A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis
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
3 other identifiers
interventional
773
23 countries
127
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2017
Typical duration for phase_3
127 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2017
CompletedFirst Posted
Study publicly available on registry
April 26, 2017
CompletedStudy Start
First participant enrolled
May 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 27, 2021
CompletedResults Posted
Study results publicly available
June 18, 2021
CompletedJune 13, 2022
May 1, 2022
3 years
April 3, 2017
May 24, 2021
May 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who do Not Experience a Flare (Combined Ixekizumab Treatment)
A flare is defined as Ankylosing Spondylitis Disease Activity Score (ASDAS ≥2.1) at 2 consecutive visits, or ASDAS \>3.5 at any visit during Period 2. ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with high sensitivity C-reactive protein (CRP) as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
Week 64
Secondary Outcomes (27)
Percentage of Participants Who do Not Experience a Flare
Week 64
Change From Baseline in Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS)
Baseline, 2 Years
Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS)20 Response
Week 64
Percentage of Participants Achieving an ASAS40 Response
Week 64
Percentage of Participants With Change of Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥1.1 Units
Week 64
- +22 more secondary outcomes
Study Arms (3)
Ixekizumab (IXE) 80Q4W
EXPERIMENTALParticipants received 80 milligram (mg) of Ixekizumab subcutaneously (SC) every four weeks (Q4W).
Ixekizumab (IXE) 80Q2W
EXPERIMENTALParticipants received 80 milligram (mg) of Ixekizumab subcutaneously (SC) every two weeks (Q2W).
Placebo
PLACEBO COMPARATORParticipants received subcutaneous dose of placebo.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (127)
Arizona Arthritis & Rheumatology Research
Phoenix, Arizona, 85032, United States
Care Access Research - Huntington Beach
Huntington Beach, California, 92648, United States
Desert Medical Advances
Palm Desert, California, 92260, United States
Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC
Colorado Springs, Colorado, 80920, United States
Clinical Research Center of CT/NY
Danbury, Connecticut, 06810, United States
Arthritis Rheumatic Disease Specialties
Aventura, Florida, 33180, United States
Sarasota Arthritis Center
Sarasota, Florida, 34239, United States
Marietta Rheumatology
Marietta, Georgia, 30060, United States
Institute of Arthritis Research
Idaho Falls, Idaho, 83404, United States
Center for Arthritis & Osteoporosis
Elizabethtown, Kentucky, 42701, United States
Klein and Associates MD, PA
Cumberland, Maryland, 21502, United States
Klein and Associates MD, PA
Hagerstown, Maryland, 21740, United States
Arthritis Consultants Inc.
St Louis, Missouri, 63141, United States
Glacier View Research Institute
Kalispell, Montana, 59901, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516, United States
Shanahan Rheumatology & Immunotherapy, PLLC
Raleigh, North Carolina, 27617, United States
Carolina Arthritis Associates
Wilmington, North Carolina, 28401, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Articularis Healthcare Group, INC dba Columbia Arthritis Ctr
Columbia, South Carolina, 29204, United States
Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
Summerville, South Carolina, 29486, United States
Univ of Texas Health Science Center - Houston
Houston, Texas, 77030, United States
Arthritis Northwest PLLC
Spokane, Washington, 99204, United States
Clinica Adventista de Belgrano
Ciudad de Buenos Aires, Buenos Aires, C1430EGF, Argentina
CER Instituto Medico
Quilmes, Buenos Aires, B1878DVC, Argentina
Centro de Enfermedades del Higado y Aparato Digestivo
Rosario, Santa Fe Province, S2000CFJ, Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina
Consultorios Reumatologicos Pampa
Ciudad Autonoma de Buenos Aire, C1428DZF, Argentina
CIR Centro de Investigacions Reumatologicas
San Miguel de Tucumán, 4000, Argentina
KH der Barmherzigen Schwestern Wien BetriebsGesmbH
Vienna, 1060, Austria
CMIP - Centro Mineiro de Pesquisa
Juiz de Fora, Minas Gerais, 36010-570, Brazil
EDUMED - Educação em Saúde Ltda.
