Other Clinical Trial - GB001 in Adult Participants With Chronic

Clinical 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Nasal Polyps
Polyps
Sinusitis

See also
	Status	Clinical Trial	Phase
	Not yet recruiting	`NCT06231004` - Correlation Between the Microbiome and Type 2 Inflammatory Diseases of CRSwNP
	Recruiting	`NCT06338995` - A Study of Lebrikizumab (LY3650150) in Adult Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)	Phase 3

See also

Status

Clinical Trial

Phase

Not yet recruiting

NCT06231004 - Correlation Between the Microbiome and Type 2 Inflammatory Diseases of CRSwNP

Recruiting

NCT06338995 - A Study of Lebrikizumab (LY3650150) in Adult Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)

Phase 3

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT03956862
Study type	Interventional
Source	Gossamer Bio Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	May 16, 2019
Completion date	August 5, 2020

GB001 in Adult Participants With Chronic Rhinosinusitis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms