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

AnaptysBio

Status and phase: Completed; Phase 2

Conditions: Chronic Rhinosinusitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03614923

ANB020-006

Details and patient eligibility

About

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

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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105 participants in 3 patient groups, including a placebo group

Etokimab 300 mg + 150 mg Q4W

Experimental group

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).

Treatment:

Drug: Mometasone Furoate Nasal Spray

Biological: Etokimab

Etokimab 300 mg + 150 mg Q8W

Experimental group

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.

Treatment:

Drug: Mometasone Furoate Nasal Spray

Biological: Etokimab

Biological: Placebo

Placebo

Placebo Comparator group

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.

Treatment:

Drug: Mometasone Furoate Nasal Spray

Biological: Placebo