Etokimab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

NCT03614923 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: ANB020-006
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 28

Brief Summary

A study to evaluate the safety and efficacy of multiple doses of etokimab in adults with chronic rhinosinusitis with nasal polyps.

Conditions

Chronic Rhinosinusitis

Keywords

ANB020; Etokimab; CRSwNP

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Change From Baseline in Eosinophil Count

  Baseline, Week 16, and Week 24

Study Arms (3)

Etokimab 300 mg + 150 mg Q4W

EXPERIMENTAL

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).

Biological: Etokimab; Drug: Mometasone Furoate Nasal Spray

Etokimab 300 mg + 150 mg Q8W

EXPERIMENTAL

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.

Biological: Etokimab; Biological: Placebo; Drug: Mometasone Furoate Nasal Spray

Placebo

PLACEBO COMPARATOR

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.

Biological: Placebo; Drug: Mometasone Furoate Nasal Spray

Interventions

Etokimab BIOLOGICAL

Administered by subcutaneous injection

Also known as: ANB020

Etokimab 300 mg + 150 mg Q4W; Etokimab 300 mg + 150 mg Q8W

Placebo BIOLOGICAL

Administered by subcutaneous injection

Etokimab 300 mg + 150 mg Q8W; Placebo

Mometasone Furoate Nasal Spray DRUG

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 Q4W; Etokimab 300 mg + 150 mg Q8W; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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 \[m\^2\]).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AnaptysBio, Inc.: lead

Study Sites (28)

Asthma & Allergy Institute

Little Rock, Arkansas, 72209, United States

Location

Alliance Research Institute

Canoga Park, California, 91304, United States

Location

DaVinci Research

Roseville, California, 95661, United States

Location

Sacramento Ear Nose and Throat Surgical and Medical Group Inc. - SacENT

Sacramento, California, 95815, United States

Location

Allergy & Asthma Medical Group and Research Center

San Diego, California, 92123, United States

Location

Colorado Allergy Asthma Centers

Denver, Colorado, 80230, United States

Location

Intermed Medical Research Center

Miami, Florida, 33175, United States

Location

Advanced Research Institute, Inc.

New Port Richey, Florida, 34653, United States

Location

Clinical Research Consultants of Atlanta

Suwanee, Georgia, 30024, United States

Location

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

Location

Chicago ENT

Chicago, Illinois, 60657, United States

Location

Advanced ENT and Allergy

Louisville, Kentucky, 40213, United States

Location

Chesapeake Clinical Research Inc.

Baltimore, Maryland, 21236, United States

Location

ENT and Allergy Associates ENTA LLP

New York, New York, 10016, United States

Location

University of North Carolina Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

Charlotte Eye Ear Nose and Throat Associates

Matthews, North Carolina, 28105, United States

Location

Ohio Sinus Institute

Dublin, Ohio, 43016, United States

Location

Allergy Asthma Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

Location

Allergy Asthma and Immunology Center P.C.

Tulsa, Oklahoma, 74136, United States

Location

Central States Research, LLC

Tulsa, Oklahoma, 74136, United States

Location

National Allergy and Asthma Research

North Charleston, South Carolina, 29420, United States

Location

Fort Worth ENT Berkson Medical

Fort Worth, Texas, 76109, United States

Location

Ear Nose and Throat Associates of Texas

McKinney, Texas, 75070, United States

Location

Intermountain Ear Nose Throat Specialist

Draper, Utah, 84020, United States

Location

Chrysalis Clinical Research

St. George, Utah, 84790, United States

Location

Eastern Virginia Medical School EVMS Medical Group

Norfolk, Virginia, 23507, United States

Location

Bellingham Asthma Allergy Immunology Clinic

Bellingham, Washington, 98225, United States

Location

Allergy, Asthma Sinus Center, SC

Greenfield, Wisconsin, 53228, United States

Location

Results Point of Contact

• Title: Clinical Project Leader
• Organization: AnaptysBio, Inc.

info@anaptysbio.com

858-362-6295

Study Officials

• SM_ANB020-006@syneoshealth.com

  AnaptysBio, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 3, 2018
• Study Start: November 29, 2018
• Primary Completion: September 2, 2020
• Study Completion: October 26, 2020
• Last Updated: January 24, 2022
• Results First Posted: January 24, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (28)