Study to Evaluate Multiple Doses in Patients With Nasal Polyposis

A Phase 2, Randomized, Double-blind, Placebo-controlled, Study to Evaluate Multiple Doses of AK001 in Patients With Moderate to Severe Nasal Polyposis

This is a phase 2 study to evaluate multiple doses of AK001 across 2 active doses. Pharmacodynamic activity will also be evaluated.

AK001 is a monoclonal antibody which may be useful in the treatment of patients with moderate to severe nasal polyposis

Inclusion Criteria:

• TPS of ≥5 for both nostrils with presence on endoscopy of nasal polyps of grade ≥2 in each nostril according to the polyp grading scale
• History of sinusitis symptoms
• SNOT-22 ≥30
• No clinically significant Screening 12-lead ECG, vital sign, hematology, chemistry, or urinalysis findings

Exclusion Criteria:

• Use of systemic corticosteroids within 6 weeks of screening
• Chronic use of antibiotic therapy within 3 months prior to Screening
• Nasal surgery (including polypectomy) within 6 months prior to Screening
• Use of investigational drugs or participation in another clinical trial within 30 days prior to Screening or 5 half-lives, whichever is longer