CompletedNCT03683576Updated Sep 16, 2021Results posted

GB001 in Adult Subjects With Moderate to Severe Asthma

A Phase 2 interventional study of GB001 and Placebo in Asthma, sponsored by GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.. Completed at 117 sites in 11 countries. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2021-09-16.

Sponsored by GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 481
Allocation: Randomized
Ages: 18 Years to 74 Years
Sex: All

Study summary

A randomized, double-blind, placebo-controlled, dose-ranging, multi-center study to evaluate the efficacy and safety of GB001 when added to standard-of care (SOC) asthma maintenance therapy in adults with moderate to severe asthma and an eosinophilic phenotype with respect to asthma worsening at the end of 24 weeks of treatment.

Conditions studied

Asthma

Browse trials for

Asthma 3,921

Keywords

GB001
eosinophilic asthma
moderate asthma
severe asthma

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 481 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 74 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

A diagnosis of asthma by a physician at least 12 months before Screening Visit.
Treated with medium or high dose inhaled corticosteroid (ICS) plus additional controller for at least 12 months prior to Screening Visit. Subjects must maintain a stable ICS dose regimen during the 4 weeks prior to the Screening Visit.
Forced Expiratory Volume in 1 second (FEV1) of ≤ 85% of predicted normal
Demonstrated reversibility of at least 12% in FEV1
Evidence of uncontrolled asthma
Eosinophilic asthma
No changes in ICS dose and compliant with standard of care asthma therapy during run-in period.

Exclusion criteria

Exclusion Criteria

Current smokers (any substance)
Serious co-morbidities
Fridericia's correction QT factor (QTcF) ≥450 msec (male) or ≥470 msec (female)
Use of other investigational drugs within 30 days, or within 5 half-lives, whichever is longer, prior to Screening Visit
Regular use of systemic corticosteroids or immunosuppressive treatments or monoclonal antibodies for asthma
Pregnant or breastfeeding

Other protocol-defined inclusion/exclusion criteria may apply.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 481 participants (actual)

Study arms

Placebo comparator
Placebo
Placebo once per day (QD) for 24 weeks
Drug: Placebo
Experimental
GB001 20 mg
GB001 20 mg QD for 24 weeks
Drug: GB001
Experimental
GB001 40 mg
GB001 40 mg QD for 24 weeks
Drug: GB001
Experimental
GB001 60 mg
GB001 60 mg QD for 24 weeks
Drug: GB001

Interventions

DrugGB001
film-coated oral tablet
DrugPlacebo
film-coated oral tablet

What researchers measure

Primary outcomes

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.
Time frame: up to Week 24

Secondary outcomes

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.
Time frame: Baseline, Week 24
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.
Time frame: Baseline, Week 24
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.
Time frame: up to Week 24
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.
Time frame: up to Week 24
Change From Baseline to Week 24 in Post-Bronchodilator FEV1
Post-albuterol/salbutamol morning FEV1 was measured using electronic spirometry.
Time frame: Baseline, Week 24
Change From Baseline to Week 24 in Morning Peak Expiratory Flow (AM PEF)
AM PEF was measured by participants using an electronic diary.
Time frame: Baseline, Week 24
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.
Time frame: From first dose of study treatment through Week 28

Results

Posted Aug 23, 2021

Participant flow

Participant flow — Overall Study
Milestone	Placebo	GB001 20 mg	GB001 40 mg	GB001 60 mg
Started	120	120	118	122
Completed	114	116	106	114
Not completed	6	4	12	8
Withdrew: Withdrawal by subject	2	0	8	3
Withdrew: Adverse event	3	0	0	4
Withdrew: Lack of efficacy	1	0	1	1
Withdrew: Lost to follow-up	0	1	2	0
Withdrew: Other, not specified	0	2	0	0
Withdrew: Protocol violation	0	1	1	0

Outcome measures

PrimaryProportion 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.

