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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
25 mg AK001 will be administered as multiple doses
250 mg AK001 will be administered as multiple doses
Placebo will be administered as multiple doses
Investigator site
Chicago, Illinois, United States
Investigator site
Boston, Massachusetts, United States
Investigator site
Pittsburgh, Pennsylvania, United States
Change in Total Polys Score (TPS)
NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Change in TPS from Baseline (prior to the first dose) to Week 12 (Day 84) was the primary outcome of the study. TPS ranges from 0 to 8 (scored 0 \[no polyp\] to 4 \[large polyps\] for each nostril), with a lower score indicating smaller-sized polyps, a higher scores mean a worse outcome.
Time frame: From Baseline (prior to the first dose) to Week 12 (Day 84)
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Investigator site
Houston, Texas, United States
Investigator site
Charlottesville, Virginia, United States
Investigator site
Ghent, Belgium
Investigator site
Leuven, Belgium
Investigator site
Düsseldorf, Germany
Investigator site
Münster, Germany
Investigator site
Amsterdam, Netherlands
...and 5 more locations