A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis
NCT ID: NCT02349295
Last Updated: 2020-07-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
363 participants
INTERVENTIONAL
2014-12-31
2019-06-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ixekizumab 80 milligram (mg) every 2 Weeks (Q2W)
Blinded Treatment Period (Week(wk) 0-24): Participants (pts) received a starting dose of 160 mg of ixekizumab (ixe) given as 2 subcutaneous (SC) injections at Wk 0 followed by 1 SC injection of 80 mg of ixe Q2W given on Wks 2,4,6,8,10,12,14,16,18,20,22, and 24.Week 16 inadequate responders (IR) from the placebo treatment group who were re-randomized (1:1) to ixe 80 mg Q2W and IR from ixekizumab 80 mg Q2W who continued on ixekizumab 80 mg Q2W. Pts receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q2W given on Wks 16,18,20,22,24. Extension Period (Wk24-156):Pts who were randomized to ixe 80 mg Q2W at week 0 and continued on ixe 80 mg Q2W during the Extension Period. Pts who received ixekizumab 80 mg Q2W,who were either completed the study or discontinued the study early entered the post-treatment follow-up period (12-24 weeks).
Placebo
Administered SC
Ixekizumab 80 mg Q2W
Administered SC
Ixekizumab 80 mg Q4W
Blinded Treatment Period (Week 0-24): Participants (pts) received a starting dose of 160 mg of ixekizumab (ixe) given as 2 subcutaneous (SC) injections at Wk 0 followed by 1 SC injection of 80 mg of ixe Q4W given on Wks 4, 8 and 12 alternating with placebo for ixe injections Q4W given on Wks 2,6,10,14,18, and 22.Week 16 inadequate responders (IR) from the placebo treatment group who were re-randomized (1:1) to ixe 80 mg Q4W and IR from ixekizumab 80 mg Q4W who continued on ixekizumab 80 mg Q4W. Pts receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q4W given on Wks 16 and 20 alternating with placebo for ixe injections Q4W given on Wks 18 and 22.Extension Period (Wk24-156):Pts who were randomized to ixe 80 mg Q4W at week 0 and continued on ixe 80 mg Q4W during the Extension Period.Pts who received ixekizumab 80 mg Q4W,who were either completed the study or discontinued the study early entered the post-treatment follow-up period (12-24 weeks).
Placebo
Administered SC
Ixekizumab 80 mg Q4W
Administered SC
Placebo
Blinded Treatment Period (Wk 0-24): Pts received placebo for Ixe as 2 SC injections followed by 1 SC injection Q2W given on Wks 2,4,6,8,10,12,14,16,18,20,22 and 24. Pts initially randomized to placebo treatment group in the double blind treatment period,flagged as IR at Wk 16,re-randomized to ixe 80 mg Q2W/Q4W for the remainder of the current period and following period. Extended Treatment Period (Wk 24-156): Pts who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W/Q4W during the Extension Period.Pts who remained on placebo at the completion of the double blind treatment period received the first dose of ixe (160 mg starting dose) at Wk 24.Pts who were IRs at Wk 16 and were re-randomized to ixe at Wk 16 received the first dose of ixe (160 mg starting dose) at Wk 16. Pts who received placebo,who were either completed the study or discontinued the study early entered the post-treatment follow-up period (12-24 weeks).
Placebo
Administered SC
Interventions
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Placebo
Administered SC
Ixekizumab 80 mg Q4W
Administered SC
Ixekizumab 80 mg Q2W
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints
* Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps)
* Men must agree to use a reliable method of birth control or remain abstinent during the study
* Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
* Have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs)
* Have had prior treatment with at least 1 and not more than 2 tumor necrosis factor (TNF) inhibitors. The participant must have discontinued at least 1 TNF inhibitor due to either an inadequate response (based on a minimum of 12 weeks on therapy) or documented intolerance.
Exclusion Criteria
* Inadequate response to greater than 2 biologic DMARDs
* Current use of more than one cDMARDs
* Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
* Have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonal antibody (MAb) therapy
* Serious disorder or illness other than psoriatic arthritis
* Serious infection within the last 3 months
* Breastfeeding or nursing (lactating) women
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Rheumatology Associates PC
Birmingham, Alabama, United States
Arizona Arthritis & Rheumatology Research
Glendale, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC
Mesa, Arizona, United States
Arizona Arthritis & Rheumatology Research
Phoenix, Arizona, United States
Little Rock Diagnostic Clinic
Little Rock, Arkansas, United States
University of California - San Diego
La Jolla, California, United States
Purushotham & Akther Kotha MD Inc
La Mesa, California, United States
Stanford University Hospital
Palo Alto, California, United States
East Bay Rheumatology Medical Group
San Leandro, California, United States
Office: Dr Robin K Dore
Tustin, California, United States
Rheumatology Associates of South Florida
Boca Raton, Florida, United States
Jeffrey Alper MD Research
Naples, Florida, United States
Arthritis & Osteoporosis Treatment Center, PA
Orange Park, Florida, United States
Florida Medical Clinic PA
Zephyrhills, Florida, United States
Diagnostic Rheumatology and Research
Indianapolis, Indiana, United States
Physicians Clinic of Iowa
Cedar Rapids, Iowa, United States
Heartland Research Associates
Wichita, Kansas, United States
Bluegrass Community Research. Inc
Lexington, Kentucky, United States
Johns Hopkins Arthritis Center
Baltimore, Maryland, United States
Klein and Associates MD, PA
Cumberland, Maryland, United States
Klein and Associates MD, PA
Hagerstown, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Beals Institute PC
Lansing, Michigan, United States
North MS Medical Clinics, Inc.