Time frame:: up to Week 24
Reported as:: Number · proportion of participants

Proportion of Participants Who Experience Worsening of Asthma by Week 24
proportion of participants	Placebo	GB001 20 mg	GB001 40 mg	GB001 60 mg
Proportion of Participants Who Experience Worsening of Asthma by Week 24	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)

Statistical analysis

Placebo vs GB001 20 mg · Regression, Logistic · p = 0.1425 · Odds ratio (or): 0.674 · 95% CI 0.398 to 1.142GB001 20 mg vs. Placebo
Placebo vs GB001 40 mg · Regression, Logistic · p = 0.1482 · Odds ratio (or): 0.677 · 95% CI 0.399 to 1.149GB001 40 mg vs. Placebo
Placebo vs GB001 60 mg · Regression, Logistic · p = 0.1086 · Odds ratio (or): 0.651 · 95% CI 0.385 to 1.100GB001 60 mg vs. Placebo

SecondaryChange 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.

Time frame:: Baseline, Week 24
Reported as:: Least squares mean · score on a scale

Change From Baseline to Week 24 in Asthma Control Questionnaire - 5 (ACQ-5) Score
score on a scale	Placebo	GB001 20 mg	GB001 40 mg	GB001 60 mg
Change From Baseline to Week 24 in Asthma Control Questionnaire - 5 (ACQ-5) Score	-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)

Statistical analysis

Placebo vs GB001 20 mg · ANCOVA · p = 0.1647 · Mean difference (net): -0.15 · 95% CI -0.36 to 0.06GB001 20 mg vs. Placebo
Placebo vs GB001 40 mg · ANCOVA · p = 0.1737 · Mean difference (net): -0.15 · 95% CI -0.37 to 0.07GB001 40 mg vs. Placebo
Placebo vs GB001 60 mg · ANCOVA · p = 0.0879 · Mean difference (net): -0.19 · 95% CI -0.40 to 0.03GB001 60 mg vs. Placebo

SecondaryChange 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.

Time frame:: Baseline, Week 24
Reported as:: Least squares mean · liters (L)

Change From Baseline to Week 24 in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
liters (L)	Placebo	GB001 20 mg	GB001 40 mg	GB001 60 mg
Change From Baseline to Week 24 in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	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)

Statistical analysis

Placebo vs GB001 20 mg · ANCOVA · p = 0.7718 · Mean difference (net): 0.016 · 95% CI -0.091 to 0.123GB001 20 mg vs. Placebo
Placebo vs GB001 40 mg · ANCOVA · p = 0.4562 · Mean difference (net): 0.041 · 95% CI -0.067 to 0.149GB001 40 mg vs. Placebo
Placebo vs GB001 60 mg · ANCOVA · p = 0.1631 · Mean difference (net): 0.075 · 95% CI -0.030 to 0.180GB001 60 mg vs. Placebo

SecondaryTime 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.

Time frame:: up to Week 24
Reported as:: Median · weeks

Time to First Asthma Worsening
weeks	Placebo	GB001 20 mg	GB001 40 mg	GB001 60 mg
Time to First Asthma Worsening	10.57 (7.857 to 16.286)	17.43 (12.143 to NA)	17.57 (13.429 to 24.286)	19.86 (14.857 to NA)

Statistical analysis

Placebo vs GB001 20 mg · Regression, Cox · p = 0.0466 · Hazard ratio (hr): 0.719 · 95% CI 0.519 to 0.995GB001 20 mg vs. Placebo
Placebo vs GB001 40 mg · Regression, Cox · p = 0.1222 · Hazard ratio (hr): 0.773 · 95% CI 0.558 to 1.071GB001 40 mg vs. Placebo
Placebo vs GB001 60 mg · Regression, Cox · p = 0.0304 · Hazard ratio (hr): 0.698 · 95% CI 0.505 to 0.967GB001 60 mg vs. Placebo

SecondaryAnnualized 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.

