Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)Phase 2NCT03956862
GB001 in Adult Participants With Chronic Rhinosinusitis
A Phase 2 study testing GB001 in people with Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) and Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), run by GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc. at 38 sites in 3 countries.
Trial summary
A Phase 2a, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of GB001 compared with placebo over 16 weeks of treatment in patients with chronic rhinosinusitis with or without nasal polyposis (NP). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP), Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
- 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
- 97 participants
- Where
- 38 sitesin 3 countries
- Study dates
- 16 May 2019to 5 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) or chronic rhinosinusitis without nasal polyps (CRSsNP) by a physician at least 12 weeks before Screening Visit
- Treated with stable intranasal corticosteroid (INCS) for at least 2 months prior to Screening Visit
- Presence of at least 2 nasal symptoms: nasal blockage/ obstruction/congestion or nasal discharge or facial pain/pressure or reduction/loss of smell
- Women of childbearing potential must use an acceptable method of contraception
Who cannot join
- Sino-Nasal Outcome Test-22 (SNOT-22) score < 20 at screening
- Asthma or chronic obstructive pulmonary disease (COPD) patients that are current smokers
- Use of other investigational drugs within 30 days, or within 5 half-lives, whichever is longer, prior to Screening Visit
- Pregnant or breastfeeding
- Pre-existing clinically important co-morbidities
- Regular use of systemic corticosteroids or immunosuppressive treatments
- Other protocol-defined inclusion/exclusion criteria will apply.
Trial locations and contacts
38 sites in 3 countries.
38 sites in 3 countries
United States29 sites
BreatheAmerica Albuquerque
Albuquerque, New Mexico, 87109
Emory University
Atlanta, Georgia, 30322
Nebraska Medical Research Institute, Inc.
Bellevue, Nebraska, 68123
Specialty Physician Associates
Bethlehem, Pennsylvania, 18017
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Medical University of South Carolina, Department of Otolaryngology
Charleston, South Carolina, 29425
Rush University Medical Center
Chicago, Illinois, 60612
ChicagoENT
Chicago, Illinois, 60657
AARA Research Center
Dallas, Texas, 75231
Iowa Head & Neck, PC
Des Moines, Iowa, 50312
Memorial Hermann Medical Plaza
Houston, Texas, 77030
NEA Baptist Clinic
Jonesboro, Arkansas, 72401
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Kentuckiana Ear, Nose, and Throat
Louisville, Kentucky, 40205
Advanced ENT and Allergy
Louisville, Kentucky, 40207
Tandem Clinical Research LLC
Marrero, Louisiana, 70072
Yale School of Medicine
New Haven, Connecticut, 06519
Northwell Health at ENT and Allergy Associates
New Hyde Park, New York, 11042
Northwell Health at ENT and Allergy Associates
New York, New York, 10016
Eastern Virginia Medical School
Norfolk, Virginia, 23507
Thomas Jefferson University Department of Otolaryngology
Philadelphia, Pennsylvania, 19107
Advanced Otolaryngology, P.C. DBA Richmond Ear, Nose and Throat
Richmond, Virginia, 23235
University of Rochester Medicine Otolaryngology
Rochester, New York, 14618
Sacramento Ear Nose and Throat Surgical and Medical Group, Inc.
Roseville, California, 95661
Bensch Clinical Research LLC
Stockton, California, 95207
Banner University of Arizona Medical Center
Tucson, Arizona, 85724
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, 74136
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, 21162
Northwell Health at ENT and Allergy Associates
White Plains, New York, 10605
Ukraine5 sites
Public Non-Profit Enterprise "Clinical Hospital of Emergency Medical Care" under Dnipro City Council
Dnipro, 49006
Public Non-Profit Enterprise under KRC "Regional Clinical Specialized Center for Radiation Protection of the Public"
Kharkiv, 61166
State Institution "O.S. Kolomiychenko Institute of Otolaryngology of National Academy of Medical Sciences of Ukraine"
Kyiv, 03680
Municipal Non-commercial Enterprise "Ternopil Municipal City Hospital #2"
Ternopil, 46023
Public Non-Profit Enterprise "City Hospital #3" under Zaporizhia City Council
Zaporizhia, 69032
Czechia4 sites
University Hospital Hradec Kralove, Department of Otorhinolaryngology and Head and Neck Surgery
Hradec Králové, 50005
ENT Outpatient Clinic Pavel Navratil
Olomouc, 77900
Medicon a.s.
