Back to resultsEtokimab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Primary Purpose
Chronic Rhinosinusitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Etokimab
Placebo
Mometasone Furoate Nasal Spray
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Rhinosinusitis focused on measuring ANB020, Etokimab, CRSwNP
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.
Sites / Locations
- Asthma & Allergy Institute
- Alliance Research Institute
- DaVinci Research
- Sacramento Ear Nose and Throat Surgical and Medical Group Inc. - SacENT
- Allergy & Asthma Medical Group and Research Center
- Colorado Allergy Asthma Centers
- Intermed Medical Research Center
- Advanced Research Institute, Inc.
- Clinical Research Consultants of Atlanta
- Treasure Valley Medical Research
- Chicago ENT
- Advanced ENT and Allergy
- Chesapeake Clinical Research Inc.
- ENT and Allergy Associates ENTA LLP
- University of North Carolina Hospitals
- Charlotte Eye Ear Nose and Throat Associates
- Ohio Sinus Institute
- Allergy Asthma Clinical Research Center
- Allergy Asthma and Immunology Center P.C.
- Central States Research, LLC
- National Allergy and Asthma Research
- Fort Worth ENT Berkson Medical
- Ear Nose and Throat Associates of Texas
- Intermountain Ear Nose Throat Specialist
- Chrysalis Clinical Research
- Eastern Virginia Medical School EVMS Medical Group
- Bellingham Asthma Allergy Immunology Clinic
- Allergy, Asthma Sinus Center, SC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Etokimab 300 mg + 150 mg Q4W
Etokimab 300 mg + 150 mg Q8W
Placebo
Arm Description
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).
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Change From Baseline in Eosinophil Count
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03614923
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 29, 2018 (Actual)
Primary Completion Date
September 2, 2020 (Actual)
Study Completion Date
October 26, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AnaptysBio, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis
Keywords
ANB020, Etokimab, CRSwNP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Etokimab 300 mg + 150 mg Q4W
Arm Type
Experimental
Arm Description
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).
Arm Title
Etokimab 300 mg + 150 mg Q8W
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Etokimab
Other Intervention Name(s)
ANB020
Intervention Description
Administered by subcutaneous injection
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Administered by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Mometasone Furoate Nasal Spray
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Nasal Polyp Score (NPS) to Week 16
Description
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.
Time Frame
Baseline and Week 16
Title
Change From Baseline in Sino-Nasal Outcome Test-22 (SNOT-22) Score at Week 16
Description
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.
Time Frame
Baseline and Week 16
Secondary Outcome Measure Information:
Title
Change From Baseline in Eosinophil Count
Time Frame
Baseline, Week 16, and Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SM_ANB020-006@syneoshealth.com
Organizational Affiliation
AnaptysBio, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Asthma & Allergy Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72209
Country
United States
Facility Name
Alliance Research Institute
City
Canoga Park
State/Province
California
ZIP/Postal Code
91304
Country
United States
Facility Name
DaVinci Research
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Sacramento Ear Nose and Throat Surgical and Medical Group Inc. - SacENT
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Allergy & Asthma Medical Group and Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Colorado Allergy Asthma Centers
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Intermed Medical Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Advanced Research Institute, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Clinical Research Consultants of Atlanta
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
Treasure Valley Medical Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Chicago ENT
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Advanced ENT and Allergy
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Chesapeake Clinical Research Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
ENT and Allergy Associates ENTA LLP
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University of North Carolina Hospitals
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Charlotte Eye Ear Nose and Throat Associates
City
Matthews
State/Province
North Carolina
ZIP/Postal Code
28105
Country
United States
Facility Name
Ohio Sinus Institute
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
Allergy Asthma Clinical Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Allergy Asthma and Immunology Center P.C.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Central States Research, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
National Allergy and Asthma Research
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29420
Country
United States
Facility Name
Fort Worth ENT Berkson Medical
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76109
Country
United States
Facility Name
Ear Nose and Throat Associates of Texas
City
McKinney
State/Province
Texas
ZIP/Postal Code
75070
Country
United States
Facility Name
Intermountain Ear Nose Throat Specialist
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Chrysalis Clinical Research
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
Eastern Virginia Medical School EVMS Medical Group
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Bellingham Asthma Allergy Immunology Clinic
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Allergy, Asthma Sinus Center, SC
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53228
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Etokimab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
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