Time frame:: up to Week 24
Reported as:: Least squares mean · events/year

Annualized Rate of Severe Asthma Exacerbations
events/year	Placebo	GB001 20 mg	GB001 40 mg	GB001 60 mg
Annualized Rate of Severe Asthma Exacerbations	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)

Statistical analysis

Placebo vs GB001 20 mg · Negative binomial regression model · p = 0.3382 · Rate ratio: 0.797 · 95% CI 0.501 to 1.268GB001 20 mg vs. Placebo
Placebo vs GB001 40 mg · Negative binomial regression model · p = 0.2248 · Rate ratio: 0.748 · 95% CI 0.469 to 1.195GB001 40 mg vs. Placebo
Placebo vs GB001 60 mg · Negative binomial regression model · p = 0.6090 · Rate ratio: 0.889 · 95% CI 0.565 to 1.397GB001 60 mg vs. Placebo

SecondaryChange From Baseline to Week 24 in Post-Bronchodilator FEV1

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

Time frame:: Baseline, Week 24
Reported as:: Least squares mean · L

Change From Baseline to Week 24 in Post-Bronchodilator FEV1
L	Placebo	GB001 20 mg	GB001 40 mg	GB001 60 mg
Change From Baseline to Week 24 in Post-Bronchodilator FEV1	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)

Statistical analysis

Placebo vs GB001 20 mg · ANCOVA · p = 0.6645 · Mean difference (net): -0.023 · 95% CI -0.127 to 0.081GB001 20 mg vs. Placebo
Placebo vs GB001 40 mg · ANCOVA · p = 0.5288 · Mean difference (net): 0.035 · 95% CI -0.074 to 0.144GB001 40 mg vs. Placebo
Placebo vs GB001 60 mg · ANCOVA · p = 0.1362 · Mean difference (net): 0.079 · 95% CI -0.025 to 0.182GB001 60 mg vs. Placebo

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

AM PEF was measured by participants using an electronic diary.

Time frame:: Baseline, Week 24
Reported as:: Least squares mean · L/min

Change From Baseline to Week 24 in Morning Peak Expiratory Flow (AM PEF)
L/min	Placebo	GB001 20 mg	GB001 40 mg	GB001 60 mg
Change From Baseline to Week 24 in Morning Peak Expiratory Flow (AM PEF)	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)

Statistical analysis

Placebo vs GB001 20 mg · ANCOVA · p = 0.3957 · Mean difference (net): 6.122 · 95% CI -8.007 to 20.251GB001 20 mg vs. Placebo
Placebo vs GB001 40 mg · ANCOVA · p = 0.0598 · Mean difference (net): 13.948 · 95% CI -0.578 to 28.474GB001 40 mg vs. Placebo
Placebo vs GB001 60 mg · ANCOVA · p = 0.4376 · Mean difference (net): 5.588 · 95% CI -8.522 to 19.698GB001 60 mg vs. Placebo

SecondaryPercentage 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.

Time frame:: From first dose of study treatment through Week 28
Reported as:: Number · percentage of participants

Percentage of Participants With a Treatment-Emergent Adverse Event (AE)
percentage of participants	Placebo	GB001 20 mg	GB001 40 mg	GB001 60 mg
Percentage of Participants With a Treatment-Emergent Adverse Event (AE)	65.8	65.8	69.5	68.0

Adverse events

Collected over From first dose of study treatment through Week 28. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	0/120 (0%)	9/120 (7.5%)	45/120 (37.5%)
GB001 20 mg	0/120 (0%)	5/120 (4.2%)	53/120 (44.2%)
GB001 40 mg	0/118 (0%)	5/118 (4.2%)	59/118 (50%)
GB001 60 mg	1/122 (0.8%)	7/122 (5.7%)	55/122 (45.1%)

