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GB001 in Adult Participants With Chronic Rhinosinusitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03956862
Recruitment Status : Completed
First Posted : May 21, 2019
Results First Posted : July 30, 2021
Last Update Posted : August 23, 2021
Sponsor:
Information provided by (Responsible Party):
Gossamer Bio Inc. ( GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc. )

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Drug: GB001 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : May 16, 2019
Actual Primary Completion Date : July 9, 2020
Actual Study Completion Date : August 5, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: GB001
GB001 40 mg once per day (QD) for 16 weeks
 Drug: GB001
film-coated oral tablet
Placebo Comparator: Placebo
Placebo QD for 16 weeks
 Drug: Placebo
film-coated oral tablet


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change From Baseline to Week 16 in Lund-Mackay Score [ Time Frame: Baseline, Week 16 ]
    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.

  2. Change From Baseline to Week 16 in Nasal Polyp Score (NPS) [ Time Frame: Baseline, Week 16 ]
    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.

  3. Time to First Response in NPS [ Time Frame: up to Week 16 ]

    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.


  4. Change From Baseline to Week 16 in Morning (AM) Nasal Congestion (NC) Score [ Time Frame: Baseline, Week 16 ]
    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).

  5. Change From Baseline to Week 16 in AM Total Symptom Score (TSS) [ Time Frame: Baseline, Week 16 ]
    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).

  6. Change From Baseline to Week 16 in University of Pennsylvania Smell Identification Test (UPSIT) Score [ Time Frame: Baseline, Week 16 ]
    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.

  7. Time to First Chronic Rhinosinusitis (CRS) Exacerbation [ Time Frame: up to Week 16 ]
    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.

  8. Percentage of Participants With a Treatment-Emergent Adverse Event (AE) [ Time Frame: From first dose of study drug through Week 20 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956862


Locations
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Sponsors and Collaborators
GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.
  Study Documents (Full-Text)

Documents provided by Gossamer Bio Inc. ( GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc. ):
Study Protocol  [PDF] April 16, 2020
Statistical Analysis Plan  [PDF] September 1, 2020

More Information
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Responsible Party: GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.
ClinicalTrials.gov Identifier: NCT03956862    
Other Study ID Numbers: GB001-2101
2019-001682-33 ( EudraCT Number )
First Posted: May 21, 2019    Key Record Dates
Results First Posted: July 30, 2021
Last Update Posted: August 23, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gossamer Bio Inc. ( GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc. ):
GB001
Gossamer Bio
Gossamer
 Nasal Polyposis
CRSwNP
CRSsNP
Additional relevant MeSH terms:
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Sinusitis
Nasal Polyps
Polyps
Pathological Conditions, Anatomical
Respiratory Tract Infections
 Infections
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases