A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis



Status:Active, not recruiting
Conditions:Arthritis, Arthritis, Orthopedic
Therapuetic Areas:Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:1/17/2019
Start Date:August 2, 2016
End Date:March 8, 2019

Use our guide to learn which trials are right for you!

A 52-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD Naive Patients With Nonradiographic Axial Spondyloarthritis

The main purpose of this study is to evaluate the safety and efficacy of the study drug known
as ixekizumab in biologic disease modifying antirheumatic drug (bDMARD) naïve participants
with nonradiographic axial spondyloarthritis (nonrad-axSpA).


Inclusion Criteria:

- Are ambulatory.

- Diagnosis of nonradiographic axial spondyloarthritis (nr-axSpA) and fulfilling the
2009 ASAS classification criteria.

- Have a history of back pain ≥3 months with age at onset <45 years.

- Have active nr-axSpA defined as BASDAI ≥4 and total back pain ≥4 on a NRS at screening
and baseline.

- Have objective signs of inflammation by presence of sacroiliitis on MRI and/or
presence of elevated CRP.

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

- If taking NSAIDS be on 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 radiographic sacroiliitis fulfilling the 1984 modified New York criteria.

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

- Have 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.

- Have evidence of active anterior uveitis (an acute episode) within the last 42 days
prior to baseline randomization.
We found this trial at
26
sites
Colorado Springs, Colorado 80920
Principal Investigator: Michael Sayers
Phone: 719-475-9613
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Atulya Deodhar
Phone: 503-494-7711
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Capital Federal,
Click here to add this to my saved trials
Columbia, South Carolina 29204
Principal Investigator: Kathleen Flint
Phone: 803-779-0911
?
mi
from
Columbia, SC
Click here to add this to my saved trials
Cumberland, Maryland 21502
Principal Investigator: Steven Klein
Phone: 301-724-4337
?
mi
from
Cumberland, MD
Click here to add this to my saved trials
Danbury, Connecticut 06810
Principal Investigator: Richard Roseff
Phone: 203-616-2710
?
mi
from
Danbury, CT
Click here to add this to my saved trials
Duncansville, Pennsylvania 16635
Principal Investigator: Alan Kivitz
Phone: 814-693-0300
?
mi
from
Duncansville, PA
Click here to add this to my saved trials
El Cajon, California 92020
Principal Investigator: Arthur Mabaquiao
Phone: 619-334-4735
?
mi
from
El Cajon, CA
Click here to add this to my saved trials
215 South Hickory Street
Escondido, California 92025
Principal Investigator: Tania Rivera
Phone: 858-336-2810
?
mi
from
Escondido, CA
Click here to add this to my saved trials
Hagerstown, Maryland 21740
Principal Investigator: Mary Howell
Phone: 301-791-6680
?
mi
from
Hagerstown, MD
Click here to add this to my saved trials
19582 Beach Boulevard
Huntington Beach, California 92648
Principal Investigator: Christine Thai
Phone: 949-385-0469
?
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
Idaho Falls, Idaho 83404
Principal Investigator: Craig Scoville
Phone: 208-542-9080
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
Kalispell, Montana 59901
Principal Investigator: Roger Diegel
Phone: 406-755-1460
?
mi
from
Kalispell, MT
Click here to add this to my saved trials
Lincoln, Nebraska 68512
Principal Investigator: Melvin Churchill
Phone: 402-420-1212
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
Marietta, Georgia 30060
Principal Investigator: Roel N. Querubin
Phone: 770-372-3962
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Monroe, Louisiana 71203
Principal Investigator: John Hull
Phone: 318-388-5830
?
mi
from
Monroe, LA
Click here to add this to my saved trials
Palm Desert, California 92260
Principal Investigator: Maria Greenwald
Phone: 760-341-6800
?
mi
from
Palm Desert, CA
Click here to add this to my saved trials
Phoenix, Arizona 85032
Principal Investigator: Eric Peters
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Raleigh, North Carolina 27617
Principal Investigator: Joseph Shanahan
Phone: 919-405-2040
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Sarasota, Florida 34239
Principal Investigator: Jeffrey Kaine
Phone: 941-366-1244
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
Seattle, Washington 98104
Principal Investigator: Philip Mease
Phone: 206-386-3201
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Spokane, Washington 99204
Principal Investigator: Eric Mueller
Phone: 509-838-6500
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Tamarac, Florida 33321
Principal Investigator: Steven Kimmel
Phone: 954-545-8400
?
mi
from
Tamarac, FL
Click here to add this to my saved trials
Upland, California 91786
Principal Investigator: Mohamed Sebai
Phone: 909-296-8700
?
mi
from
Upland, CA
Click here to add this to my saved trials
Wilmington, North Carolina 28401
Principal Investigator: Mark Harris
Phone: 910-762-1182
?
mi
from
Wilmington, NC
Click here to add this to my saved trials