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Study to Evaluate Multiple Doses in Patients With Nasal Polyposis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02734849
Recruitment Status : Completed
First Posted : April 12, 2016
Results First Posted : December 28, 2020
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
Allakos Inc.

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

Condition or disease Intervention/treatment Phase
Nasal Polyposis Drug: AK001 low dose Drug: AK001 high dose Drug: Placebo Phase 2

Detailed Description:
AK001 is a monoclonal antibody which may be useful in the treatment of patients with moderate to severe nasal polyposis
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734849


Locations
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United States, Illinois
Investigator site
Chicago, Illinois, United States, 60007
United States, Massachusetts
Investigator site
Boston, Massachusetts, United States, 02101
United States, Pennsylvania
Investigator site
Pittsburgh, Pennsylvania, United States, 15106
United States, Texas
Investigator site
Houston, Texas, United States, 77001
United States, Virginia
Investigator site
Charlottesville, Virginia, United States, 22901
Belgium
Investigator site
Ghent, Belgium
Investigator site
Leuven, Belgium
Germany
Investigator site
Dusseldorf, Germany
Investigator site
Muenster, Germany
Netherlands
Investigator site
Amsterdam, Netherlands
Spain
Investigator site
Barcelona, Spain
Investigator site
Jerez de la Frontera, Spain
Investigator
Valencia, Spain
United Kingdom
Investigator site
Cambridge, United Kingdom
Investigator site
Manchester, United Kingdom
Sponsors and Collaborators
Allakos Inc.
Investigators
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Principal Investigator: Claus Bachert University Hospital, Ghent
  Study Documents (Full-Text)

Documents provided by Allakos Inc.:
Study Protocol  [PDF] October 27, 2016
Statistical Analysis Plan  [PDF] August 16, 2017

More Information
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Responsible Party: Allakos Inc.
ClinicalTrials.gov Identifier: NCT02734849    
Other Study ID Numbers: AK001-002
First Posted: April 12, 2016    Key Record Dates
Results First Posted: December 28, 2020
Last Update Posted: January 25, 2021
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Nasopharyngeal Neoplasms
Nasal Polyps
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
 Rectal Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Nose Diseases
Respiratory Tract Diseases
Polyps
Pathological Conditions, Anatomical