Study to Evaluate Multiple Doses in Patients With Nasal Polyposis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-01-31

Brief Summary

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

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Detailed Description

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

Conditions

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Nasal Polyposis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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25 mg AK001

25 mg AK001 will be administered as multiple doses

Group Type EXPERIMENTAL

AK001 low dose

Intervention Type DRUG

25 mg AK001 will be administered as multiple doses

250 mg AK001

250 mg AK001 will be administered as multiple doses

Group Type EXPERIMENTAL

AK001 high dose

Intervention Type DRUG

250 mg AK001 will be administered as multiple doses

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered as multiple doses

Interventions

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AK001 low dose

25 mg AK001 will be administered as multiple doses

Intervention Type DRUG

AK001 high dose

250 mg AK001 will be administered as multiple doses

Intervention Type DRUG

Placebo

Placebo will be administered as multiple doses

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No