GB001 in Adult Participants With Chronic Rhinosinusitis

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).

Timeline

Start

2019-05-16

Primary completion

2020-07-09

Completion

2020-08-05

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs GB001; p = 0.9499; Mean Difference (Net) -0.2 (95% CI -7.6 to 7.1); Mixed Models Analysis NCT03956862 ↗

Drugs

Indications