GB001 in Adult Participants With Chronic Rhinosinusitis (NCT03956862) | Clinical Trial Compass
CompletedPhase 2
GB001 in Adult Participants With Chronic Rhinosinusitis
United States, Czechia, Ukraine97 participantsStarted 2019-05-16
Plain-language 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).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline to Week 16 in Sino-Nasal Outcome Test (SNOT) 22 Total Score
Timeframe: Baseline, Week 16
Trial details
NCT IDNCT03956862
SponsorGB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.