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

Chronic Rhinosinusitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03614923
• Other study ID #: ANB020-006
• Status: Completed
• Phase: Phase 2
• Start date: November 29, 2018
• Est. completion date: October 26, 2020

Study information

• Verified date: August 2021
• Source: AnaptysBio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: October 26, 2020
• Est. primary completion date: September 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Rhinosinusitis
• Sinusitis

Intervention

Biological:
• Etokimab
Administered by subcutaneous injection
• 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.

Locations

Country	Name	City	State
United States	Chesapeake Clinical Research Inc.	Baltimore	Maryland
United States	Bellingham Asthma Allergy Immunology Clinic	Bellingham	Washington
United States	Treasure Valley Medical Research	Boise	Idaho
United States	Alliance Research Institute	Canoga Park	California
United States	University of North Carolina Hospitals	Chapel Hill	North Carolina
United States	Chicago ENT	Chicago	Illinois
United States	Colorado Allergy Asthma Centers	Denver	Colorado
United States	Intermountain Ear Nose Throat Specialist	Draper	Utah
United States	Ohio Sinus Institute	Dublin	Ohio
United States	Fort Worth ENT Berkson Medical	Fort Worth	Texas
United States	Allergy, Asthma Sinus Center, SC	Greenfield	Wisconsin
United States	Asthma & Allergy Institute	Little Rock	Arkansas
United States	Advanced ENT and Allergy	Louisville	Kentucky
United States	Charlotte Eye Ear Nose and Throat Associates	Matthews	North Carolina
United States	Ear Nose and Throat Associates of Texas	McKinney	Texas
United States	Intermed Medical Research Center	Miami	Florida
United States	Advanced Research Institute, Inc.	New Port Richey	Florida
United States	ENT and Allergy Associates ENTA LLP	New York	New York
United States	Eastern Virginia Medical School EVMS Medical Group	Norfolk	Virginia
United States	National Allergy and Asthma Research	North Charleston	South Carolina
United States	Allergy Asthma Clinical Research Center	Oklahoma City	Oklahoma
United States	DaVinci Research	Roseville	California
United States	Sacramento Ear Nose and Throat Surgical and Medical Group Inc. - SacENT	Sacramento	California
United States	Chrysalis Clinical Research	Saint George	Utah
United States	Allergy & Asthma Medical Group and Research Center	San Diego	California
United States	Clinical Research Consultants of Atlanta	Suwanee	Georgia
United States	Allergy Asthma and Immunology Center P.C.	Tulsa	Oklahoma
United States	Central States Research, LLC	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
AnaptysBio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Nasal Polyp Score (NPS) to 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.	Baseline and Week 16
Primary	Change From Baseline in Sino-Nasal Outcome Test-22 (SNOT-22) Score at 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.	Baseline and Week 16
Secondary	Change From Baseline in Eosinophil Count		Baseline, Week 16, and Week 24