GB001 in Adult Subjects With Moderate to Severe Asthma | NCT03683576

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo once per day (QD) for 24 weeks	Drug: Placebo
GB001 20 mg	Experimental	GB001 20 mg QD for 24 weeks	Drug: GB001
GB001 40 mg	Experimental	GB001 40 mg QD for 24 weeks	Drug: GB001
GB001 60 mg	Experimental	GB001 60 mg QD for 24 weeks	Drug: GB001

Name	Type	Description	Arm Group Labels	Other Names
GB001	Drug	film-coated oral tablet	GB001 20 mg GB001 40 mg GB001 60 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of Participants Who Experience Worsening of Asthma by Week 24	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.	up to Week 24

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline to Week 24 in Asthma Control Questionnaire - 5 (ACQ-5) Score	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.

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Center of Albama, LLC		Birmingham	Alabama	35209	United States
Banner University of Arizona Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35248549	Derived	Moss MH, Lugogo NL, Castro M, Hanania NA, Ludwig-Sengpiel A, Saralaya D, Dobek R, Ojanguren I, Vyshnyvetskyy I, Bruey JM, Osterhout R, Tompkins CA, Dittrich K, Raghupathi K, Ortega H; LEDA Investigators. Results of a Phase 2b Trial With GB001, a Prostaglandin D2 Receptor 2 Antagonist, in Moderate to Severe Eosinophilic Asthma. Chest. 2022 Aug;162(2):297-308. doi: 10.1016/j.chest.2022.02.038. Epub 2022 Mar 3.
31659803

IPD Sharing Statement Module

Results Section

Participant Flow Module

ID	Title	Description
FG000	Placebo	Placebo once per day (QD) for 24 weeks
FG001	GB001 20 mg	GB001 20 mg QD for 24 weeks

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 16, 2020	Jul 6, 2021

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Arm/Group Information

ID	Title	Description
BG000	Placebo	Placebo QD for 24 weeks
BG001	GB001 20 mg	GB001 20 mg QD for 24 weeks
BG002	GB001 40 mg	GB001 40 mg QD for 24 weeks
BG003	GB001 60 mg	GB001 60 mg QD for 24 weeks
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00051.5± 11.91 BG00152.8± 11.81 BG00252.9± 13.32 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00076 BG00186 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG000108 BG001109 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Not Hispanic or Latino

Title	Measurements
	BG000107 BG001113 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Proportion of Participants Who Experience Worsening of Asthma by Week 24

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.

ITT Population: all participants who were randomized and received at least 1 dose of study treatment.

Posted

Number

95% Confidence Interval

proportion of participants

up to Week 24

ID	Title	Description
OG000	Placebo	Placebo QD for 24 weeks
OG001	GB001 20 mg	GB001 20 mg QD for 24 weeks
OG002	GB001 40 mg	GB001 40 mg QD for 24 weeks
OG003	GB001 60 mg	GB001 60 mg QD for 24 weeks

Units	Counts
Participants	OG000120 OG001120 OG002118 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.658(0.570 to 0.737) OG0010.567(0.477 to 0.652) OG0020.568(0.478 to 0.654) OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic		0.1425		Odds Ratio (OR)	0.674			2-Sided	95	0.398	1.142			GB001 20 mg vs. Placebo		Superiority
OG000 OG002		Regression, Logistic

Secondary

Change From Baseline to Week 24 in Asthma Control Questionnaire - 5 (ACQ-5) Score

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.

ITT Population: all participants who were randomized and received at least 1 dose of study treatment.

Posted

Least Squares Mean

95% Confidence Interval

score on a scale

Baseline, Week 24

ID	Title	Description
OG000	Placebo	Placebo QD for 24 weeks
OG001	GB001 20 mg	GB001 20 mg QD for 24 weeks
OG002	GB001 40 mg	GB001 40 mg QD for 24 weeks
OG003	GB001 60 mg

Secondary

Change From Baseline to Week 24 in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

Pre-albuterol/salbutamol morning FEV1 was measured using electronic spirometry.

ITT Population: all participants who were randomized and received at least 1 dose of study treatment.

Posted

Least Squares Mean

95% Confidence Interval

liters (L)

Baseline, Week 24

ID	Title	Description
OG000	Placebo	Placebo QD for 24 weeks
OG001	GB001 20 mg	GB001 20 mg QD for 24 weeks
OG002	GB001 40 mg	GB001 40 mg QD for 24 weeks
OG003	GB001 60 mg	GB001 60 mg QD for 24 weeks

Units	Counts
Participants

Secondary

Time to First Asthma Worsening

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.

ITT Population: all participants who were randomized and received at least 1 dose of study treatment.

Posted

Median

95% Confidence Interval

weeks

up to Week 24

ID	Title	Description
OG000	Placebo	Placebo QD for 24 weeks
OG001	GB001 20 mg	GB001 20 mg QD for 24 weeks
OG002	GB001 40 mg	GB001 40 mg QD for 24 weeks
OG003	GB001 60 mg	GB001 60 mg QD for 24 weeks

Units	Counts

Secondary

Annualized Rate of Severe Asthma Exacerbations

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.

ITT Population: all participants who were randomized and received at least 1 dose of study treatment.

Posted

Least Squares Mean

95% Confidence Interval

events/year

up to Week 24

ID	Title	Description
OG000	Placebo	Placebo QD for 24 weeks
OG001	GB001 20 mg	GB001 20 mg QD for 24 weeks
OG002	GB001 40 mg	GB001 40 mg QD for 24 weeks
OG003	GB001 60 mg	GB001 60 mg QD for 24 weeks

Units	Counts

Secondary

Change From Baseline to Week 24 in Post-Bronchodilator FEV1

Post-albuterol/salbutamol morning FEV1 was measured using electronic spirometry.

