search
Back to results

Study to Evaluate Multiple Doses in Patients With Nasal Polyposis

Primary Purpose

Nasal Polyposis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AK001 low dose
AK001 high dose
Placebo
Sponsored by
Allakos Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Polyposis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigator site
  • Investigator site
  • Investigator site
  • Investigator site
  • Investigator site
  • Investigator site
  • Investigator site
  • Investigator site
  • Investigator site
  • Investigator site
  • Investigator site
  • Investigator site
  • Investigator
  • Investigator site
  • Investigator site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

25 mg AK001

250 mg AK001

Placebo

Arm Description

25 mg AK001 will be administered as multiple doses

250 mg AK001 will be administered as multiple doses

A placebo comparator consisting of inactive excipients will be administered as multiple doses

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 24, 2016
Last Updated
January 5, 2021
Sponsor
Allakos Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02734849
Brief Title
Study to Evaluate Multiple Doses in Patients With Nasal Polyposis
Official Title
A Phase 2, Randomized, Double-blind, Placebo-controlled, Study to Evaluate Multiple Doses of AK001 in Patients With Moderate to Severe Nasal Polyposis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allakos Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Polyposis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
25 mg AK001
Arm Type
Experimental
Arm Description
25 mg AK001 will be administered as multiple doses
Arm Title
250 mg AK001
Arm Type
Experimental
Arm Description
250 mg AK001 will be administered as multiple doses
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A placebo comparator consisting of inactive excipients will be administered as multiple doses
Intervention Type
Drug
Intervention Name(s)
AK001 low dose
Intervention Description
25 mg AK001 will be administered as multiple doses
Intervention Type
Drug
Intervention Name(s)
AK001 high dose
Intervention Description
250 mg AK001 will be administered as multiple doses
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered as multiple doses
Primary Outcome Measure Information:
Title
Change in Total Polys Score (TPS)
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus Bachert
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Investigator site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Investigator site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02101
Country
United States
Facility Name
Investigator site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15106
Country
United States
Facility Name
Investigator site
City
Houston
State/Province
Texas
ZIP/Postal Code
77001
Country
United States
Facility Name
Investigator site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22901
Country
United States
Facility Name
Investigator site
City
Ghent
Country
Belgium
Facility Name
Investigator site
City
Leuven
Country
Belgium
Facility Name
Investigator site
City
Dusseldorf
Country
Germany
Facility Name
Investigator site
City
Muenster
Country
Germany
Facility Name
Investigator site
City
Amsterdam
Country
Netherlands
Facility Name
Investigator site
City
Barcelona
Country
Spain
Facility Name
Investigator site
City
Jerez de la Frontera
Country
Spain
Facility Name
Investigator
City
Valencia
Country
Spain
Facility Name
Investigator site
City
Cambridge
Country
United Kingdom
Facility Name
Investigator site
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study to Evaluate Multiple Doses in Patients With Nasal Polyposis

We'll reach out to this number within 24 hrs