mg vs. Placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GB001 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1737
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-0.37 to 0.07
Estimation Comments GB001 40 mg vs. Placebo
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GB001 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0879
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.40 to 0.03
Estimation Comments GB001 60 mg vs. Placebo
3.Secondary Outcome
Title Change From Baseline to Week 24 in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Hide Description Pre-albuterol/salbutamol morning FEV1 was measured using electronic spirometry.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants who were randomized and received at least 1 dose of study treatment.
Arm/Group Title Placebo GB001 20 mg GB001 40 mg GB001 60 mg
Hide Arm/Group Description:
Placebo QD for 24 weeks
GB001 20 mg QD for 24 weeks
GB001 40 mg QD for 24 weeks
GB001 60 mg QD for 24 weeks
Overall Number of Participants Analyzed 120 120 118 122
Least Squares Mean (95% Confidence Interval)
Unit of Measure: liters (L)
0.105
(0.027 to 0.182)
0.121
(0.041 to 0.200)
0.146
(0.064 to 0.227)
0.180
(0.102 to 0.257)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GB001 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7718
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.016
Confidence Interval (2-Sided) 95%
-0.091 to 0.123
Estimation Comments GB001 20 mg vs. Placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GB001 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4562
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.041
Confidence Interval (2-Sided) 95%
-0.067 to 0.149
Estimation Comments GB001 40 mg vs. Placebo
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GB001 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1631
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.075
Confidence Interval (2-Sided) 95%
-0.030 to 0.180
Estimation Comments GB001 60 mg vs. Placebo
4.Secondary Outcome
Title Time to First Asthma Worsening
Hide Description Time to first asthma worsening is defined as the time from the date of the first dose of study treatment to the first date that any of the components of asthma worsening endpoint is met. See Outcome Measure 1 for the definition of asthma worsening.
Time Frame up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants who were randomized and received at least 1 dose of study treatment.
Arm/Group Title Placebo GB001 20 mg GB001 40 mg GB001 60 mg
Hide Arm/Group Description:
Placebo QD for 24 weeks
GB001 20 mg QD for 24 weeks
GB001 40 mg QD for 24 weeks
GB001 60 mg QD for 24 weeks
Overall Number of Participants Analyzed 120 120 118 122
Median (95% Confidence Interval)
Unit of Measure: weeks
10.57
(7.857 to 16.286)
17.43 [1] 
(12.143 to NA)
17.57
(13.429 to 24.286)
19.86 [1] 
(14.857 to NA)
[1]
NA (Not Available) indicates the value is not estimable due to an insufficient number of observed events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GB001 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0466
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.719
Confidence Interval (2-Sided) 95%
0.519 to 0.995
Estimation Comments GB001 20 mg vs. Placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GB001 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1222
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.773
Confidence Interval (2-Sided) 95%
0.558 to 1.071
Estimation Comments GB001 40 mg vs. Placebo
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GB001 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0304
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.698
Confidence Interval (2-Sided) 95%
0.505 to 0.967
Estimation Comments GB001 60 mg vs. Placebo
5.Secondary Outcome
Title Annualized Rate of Severe Asthma Exacerbations
Hide Description A severe asthma exacerbation is defined as deterioration of asthma that leads to the use of systemic corticosteroids for at least 3 days, hospitalization, or an Emergency Department visit.
Time Frame up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants who were randomized and received at least 1 dose of study treatment.
Arm/Group Title Placebo GB001 20 mg GB001 40 mg GB001 60 mg
Hide Arm/Group Description:
Placebo QD for 24 weeks
GB001 20 mg QD for 24 weeks
GB001 40 mg QD for 24 weeks
GB001 60 mg QD for 24 weeks
Overall Number of Participants Analyzed 120 120 118 122
Least Squares Mean (95% Confidence Interval)
Unit of Measure: events/year
0.933
(0.664 to 1.311)
0.744
(0.517 to 1.070)
0.698
(0.480 to 1.015)
0.829
(0.585 to 1.174)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GB001 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3382
Comments [Not Specified]
Method Negative binomial regression model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.797
Confidence Interval (2-Sided) 95%
0.501 to 1.268
Estimation Comments GB001 20 mg vs. Placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GB001 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2248
Comments [Not Specified]
Method Negative binomial regression model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.748
Confidence Interval (2-Sided) 95%
0.469 to 1.195
Estimation Comments GB001 40 mg vs. Placebo
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GB001 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6090
Comments [Not Specified]
Method Negative binomial regression model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.889
Confidence Interval (2-Sided) 95%
0.565 to 1.397
Estimation Comments GB001 60 mg vs. Placebo
6.Secondary Outcome
Title Change From Baseline to Week 24 in Post-Bronchodilator FEV1
Hide Description Post-albuterol/salbutamol morning FEV1 was measured using electronic spirometry.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants who were randomized and received at least 1 dose of study treatment.
