AzTrials
AzTrials

AsthmaPhase 2NCT03683576

GB001 in Adult Subjects With Moderate to Severe Asthma

A Phase 2 study testing GB001 in people with Asthma, run by GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc. at 117 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Asthma
What is being tested?
GB001
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
481 participants
Where
117 sitesin 11 countries
Study dates
22 Oct 2018to 18 Aug 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

117 sites in 11 countries.

117 sites in 11 countries

United States47 sites

  • Pulmonary Research of Abingdon, LLC

    Abingdon, Virginia, 24210

  • Central Florida Pulmonary Group, PA

    Altamonte Springs, Florida, 32701

  • University of Michigan Medicine

    Ann Arbor, Michigan, 48109

  • The Emory Clinic

    Atlanta, Georgia, 30322

  • John Hopkins Asthma and Allergy Center

    Baltimore, Maryland, 21224

  • Clinical Research Center of Albama, LLC

    Birmingham, Alabama, 35209

  • Treasure Valley Medical Research

    Boise, Idaho, 83706

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • American Health Research

    Charlotte, North Carolina, 28207

  • Clinical Research of Charlotte

    Charlotte, North Carolina, 28277

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Bernstein Clinical Research Center, LLC

    Cincinnati, Ohio, 45231

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Pulmonary Associates

    Colorado Springs, Colorado, 80909

  • Corsicana Medical Research, LLC

    Corsicana, Texas, 75110

  • Western Sky Medical Research

    El Paso, Texas, 79903

  • Baylor College of Medicine

    Houston, Texas, 77030

  • California Allergy and Asthma Medical Group

    Los Angeles, California, 90025

  • Southern California Institute for Respiratory Diseases, Inc.

    Los Angeles, California, 90048

  • University of Wisconsin School of Medicine and Public Health Asthma, Allergy, and Pulmonary Clinical Research

    Madison, Wisconsin, 53792-9988

  • Atlanta Allergy & Asthma Clinic, PA,

    Marietta, Georgia, 30060

  • Crisor, LLC

    Medford, Oregon, 97504

  • Clinical Research Institute, Inc.

    Minneapolis, Minnesota, 55402

  • North Bay Clinical Trials, Inc

    Napa, California, 94558

  • Yale New Haven Hospital

    New Haven, Connecticut, 06519

  • Atlantic Research Center, LLC

    Ocean City, New Jersey, 07712

  • Oklahoma Institute of Allergy & Asthma Clinical Research, LLC

    Oklahoma City, Oklahoma, 73131

  • Central Florida Pulmonary Group, PA

    Orlando, Florida, 32803

  • Allergy & Asthma Specialists, PSC

    Owensboro, Kentucky, 42301

  • Emerald Coast Research Associates

    Panama City, Florida, 32405

  • Allergy and Clinical Immunology Associates

    Pittsburgh, Pennsylvania, 15241

  • Allergy, Asthma & Sinus Consultants, Inc

    Riverside, California, 92506

  • Integrated Research of Inland, Inc.

    Riverside, California, 92506

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina, 29732

  • Allergy and Asthma Research Center, PA

    San Antonio, Texas, 78229

  • Allergy & Asthma Medical Group and Research Center, A P.C.

    San Diego, California, 92123

  • Allergy and Asthma Associates of Santa Clara Valley Research Center

    San Jose, California, 95117

  • Washington University School of Medicine

    St Louis, Missouri, 63108

  • Atlanta Allergy & Asthma Clinic, PA

    Stockbridge, Georgia, 30281

  • Bensch Clinical Research LLC

    Stockton, California, 95207

  • MultiCare Institute for Research & Innovation

    Tacoma, Washington, 98405

  • Allergy and Asthma Diagnostic Treatment Center

    Tallahassee, Florida, 32308

  • Clinical Research Trials of Florida, Inc.

    Tampa, Florida, 33607

  • Banner University of Arizona Medical Center

    Tucson, Arizona, 85724

  • AAPRI Clinical Research Institute

    Warwick, Rhode Island, 02886

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27104

  • Berks Schuylkill Respiratory Specialists, Ltd.

