At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 40 enrolled
Drug / intervention
AK001 low dose +2 moredrug
Likely dose
AK001 25 mg (low dose) or 250 mg (high dose) as multiple dosesAI-extracted
Key inclusion· 4
- ✓Bilateral nasal polyps grade ≥2 on each side with TPS ≥5 in both nostrils on endoscopy
- ✓History of sinusitis symptoms
- ✓SNOT-22 score ≥30 (symptom burden assessment)
- ✓No clinically significant abnormalities on ECG, vital signs, hematology, chemistry, or urinalysis
Key exclusion· 4
- ✕Systemic corticosteroid use within 6 weeks of screening
- ✕Chronic antibiotic therapy within 3 months prior to screening
- ✕Nasal surgery including polypectomy within 6 months prior to screening
- ✕Investigational drugs or participation in another clinical trial within 30 days or 5 half-lives, whichever is longer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Double-blind, Placebo-controlled, Study to Evaluate Multiple Doses of AK001 in Patients With Moderate to Severe Nasal Polyposis
In Brief
A Phase 2 clinical trial evaluating AK001 low dose, AK001 high dose, and 1 other intervention for Nasal Polyposis. Completed, enrolled 40 participants across 15 sites in 6 countries.
Detailed Summary
This is a phase 2 study to evaluate multiple doses of AK001 across 2 active doses. Pharmacodynamic activity will also be evaluated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasal Polyposis
CountriesBelgium, Germany, Netherlands, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartApr 2016
First PostedApr 2016
Primary CompletionJan 2018
TodayJul 2026
First PostedApr 12, 2016
Enrollment StartApr 1, 2016
Primary CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.2 years ago
Interventions
AK001 low dosedrug
25 mg AK001 will be administered as multiple doses
AK001 high dosedrug
250 mg AK001 will be administered as multiple doses
Placebodrug
Placebo will be administered as multiple doses