Study of Efficacy and Safety of Brodalumab Compared With Placebo in Subjects With Axial Spondyloarthritis

June 17, 2015 updated by: Amgen

A Randomized, Double-blind, Placebo-controlled Study With an Open Label Extension to Evaluate the Safety and Efficacy of Brodalumab in Subjects With Axial Spondyloarthritis

The purpose of this study is to assess the safety and efficacy of brodalumab compared with placebo in participants with axial spondyloarthritis. Subjects will be randomized in a 1:1 ratio to brodalumab or placebo for the first part of the study. Subjects will then receive open label brodalumab for the remainder of the study. The entire study will be 312 weeks in duration for each subject.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • Research Site
      • Winnipeg, Manitoba, Canada, R3N 0K6
        • Research Site
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject fulfills the ASAS classification criteria of axial spondyloarthritis (except Crohn's disease criterion) for > 3 months with age of onset < 45 years of age
  • Subject has Bath Ankylosing Spondylitis DIsease Activity Index (BASDAI) score greater than or equal to 4 at screening and baseline
  • Subject has spinal pain score (BASDAI question #2) greater than or equal to 4 at screening and baseline
  • Subject has had adequate therapeutic trial (at least 4 weeks) of greater than or equal to 2 non-steroidal anti-inflammatory drgs (NSAIDs) at the maximum recommended dose unless contraindicated or subject is intolerant
  • For subjects receiving non-biologic DMARDS subject has received treatment for greater than or equal to 3 months with a stable doe for greater than or equal to 4 weeks prior to initiation of IM
  • For subjects receiving oral corticosteroids: the subject must be on a stable dose (not to exceed the equivalent of 10 mg of prednisone per day) for equal to or greater than 4 weeks prior to initiation of IMP

Exclusion Criteria:

  • Complete ankylosis (fusion) of the spine; Subject has a positive test for tuberculosis
  • Subject has a planned surgical intervention between baeline and week 16
  • Subject has an active infection or history of infections as follows (any active infection for which systemic anti-infectives were used within 28 day prior to the first MP dose
  • A serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first IMP dose
  • Recurrent or chronic infections or other active infection that, in the opinion ofthe investigator might cause this study to be detrimental to the subject)
  • Subject has active Crohn's disease or a history of Crohn's disease
  • Subject has active ulcerative colitis requiring daily use of immunosuppressive therapy
  • Subject has had active fibromyalgia within the past 12 months
  • Subject has a prior history of greater than 1 anti-TNF therapy for ankylosing spondylitis

  • Subject has used commercially available or investigational biologic therapies for ankylosing spondylitis as follows

    • Anti-tumor necrosis factor (TNF) therapy as follows: within 1 month prior to IMP initiation for etanercept and within 2 months prior to IMP initiation for other anti-TNF agents.
    • Other experimental or commercially available biologic therapies for ankylosing spondylitis within 3 months prior to IMP initiation
    • Anti-IL17 biologics (eg, brodalumab, secukinumab, ixekizumab) or anti-IL12/IL23 biologic therapy (eg, ustekinumab, briakinumab) at any time
    • Rituximab at any time

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Brodalumab 210 mg
210 mg brodalumab will be administered subcutaneously
Experimental: Brodalumab
Drug: Placebo
Placebo will be administered subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of SpondyloArthritis international Society (ASAS)
Time Frame: Week 16
Achievement of Assessment of SpondyloArthritis international Society (ASAS) 20 response at week 16
Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

April 24, 2015

First Submitted That Met QC Criteria

April 24, 2015

First Posted (Estimate)

April 29, 2015

Study Record Updates

Last Update Posted (Estimate)

June 19, 2015

Last Update Submitted That Met QC Criteria

June 17, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20101228
  • 2014-003701-15 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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