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Study to Evaluate Multiple Doses in Patients With Nasal Polyposis

A Phase 2, Randomized, Double-blind, Placebo-controlled, Study to Evaluate Multiple Doses of AK001 in Patients With Moderate to Severe Nasal Polyposis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02734849
Enrollment
40
Registered
2016-04-12
Start date
2016-04-30
Completion date
2018-01-31
Last updated
2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal Polyposis

Brief summary

This is a phase 2 study to evaluate multiple doses of AK001 across 2 active doses. Pharmacodynamic activity will also be evaluated.

Detailed description

AK001 is a monoclonal antibody which may be useful in the treatment of patients with moderate to severe nasal polyposis

Interventions

DRUGAK001 low dose

25 mg AK001 will be administered as multiple doses

DRUGAK001 high dose

250 mg AK001 will be administered as multiple doses

DRUGPlacebo

Placebo will be administered as multiple doses

Sponsors

Allakos Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Total Polys Score (TPS)From Baseline (prior to the first dose) to Week 12 (Day 84)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.

Countries

Belgium, Germany, Netherlands, Spain, United Kingdom, United States

Participant flow

Recruitment details

Date First Patient First Visit 04 April 2016 Date Last Patient Last Visit 05 January 2018 Date Enrollment was Terminated 31 May 2017

Participants by arm

ArmCount
25 mg AK001
25 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.
15
250 mg AK001
250 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.
14
Placebo
Placebo was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.
10
Total39

Baseline characteristics

Characteristic25 mg AK001250 mg AK001PlaceboTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
2 Participants0 Participants0 Participants2 Participants
Age, Categorical
Between 18 and 65 years
13 Participants14 Participants10 Participants37 Participants
Age, Continuous48.0 Years46.5 Years45.0 Years45.0 Years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
15 Participants14 Participants10 Participants39 Participants
Region of Enrollment
Europe
10 participants9 participants6 participants25 participants
Region of Enrollment
United States
5 participants5 participants4 participants14 participants
Sex: Female, Male
Female
5 Participants8 Participants5 Participants18 Participants
Sex: Female, Male
Male
10 Participants6 Participants5 Participants21 Participants
Total Polyp Score (TPS)6.0 units on a scale6.0 units on a scale6.0 units on a scale6.0 units on a scale

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 150 / 140 / 10
other
Total, other adverse events
11 / 1510 / 147 / 10
serious
Total, serious adverse events
0 / 150 / 140 / 10

Outcome results

Primary

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)

Population: Modified Intent-to-Treat (MITT) population included all randomized subjects who have taken at least one dose of the study drug and had both a baseline and at least one post-baseline efficacy assessment.

ArmMeasureValue (MEAN)
25 mg AK001Change in Total Polys Score (TPS)-0.5 score on a scale
250 mg AK001Change in Total Polys Score (TPS)-0.3 score on a scale
PlaceboChange in Total Polys Score (TPS)-0.2 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026