Curitiba, Paraná, 80440-080, Brazil
CCBR Brasil Centro de Analises e Pesquisas Clínicas LTDA
Rio de Janeiro, Rio de Janeiro, 22271-100, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
LMK Serviços Médicos S/S
Porto Alegre, Rio Grande do Sul, 90540-000, Brazil
Cpclin Centro de Pesquisas Clinicas
São Paulo, São Paulo, 01228-200, Brazil
CIP - Centro Internacional de Pesquisa
Goiás, 74110-120, Brazil
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
St. Clare's Mercy Hospital
St. John's, Newfoundland and Labrador, A1C 5B8, Canada
Centre de Recherche Musculo-Squelettique
Trois-Rivières, Quebec, G8Z 1Y2, Canada
Group de recherche en maladies osseuses
Québec, G1V 3M7, Canada
Revmaclinic, s.r.o
Brno, 611 41, Czechia
Interni a revmatologicka ambulance, Inrea s.r.o.
Ostrava, 703 00, Czechia
Arthrohelp s.r.o
Pardubice, 530 02, Czechia
Revmatologicky ustav
Prague, 128 50, Czechia
MEDICAL PLUS, s.r.o.
Uherské Hradiště, 686 01, Czechia
Helsinki University Hospital, HYKS
Helsinki, 00029, Finland
Terveystalo Kamppi
Helsinki, 00100, Finland
Kiljava Medical Research
Hyvinkää, 05800, Finland
Hôpital Trousseau, CHRU de Tours
Chambray-lès-Tours, 37170, France
Centre hospitalier universitaire Lapeyronie
Montpellier, 34295, France
Nouvel Hôpital Orléans La Source
Orléans, 45067, France
Rheumazentrum Prof. Neeck
Bad Doberan, Mecklenburg-Vorpommern, 18209, Germany
Rheumazentrum Ruhrgebiet
Herne, North Rhine-Westphalia, 44649, Germany
Charité Universitätsmedizin Berlin
Berlin, 12203, Germany
HRF Hamburger Rheuma Forschungszentrum
Hamburg, 20095, Germany
Revita Reumatologiai Kft.
Budapest, 1027, Hungary
Vital Medical Center
Veszprém, 8200, Hungary
Barzilai Medical Center
Ashkelon, 7830604, Israel
Rambam Medical Center
Haifa, 3109601, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia
Reggio Emilia, 42123, Italy
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, 761-0793, Japan
Kochi Medical School Hospital
Nankoku, Kochi, 783-8505, Japan
Kuwana City Medical Center
Kuwana, Mie-ken, 511-0061, Japan
Sasebo Chuo Hospital
Sasebo, Nagasaki, 857-1195, Japan
Osaka University Hospital
Suita-shi, Osaka, 565 0871, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431, Japan
St. Lukes International Hospital
Chuo-Ku, Tokyo, 104 8560, Japan
Japanese Red Cross Okayama Hospital
Okayama, 700-8607, Japan
Osaka City General Hospital
Osaka, 534-0021, Japan
Osaka City University Hospital
Osaka, 545-8586, Japan
Yamagata University Hospital
Yamagata, 990-9585, Japan
Ctro Inv en Artritis y Osteoporosis SC
Mexicali, Estado de Baja California, 21200, Mexico
Unidad de Investigacion en Enfermedades Cronico Degenerative
Guadalajara, Jalisco, 44620, Mexico
Clinica en Investigación en Reumatologia y Obesidad S.C.
Guadalajara, Jalisco, 44650, Mexico
Hospital Universitario de Monterrey
Monterrey, Nuevo León, 64460, Mexico
Centro de Alta Especialidad Reumatologia Inv del Potosi SC
San Luis Potosí City, San Luis Potosí, 78213, Mexico
Medical Care and Research, S.A. de C.V.
