NCT02734849

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2016

Geographic Reach
6 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
3 years until next milestone

Results Posted

Study results publicly available

December 28, 2020

Completed
Last Updated

January 25, 2021

Status Verified

December 1, 2018

Enrollment Period

1.8 years

First QC Date

March 24, 2016

Results QC Date

December 2, 2020

Last Update Submit

January 5, 2021

Conditions

Nasal Polyposis

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (3)

25 mg AK001

EXPERIMENTAL

25 mg AK001 will be administered as multiple doses

Drug: AK001 low dose

250 mg AK001

EXPERIMENTAL

250 mg AK001 will be administered as multiple doses

Drug: AK001 high dose

Placebo

PLACEBO COMPARATOR

A placebo comparator consisting of inactive excipients will be administered as multiple doses

Drug: Placebo

Interventions

AK001 low doseDRUG

25 mg AK001 will be administered as multiple doses

25 mg AK001
AK001 high doseDRUG

250 mg AK001 will be administered as multiple doses

250 mg AK001
PlaceboDRUG

Placebo will be administered as multiple doses

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Investigator site

Chicago, Illinois, 60007, United States

Location

Investigator site

Boston, Massachusetts, 02101, United States

Location

Investigator site

Pittsburgh, Pennsylvania, 15106, United States

Location

Investigator site

Houston, Texas, 77001, United States

Location

Investigator site

Charlottesville, Virginia, 22901, United States

Location

Investigator site

Ghent, Belgium

Location

Investigator site

Leuven, Belgium

Location

Investigator site

Düsseldorf, Germany

Location

Investigator site

Münster, Germany

Location

Investigator site

Amsterdam, Netherlands

Location

Investigator site

Barcelona, Spain

Location

Investigator site

Jerez de la Frontera, Spain

Location

Investigator

Valencia, Spain

Location

Investigator site

Cambridge, United Kingdom

Location

Investigator site

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Nasal Polyps

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Limitations and Caveats

After 40 of the 70 patients planned were randomized in the study, enrollment was stopped as the Sponsor decided not to pursue further development of AK001. The study was not stopped for any safety concern. Early termination resulted uninterpretable data.

Results Point of Contact

Title
Henrik Rasmussen, MD, PhD, Chief Medical Officer
Organization
Allakos, Inc.
hrasmussen@allakos.com
1 6505975002

Study Officials

  • Claus Bachert

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2016

First Posted

April 12, 2016

Study Start

April 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

January 25, 2021

Results First Posted

December 28, 2020

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)NL(1)ES(3)GB(2)US(5)DE(2)