A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis



Status:Recruiting
Conditions:Arthritis, Arthritis, Orthopedic
Therapuetic Areas:Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:May 9, 2017
End Date:March 1, 2021
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Email:ClinicalTrials.gov@lilly.com
Phone:1-317-615-4559

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

A Multicenter, Long-Term Extension Study of 104 Weeks, Including a Double-Blind, Placebo-Controlled 40-Week Randomized Withdrawal-Retreatment Period, to Evaluate the Maintenance of Treatment Effect of Ixekizumab (LY2439821) in Patients With Axial Spondyloarthritis

The purpose of this study is to evaluate, in participants having achieved a state of
sustained remission, if the ixekizumab treatment groups are superior to the placebo group in
maintaining response during the randomized withdrawal-retreatment period in participants with
axial spondyloarthritis.


Inclusion Criteria:

- Have completed the final study visit in Study RHBV (NCT02696785), RHBW (NCT02696798),
or RHBX (NCT02757352).

(Note: Participants from Study RHBX are not eligible if they permanently discontinued
ixekizumab and were receiving a tumor necrosis factor [TNF] inhibitor).

- Must agree to use a reliable method of birth control.

Exclusion Criteria:

- Have significant uncontrolled disorders or abnormal laboratory values that, in the
opinion of the investigator, pose an unacceptable risk to the participant if
investigational product continues to be administered.

- Have a known hypersensitivity to ixekizumab or any component of this investigational
product.

- Had investigational product permanently discontinued during a previous ixekizumab
study.

- Had temporary investigational product interruption at any time during or at the final
study visit of a previous ixekizumab study and, in the opinion of the investigator,
restarting ixekizumab poses an unacceptable risk for the participant's participation
in the study.

- Have any other condition that, in the opinion of the investigator, renders the
participant unable to understand the nature, scope, and possible consequences of the
study or precludes the participant from following and completing the protocol.

- Are currently enrolled in any other clinical trial involving an investigational
product or any other type of medical research judged not to be scientifically or
medically compatible with this study.
We found this trial at
24
sites
Spokane, Washington 99204
Principal Investigator: Eric C Mueller
Phone: 509-838-6500
?
mi
from
Spokane, WA
Click here to add this to my saved trials
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: John Reveille
Phone: 713-500-6900
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
?
mi
from
Houston, TX
Click here to add this to my saved trials
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Atulya A Deodhar
Phone: 503-494-5571
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
Aventura, Florida 33180
Principal Investigator: Norman B Gaylis
Phone: 305-932-4162
?
mi
from
Aventura, FL
Click here to add this to my saved trials
Ciudad de Buenos Aires, Buenos Aires
Principal Investigator: Federico Javier Ariel
Phone: 541145445522
?
mi
from
Ciudad de Buenos Aires,
Click here to add this to my saved trials
Colorado Springs, Colorado 80920
Principal Investigator: Michael E Sayers
Phone: 719-475-9616
?
mi
from
Colorado Springs, CO
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 J 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 J. Kivitz
Phone: 814-693-0300
?
mi
from
Duncansville, PA
Click here to add this to my saved trials
Elizabethtown, Kentucky 42701
Principal Investigator: Daksha Mehta
Phone: 270-769-2535
?
mi
from
Elizabethtown, KY
Click here to add this to my saved trials
Hagerstown, Maryland 21740
Principal Investigator: Mary P 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: 714-378-2440
?
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
Idaho Falls, Idaho 83404
Principal Investigator: Craig D. 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 A 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: 770-590-8328
?
mi
from
Marietta, GA
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 85037
Principal Investigator: Eric A Peters
Phone: 480-626-6653
?
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
Saint Louis, Missouri 63141
Principal Investigator: Akgun Ince
Phone: 314-567-5100
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Sarasota, Florida 34239
Principal Investigator: Yoel Drucker
Phone: 941-485-8314
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
Summerville, South Carolina 29486
Principal Investigator: Clarence Legerton
Phone: 843-572-1818
?
mi
from
Summerville, SC
Click here to add this to my saved trials
Wilmington, North Carolina 28401
Principal Investigator: Mark D Harris
Phone: 910-762-1182
?
mi
from
Wilmington, NC
Click here to add this to my saved trials