Prague, 14046
Pulmonary Outpatient Clinic Rokycany s.r.o.
Rokycany, 33722
About this study
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Effect of GB001 in Patients With Chronic Rhinosinusitis With or Without Nasal Polyps
A Phase 2a, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of GB001 compared with placebo over 16 weeks of treatment in patients with chronic rhinosinusitis with or without nasal polyposis (NP).
- Conditions
- Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP), Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
- Being tested
- GB001, Placebo
- Keywords
- GB001, Gossamer Bio, Gossamer, Nasal Polyposis, CRSwNP, CRSsNP
- Medical subject headings
- Nasal Polyps
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 group | Role | What they receive |
|---|---|---|
| GB001 | Experimental | GB001 40 mg once per day (QD) for 16 weeks Receives: Drug: GB001 |
| Placebo | Placebo comparator | Placebo QD for 16 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 16 in Sino-Nasal Outcome Test (SNOT) 22 Total Score
The SNOT-22 is a validated questionnaire to assess the impact of chronic rhinosinusitis (CRS) on quality of life and utilizes a 2-week recall period. It is a 22-item outcome measure on a 5-point category scale applicable to sinonasal conditions and surgical treatments. The total scores range from 0 to 110 with higher total scores implying greater impact of CRS on quality of life.
Measured: Baseline, Week 16
Secondary outcomes (8)
Change From Baseline to Week 16 in Lund-Mackay Score
Lund-Mackay scores are based on centralized imaging data assessments and are scored by blinded central reading at the imaging core laboratory. The Lund-Mackay system is based on localization with points given for degree of opacification: 0=normal, 1=partial opacification, 2=total opacification. These points are then applied to each sinus (maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal sinus) on each side. The osteomeatal complex on each side is graded as 0=not occluded, or 2=occluded. The maximum score is 12 per side, for a total score ranging from 0 to 24.
Measured: Baseline, Week 16
Change From Baseline to Week 16 in Nasal Polyp Score (NPS)
The bilateral endoscopic NPS is the sum of the right and left nostril scores, as evaluated by means of blinded, centrally read nasal endoscopy and ranges from 0 to 8. NP is graded based on polyp size: 0 = No polyps, 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle turbinate, 2 = Polyps reaching below the lower border of the middle turbinate, 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate, and 4 = Large polyps causing complete obstruction of the inferior nasal cavity.
Measured: Baseline, Week 16
Time to First Response in NPS
Response was defined as ≥ 1-point improvement from baseline.
The bilateral endoscopic NPS is the sum of the right and left nostril scores, as evaluated by means of blinded, centrally read nasal endoscopy and ranges from 0-8. NP is graded based on polyp size: 0 = No polyps, 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle turbinate, 2 = Polyps reaching below the lower border of the middle turbinate, 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate, and 4 = Large polyps causing complete obstruction of the inferior nasal cavity.
Measured: up to Week 16
Change From Baseline to Week 16 in Morning (AM) Nasal Congestion (NC) Score
AM NC score was assessed using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms).
Measured: Baseline, Week 16
Change From Baseline to Week 16 in AM Total Symptom Score (TSS)
AM TSS is the sum of the scores from the 4 AM symptom categories (congestion and/or obstruction, anterior rhinorrhea, posterior rhinorrhea, loss of sense of smell) and ranges from 0-12. Each symptom category was assessed using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms).
Measured: Baseline, Week 16
Change From Baseline to Week 16 in University of Pennsylvania Smell Identification Test (UPSIT) Score
The UPSIT test consists of four booklets, each containing 10 odorants with one odorant per page. The test-time is about 15 minutes. The stimuli are embedded in 10-50 μm diameter plastic microcapsules on brown strips at the bottom of each page. Above each odorant strip is a multiple-choice question with four alternative words to describe the odor. The participant is asked to release the odorant by rubbing the brown-strip with the tip of a pencil and to indicate which of 4 words best describes the odor. An UPSIT result is scored from 0 to 40 where a higher score indicates better olfaction.
Measured: Baseline, Week 16
Time to First Chronic Rhinosinusitis (CRS) Exacerbation
Chronic rhinosinusitis exacerbation is defined as deterioration of CRS symptoms requiring treatment with an antibiotic, an anti-inflammatory drug, or a symptom reliever; an Emergency Department visit; or hospitalization.