Arm/Group Title Placebo GB001 20 mg GB001 40 mg GB001 60 mg
Hide Arm/Group Description:
Placebo QD for 24 weeks
GB001 20 mg QD for 24 weeks
GB001 40 mg QD for 24 weeks
GB001 60 mg QD for 24 weeks
Overall Number of Participants Analyzed 120 120 118 122
Least Squares Mean (95% Confidence Interval)
Unit of Measure: L
0.012
(-0.064 to 0.088)
-0.011
(-0.088 to 0.066)
0.047
(-0.037 to 0.131)
0.091
(0.015 to 0.166)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GB001 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6645
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.023
Confidence Interval (2-Sided) 95%
-0.127 to 0.081
Estimation Comments GB001 20 mg vs. Placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GB001 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5288
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.035
Confidence Interval (2-Sided) 95%
-0.074 to 0.144
Estimation Comments GB001 40 mg vs. Placebo
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GB001 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1362
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.079
Confidence Interval (2-Sided) 95%
-0.025 to 0.182
Estimation Comments GB001 60 mg vs. Placebo
7.Secondary Outcome
Title Change From Baseline to Week 24 in Morning Peak Expiratory Flow (AM PEF)
Hide Description AM PEF was measured by participants using an electronic diary.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: all participants who were randomized and received at least 1 dose of study treatment.
Arm/Group Title Placebo GB001 20 mg GB001 40 mg GB001 60 mg
Hide Arm/Group Description:
Placebo QD for 24 weeks
GB001 20 mg QD for 24 weeks
GB001 40 mg QD for 24 weeks
GB001 60 mg QD for 24 weeks
Overall Number of Participants Analyzed 120 120 118 122
Least Squares Mean (95% Confidence Interval)
Unit of Measure: L/min
8.993
(-1.514 to 19.499)
15.115
(4.779 to 25.451)
22.941
(12.042 to 33.839)
14.581
(4.140 to 25.021)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GB001 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3957
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 6.122
Confidence Interval (2-Sided) 95%
-8.007 to 20.251
Estimation Comments GB001 20 mg vs. Placebo
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GB001 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0598
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 13.948
Confidence Interval (2-Sided) 95%
-0.578 to 28.474
Estimation Comments GB001 40 mg vs. Placebo
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GB001 60 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4376
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 5.588
Confidence Interval (2-Sided) 95%
-8.522 to 19.698
Estimation Comments GB001 60 mg vs. Placebo
8.Secondary Outcome
Title Percentage of Participants With a Treatment-Emergent Adverse Event (AE)
Hide Description An adverse event (AE) is any untoward medical occurrence in a participant, whether or not considered related to study treatment. Abnormal laboratory test results or other safety assessments, including those that worsened from baseline, that were considered clinically significant in the medical and scientific judgment of the investigator were to be reported as AEs.
Time Frame From first dose of study treatment through Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants who received at least 1 dose of study treatment.
Arm/Group Title Placebo GB001 20 mg GB001 40 mg GB001 60 mg
Hide Arm/Group Description:
Placebo QD for 24 weeks
GB001 20 mg QD for 24 weeks
GB001 40 mg QD for 24 weeks
GB001 60 mg QD for 24 weeks
Overall Number of Participants Analyzed 120 120 118 122
Measure Type: Number
Unit of Measure: percentage of participants
65.8 65.8 69.5 68.0
Time Frame From first dose of study treatment through Week 28
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo GB001 20 mg GB001 40 mg GB001 60 mg
Hide Arm/Group Description Placebo QD for 24 weeks GB001 20 mg QD for 24 weeks GB001 40 mg QD for 24 weeks GB001 60 mg QD for 24 weeks
All-Cause Mortality
Placebo GB001 20 mg GB001 40 mg GB001 60 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/120 (0.00%)   0/120 (0.00%)   0/118 (0.00%)   1/122 (0.82%) 
Hide Serious Adverse Events
Placebo GB001 20 mg GB001 40 mg GB001 60 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/120 (7.50%)   5/120 (4.17%)   5/118 (4.24%)   7/122 (5.74%) 
Cardiac disorders         
Left ventricular failure  1  0/120 (0.00%)  0/120 (0.00%)  1/118 (0.85%)  0/122 (0.00%) 
