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NCT Number: NCT03614923

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

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

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Key information

Conditions

Chronic Rhinosinusitis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asthma & Allergy Institute, Little Rock, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinically confirmed diagnosis of CRSwNP
  • Nasal polyp score (NPS) ≥ 4 out of a maximum score for both nostrils (with at least a score of 1 for each nostril).
  • 22 Item Sino-Nasal Outcome Test (SNOT-22) score > 15.
  • Presence of at least two of the following symptoms prior to screening: nasal blockade/obstruction/congestion or nasal discharge (anterior/posterior nasal drip); facial pain/pressure; reduction or loss of smell
  • Body mass index (BMI) of 18 to 42 kg/m^2 (inclusive) and total body weight > 50 kg (110 lb). BMI=weight (kg)/(height [m^2]).

Exclusion criteria

  • Use of investigational drugs or prohibited therapy for this study within 8 weeks before screening or 5 half-lives, whichever is longer.
  • Have experienced severe life threatening anaphylactic reactions.
  • Participation in any interventional study for the treatment of CRSwNP in the 3 months before screening.
  • If female, is pregnant or lactating, or intend to become pregnant during the study period.
  • History (or suspected history) of alcohol or substance abuse.
  • Current smokers or former smokers with a smoking history of ≥ 10 pack years. If a patient has less than 10 pack years smoking history, he or she should have quit smoking at least 2 months before screening to enroll in the study.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

Etokimab

Biological

Administered by subcutaneous injection

Other names: ANB020

Placebo

Biological

Administered by subcutaneous injection

Mometasone Furoate Nasal spray

Drug

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.

Primary outcomes

  1. Change From Baseline in Nasal Polyp Score (NPS) to Week 16

    Time frame: Baseline and Week 16

    Nasal polyps were evaluated by nasal endoscopy using centralized imaging data assessments scored by an independent reviewer.

    Each nostril was scored on a scale from 0 to 4, where a score of 0 means no polyps, and a score of 4 means the presence of polyps causing complete obstruction of the inferior nasal cavity.

    The bilateral NPS score is the sum of the right and left nostril scores, and hence the total NPS value is between 0 and 8 (worst). A negative change from Baseline indicates improvement.

  2. Change From Baseline in Sino-Nasal Outcome Test-22 (SNOT-22) Score at Week 16

    Time frame: Baseline and Week 16

    SNOT-22 is a 22-item outcome measure on a 5-category scale that assesses symptoms and social/emotional consequences of rhinosinusitis. Each item is scored from 0 (No problem at all) to 5 (Problem as bad as it can be), and the total score ranges from 0 to 110. Higher SNOT-22 scores are indicative of greater impact of rhinosinusitis on quality of life. A negative change from Baseline indicates improvement.

Secondary outcomes

  1. Change From Baseline in Eosinophil Count

    Time frame: Baseline, Week 16, and Week 24

Sponsors and collaborators

Lead sponsor

AnaptysBio, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 3, 2018
Registry last updated
Jan 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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