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

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Rhinosinusitis

In brief

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

Key facts

Study ID

NCT03614923

Run by

AnaptysBio, Inc.

People needed

105

Starts

2018-11-29

Expected to finish

2020-10-26

Last updated by the study team

2022-01-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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).
• 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]).

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.
• Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it is running

• 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

Full record on ClinicalTrials.gov

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