Etokimab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
- Conditions
- Chronic Rhinosinusitis
- Interventions
- Registration Number
- NCT03614923
- Lead Sponsor
- AnaptysBio, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
- 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]).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Etokimab 300 mg + 150 mg Q4W Mometasone Furoate Nasal Spray Participants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then 150 mg etokimab by subcutaneous injection every 4 weeks (Q4W) up to Week 12 (Weeks 4, 8, and 12). Participants also used mometasone furoate nasal spray (MFNS) of 2 actuations (50 μg/actuation) in each nostril twice daily (BID). Etokimab 300 mg + 150 mg Q4W Etokimab Participants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then 150 mg etokimab by subcutaneous injection every 4 weeks (Q4W) up to Week 12 (Weeks 4, 8, and 12). Participants also used mometasone furoate nasal spray (MFNS) of 2 actuations (50 μg/actuation) in each nostril twice daily (BID). Etokimab 300 mg + 150 mg Q8W Mometasone Furoate Nasal Spray Participants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then etokimab 150 mg by subcutaneous injection every 8 weeks (Q8W) up to Week 12 and placebo at Weeks 4 and 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID. Placebo Placebo Participants received placebo subcutaneous injection once every 4 weeks up to Week 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID. Etokimab 300 mg + 150 mg Q8W Etokimab Participants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then etokimab 150 mg by subcutaneous injection every 8 weeks (Q8W) up to Week 12 and placebo at Weeks 4 and 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID. Etokimab 300 mg + 150 mg Q8W Placebo Participants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then etokimab 150 mg by subcutaneous injection every 8 weeks (Q8W) up to Week 12 and placebo at Weeks 4 and 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID. Placebo Mometasone Furoate Nasal Spray Participants received placebo subcutaneous injection once every 4 weeks up to Week 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID.
- Primary Outcome Measures
Name Time Method Change From Baseline in Nasal Polyp Score (NPS) to Week 16 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.Change From Baseline in Sino-Nasal Outcome Test-22 (SNOT-22) Score at Week 16 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 Outcome Measures
Name Time Method Change From Baseline in Eosinophil Count Baseline, Week 16, and Week 24
Trial Locations
- Locations (28)
Intermountain Ear Nose Throat Specialist
🇺🇸Draper, Utah, United States
Chesapeake Clinical Research Inc.
🇺🇸Baltimore, Maryland, United States
Asthma & Allergy Institute
🇺🇸Little Rock, Arkansas, United States
Chrysalis Clinical Research
🇺🇸Saint George, Utah, United States
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
National Allergy and Asthma Research
🇺🇸North Charleston, South Carolina, United States
Sacramento Ear Nose and Throat Surgical and Medical Group Inc. - SacENT
🇺🇸Sacramento, California, United States
Allergy & Asthma Medical Group and Research Center
🇺🇸San Diego, California, United States
Intermed Medical Research Center
🇺🇸Miami, Florida, United States
Charlotte Eye Ear Nose and Throat Associates
🇺🇸Matthews, North Carolina, United States
Advanced ENT and Allergy
🇺🇸Louisville, Kentucky, United States
Colorado Allergy Asthma Centers
🇺🇸Denver, Colorado, United States
Fort Worth ENT Berkson Medical
🇺🇸Fort Worth, Texas, United States
Central States Research, LLC
🇺🇸Tulsa, Oklahoma, United States
DaVinci Research
🇺🇸Roseville, California, United States
Chicago ENT
🇺🇸Chicago, Illinois, United States
ENT and Allergy Associates ENTA LLP
🇺🇸New York, New York, United States
Ohio Sinus Institute
🇺🇸Dublin, Ohio, United States
Allergy Asthma and Immunology Center P.C.
🇺🇸Tulsa, Oklahoma, United States
Alliance Research Institute
🇺🇸Canoga Park, California, United States
Advanced Research Institute, Inc.
🇺🇸New Port Richey, Florida, United States
Clinical Research Consultants of Atlanta
🇺🇸Suwanee, Georgia, United States
University of North Carolina Hospitals
🇺🇸Chapel Hill, North Carolina, United States
Allergy Asthma Clinical Research Center
🇺🇸Oklahoma City, Oklahoma, United States
Bellingham Asthma Allergy Immunology Clinic
🇺🇸Bellingham, Washington, United States
Ear Nose and Throat Associates of Texas
🇺🇸McKinney, Texas, United States
Eastern Virginia Medical School EVMS Medical Group
🇺🇸Norfolk, Virginia, United States
Allergy, Asthma Sinus Center, SC
🇺🇸Greenfield, Wisconsin, United States