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Study to Evaluate Multiple Doses in Patients With Nasal Polyposis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allakos, Inc.
ClinicalTrials.gov Identifier:
NCT02734849
First received: March 24, 2016
Last updated: July 31, 2017
Last verified: July 2017
  Purpose
This is a phase 2 study to evaluate multiple doses of AK001 across 2 active doses. Pharmacodynamic activity will also be evaluated.

Condition Intervention Phase
Nasal Polyposis Drug: AK001 low dose Drug: AK001 high dose Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Allakos, Inc.:

Primary Outcome Measures:
  • Evaluation of AK001 in combination with an intranasal steroid versus intranasal steroid alone in the reduction of nasal polyp size. [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Size of polyps as evaluated by Lund-Mackay score at selected sites by computed tomography (CT) scan [ Time Frame: 12 weeks ]

Enrollment: 40
Study Start Date: April 2016
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AK001 low dose
A low dose of AK001 will be administered in multiple doses
Drug: AK001 low dose
A low dose of AK001 will be administered as multiple doses
Experimental: AK001 high dose
A high dose of AK001 will be administered in multiple doses
Drug: AK001 high dose
A high dose of AK001 will be administered as multiple doses
Placebo Comparator: Placebo
A placebo comparator consisting of inactive excipients
Drug: Placebo
Placebo will be administered as multiple doses

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

Ages Eligible for Study:   18 Years to 65 Years   (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02734849

Locations
United States, Illinois
Investigator site
Chicago, Illinois, United States
United States, Massachusetts
Investigator site
Boston, Massachusetts, United States
United States, Pennsylvania
Investigator site
Pittsburgh, Pennsylvania, United States
United States, Texas
Investigator site
Houston, Texas, United States
United States, Virginia
Investigator site
Charlottesville, Virginia, United States
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
Principal Investigator: Claus Bachert University Hospital, Ghent
  More Information

Responsible Party: Allakos, Inc.
ClinicalTrials.gov Identifier: NCT02734849     History of Changes
Other Study ID Numbers: AK001-002
Study First Received: March 24, 2016
Last Updated: July 31, 2017

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 21, 2017