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Germany12 sites

  • RCMS Dr. Linhoff

    Berlin, 10717

  • Pneumologisches Studienzentrum Margrafenstrasse

    Berlin, 10969

  • Institut fuer Allergie - und Asthmaforschung

    Berlin, 12159

  • Pneumologische Praxis am Schloss

    Berlin

  • IKF Pneumologie GmbH & Co. KG

    Frankfurt am Main, 60596

  • Pneumologicum im Suedstadtforum

    Hanover, 30173

  • Universitatsklinikum des Saarlandes, Klinik fur Innere Medizin V

    Homburg, Saarland, 66421

  • Schmid

    Koblenz, 56068

  • BAG Prof. Hoheisel/Dr. A. Bonitz

    Leipzig, 04275

  • Pneumologische Praxis PD Dr. med.

    Leipzig

  • KLB Gesundheitsforschung Luebeck GmbH

    Lübeck, 23552

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Hospital

    Mainz

Other trials in Germany

Poland10 sites

  • Centrum Medycyny Oddechowej Mroz sp. j.

    Bialystok

  • Malopolskie Centrum Alergologii

    Krakow

  • Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ)

    Krakow

  • SPZOZ Uniwersytecki Szpital Kliniczny nr 1

    Lodz

  • Ostrowieckie Centrum Medyczne

    Ostrowiec Świętokrzyski

  • SPZOZ Proszowice

    Proszowice

  • Gabinet Lekarski Zenon Bukowczan

    Sucha Beskidzka

  • ALL-MED - Specjalistyczna Opieka Medyczna - Medyczny Instytut Badawczy Marek Jutel

    Wroclaw

  • Centrum Medyczne Melita Medical

    Wroclaw

  • NZOZ Lekarze Specjalisci

    Wroclaw

Other trials in Poland

Czechia9 sites

  • St. Anne's University Hospital Brno, Institute of Clinical Immunology and Allergology

    Brno

  • University Hospital Hradec Kralove, Institute of Clinical Immunology and Allergollogy

    Hradec Králové

  • MediTrial s.r.o.

    Jindřichův Hradec, 37701

  • PNEUMO-KV s.r.o.

    Karlovy Vary, 36017

  • Pulmonary Outpatient Clinic - Dr. Otakar Hokynar

    Kralupy nad Vltavou, 27801

  • University Hospital Olomouc, Department of Allergology and Clinical Immunology

    Olomouc, 779 00

  • Medicon a.s.

    Prague

  • Pulmonary Outpatient Clinic Rokycany s.r.o.

    Rokycany, 33722

  • Outpatient Allergology and Neurology Clinic Kasmed Ltd.

    Tábor, 39002

Other trials in Czechia

Ukraine9 sites

  • Public Institution: Dnipro Clinical Association of Urgent Medical Care under Dnipro City Council

    Dnipro, 49006

  • Public Institution "City Clinical Hospital #4" under Dnipro City Council

    Dnipro, 49102

  • Ivano-Frankivsk Central City Clinical Hospital

    Ivano-Frankivsk, 76018

  • Public Non-Profit Enterprise: City Clinical Hospital #13 under Kharkiv City Council

    Kharkiv

  • State Organization "National Institute of Phthisiology and Pulmonolgy named after F.G. Yanovsky NAMSU"

    Kyiv, 03680

  • State Organization "National Institute of Phthisiology and Pulmonolgy named after F.G. Yanovsky NAMSU"

    Kyiv

  • Public Institution: City Clinical Hospital #6

    Zaporizhia, 69035

  • Public Non-Profit Enterprise City Hospital #1 under Zaporizhia City Council

    Zaporizhia, 69104

  • Public Enterprise "Hospital #1" under Zhytomyr City Council

    Zhytomyr, 10002

Other trials in Ukraine

Canada8 sites

  • CHUM - Departement de pneumologie

    Montreal, Quebec, H2X 3E4

  • Allergiste & Immunologue - Clinic/Outpatient Facility

    Montreal, Quebec, H3G 1L5

  • Centre integre universitaire de sante et de services sociaux du Nord-de-I'lle-de-Montreal - Hopital du Sacre-Coeur de Montreal

    Montreal

  • Dr. Jamie Del Carpio's Clinic

    Montreal

  • Inspiration Research Limited

    Toronto, Ontario, M5T 3A9

  • Inspirational Research Limited

    Toronto

  • C. I. C Mauricie Inc.

