Clinical trial NCT03614923: Etokimab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Rhinosinusitis
Keywords: ANB020
Etokimab
CRSwNP
Lead sponsor: AnaptysBio, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-03
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Nasal Polyp Score (NPS) to Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Sino-Nasal Outcome Test-22 (SNOT-22) Score at Week 16
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: Change From Baseline in Eosinophil Count
timeFrame: Baseline, Week 16, and Week 24
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Asthma & Allergy Institute
state: Arkansas
city: Canoga Park
country: United States
facility: Alliance Research Institute
state: California
city: Roseville
country: United States
facility: DaVinci Research
state: California
city: Sacramento
country: United States
facility: Sacramento Ear Nose and Throat Surgical and Medical Group Inc. - SacENT
state: California
city: San Diego
country: United States
facility: Allergy & Asthma Medical Group and Research Center
state: California
city: Denver
country: United States
facility: Colorado Allergy Asthma Centers
state: Colorado
city: Miami
country: United States
facility: Intermed Medical Research Center
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute, Inc.
state: Florida
city: Suwanee
country: United States
facility: Clinical Research Consultants of Atlanta
state: Georgia
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Chicago
country: United States
facility: Chicago ENT
state: Illinois
city: Louisville
country: United States
facility: Advanced ENT and Allergy
state: Kentucky
city: Baltimore
country: United States
facility: Chesapeake Clinical Research Inc.
state: Maryland
city: New York
country: United States
facility: ENT and Allergy Associates ENTA LLP
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals
state: North Carolina
city: Matthews
country: United States
facility: Charlotte Eye Ear Nose and Throat Associates
state: North Carolina
city: Dublin
country: United States
facility: Ohio Sinus Institute
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy Asthma Clinical Research Center
state: Oklahoma
city: Tulsa
country: United States
facility: Allergy Asthma and Immunology Center P.C.
state: Oklahoma
city: Tulsa
country: United States
facility: Central States Research, LLC
state: Oklahoma
city: North Charleston
country: United States
facility: National Allergy and Asthma Research
state: South Carolina
city: Fort Worth
country: United States
facility: Fort Worth ENT Berkson Medical
state: Texas
city: McKinney
country: United States
facility: Ear Nose and Throat Associates of Texas
state: Texas
city: Draper
country: United States
facility: Intermountain Ear Nose Throat Specialist
state: Utah
city: Saint George
country: United States
facility: Chrysalis Clinical Research
state: Utah
city: Norfolk
country: United States
facility: Eastern Virginia Medical School EVMS Medical Group
state: Virginia
city: Bellingham
country: United States
facility: Bellingham Asthma Allergy Immunology Clinic
state: Washington
city: Greenfield
country: United States
facility: Allergy, Asthma Sinus Center, SC
state: Wisconsin
Study officials:
affiliation: AnaptysBio, Inc.
name: SM_ANB020-006@syneoshealth.com
role: STUDY_DIRECTOR
References: