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
Verified date | August 2021 |
Source | AnaptysBio, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A study to evaluate the safety and efficacy of multiple doses of etokimab in adults with chronic rhinosinusitis with nasal polyps.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
AnaptysBio, Inc. |
United States,
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 |
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