Mérida, Yucatán, 97070, Mexico
Investigación y Biomedicina de Chihuahua, SC
Chihuahua City, 31000, Mexico
Academisch Medisch Centrum
Amsterdam, 1105 AZ, Netherlands
Antonius Ziekenhuis
Sneek, 8601 ZK, Netherlands
NZOZ ZDROWIE Osteo-Medic
Bialystok, 15-351, Poland
Szpital Uniwersytecki nr 2 im. dr J. Biziela
Bydgoszcz, 85-168, Poland
Centrum Kliniczno-Badawcze
Elblag, 82-300, Poland
Centrum Leczenia Osteoporozy Klinika Zdrowej Kosci
Lodz, 90-558, Poland
Lecznica MAK-MED, NZOZ
Nadarzyn, 05-830, Poland
Prywatna Praktyka Lekarska P. Hrycaj
Poznan, 61-397, Poland
Lubelskie Centrum Diagnostyczne
Świdnik, 21-040, Poland
Reumatika Centrum Reumatologii
Warsaw, 02-691, Poland
Centrum Medyczne AMED
Warsaw, 03-291, Poland
GCM Medical Group PSC
San Juan, PR, 00909, Puerto Rico
Latin Clinical Trial Center
San Juan, PR, 00909, Puerto Rico
Mindful Medical Research
San Juan, PR, 00918, Puerto Rico
Spitalul Clinic Sf Maria Bucuresti
Bucharest, 011172, Romania
Sp Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta
Constanța, 900591, Romania
V.A. Nasonova Research Institute of Rheumatology
Moscow, 115522, Russia
City Clinical Hospital N1
Moscow, 119049, Russia
Ryazan Regional Clinincal Cardiology Dispensary
Ryazan, 390026, Russia
Clinical Rheumatology Hospital # 25
Saint Petersburg, 190068, Russia
Saratov State Medical University
Saratov, 410026, Russia
Clinical Hospital for Emergency Care
Yaroslavl, 150003, Russia
Kyung Hee University Hospital
Seoul, Korea, 02447, South Korea
Seoul St. Mary's Hospital
Seoul, Korea, 06591, South Korea
Asan Medical Center
Songpa-gu, Seoul, 05505, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Hanyang University Medical Center
Seoul, 04763, South Korea
Konkuk University Hospital
Seoul, 05030, South Korea
Kyunghee University Hospital at Gangdong
Seoul, 05278, South Korea
Gangnam Severance Hospital
Seoul, 06273, South Korea
Seoul Municipal Boramae Hospital
Seoul, 07061, South Korea
Centro de Salud Mental Parc Tauli
Sabadell, Barcelona, 08208, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Infanta Luisa
Seville, 41010, Spain
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City, 83301, Taiwan
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Chi-Mei Medical Center
Yongkang District, 71004, Taiwan
Wythenshawe Hospital
Wythenshawe, Manchester, M23 9LT, United Kingdom
Norfolk and Norwich Hospital
Norwich, Norfolk, NR4 7UY, United Kingdom
Haywood Hospital
Stoke-on-Trent, Staffordshire, ST6 7AG, United Kingdom
New Cross Hospital
Wolverhampton, West Midlands, WV10 0QP, United Kingdom
Solihull Hospital
Solihull, West Midland, B91 2JL, United Kingdom
Related Publications (2)
Deodhar A, Poddubnyy D, Rahman P, Ermann J, Tomita T, Bolce R, Leage SL, Kronbergs A, Johnson C, Araujo J, Leung A, van der Heijde D. Long-Term Safety and Efficacy of Ixekizumab in Patients With Axial Spondyloarthritis: 3-year Data From the COAST Program. J Rheumatol. 2023 Aug;50(8):1020-1028. doi: 10.3899/jrheum.221022. Epub 2023 Feb 15.
PMID: 36792107DERIVEDBraun J, Kiltz U, Deodhar A, Tomita T, Dougados M, Bolce R, Sandoval D, Lin CY, Walsh J. Efficacy and safety of ixekizumab treatment in patients with axial spondyloarthritis: 2-year results from COAST. RMD Open. 2022 Jul;8(2):e002165. doi: 10.1136/rmdopen-2021-002165.
PMID: 35853675DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2017
First Posted
April 26, 2017
Study Start
May 9, 2017
Primary Completion
May 26, 2020
Study Completion
May 27, 2021
Last Updated
June 13, 2022
Results First Posted
June 18, 2021
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.