Clinical Trial Details

NCT ID: NCT02696785
Date Last Changed: April 19, 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
18 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 (87)

Country State City Zip Facility and Contact
United States Arizona Phoenix 85032 Arizona Arthritis Research, PLC
480-626-6653

Eric Peters
Principal Investigator
United States Arizona Tucson 85724 University of Boards Regent
520-626-6399

Dominick Sudano
Principal Investigator
United States California Huntington Beach 92648 Care Access Research - Huntington Beach
949-385-0469

Christine Thai
Principal Investigator
United States California Palm Desert 92260 Desert Medical Advances
760-341-6800

Maria Greenwald
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 Connecticut Danbury 06810 Clinical Research Center of CT/NY
203-616-2710

Richard Roseff
Principal Investigator
United States Connecticut Trumbull 06611 New England Research Associates
203-374-9816

Geoffrey Gladstein
Principal Investigator
United States Florida Sarasota 34239 Sarasota Arthritis Center
941-485-8314

Jeffrey Kaine
Principal Investigator
United States Georgia Marietta 30060 Marietta Rheumatology
770-590-8328

Roel Querubin
Principal Investigator
United States Idaho Idaho Falls 83404 Institute of Arthritis Research
208-542-9080

Craig Scoville
Principal Investigator
United States Kentucky Elizabethtown 42701 Center for Arthritis & Osteoporosis
270-769-2535

Daksha Mehta
Principal Investigator
United States Maryland Cumberland 21502 Klein and Associates MD, PA
301-724-4337

Steven Klein
Principal Investigator
United States Maryland Hagerstown 21740 Klein and Associates MD, PA
301-791-6680

Mary Howell
Principal Investigator
United States Missouri Saint Louis 63141 Arthritis Consultants
314-567-5100

Akgun Ince
Principal Investigator
United States Montana Kalispell 59901 Glacier View Research Institute
406-755-1460

Roger Diegel
Principal Investigator
United States Nebraska Lincoln 68516 Physician Research Collaboration, LLC
402-420-1212

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

Joel Kremer
Principal Investigator
United States North Carolina Raleigh 27617 Shanahan Rheumatology & Immunotherapy
919-405-2040

Joseph Shanahan
Principal Investigator
United States South Carolina Columbia 29204 Columbia Arthritis Center
803-779-0911

Kathleen Flint
Principal Investigator
United States South Carolina North Charleston 29406 Low Country Research Center
843-572-1818

Clarence Legerton
Principal Investigator
United States Texas Houston 77030 Univ of Texas Health Science Center - Houston
713-500-6900

John Reveille
Principal Investigator
United States Washington Kennewick 99336 Apex Clinical Research
509-942-2528

Kalpita Hatti
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
Canada Sainte-Foy G1V 3M7 For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Eli Lilly and Company
Canada St. John's A1C 5B8 For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Eli Lilly and Company
Canada Trois-Rivieres G8Z 1Y2 For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Eli Lilly and Company
Czechia Brno 611 41 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
Czechia Ostrava 703 00 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
Czechia Pardubice 530 02 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
Czechia Praha 2 128 50 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
Czechia Uherske Hradiste 686 01 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
Germany Bad Doberan 18209 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
Germany Berlin 12203 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
Germany Halle 06108 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
Germany Köln 50937 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
Hungary Bekescsaba 5600 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
Hungary Budapest 1027 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
Hungary Veszprem 8200 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
Japan Bunkyo-ku 113-8431 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
Japan Chuo-Ku 104-8560 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
Japan Hyogo 663-8501 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
Japan Kita-gun 761-0793 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
Japan Kuwana 511-0061 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
Japan Okayama 700-8607 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
Japan Osaka 534-0021 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
Japan Osaka 545-8586 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
Japan Sapporo 060-8648 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
Japan Sasebo 857-1195 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
Japan Suita-shi 565-0871 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
Japan Tenri 632-8552 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 Daejeon 35015 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
Korea, Republic of Seoul 02447 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 Seoul 03080 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 Seoul 04763 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 Seoul 05030 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 Seoul 05278 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 Seoul 05505 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 Seoul 06273 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 Seoul 06591 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 Seoul 07061 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
Mexico Chihuahua 31000 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
Mexico Guadalajara 44620 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
Mexico Guadalajara 44650 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
Mexico Merida 97070 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
Mexico Mexicali 21200 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
Mexico Monterrey 64020 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
Mexico San Luis Potosi 78213 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
Netherlands Amsterdam 1105 AZ 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
Netherlands Sneek 8601 ZK 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 Bialystok 15-351 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 Bydgoszcz 85-168 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 Swidnik 21-040 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 Warsaw 03-291 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
Russian Federation Moscow 119049 City Clinical Hospital #1
+7 495 536 92 33

Evgenia Shmidt
Principal Investigator
Russian Federation Ryazan 390026 Ryazan State Medical University/Ryazan Clinical Regional Cardiological Dispensary
+7 4912 97 51 78

Sergey Yakushin
Principal Investigator
Russian Federation Saratov 410053 Saratov Regional Clinical Hospital
+7 8452 49 14 37

Andrey Rebrov
Principal Investigator
Russian Federation St. Petersburg 190068 Saint-Petersburg Healthcare Institution "Clinical Rheumatology Hospital #25"
+7 812 310 82 48

Galina Matsievskaya
Principal Investigator
Russian Federation Yaroslavl 150003 Municipal Health Care Institution Clinical Hospital for Emergency Medical Care named after N.V.Solovyev
+7 4852 731 03

Olga Ershova
Principal Investigator
Taiwan Kaohsiung 33378 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
Taiwan Taichung City 40201 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
Taiwan Taichung 40447 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
Taiwan Tainan 71004 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
Taiwan Taipei 10048 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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