Study to Evaluate Multiple Doses in Patients With Nasal Polyposis

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Allakos, Inc.

Criteria

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