Study to Evaluate Multiple Doses in Patients With Nasal Polyposis

Allakos

Status and phase: Completed; Phase 2

Conditions: Nasal Polyposis

Treatments: Drug: AK001 high dose; Drug: Placebo; Drug: AK001 low dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02734849

AK001-002

Details and patient eligibility

About

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

Full description

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 3 patient groups, including a placebo group

25 mg AK001

Experimental group

Description:

25 mg AK001 will be administered as multiple doses

Treatment:

Drug: AK001 low dose

250 mg AK001

Experimental group

Description:

250 mg AK001 will be administered as multiple doses

Treatment:

Drug: AK001 high dose

Placebo

Placebo Comparator group

Description:

A placebo comparator consisting of inactive excipients will be administered as multiple doses

Treatment:

Drug: Placebo