ITT Population: all participants who were randomized and received at least 1 dose of study treatment.

Posted

Least Squares Mean

95% Confidence Interval

Baseline, Week 24

ID	Title	Description
OG000	Placebo	Placebo QD for 24 weeks
OG001	GB001 20 mg	GB001 20 mg QD for 24 weeks
OG002	GB001 40 mg	GB001 40 mg QD for 24 weeks
OG003	GB001 60 mg	GB001 60 mg QD for 24 weeks

Units	Counts
Participants

Secondary

Change From Baseline to Week 24 in Morning Peak Expiratory Flow (AM PEF)

AM PEF was measured by participants using an electronic diary.

ITT Population: all participants who were randomized and received at least 1 dose of study treatment.

Posted

Least Squares Mean

95% Confidence Interval

L/min

Baseline, Week 24

ID	Title	Description
OG000	Placebo	Placebo QD for 24 weeks
OG001	GB001 20 mg	GB001 20 mg QD for 24 weeks
OG002	GB001 40 mg	GB001 40 mg QD for 24 weeks
OG003	GB001 60 mg	GB001 60 mg QD for 24 weeks

Units	Counts
Participants

Secondary

Percentage of Participants With a Treatment-Emergent Adverse Event (AE)

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.

Safety Population: all participants who received at least 1 dose of study treatment.

Posted

Number

percentage of participants

From first dose of study treatment through Week 28

ID	Title	Description
OG000	Placebo	Placebo QD for 24 weeks
OG001	GB001 20 mg	GB001 20 mg QD for 24 weeks
OG002	GB001 40 mg	GB001 40 mg QD for 24 weeks
OG003	GB001 60 mg	GB001 60 mg QD for 24 weeks

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo QD for 24 weeks	0	120	9	120	45	120
EG001	GB001 20 mg	GB001 20 mg QD for 24 weeks	0	120	5	120	53	120
EG002	GB001 40 mg	GB001 40 mg QD for 24 weeks	0	118	5	118	59	118
EG003	GB001 60 mg	GB001 60 mg QD for 24 weeks	1	122	7	122	55	122

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected120 at risk EG0010 affected120 at risk EG0020 affected118 at risk EG0031 affected122 at risk
Sinusitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected120 at risk EG0010 affected120 at risk EG0021 affected118 at risk EG003
Influenza	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected120 at risk EG0010 affected120 at risk EG0020 affected118 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected120 at risk EG0010 affected120 at risk EG0020 affected118 at risk EG003
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 affected120 at risk EG0010 affected120 at risk EG0020 affected118 at risk EG003
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 affected120 at risk EG0010 affected120 at risk EG0020 affected118 at risk EG003
Mineral metabolism disorder	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected120 at risk EG0010 affected120 at risk EG0020 affected118 at risk EG003
Myasthenia gravis	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected120 at risk EG0010 affected120 at risk EG0020 affected118 at risk EG003
Left ventricular failure	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected120 at risk EG0010 affected120 at risk EG0021 affected118 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected120 at risk EG0010 affected120 at risk EG0020 affected118 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected120 at risk EG0010 affected120 at risk EG0020 affected118 at risk EG003
Hypertension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected120 at risk EG0010 affected120 at risk EG0021 affected118 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected120 at risk EG0012 affected120 at risk EG0022 affected118 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected120 at risk EG0010 affected120 at risk EG0021 affected118 at risk EG003
Allergic bronchitis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected120 at risk EG0010 affected120 at risk EG0021 affected118 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected120 at risk EG0010 affected120 at risk EG0021 affected118 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected120 at risk EG0010 affected120 at risk EG0020 affected118 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected120 at risk EG0011 affected120 at risk EG0020 affected118 at risk EG003
Liver injury	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected120 at risk EG0010 affected120 at risk EG0020 affected118 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected120 at risk EG0011 affected120 at risk EG0020 affected118 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected120 at risk EG0010 affected120 at risk EG0021 affected118 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected120 at risk EG0011 affected120 at risk EG0020 affected118 at risk EG003
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected120 at risk EG0010 affected120 at risk EG0021 affected118 at risk EG003
Uterine polyp	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected120 at risk EG0010 affected120 at risk EG0021 affected118 at risk EG003
Metrorrhagia	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected120 at risk EG0010 affected120 at risk EG0020 affected118 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected120 at risk EG0010 affected120 at risk EG0020 affected118 at risk EG003
Fracture displacement	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected120 at risk EG0010 affected120 at risk EG0020 affected118 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00019 affected120 at risk EG00123 affected120 at risk EG00229 affected118 at risk EG00317 affected122 at risk
Sinusitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 affected120 at risk EG0014 affected120 at risk EG00210 affected118 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0007 affected120 at risk EG0013 affected120 at risk EG0028 affected118 at risk EG003
Rhinitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0006 affected120 at risk EG0011 affected120 at risk EG0022 affected118 at risk EG003
Bronchitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0006 affected120 at risk EG0014 affected120 at risk EG0021 affected118 at risk EG003
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00011 affected120 at risk EG00114 affected120 at risk EG00214 affected118 at risk EG003
Hypertension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected120 at risk EG0013 affected120 at risk EG0026 affected118 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected120 at risk EG0016 affected120 at risk EG0021 affected118 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected120 at risk EG0011 affected120 at risk EG0022 affected118 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0002 affected120 at risk EG0012 affected120 at risk EG0024 affected118 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 affected120 at risk EG0012 affected120 at risk EG0023 affected118 at risk EG003

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases
D017681	Hypereosinophilic Syndrome
D004802	Eosinophilia
D007960	Leukocyte Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases