NCT03614923

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

A Phase 2, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Study to Investigate Etokimab (ANB020) in Adult Subjects With Chronic Rhinosinusitis With Nasal Polyposis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: AnaptysBio, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This study is a randomized, placebo controlled, double-blind, multi-dose study to assess the efficacy of two different dose regimens of etokimab compared to placebo in adults with moderate-to-severe chronic sinusitis with nasal polyposis (CRSwNP). During the screening period, all subjects will undergo evaluation for eligibility. A centralized reader will be used to confirm the diagnosis of CRSwNP as assessed by nasal endoscopy, computed tomography (CT) scan of sinuses, and symptom scoring to reduce the risk of interpretation variation. Participants will also be provided mometasone furoate nasal spray (MFNS) for use during the trial and are required to undergo a minimum run-in period of 20 days prior to Day 1 with approximately 80% compliance. Participants will be randomly assigned on Day 1 to one of the three treatment arms in a 1:1:1 ratio.

Conditions

• Chronic Rhinosinusitis

Interventions

Type	Name	Description
BIOLOGICAL	Etokimab	Administered by subcutaneous injection
BIOLOGICAL	Placebo	Administered by subcutaneous injection
DRUG	Mometasone Furoate Nasal Spray	Mometasone Furoate Nasal Spray (MFNS) was used from 4 weeks prior to Day 1 (Run-in period) through the end of the study. Participants used 2 actuations (50 μg/actuation) in each nostril BID, total daily dose of 400 μg. Participants intolerant to BID intranasal corticosteroids (INCS) could use the lower dose regimen of 1 actuation in each nostril BID, total daily dose of 200 μg.

Timeline

• Start date: 2018-11-29
• Primary completion: 2020-09-02
• Completion: 2020-10-26
• First posted: 2018-08-03
• Last updated: 2022-01-24
• Results posted: 2022-01-24

Locations

28 sites across 1 country: United States

Regulatory

• FDA-regulated drug study