- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03614923
Etokimab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72209
- Asthma & Allergy Institute
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California
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Canoga Park, California, United States, 91304
- Alliance Research Institute
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Roseville, California, United States, 95661
- DaVinci Research
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Sacramento, California, United States, 95815
- Sacramento Ear Nose and Throat Surgical and Medical Group Inc. - SacENT
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San Diego, California, United States, 92123
- Allergy & Asthma Medical Group and Research Center
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Colorado
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Denver, Colorado, United States, 80230
- Colorado Allergy Asthma Centers
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Florida
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Miami, Florida, United States, 33175
- Intermed Medical Research Center
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New Port Richey, Florida, United States, 34653
- Advanced Research Institute, Inc.
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Georgia
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Suwanee, Georgia, United States, 30024
- Clinical Research Consultants of Atlanta
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Idaho
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Boise, Idaho, United States, 83706
- Treasure Valley Medical Research
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Illinois
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Chicago, Illinois, United States, 60657
- Chicago ENT
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Kentucky
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Louisville, Kentucky, United States, 40213
- Advanced ENT and Allergy
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Maryland
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Baltimore, Maryland, United States, 21236
- Chesapeake Clinical Research Inc.
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New York
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New York, New York, United States, 10016
- ENT and Allergy Associates ENTA LLP
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina Hospitals
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Matthews, North Carolina, United States, 28105
- Charlotte Eye Ear Nose and Throat Associates
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Ohio
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Dublin, Ohio, United States, 43016
- Ohio Sinus Institute
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73120
- Allergy Asthma Clinical Research Center
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Tulsa, Oklahoma, United States, 74136
- Central States Research, LLC
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Tulsa, Oklahoma, United States, 74136
- Allergy Asthma and Immunology Center P.C.
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South Carolina
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North Charleston, South Carolina, United States, 29420
- National Allergy and Asthma Research
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Texas
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Fort Worth, Texas, United States, 76109
- Fort Worth ENT Berkson Medical
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McKinney, Texas, United States, 75070
- Ear Nose and Throat Associates of Texas
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Utah
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Draper, Utah, United States, 84020
- Intermountain Ear Nose Throat Specialist
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Saint George, Utah, United States, 84790
- Chrysalis Clinical Research
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Virginia
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Norfolk, Virginia, United States, 23507
- Eastern Virginia Medical School EVMS Medical Group
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Washington
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Bellingham, Washington, United States, 98225
- Bellingham Asthma Allergy Immunology Clinic
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Wisconsin
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Greenfield, Wisconsin, United States, 53228
- Allergy, Asthma Sinus Center, SC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Etokimab 300 mg + 150 mg Q4W
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).
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Administered by subcutaneous injection
Other Names:
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.
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Experimental: Etokimab 300 mg + 150 mg Q8W
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.
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Administered by subcutaneous injection
Other Names:
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.
Administered by subcutaneous injection
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Placebo Comparator: 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.
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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.
Administered by subcutaneous injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Nasal Polyp Score (NPS) to Week 16
Time Frame: Baseline and Week 16
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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
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Change From Baseline in Sino-Nasal Outcome Test-22 (SNOT-22) Score at Week 16
Time Frame: Baseline and Week 16
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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.
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Baseline and Week 16
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Change From Baseline in Eosinophil Count
Time Frame: Baseline, Week 16, and Week 24
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Baseline, Week 16, and Week 24
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: SM_ANB020-006@syneoshealth.com, AnaptysBio, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANB020-006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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