Study to Evaluate Multiple Doses in Patients With Nasal Polyposis

January 5, 2021 updated by: Allakos Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium
        • Investigator Site
      • Leuven, Belgium
        • Investigator Site
  • Germany
      • Dusseldorf, Germany
        • Investigator Site
      • Muenster, Germany
        • Investigator Site
  • Netherlands
      • Amsterdam, Netherlands
        • Investigator Site
  • Spain
      • Barcelona, Spain
        • Investigator Site
      • Jerez de la Frontera, Spain
        • Investigator Site
      • Valencia, Spain
        • Investigator
  • United Kingdom
      • Cambridge, United Kingdom
        • Investigator Site
      • Manchester, United Kingdom
        • Investigator Site
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60007
        • Investigator Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02101
        • Investigator Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15106
        • Investigator Site
    • Texas
      • Houston, Texas, United States, 77001
        • Investigator Site
    • Virginia
      • Charlottesville, Virginia, United States, 22901
        • Investigator Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 25 mg AK001
25 mg AK001 will be administered as multiple doses
Drug: AK001 low dose
25 mg AK001 will be administered as multiple doses
Experimental: 250 mg AK001
250 mg AK001 will be administered as multiple doses
Drug: AK001 high dose
250 mg AK001 will be administered as multiple doses
Placebo Comparator: Placebo
A placebo comparator consisting of inactive excipients will be administered as multiple doses
Drug: Placebo
Placebo will be administered as multiple doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Total Polys Score (TPS)
Time Frame: 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.
From Baseline (prior to the first dose) to Week 12 (Day 84)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allakos Inc.

Investigators

  • Principal Investigator: Claus Bachert, University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

March 24, 2016

First Submitted That Met QC Criteria

April 6, 2016

First Posted (Estimate)

April 12, 2016

Study Record Updates

Last Update Posted (Actual)

January 25, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK001-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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