Most frequent serious events

Showing 10 of 27

Most frequent serious events
Event	Placebo	GB001 20 mg	GB001 40 mg	GB001 60 mg
AsthmaRespiratory, thoracic and mediastinal disorders	2/120	2/120	2/118	1/122
SinusitisInfections and infestations	0/120	0/120	1/118	0/122
Left ventricular failureCardiac disorders	0/120	0/120	1/118	0/122
HypertensionVascular disorders	0/120	0/120	1/118	0/122
Acute respiratory failureRespiratory, thoracic and mediastinal disorders	0/120	0/120	1/118	0/122
Allergic bronchitisRespiratory, thoracic and mediastinal disorders	0/120	0/120	1/118	0/122
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders	0/120	0/120	1/118	0/122
Back painMusculoskeletal and connective tissue disorders	0/120	0/120	1/118	0/122
Uterine haemorrhageReproductive system and breast disorders	0/120	0/120	1/118	0/122
Uterine polypReproductive system and breast disorders	0/120	0/120	1/118	0/122

Most frequent other events

Showing 10 of 11

Most frequent other events
Event	Placebo	GB001 20 mg	GB001 40 mg	GB001 60 mg
NasopharyngitisInfections and infestations	19/120	23/120	29/118	17/122
HeadacheNervous system disorders	11/120	14/120	14/118	13/122
Aspartate aminotransferase increasedInvestigations	2/120	2/120	4/118	13/122
Alanine aminotransferase increasedInvestigations	1/120	2/120	3/118	13/122
SinusitisInfections and infestations	3/120	4/120	10/118	3/122
Upper respiratory tract infectionInfections and infestations	7/120	3/120	8/118	4/122
PruritusSkin and subcutaneous tissue disorders	1/120	1/120	2/118	8/122
RhinitisInfections and infestations	6/120	1/120	2/118	7/122
HypertensionVascular disorders	2/120	3/120	6/118	5/122
BronchitisInfections and infestations	6/120	4/120	1/118	1/122

Baseline characteristics

Intent to Treat (ITT) Population: all participants who were randomized and received at least 1 dose of study treatment

Age, Continuous
Age, Continuous(years)	Placebo	GB001 20 mg	GB001 40 mg	GB001 60 mg	Total
Mean	51.5 ± 11.91	52.8 ± 11.81	52.9 ± 13.32	49.9 ± 14.37	51.8 ± 12.92

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	GB001 20 mg	GB001 40 mg	GB001 60 mg	Total
Female	76	86	74	72	308
Male	44	34	44	50	172

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Placebo	GB001 20 mg	GB001 40 mg	GB001 60 mg	Total
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
Race/Ethnicity, Customized(Participants)	Placebo	GB001 20 mg	GB001 40 mg	GB001 60 mg	Total
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

