Phase 2
N=40
Study to Evaluate Multiple Doses in Patients With Nasal Polyposis
Nasal Polyposis
Bottom Line
View on ClinicalTrials.gov: NCT02734849 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Change in Total Polys Score (TPS) — -0.5; -0.3; -0.2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AK001 low dose (Drug); AK001 high dose (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allakos Inc.
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Polys Score (TPS) |
-0.5; -0.3; -0.2 | — |
Summary
This is a phase 2 study to evaluate multiple doses of AK001 across 2 active doses. Pharmacodynamic activity will also be evaluated.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02734849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.