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Study to Evaluate Multiple Doses in Patients With Nasal Polyposis

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Allakos, Inc.
Sponsor:
Information provided by (Responsible Party):
Allakos, Inc.
ClinicalTrials.gov Identifier:
NCT02734849
First received: March 24, 2016
Last updated: March 13, 2017
Last verified: March 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: 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 ]

Estimated Enrollment: 70
Study Start Date: April 2016
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: June 2017 (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

Contacts
Contact: Minh Afaga mafaga@allakos.com

Locations
United States, Illinois
Investigator site Recruiting
Chicago, Illinois, United States
Contact: Investigator         
United States, Massachusetts
Investigator site Recruiting
Boston, Massachusetts, United States
Contact: Investigator         
United States, Pennsylvania
Investigator site Recruiting
Pittsburgh, Pennsylvania, United States
Contact: Investigator         
United States, Texas
Investigator site Recruiting
Houston, Texas, United States
Contact: Investigator         
United States, Virginia
Investigator site Recruiting
Charlottesville, Virginia, United States
Contact: Investigator         
Belgium
Investigator site Recruiting
Ghent, Belgium
Contact: Investigator         
Investigator site Recruiting
Leuven, Belgium
Contact: Investigator         
Germany
Investigator site Recruiting
Dusseldorf, Germany
Contact: Investigator         
Investigator site Recruiting
Muenster, Germany
Contact: Investigator         
Netherlands
Investigator site Recruiting
Amsterdam, Netherlands
Contact: Investigator         
Spain
Investigator site Recruiting
Barcelona, Spain
Contact: Investigator         
Investigator site Recruiting
Jerez de la Frontera, Spain
Contact: Investigator         
Investigator Recruiting
Valencia, Spain
Contact: Investigator         
United Kingdom
Investigator site Recruiting
Cambridge, United Kingdom
Contact: Investigator         
Investigator site Recruiting
Manchester, United Kingdom
Contact: Investigator         
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: March 13, 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 March 24, 2017