Measured: up to Week 16
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 drug. 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 drug through Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start16 May 2019
- Primary completion9 Jul 2020
- Study completion5 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956862
- Sponsor's protocol ID
- GB001-2101
- Other IDs
- 2019-001682-33, 2019
- Status last verified
- Aug 2021
- First submitted
- 17 May 2019
- Last updated
- 23 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Effect of GB001 in Patients With Chronic Rhinosinusitis With or Without Nasal Polyps
- ClinicalTrials.gov ID
- NCT03956862
- Acronym / sponsor ID
- GB001-2101
- Conditions
- Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP), Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
- Keywords
- GB001, Gossamer Bio, Gossamer, Nasal Polyposis, CRSwNP, CRSsNP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 May 2019 (actual)
- Primary completion
- 9 Jul 2020 (actual)
- Study completion
- 5 Aug 2020 (actual)
- First posted
- 21 May 2019 (actual)
- Results
- Posted 30 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2a, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of GB001 compared with placebo over 16 weeks of treatment in patients with chronic rhinosinusitis with or without nasal polyposis (NP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GB001 | Experimental | Drug: GB001GB001 40 mg once per day (QD) for 16 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo QD for 16 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) or chronic rhinosinusitis without nasal polyps (CRSsNP) by a physician at least 12 weeks before Screening Visit
- Treated with stable intranasal corticosteroid (INCS) for at least 2 months prior to Screening Visit
- Presence of at least 2 nasal symptoms: nasal blockage/ obstruction/congestion or nasal discharge or facial pain/pressure or reduction/loss of smell
- Women of childbearing potential must use an acceptable method of contraception
Key exclusion criteria (7 listed)
- Sino-Nasal Outcome Test-22 (SNOT-22) score < 20 at screening
- Asthma or chronic obstructive pulmonary disease (COPD) patients that are current smokers
- Use of other investigational drugs within 30 days, or within 5 half-lives, whichever is longer, prior to Screening Visit
- Pregnant or breastfeeding
- Pre-existing clinically important co-morbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GB001film-coated oral tablet | Drug | GB001 |
| Placebofilm-coated oral tablet | Drug | Placebo |
Primary outcome
Change From Baseline to Week 16 in Sino-Nasal Outcome Test (SNOT) 22 Total Score
Time frame: Baseline, Week 16
The SNOT-22 is a validated questionnaire to assess the impact of chronic rhinosinusitis (CRS) on quality of life and utilizes a 2-week recall period. It is a 22-item outcome measure on a 5-point category scale applicable to sinonasal conditions and surgical treatments. The total scores range from 0 to 110 with higher total scores implying greater impact of CRS on quality of life.
8 secondary outcomes
Change From Baseline to Week 16 in Lund-Mackay Score
Time frame: Baseline, Week 16
Change From Baseline to Week 16 in Nasal Polyp Score (NPS)
Time frame: Baseline, Week 16
Time to First Response in NPS
Time frame: up to Week 16
Change From Baseline to Week 16 in Morning (AM) Nasal Congestion (NC) Score
Time frame: Baseline, Week 16
Change From Baseline to Week 16 in AM Total Symptom Score (TSS)
Time frame: Baseline, Week 16
Change From Baseline to Week 16 in University of Pennsylvania Smell Identification Test (UPSIT) Score
Time frame: Baseline, Week 16
Time to First Chronic Rhinosinusitis (CRS) Exacerbation
Time frame: up to Week 16
Percentage of Participants With a Treatment-Emergent Adverse Event (AE)
Time frame: From first dose of study drug through Week 20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Not yet recruitingObservational study
The German National CRS Registry (GenreCRS): Clinical Evaluation of the New European Academy for Allergy and Clinical Immunology (EAACI) Criteria for CRSwNP Disease Control, Remission and Cure in a Real-World Evidence Study Approach
Chronic Rhinosinusitis (CRS), Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
38 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GB001 in people with Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) and Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), run by GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc. at 38 sites in 3 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 4 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 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Ukraine, Czechia. 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 30 Jul 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?
Change From Baseline to Week 16 in Sino-Nasal Outcome Test (SNOT) 22 Total Score (time frame: Baseline, Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2021.