MedTrace Logo

GB001 in Adult Participants With Chronic Rhinosinusitis

NCT03956862 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2021-08-23

Study results available
· View outcomes & findings →

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).

Conditions

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

Interventions

DRUG

GB001

film-coated oral tablet

DRUG

Placebo

film-coated oral tablet

Sponsors & Collaborators

  • GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-16
Primary Completion
2020-07-09
Completion
2020-08-05
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03956862 on ClinicalTrials.gov