Trial Outcomes & Findings for GB001 in Adult Subjects With Moderate to Severe Asthma (NCT NCT03683576)
NCT ID: NCT03683576
Last Updated: 2021-09-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
481 participants
Primary outcome timeframe
up to Week 24
Results posted on
2021-09-16
Participant Flow
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.
Participant milestones
| Measure |
Placebo
Placebo once per day (QD) for 24 weeks
|
GB001 20 mg
GB001 20 mg QD for 24 weeks
|
GB001 40 mg
GB001 40 mg QD for 24 weeks
|
GB001 60 mg
GB001 60 mg QD for 24 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
120
|
120
|
118
|
122
|
|
Overall Study
COMPLETED
|
114
|
116
|
106
|
114
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
12
|
8
|
Reasons for withdrawal
| Measure |
Placebo
Placebo once per day (QD) for 24 weeks
|
GB001 20 mg
GB001 20 mg QD for 24 weeks
|
GB001 40 mg
GB001 40 mg QD for 24 weeks
|
GB001 60 mg
GB001 60 mg QD for 24 weeks
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
8
|
3
|
|
Overall Study
Adverse Event
|
3
|
0
|
0
|
4
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
2
|
0
|
|
Overall Study
Other, Not Specified
|
0
|
2
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
0
|
Baseline Characteristics
GB001 in Adult Subjects With Moderate to Severe Asthma
Baseline characteristics by cohort
| Measure |
Placebo
n=120 Participants
Placebo QD for 24 weeks
|
GB001 20 mg
n=120 Participants
GB001 20 mg QD for 24 weeks
|
GB001 40 mg
n=118 Participants
GB001 40 mg QD for 24 weeks
|
GB001 60 mg
n=122 Participants
GB001 60 mg QD for 24 weeks
|
Total
n=480 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 11.91 • n=5 Participants
|
52.8 years
STANDARD_DEVIATION 11.81 • n=7 Participants
|
52.9 years
STANDARD_DEVIATION 13.32 • n=5 Participants
|
49.9 years
STANDARD_DEVIATION 14.37 • n=4 Participants
|
51.8 years
STANDARD_DEVIATION 12.92 • n=21 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
308 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
172 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
108 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
438 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other, Not Specified
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
107 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
448 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: up to Week 24Population: ITT Population: all participants who were randomized and received at least 1 dose of study treatment.
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.
Outcome measures
| Measure |
Placebo
n=120 Participants
Placebo QD for 24 weeks
|
GB001 20 mg
n=120 Participants
GB001 20 mg QD for 24 weeks
|
GB001 40 mg
n=118 Participants
GB001 40 mg QD for 24 weeks
|
GB001 60 mg
n=122 Participants
GB001 60 mg QD for 24 weeks
|
|---|---|---|---|---|
|
Proportion of Participants Who Experience Worsening of Asthma by Week 24
|
0.658 proportion of participants
Interval 0.57 to 0.737
|
0.567 proportion of participants
Interval 0.477 to 0.652
|
0.568 proportion of participants
Interval 0.478 to 0.654
|
0.557 proportion of participants
Interval 0.469 to 0.642
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: ITT Population: all participants who were randomized and received at least 1 dose of study treatment.
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.
Outcome measures
| Measure |
Placebo
n=120 Participants
Placebo QD for 24 weeks
|
GB001 20 mg
n=120 Participants
GB001 20 mg QD for 24 weeks
|
GB001 40 mg
n=118 Participants
GB001 40 mg QD for 24 weeks
|
GB001 60 mg
n=122 Participants
GB001 60 mg QD for 24 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 24 in Asthma Control Questionnaire - 5 (ACQ-5) Score
|
-0.89 score on a scale
Interval -1.05 to -0.73
|
-1.04 score on a scale
Interval -1.2 to -0.89
|
-1.04 score on a scale
Interval -1.2 to -0.88
|
-1.08 score on a scale
Interval -1.24 to -0.92
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: ITT Population: all participants who were randomized and received at least 1 dose of study treatment.
Pre-albuterol/salbutamol morning FEV1 was measured using electronic spirometry.
Outcome measures
| Measure |
Placebo
n=120 Participants
Placebo QD for 24 weeks
|
GB001 20 mg
n=120 Participants
GB001 20 mg QD for 24 weeks
|
GB001 40 mg
n=118 Participants
GB001 40 mg QD for 24 weeks
|
GB001 60 mg
n=122 Participants
GB001 60 mg QD for 24 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 24 in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
|
0.105 liters (L)
Interval 0.027 to 0.182
|
0.121 liters (L)
Interval 0.041 to 0.2
|
0.146 liters (L)
Interval 0.064 to 0.227
|
0.180 liters (L)
Interval 0.102 to 0.257
|
SECONDARY outcome
Timeframe: up to Week 24Population: ITT Population: all participants who were randomized and received at least 1 dose of study treatment.