Study locations

117 sites

Clinical Research Center of Albama, LLC
Birmingham, Alabama 35209, United States
Banner University of Arizona Medical Center
Tucson, Arizona 85724, United States
California Allergy and Asthma Medical Group
Los Angeles, California 90025, United States
Southern California Institute for Respiratory Diseases, Inc.
Los Angeles, California 90048, United States
North Bay Clinical Trials, Inc
Napa, California 94558, United States
Allergy, Asthma & Sinus Consultants, Inc
Riverside, California 92506, United States
Integrated Research of Inland, Inc.
Riverside, California 92506, United States
Allergy & Asthma Medical Group and Research Center, A P.C.
San Diego, California 92123, United States
Allergy and Asthma Associates of Santa Clara Valley Research Center
San Jose, California 95117, United States
Bensch Clinical Research LLC
Stockton, California 95207, United States
Pulmonary Associates
Colorado Springs, Colorado 80909, United States
Yale New Haven Hospital
New Haven, Connecticut 06519, United States
Central Florida Pulmonary Group, PA
Altamonte Springs, Florida 32701, United States
Central Florida Pulmonary Group, PA
Orlando, Florida 32803, United States
Emerald Coast Research Associates
Panama City, Florida 32405, United States
Allergy and Asthma Diagnostic Treatment Center
Tallahassee, Florida 32308, United States
Clinical Research Trials of Florida, Inc.
Tampa, Florida 33607, United States
The Emory Clinic
Atlanta, Georgia 30322, United States
Atlanta Allergy & Asthma Clinic, PA,
Marietta, Georgia 30060, United States
Atlanta Allergy & Asthma Clinic, PA
Stockbridge, Georgia 30281, United States
Treasure Valley Medical Research
Boise, Idaho 83706, United States
Rush University Medical Center
Chicago, Illinois 60612, United States
Allergy & Asthma Specialists, PSC
Owensboro, Kentucky 42301, United States
John Hopkins Asthma and Allergy Center
Baltimore, Maryland 21224, United States
Brigham and Women's Hospital
Boston, Massachusetts 02115, United States
University of Michigan Medicine
Ann Arbor, Michigan 48109, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota 55402, United States
Washington University School of Medicine
Saint Louis, Missouri 63108, United States
Atlantic Research Center, LLC
Ocean City, New Jersey 07712, United States
American Health Research
Charlotte, North Carolina 28207, United States
Clinical Research of Charlotte
Charlotte, North Carolina 28277, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina 27104, United States
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio 45231, United States
Cleveland Clinic
Cleveland, Ohio 44195, United States
Oklahoma Institute of Allergy & Asthma Clinical Research, LLC
Oklahoma City, Oklahoma 73131, United States
Crisor, LLC
Medford, Oregon 97504, United States
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania 15241, United States
Berks Schuylkill Respiratory Specialists, Ltd.
Wyomissing, Pennsylvania 19610, United States
AAPRI Clinical Research Institute
Warwick, Rhode Island 02886, United States
Clinical Research of Rock Hill
Rock Hill, South Carolina 29732, United States
Corsicana Medical Research, LLC
Corsicana, Texas 75110, United States
Western Sky Medical Research
El Paso, Texas 79903, United States
Baylor College of Medicine
Houston, Texas 77030, United States
Allergy and Asthma Research Center, PA
San Antonio, Texas 78229, United States
Pulmonary Research of Abingdon, LLC
Abingdon, Virginia 24210, United States
MultiCare Institute for Research & Innovation
Tacoma, Washington 98405, United States
University of Wisconsin School of Medicine and Public Health Asthma, Allergy, and Pulmonary Clinical Research
Madison, Wisconsin 53792-9988, United States
Ordination Dr. Robert Voves
Feldbach, 8330, Austria
SALK University Hospital Salzburg, State Hospital Salzburg
Salzburg, Austria
Medical University of Vienna, Department of Internal Medicine II, Clinical Division of Pulmonolog
Vienna, Austria
UCL Saint-Luc - Pneumology Department
Bruxelles, Belgium
Pneumocare sprl
Erpent, Belgium
UZ Gent - Department of Respiratory Medicine
