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GB001 in Adult Subjects With Chronic Rhinosinusitis

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ClinicalTrials.gov Identifier: NCT03956862
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Gossamer Bio Inc. ( GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc. )

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 Chronic Rhinosinusitis With Nasal Polyps Drug: GB001 Other: Matched Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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 : April 30, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Experimental: GB001
GB001 Oral administration. Once per day (QD)
Drug: GB001
GB001 taken orally on a daily basis

Placebo Comparator: Placebo
Matched Placebo; Oral administration QD
Other: Matched Placebo
Matched placebo control taken orally on a daily basis




Primary Outcome Measures :
  1. Sino-Nasal Outcome Test-22 (SNOT-22) [ Time Frame: 16 Weeks ]
    Change from baseline in SNOT-22


Secondary Outcome Measures :
  1. CT Scan [ Time Frame: 16 Weeks ]
    Change from baseline in Lund-Mackay score

  2. Endoscopic nasal polyp score (NPS) [ Time Frame: 16 Weeks ]
    Change from baseline in endoscopic NPS in subset of participants with nasal polyps at baseline and time to improvement of endoscopic NPS

  3. Patient Reported Symptoms [ Time Frame: 16 Weeks ]
    Change from baseline in nasal congestion and total symptom score

  4. Change in Sense of Smell (UPSIT) [ Time Frame: 16 Weeks ]
    Change from baseline in UPSIT

  5. Chronic Rhinosinusitis (CRS) Exacerbation [ Time Frame: 16 weeks ]
    Time to first CRS exacerbation

  6. Incidence of Treatment Emergent Adverse Events [ Time Frame: 20 Weeks ]
    To evaluate the safety and tolerability of GB001 as compared to placebo looking at only those adverse events that start on or after first dose of the study drug or placebo respectively.



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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:

  • Women of childbearing potential must use an acceptable method of contraception
  • A diagnosis of CRSwNP or 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

Exclusion Criteria:

  • SNOT-22 score <20 at screening
  • Asthma or 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


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


Contacts
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Contact: GB001, Inc., wholly owned subsidiary of Gossamer Bio Inc. 1-866-668-4083 ClinicalTrials@gossamerbio.com

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Sponsors and Collaborators
GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.

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Responsible Party: GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.
ClinicalTrials.gov Identifier: NCT03956862     History of Changes
Other Study ID Numbers: GB001-2101
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
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
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases