Study to Evaluate Multiple Doses in Patients With Nasal Polyposis
Completed · Phase 2 · Has a placebo group
Conditions studied: Nasal Polyposis
In brief
This is a phase 2 study to evaluate multiple doses of AK001 across 2 active doses. Pharmacodynamic activity will also be evaluated.
Key facts
- Study ID
- NCT02734849
- Run by
- Allakos Inc.
- People needed
- 40
- Starts
- 2016-04-01
- Expected to finish
- 2018-01-01
- Last updated by the study team
- 2021-01-25
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Investigator site — Chicago, Illinois, United States
- Investigator site — Boston, Massachusetts, United States
- Investigator site — Pittsburgh, Pennsylvania, United States
- 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
- Investigator site — Barcelona, Spain
- Investigator site — Jerez de la Frontera, Spain
- Investigator — Valencia, Spain
- Investigator site — Cambridge, United Kingdom
- Investigator site — Manchester, United Kingdom
Full record on ClinicalTrials.gov
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