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.
Outcome measures
| Measure |
Placebo
n=120 Participants
Placebo QD for 24 weeks
|
GB001 20 mg
n=120 Participants
GB001 20 mg QD for 24 weeks
|
GB001 40 mg
n=118 Participants
GB001 40 mg QD for 24 weeks
|
GB001 60 mg
n=122 Participants
GB001 60 mg QD for 24 weeks
|
|---|---|---|---|---|
|
Time to First Asthma Worsening
|
10.57 weeks
Interval 7.857 to 16.286
|
17.43 weeks
Interval 12.143 to
NA (Not Available) indicates the value is not estimable due to an insufficient number of observed events.
|
17.57 weeks
Interval 13.429 to 24.286
|
19.86 weeks
Interval 14.857 to
NA (Not Available) indicates the value is not estimable due to an insufficient number of observed events.
|
SECONDARY outcome
Timeframe: up to Week 24Population: ITT Population: all participants who were randomized and received at least 1 dose of study treatment.
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.
Outcome measures
| Measure |
Placebo
n=120 Participants
Placebo QD for 24 weeks
|
GB001 20 mg
n=120 Participants
GB001 20 mg QD for 24 weeks
|
GB001 40 mg
n=118 Participants
GB001 40 mg QD for 24 weeks
|
GB001 60 mg
n=122 Participants
GB001 60 mg QD for 24 weeks
|
|---|---|---|---|---|
|
Annualized Rate of Severe Asthma Exacerbations
|
0.933 events/year
Interval 0.664 to 1.311
|
0.744 events/year
Interval 0.517 to 1.07
|
0.698 events/year
Interval 0.48 to 1.015
|
0.829 events/year
Interval 0.585 to 1.174
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: ITT Population: all participants who were randomized and received at least 1 dose of study treatment.
Post-albuterol/salbutamol morning FEV1 was measured using electronic spirometry.
Outcome measures
| Measure |
Placebo
n=120 Participants
Placebo QD for 24 weeks
|
GB001 20 mg
n=120 Participants
GB001 20 mg QD for 24 weeks
|
GB001 40 mg
n=118 Participants
GB001 40 mg QD for 24 weeks
|
GB001 60 mg
n=122 Participants
GB001 60 mg QD for 24 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 24 in Post-Bronchodilator FEV1
|
0.012 L
Interval -0.064 to 0.088
|
-0.011 L
Interval -0.088 to 0.066
|
0.047 L
Interval -0.037 to 0.131
|
0.091 L
Interval 0.015 to 0.166
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: ITT Population: all participants who were randomized and received at least 1 dose of study treatment.
AM PEF was measured by participants using an electronic diary.
Outcome measures
| Measure |
Placebo
n=120 Participants
Placebo QD for 24 weeks
|
GB001 20 mg
n=120 Participants
GB001 20 mg QD for 24 weeks
|
GB001 40 mg
n=118 Participants
GB001 40 mg QD for 24 weeks
|
GB001 60 mg
n=122 Participants
GB001 60 mg QD for 24 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 24 in Morning Peak Expiratory Flow (AM PEF)
|
8.993 L/min
Interval -1.514 to 19.499
|
15.115 L/min
Interval 4.779 to 25.451
|
22.941 L/min
Interval 12.042 to 33.839
|
14.581 L/min
Interval 4.14 to 25.021
|
SECONDARY outcome
Timeframe: From first dose of study treatment through Week 28Population: Safety Population: all participants who received at least 1 dose of study treatment.
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.
