Etokimab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Summary

A study to evaluate the safety and efficacy of multiple doses of etokimab in adults with chronic rhinosinusitis with nasal polyps.

Timeline

Start

2018-11-29

Primary completion

2020-09-02

Completion

2020-10-26

Outcome

Missed primary endpoint

registry analysis (superiority test); Etokimab 300 mg + 150 mg Q4W vs Placebo; p = 0.2364; Least Squares (LS) Mean Difference -0.38 (95% CI -1.01 to 0.25); NCT03614923 ↗

registry analysis (superiority test); Etokimab 300 mg + 150 mg Q4W vs Placebo; p = 0.1330; LS Mean Difference -6.64 (95% CI -15.34 to 2.06); NCT03614923 ↗

release “chronic rhinosinusitis with nasal polyps (CRSwNP). Patients dosed with etokimab every four (q4w) or eight weeks (q8w) failed to achieve statistically significant improvement” anaptysbio.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Etokimab	Monoclonal antibody	150 mg	Subcutaneous
Background	Mometasone furoate	Other / unclassified	200 ug	Intranasal
Background	Mometasone furoate	Other / unclassified	400 ug	Intranasal

Indications