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

• Status: Completed
• Trial end date: 2020-10-26
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AnaptysBio, Inc.
• Treatments: Mometasone Furoate

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.