Gent, Belgium
CHU de Charleroi - Site André Vésale
Montigny-le-Tilleul, Belgium
Inspiration Research Limited
Toronto, Ontario M5T 3A9, Canada
CHUM - Departement de pneumologie
Montreal, Quebec H2X 3E4, Canada
Allergiste & Immunologue - Clinic/Outpatient Facility
Montreal, Quebec H3G 1L5, Canada
Centre integre universitaire de sante et de services sociaux du Nord-de-I'lle-de-Montreal - Hopital du Sacre-Coeur de Montreal
Montréal, Canada
Dr. Jamie Del Carpio's Clinic
Montréal, Canada
Inspirational Research Limited
Toronto, Canada
C. I. C Mauricie Inc.
Trois-Rivières, Canada
The Lung Centre, Vancouver General Hospital
Vancouver, Canada
St. Anne's University Hospital Brno, Institute of Clinical Immunology and Allergology
Brno, Czechia
University Hospital Hradec Kralove, Institute of Clinical Immunology and Allergollogy
Hradec Kralove, Czechia
MediTrial s.r.o.
Jindrichuv Hradec, 37701, Czechia
PNEUMO-KV s.r.o.
Karlovy Vary, 36017, Czechia
Pulmonary Outpatient Clinic - Dr. Otakar Hokynar
Kralupy nad Vltavou, 27801, Czechia
University Hospital Olomouc, Department of Allergology and Clinical Immunology
Olomouc, 779 00, Czechia
Medicon a.s.
Praha 4, Czechia
Pulmonary Outpatient Clinic Rokycany s.r.o.
Rokycany, 33722, Czechia
Outpatient Allergology and Neurology Clinic Kasmed Ltd.
Tábor, 39002, Czechia
La Croix Rousse Hospital
Lyon, France
Nord G&R Laennec Hospital
Nantes, France
Centre Hospitalier Annecy Genevois
Pringy, France
NOUVEL HOPITAL CIVIL - New Civil Hospital
Strasbourg, 67091, France
Universitatsklinikum des Saarlandes, Klinik fur Innere Medizin V
Homburg, Saarland 66421, Germany
RCMS Dr. Linhoff
Berlin, 10717, Germany
Pneumologisches Studienzentrum Margrafenstrasse
Berlin, 10969, Germany
Institut fuer Allergie - und Asthmaforschung
Berlin, 12159, Germany
Pneumologische Praxis am Schloss
Berlin, Germany
IKF Pneumologie GmbH & Co. KG
Frankfurt am Main, 60596, Germany
Pneumologicum im Suedstadtforum
Hannover, 30173, Germany
Schmid
Koblenz, 56068, Germany
BAG Prof. Hoheisel/Dr. A. Bonitz
Leipzig, 04275, Germany
Pneumologische Praxis PD Dr. med.
Leipzig, Germany
KLB Gesundheitsforschung Luebeck GmbH
Luebeck, 23552, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Hospital
Mainz, Germany
Centrum Medycyny Oddechowej Mroz sp. j.
Białystok, Poland
Malopolskie Centrum Alergologii
Kraków, Poland
Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ)
Kraków, Poland
Ostrowieckie Centrum Medyczne
Ostrowiec Świętokrzyski, Poland
SPZOZ Proszowice
Proszowice, Poland
Gabinet Lekarski Zenon Bukowczan
Sucha Beskidzka, Poland
ALL-MED - Specjalistyczna Opieka Medyczna - Medyczny Instytut Badawczy Marek Jutel
Wrocław, Poland
Centrum Medyczne Melita Medical
Wrocław, Poland
NZOZ Lekarze Specjalisci
Wrocław, Poland
SPZOZ Uniwersytecki Szpital Kliniczny nr 1
Łódź, Poland
Hospital Clinico Universitario de Santiago de Compostela
Santiago De Compostela, A Coruna 15706, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona 08907, Spain
Instituto de Ciencias Medicas
Alicante, 03004, Spain

Showing the first 100 of 117 sites across 11 countries.

References and documents

Publications

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. PubMed 35248549 ↗
Ortega H, Fitzgerald M, Raghupathi K, Tompkins CA, Shen J, Dittrich K, Pattwell C, Singh D. A phase 2 study to evaluate the safety, efficacy and pharmacokinetics of DP2 antagonist GB001 and to explore biomarkers of airway inflammation in mild-to-moderate asthma. Clin Exp Allergy. 2020 Feb;50(2):189-197. doi: 10.1111/cea.13524. Epub 2019 Nov 26. PubMed 31659803 ↗

Study documents

Study protocol · Apr 16, 2020
Statistical analysis plan · Apr 11, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03683576
Lead sponsor: GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.
Responsible party: Sponsor
First posted: Sep 25, 2018
Start date: Oct 22, 2018
Primary completion: Jul 23, 2020
Completion: Aug 18, 2020
Results posted: Aug 23, 2021
Last update: Sep 16, 2021

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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