Etokimab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
NCT ID: NCT03614923
Last Updated: 2022-01-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
105 participants
INTERVENTIONAL
2018-11-29
2020-10-26
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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).
Etokimab
Administered by subcutaneous injection
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.
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.
Etokimab
Administered by subcutaneous injection
Placebo
Administered by subcutaneous injection
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.
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.
Placebo
Administered by subcutaneous injection
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.
Interventions
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Etokimab
Administered by subcutaneous injection
Placebo
Administered by subcutaneous injection
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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AnaptysBio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Asthma & Allergy Institute
Little Rock, Arkansas, United States
Alliance Research Institute
Canoga Park, California, United States
DaVinci Research
Roseville, California, 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
Colorado Allergy Asthma Centers
Denver, Colorado, United States
Intermed Medical Research Center
Miami, Florida, United States
Advanced Research Institute, Inc.
New Port Richey, Florida, United States
Clinical Research Consultants of Atlanta
Suwanee, Georgia, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Chicago ENT
Chicago, Illinois, United States
Advanced ENT and Allergy
Louisville, Kentucky, United States
Chesapeake Clinical Research Inc.
Baltimore, Maryland, United States
ENT and Allergy Associates ENTA LLP
New York, New York, United States
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States
Charlotte Eye Ear Nose and Throat Associates
Matthews, North Carolina, United States
Ohio Sinus Institute
Dublin, Ohio, United States
Allergy Asthma Clinical Research Center
Oklahoma City, Oklahoma, United States
Allergy Asthma and Immunology Center P.C.
Tulsa, Oklahoma, United States
Central States Research, LLC
Tulsa, Oklahoma, United States
National Allergy and Asthma Research
North Charleston, South Carolina, United States
Fort Worth ENT Berkson Medical
Fort Worth, Texas, United States
Ear Nose and Throat Associates of Texas
McKinney, Texas, United States
Intermountain Ear Nose Throat Specialist
Draper, Utah, United States
Chrysalis Clinical Research
St. George, Utah, United States
Eastern Virginia Medical School EVMS Medical Group
Norfolk, Virginia, United States
Bellingham Asthma Allergy Immunology Clinic
Bellingham, Washington, United States
Allergy, Asthma Sinus Center, SC
Greenfield, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ANB020-006
Identifier Type: -
Identifier Source: org_study_id
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