Acute myocardial infarction  1  1/120 (0.83%)  0/120 (0.00%)  0/118 (0.00%)  0/122 (0.00%) 
Myocardial infarction  1  1/120 (0.83%)  0/120 (0.00%)  0/118 (0.00%)  0/122 (0.00%) 
Gastrointestinal disorders         
Gastrooesophageal reflux disease  1  0/120 (0.00%)  1/120 (0.83%)  0/118 (0.00%)  0/122 (0.00%) 
Hepatobiliary disorders         
Liver injury  1  0/120 (0.00%)  0/120 (0.00%)  0/118 (0.00%)  1/122 (0.82%) 
Infections and infestations         
Pneumonia  1  1/120 (0.83%)  0/120 (0.00%)  0/118 (0.00%)  1/122 (0.82%) 
Sinusitis  1  0/120 (0.00%)  0/120 (0.00%)  1/118 (0.85%)  0/122 (0.00%) 
Influenza  1  1/120 (0.83%)  0/120 (0.00%)  0/118 (0.00%)  0/122 (0.00%) 
Respiratory tract infection  1  1/120 (0.83%)  0/120 (0.00%)  0/118 (0.00%)  0/122 (0.00%) 
Injury, poisoning and procedural complications         
Foot fracture  1  0/120 (0.00%)  0/120 (0.00%)  0/118 (0.00%)  1/122 (0.82%) 
Fracture displacement  1  1/120 (0.83%)  0/120 (0.00%)  0/118 (0.00%)  0/122 (0.00%) 
Metabolism and nutrition disorders         
Mineral metabolism disorder  1  0/120 (0.00%)  0/120 (0.00%)  0/118 (0.00%)  1/122 (0.82%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  0/120 (0.00%)  0/120 (0.00%)  1/118 (0.85%)  0/122 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Chronic myeloid leukaemia  1  0/120 (0.00%)  0/120 (0.00%)  0/118 (0.00%)  1/122 (0.82%) 
Small cell lung cancer  1  0/120 (0.00%)  0/120 (0.00%)  0/118 (0.00%)  1/122 (0.82%) 
Nervous system disorders         
Myasthenia gravis  1  1/120 (0.83%)  0/120 (0.00%)  0/118 (0.00%)  0/122 (0.00%) 
Renal and urinary disorders         
Ureterolithiasis  1  0/120 (0.00%)  1/120 (0.83%)  0/118 (0.00%)  0/122 (0.00%) 
Reproductive system and breast disorders         
Uterine haemorrhage  1  0/120 (0.00%)  0/120 (0.00%)  1/118 (0.85%)  0/122 (0.00%) 
Uterine polyp  1  0/120 (0.00%)  0/120 (0.00%)  1/118 (0.85%)  0/122 (0.00%) 
Metrorrhagia  1  1/120 (0.83%)  0/120 (0.00%)  0/118 (0.00%)  0/122 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Asthma  1  2/120 (1.67%)  2/120 (1.67%)  2/118 (1.69%)  1/122 (0.82%) 
Acute respiratory failure  1  0/120 (0.00%)  0/120 (0.00%)  1/118 (0.85%)  0/122 (0.00%) 
Allergic bronchitis  1  0/120 (0.00%)  0/120 (0.00%)  1/118 (0.85%)  0/122 (0.00%) 
Chronic obstructive pulmonary disease  1  0/120 (0.00%)  0/120 (0.00%)  1/118 (0.85%)  0/122 (0.00%) 
Pneumothorax  1  0/120 (0.00%)  0/120 (0.00%)  0/118 (0.00%)  1/122 (0.82%) 
Skin and subcutaneous tissue disorders         
Angioedema  1  0/120 (0.00%)  1/120 (0.83%)  0/118 (0.00%)  0/122 (0.00%) 
Vascular disorders         
Hypertension  1  0/120 (0.00%)  0/120 (0.00%)  1/118 (0.85%)  0/122 (0.00%) 
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo GB001 20 mg GB001 40 mg GB001 60 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   45/120 (37.50%)   53/120 (44.17%)   59/118 (50.00%)   55/122 (45.08%) 
Gastrointestinal disorders         
Diarrhoea  1  3/120 (2.50%)  6/120 (5.00%)  1/118 (0.85%)  4/122 (3.28%) 
Infections and infestations         
Nasopharyngitis  1  19/120 (15.83%)  23/120 (19.17%)  29/118 (24.58%)  17/122 (13.93%) 
Sinusitis  1  3/120 (2.50%)  4/120 (3.33%)  10/118 (8.47%)  3/122 (2.46%) 
Upper respiratory tract infection  1  7/120 (5.83%)  3/120 (2.50%)  8/118 (6.78%)  4/122 (3.28%) 
Rhinitis  1  6/120 (5.00%)  1/120 (0.83%)  2/118 (1.69%)  7/122 (5.74%) 
Bronchitis  1  6/120 (5.00%)  4/120 (3.33%)  1/118 (0.85%)  1/122 (0.82%) 
Investigations         
Aspartate aminotransferase increased  1  2/120 (1.67%)  2/120 (1.67%)  4/118 (3.39%)  13/122 (10.66%) 
Alanine aminotransferase increased  1  1/120 (0.83%)  2/120 (1.67%)  3/118 (2.54%)  13/122 (10.66%) 
Nervous system disorders         
Headache  1  11/120 (9.17%)  14/120 (11.67%)  14/118 (11.86%)  13/122 (10.66%) 
Skin and subcutaneous tissue disorders         
Pruritus  1  1/120 (0.83%)  1/120 (0.83%)  2/118 (1.69%)  8/122 (6.56%) 
Vascular disorders         
Hypertension  1  2/120 (1.67%)  3/120 (2.50%)  6/118 (5.08%)  5/122 (4.10%) 
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
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: Gossamer Study Director
Organization: GB001, 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. ( GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc. )
ClinicalTrials.gov Identifier: NCT03683576    
Other Study ID Numbers: GB001-2001
First Submitted: September 11, 2018
First Posted: September 25, 2018
Results First Submitted: July 23, 2021
Results First Posted: August 23, 2021
Last Update Posted: September 16, 2021