Study to Evaluate Multiple Doses in Patients With Nasal Polyposis



Status:Completed
Conditions:Colorectal Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 65
Updated:12/19/2018
Start Date:April 2016
End Date:January 2018

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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
We found this trial at
6
sites
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from
Boston, MA
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Charlottesville, VA
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Chicago, IL
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from
Ghent,
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from
Houston, TX
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from
Pittsburgh, PA
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