Clinical Trial Details

NCT ID: NCT02696785
Date Last Changed: October 2, 2017

Overview

Research Study Summary

A clinical research study of Ixekizumab, Placebo and Adalimumab for the treatment of Spondyloarthritis

Research Study Title

A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD-Naive Patients With Radiographic Axial Spondyloarthritis

Purpose

The main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biological disease-modifying anti-rheumatic drugs (bDMARDs)-naive participants with radiographic axial spondyloarthritis (rad-axSpA).

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Eli Lilly and Company
Duration
19 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Inclusion Criteria:

  • Are ambulatory.

  • Diagnosis of radiographic axial spondyloarthritis (rad-xSpA) with sacroiliitis defined radiographically according to the modified New York criteria.

  • Participants have a history of back pain ≥3 months with age at onset < 45 years.

  • In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (for duration 4 weeks) or cannot tolerate NSAIDS.

  • If taking NSAIDS be on a stable dose for at least 2 weeks prior to randomization.

  • Have a history of prior therapy for axSpa for at least 12 weeks prior to screening.

Exclusion Criteria:

  • Have total ankylosis of the spine.

  • Have received any prior, or are currently receiving, treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents.

  • Have recently received a live vaccine within 12 weeks or have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year.

  • Have an ongoing or serious infection within the last 12 weeks or evidence of active tuberculosis.

  • Have a compromised immune system.

  • Have any other serious and/or uncontrolled diseases.

  • Have either a current diagnosis or a recent history of malignant disease.

  • Have had major surgery within 8 weeks of baseline, or will require surgery during the study.

  • Are pregnant or breastfeeding.

Site Locations (10)

Country State City Zip Facility and Contact
United States Arizona Tucson 85724 University of Arizona
520-626-6399

Dominick Sudano
Principal Investigator
United States Colorado Colorado Springs 80920 Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC
719-475-9616

Michael Sayers
Principal Investigator
United States Colorado Denver 80230 Denver Arthritis Center
303-394-2828

Ryan Antolini
Principal Investigator
United States Idaho Idaho Falls 83404 Institute of Arthritis Research
208-542-9080

Craig Scoville
Principal Investigator
United States New York Albany 12203 The Center for Rheumatology
518-489-4471

Joel Kremer
Principal Investigator
United States Washington Spokane 99204 Arthritis Northwest Rheumatology
509-838-6500

Eric Mueller
Principal Investigator
United States Washington Vancouver 98664 Vancouver Clinic
360-397-3388

Theresa Karplus
Principal Investigator
Japan Hyōgo 366 8501 "For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Eli Lilly and Company
Korea, Republic of Gwangjin-gu 05080 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
Poland Warszawa 02-691 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company

Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559

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