Study to Evaluate Multiple Doses in Patients With Nasal Polyposis

Nasal Polyposis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02734849
• Other study ID #: AK001-002
• Status: Completed
• Phase: Phase 2
• Start date: April 2016
• Est. completion date: January 2018

Study information

• Verified date: December 2018
• Source: Allakos, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Nasal Polyposis
• Nasal Polyps
• Nasopharyngeal Neoplasms

Intervention

Drug:
• AK001 low dose
25 mg AK001 will be administered as multiple doses
• AK001 high dose
250 mg AK001 will be administered as multiple doses
• Placebo
Placebo will be administered as multiple doses

Locations

Country	Name	City	State
Belgium	Investigator site	Ghent
Belgium	Investigator site	Leuven
Germany	Investigator site	Dusseldorf
Germany	Investigator site	Muenster
Netherlands	Investigator site	Amsterdam
Spain	Investigator site	Barcelona
Spain	Investigator site	Jerez de la Frontera
Spain	Investigator	Valencia
United Kingdom	Investigator site	Cambridge
United Kingdom	Investigator site	Manchester
United States	Investigator site	Boston	Massachusetts
United States	Investigator site	Charlottesville	Virginia
United States	Investigator site	Chicago	Illinois
United States	Investigator site	Houston	Texas
United States	Investigator site	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Allakos, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From Baseline (prior to the first dose) to Week 12 (Day 84)