Outcome measures
| Measure |
Placebo
n=120 Participants
Placebo QD for 24 weeks
|
GB001 20 mg
n=120 Participants
GB001 20 mg QD for 24 weeks
|
GB001 40 mg
n=118 Participants
GB001 40 mg QD for 24 weeks
|
GB001 60 mg
n=122 Participants
GB001 60 mg QD for 24 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With a Treatment-Emergent Adverse Event (AE)
|
65.8 percentage of participants
|
65.8 percentage of participants
|
69.5 percentage of participants
|
68.0 percentage of participants
|
Adverse Events
Placebo
Serious events: 9 serious events
Other events: 45 other events
Deaths: 0 deaths
GB001 20 mg
Serious events: 5 serious events
Other events: 53 other events
Deaths: 0 deaths
GB001 40 mg
Serious events: 5 serious events
Other events: 59 other events
Deaths: 0 deaths
GB001 60 mg
Serious events: 7 serious events
Other events: 55 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=120 participants at risk
Placebo QD for 24 weeks
|
GB001 20 mg
n=120 participants at risk
GB001 20 mg QD for 24 weeks
|
GB001 40 mg
n=118 participants at risk
GB001 40 mg QD for 24 weeks
|
GB001 60 mg
n=122 participants at risk
GB001 60 mg QD for 24 weeks
|
|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.83%
1/120 • From first dose of study treatment through Week 28
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/118 • From first dose of study treatment through Week 28
|
0.82%
1/122 • From first dose of study treatment through Week 28
|
|
Infections and infestations
Sinusitis
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.85%
1/118 • From first dose of study treatment through Week 28
|
0.00%
0/122 • From first dose of study treatment through Week 28
|
|
Infections and infestations
Influenza
|
0.83%
1/120 • From first dose of study treatment through Week 28
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/118 • From first dose of study treatment through Week 28
|
0.00%
0/122 • From first dose of study treatment through Week 28
|
|
Infections and infestations
Respiratory tract infection
|
0.83%
1/120 • From first dose of study treatment through Week 28
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/118 • From first dose of study treatment through Week 28
|
0.00%
0/122 • From first dose of study treatment through Week 28
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/118 • From first dose of study treatment through Week 28
|
0.82%
1/122 • From first dose of study treatment through Week 28
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/118 • From first dose of study treatment through Week 28
|
0.82%
1/122 • From first dose of study treatment through Week 28
|
|
Metabolism and nutrition disorders
Mineral metabolism disorder
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/118 • From first dose of study treatment through Week 28
|
0.82%
1/122 • From first dose of study treatment through Week 28
|
|
Nervous system disorders
Myasthenia gravis
|
0.83%
1/120 • From first dose of study treatment through Week 28
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/118 • From first dose of study treatment through Week 28
|
0.00%
0/122 • From first dose of study treatment through Week 28
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.85%
1/118 • From first dose of study treatment through Week 28
|
0.00%
0/122 • From first dose of study treatment through Week 28
|
|
Cardiac disorders
Acute myocardial infarction
|
0.83%
1/120 • From first dose of study treatment through Week 28
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/118 • From first dose of study treatment through Week 28
|
0.00%
0/122 • From first dose of study treatment through Week 28
|
|
Cardiac disorders
Myocardial infarction
|
0.83%
1/120 • From first dose of study treatment through Week 28
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/118 • From first dose of study treatment through Week 28
|
0.00%
0/122 • From first dose of study treatment through Week 28
|
|
Vascular disorders
Hypertension
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.85%
1/118 • From first dose of study treatment through Week 28
|
0.00%
0/122 • From first dose of study treatment through Week 28
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.7%
2/120 • From first dose of study treatment through Week 28
|
1.7%
2/120 • From first dose of study treatment through Week 28
|
1.7%
2/118 • From first dose of study treatment through Week 28
|
0.82%
1/122 • From first dose of study treatment through Week 28
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.85%
1/118 • From first dose of study treatment through Week 28
|
0.00%
0/122 • From first dose of study treatment through Week 28
|
|
Respiratory, thoracic and mediastinal disorders
Allergic bronchitis
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.85%
1/118 • From first dose of study treatment through Week 28
|
0.00%
0/122 • From first dose of study treatment through Week 28
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.85%
1/118 • From first dose of study treatment through Week 28
|
0.00%
0/122 • From first dose of study treatment through Week 28
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/118 • From first dose of study treatment through Week 28
|
0.82%
1/122 • From first dose of study treatment through Week 28
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.83%
1/120 • From first dose of study treatment through Week 28
|
0.00%
0/118 • From first dose of study treatment through Week 28
|
0.00%
0/122 • From first dose of study treatment through Week 28
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/118 • From first dose of study treatment through Week 28
|
0.82%
1/122 • From first dose of study treatment through Week 28