    Trois-Rivières

  • The Lung Centre, Vancouver General Hospital

    Vancouver

Other trials in Canada

Spain6 sites

  • Instituto de Ciencias Medicas

    Alicante, 03004

  • Hospital Clinic de Barcelona

    Barcelona

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Clinico Universitario de Santiago de Compostela

    Santiago de Compostela, A Coruna, 15706

  • Hospital Universitario Doctor Peset

    Valencia, 46017

Other trials in Spain

United Kingdom5 sites

  • Birmingham Heartlands Hospital

    Birmingham

  • Bradford Royal Infirmary

    Bradford

  • Glasgow Clinical Research Facility, Glasgow Royal Infirmary

    Glasgow

  • Royal Liverpool University Hospital

    Liverpool

  • University Hospital Southampton

    Southampton

Other trials in United Kingdom

Belgium4 sites

  • UCL Saint-Luc - Pneumology Department

    Brussels

  • Pneumocare sprl

    Erpent

  • UZ Gent - Department of Respiratory Medicine

    Ghent

  • CHU de Charleroi - Site André Vésale

    Montigny-le-Tilleul

Other trials in Belgium

France4 sites

  • La Croix Rousse Hospital

    Lyon

  • Nord G&R Laennec Hospital

    Nantes

  • Centre Hospitalier Annecy Genevois

    Pringy

  • NOUVEL HOPITAL CIVIL - New Civil Hospital

    Strasbourg, 67091

Other trials in France

Austria3 sites

  • Ordination Dr. Robert Voves

    Feldbach, 8330

  • SALK University Hospital Salzburg, State Hospital Salzburg

    Salzburg

  • Medical University of Vienna, Department of Internal Medicine II, Clinical Division of Pulmonolog

    Vienna

Other trials in Austria

About this study

Official title: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Multi-center Study to Evaluate the Efficacy and Safety of GB001 as Maintenance Therapy in Adult Subjects With Moderate to Severe Asthma

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
Asthma
Being tested
GB001, Placebo
Keywords
GB001, eosinophilic asthma, moderate asthma, severe asthma
Medical subject headings
Asthma, Pulmonary Eosinophilia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GB001Drug

    film-coated oral tablet

  • PlaceboDrug

    film-coated oral tablet

Study groups in NCT03683576
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo once per day (QD) for 24 weeks
Receives: Drug: Placebo
GB001 20 mgExperimentalGB001 20 mg QD for 24 weeks
Receives: Drug: GB001
GB001 40 mgExperimentalGB001 40 mg QD for 24 weeks
Receives: Drug: GB001
GB001 60 mgExperimentalGB001 60 mg QD for 24 weeks
Receives: Drug: GB001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to Week 24

Secondary outcomes (7)

  1. 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.

    Measured: Baseline, Week 24

  2. 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.

    Measured: Baseline, Week 24

  3. 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.

    Measured: up to Week 24

  4. 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.

    Measured: up to Week 24

  5. Change From Baseline to Week 24 in Post-Bronchodilator FEV1

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

    Measured: Baseline, Week 24

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

    AM PEF was measured by participants using an electronic diary.

    Measured: Baseline, Week 24

  7. 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.

    Measured: From first dose of study treatment through Week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2018
  2. Study start22 Oct 2018
  3. Primary completion23 Jul 2020
  4. Study completion18 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
481 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03683576
Sponsor's protocol ID
GB001-2001
Status last verified
Aug 2021
First submitted
11 Sep 2018
Last updated
16 Sep 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GB001 in people with Asthma, run by GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc. at 117 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in United States, Germany, Poland, Czechia, Ukraine and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants Who Experience Worsening of Asthma by Week 24 (time frame: up to Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03683576, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in