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 |
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.
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
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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