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.83%
1/120 • From first dose of study treatment through Week 28
|
0.00%
0/118 • From first dose of study treatment through Week 28
|
0.00%
0/122 • From first dose of study treatment through Week 28
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.85%
1/118 • From first dose of study treatment through Week 28
|
0.00%
0/122 • From first dose of study treatment through Week 28
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.83%
1/120 • From first dose of study treatment through Week 28
|
0.00%
0/118 • From first dose of study treatment through Week 28
|
0.00%
0/122 • From first dose of study treatment through Week 28
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.85%
1/118 • From first dose of study treatment through Week 28
|
0.00%
0/122 • From first dose of study treatment through Week 28
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.85%
1/118 • From first dose of study treatment through Week 28
|
0.00%
0/122 • From first dose of study treatment through Week 28
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.83%
1/120 • From first dose of study treatment through Week 28
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/118 • From first dose of study treatment through Week 28
|
0.00%
0/122 • From first dose of study treatment through Week 28
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/118 • From first dose of study treatment through Week 28
|
0.82%
1/122 • From first dose of study treatment through Week 28
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.83%
1/120 • From first dose of study treatment through Week 28
|
0.00%
0/120 • From first dose of study treatment through Week 28
|
0.00%
0/118 • From first dose of study treatment through Week 28
|
0.00%
0/122 • From first dose of study treatment through Week 28
|
Other adverse events
| Measure |
Placebo
n=120 participants at risk
Placebo QD for 24 weeks
|
GB001 20 mg
n=120 participants at risk
GB001 20 mg QD for 24 weeks
|
GB001 40 mg
n=118 participants at risk
GB001 40 mg QD for 24 weeks
|
GB001 60 mg
n=122 participants at risk
GB001 60 mg QD for 24 weeks
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
15.8%
19/120 • From first dose of study treatment through Week 28
|
19.2%
23/120 • From first dose of study treatment through Week 28
|
24.6%
29/118 • From first dose of study treatment through Week 28
|
13.9%
17/122 • From first dose of study treatment through Week 28
|
|
Infections and infestations
Sinusitis
|
2.5%
3/120 • From first dose of study treatment through Week 28
|
3.3%
4/120 • From first dose of study treatment through Week 28
|
8.5%
10/118 • From first dose of study treatment through Week 28
|
2.5%
3/122 • From first dose of study treatment through Week 28
|
|
Infections and infestations
Upper respiratory tract infection
|
5.8%
7/120 • From first dose of study treatment through Week 28
|
2.5%
3/120 • From first dose of study treatment through Week 28
|
6.8%
8/118 • From first dose of study treatment through Week 28
|
3.3%
4/122 • From first dose of study treatment through Week 28
|
|
Infections and infestations
Rhinitis
|
5.0%
6/120 • From first dose of study treatment through Week 28
|
0.83%
1/120 • From first dose of study treatment through Week 28
|
1.7%
2/118 • From first dose of study treatment through Week 28
|
5.7%
7/122 • From first dose of study treatment through Week 28
|
|
Infections and infestations
Bronchitis
|
5.0%
6/120 • From first dose of study treatment through Week 28
|
3.3%
4/120 • From first dose of study treatment through Week 28
|
0.85%
1/118 • From first dose of study treatment through Week 28
|
0.82%
1/122 • From first dose of study treatment through Week 28
|
|
Nervous system disorders
Headache
|
9.2%
11/120 • From first dose of study treatment through Week 28
|
11.7%
14/120 • From first dose of study treatment through Week 28
|
11.9%
14/118 • From first dose of study treatment through Week 28
|
10.7%
13/122 • From first dose of study treatment through Week 28
|
|
Vascular disorders
Hypertension
|
1.7%
2/120 • From first dose of study treatment through Week 28
|
2.5%
3/120 • From first dose of study treatment through Week 28
|
5.1%
6/118 • From first dose of study treatment through Week 28
|
4.1%
5/122 • From first dose of study treatment through Week 28
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
3/120 • From first dose of study treatment through Week 28
|
5.0%
6/120 • From first dose of study treatment through Week 28
|
0.85%
1/118 • From first dose of study treatment through Week 28
|
3.3%
4/122 • From first dose of study treatment through Week 28
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.83%
1/120 • From first dose of study treatment through Week 28
|
0.83%
1/120 • From first dose of study treatment through Week 28
|
1.7%
2/118 • From first dose of study treatment through Week 28
|
6.6%
8/122 • From first dose of study treatment through Week 28
|
|
Investigations
Aspartate aminotransferase increased
|
1.7%
2/120 • From first dose of study treatment through Week 28
|
1.7%
2/120 • From first dose of study treatment through Week 28
|
3.4%
4/118 • From first dose of study treatment through Week 28
|
10.7%
13/122 • From first dose of study treatment through Week 28
|
|
Investigations
Alanine aminotransferase increased
|
0.83%
1/120 • From first dose of study treatment through Week 28
|
1.7%
2/120 • From first dose of study treatment through Week 28
|
2.5%
3/118 • From first dose of study treatment through Week 28
|
10.7%
13/122 • From first dose of study treatment through Week 28
|
Additional Information
Gossamer Study Director
GB001, 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