Phase 2 N=105 Randomized Triple-blind Treatment

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

Chronic Rhinosinusitis

Bottom Line

View on ClinicalTrials.gov: NCT03614923 ↗

Enrolled (actual)

105

Serious AEs

1.9%

Results posted

Jan 2022

Primary outcome: Primary: Change From Baseline in Nasal Polyp Score (NPS) to Week 16 — -0.87; -0.89; -0.49 score on a scale — p=0.2364

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Etokimab (Biological); Placebo (Biological); Mometasone Furoate Nasal Spray (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AnaptysBio, Inc.
Primary completion: Sep 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Nasal Polyp Score (NPS) to Week 16	-0.87; -0.89; -0.49	0.2364
PRIMARY Change From Baseline in Sino-Nasal Outcome Test-22 (SNOT-22) Score at Week 16	-22.97; -18.34; -16.32	0.1330
SECONDARY Change From Baseline in Eosinophil Count	0.437; 0.350; 0.434; -0.162; -0.117; -0.020	—

Summary

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03614923). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.