Tupelo, Mississippi, United States
Washington University School of Medicine
St Louis, Missouri, United States
Glacier View Research Institute
Kalispell, Montana, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, United States
New Jersey Physicians
Clifton, New Jersey, United States
Atlantic Coastal Research
Toms River, New Jersey, United States
Arthritis, Rheumatic & Back Disease Associates
Voorhees Township, New Jersey, United States
Albuquerque Rehabilitation & Rheumatology, PC
Albuquerque, New Mexico, United States
The Center for Rheumatology
Albany, New York, United States
Weill Cornell Medical College
Brooklyn, New York, United States
Allergy Asthma Immunology of Rochester, AAIR Research Ctr
Rochester, New York, United States
Rheumatology Associates of Long Island
Smithtown, New York, United States
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, United States
PMG Research of Hickory, LLC
Hickory, North Carolina, United States
STAT Research
Dayton, Ohio, United States
Health Research Institute
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
PMA Medical Specialists, LLC
Limerick, Pennsylvania, United States
Clinical Research Center of Reading, LLC
Wyomissing, Pennsylvania, United States
Pennsylvania Regional Center for Arthritis & Osteoarthritis
Wyomissing, Pennsylvania, United States
Methodist Healthcare
Memphis, Tennessee, United States
Ramesh C. Gupta MD
Memphis, Tennessee, United States
Austin Rheumatology Research PA
Austin, Texas, United States
Austin Regional Clinic
Austin, Texas, United States
Arthritis Care & Diagnostic Center P.A.
Dallas, Texas, United States
Pioneer Research Solutions
Houston, Texas, United States
Houston Institute for Clinical Research
Houston, Texas, United States
Accurate Clinical Research
Houston, Texas, United States
Accurate Clinical Research
League City, Texas, United States
Arthritis & Osteoporosis Associates LLP
Lubbock, Texas, United States
Kadlec Clinic Rheumatology
Kennewick, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
Arthritis Northwest PLLC
Spokane, Washington, United States
Rheumatology and Immunotherapy Center
Franklin, Wisconsin, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Coast Joint Care
Maroochydore, Queensland, Australia
Emeritus Research
Camberwell, Victoria, Australia
CCBR Czech Prague, s.r.o.
Prague, , Czechia
MEDICAL PLUS, s.r.o.
Uherské Hradiště, , Czechia
PV-MEDICAL s.r.o. Revmatologicka ambulance
Zlín, , Czechia
Hôpital Trousseau, CHRU de Tours
Chambray-lès-Tours, , France
CHU de Montpellier-Hopital Arnaud de Villeneuve
Montpellier, , France
Chru De Nantes Hotel-Dieu
Nantes, , France
Hopital Cochin
Paris, , France
Hopital Purpan
Toulouse, , France
CHU Brabois
Vandœuvre-lès-Nancy, , France
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt am Main, Hesse, Germany
Rheumazentrum Ruhrgebiet
Herne, North Rhine-Westphalia, Germany
Krankenhaus Dresden-Friedrichstadt Städtisches Klinikum
Dresden, Saxony, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, Germany
Universität Leipzig - Universitätsklinikum
Leipzig, Saxony, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany
Charité Universitätsmedizin Berlin
Berlin, , Germany
HRF Hamburger Rheuma Forschungszentrum
Hamburg, , Germany
Istituto Ortopedico Gaetano Pini
Milan, , Italy
Azienda Ospedaliera - Universitaria Pisana
Pisa, , Italy
Malopolskie Centrum Medyczne S.C.
Krakow, , Poland
Medica pro Familia Sp z o.o. S.K.A
Krakow, , Poland
AI Centrum Medyczne
Poznan, , Poland
Medica pro Familia Sp z o.o. S.K.A
Warsaw, , Poland
Rheuma Medicus Zakład Opieki Zdrowotnej
Warsaw, , Poland
Hospital Infanta Luisa
Seville, Andalusia, Spain
Centro de Salud Mental Parc Tauli
Sabadell, Barcelona, Spain
Hospital Universitario Marques De Valdecilla
Santander, Cantabria, Spain
Hospital De Fuenlabrada
Fuenlabrada, Madrid, Spain
Hospital De Basurto
Bilbao, Vizcaya, Spain
Complexo Hospitalario Universitario A Coruña, CHUAC
A Coruña, , Spain
Hospital Regional Universitario de Málaga
Málaga, , Spain
Hospital Universitario Nuestra Señora de Valme
Seville, , Spain
Chi-Mei Hospital, Liouying
Tainan City, Yongkang Dist, Taiwan
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City (r.o.c), , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan, , Taiwan
Basildon and Thurrock University Hospital
Basildon, Essex, United Kingdom
King George Hospital
Goodmayes, Essex, United Kingdom
Princess Alexandra Hospital
Harlow, Essex, United Kingdom
Whipps Cross University Hospital
London, Surrey, United Kingdom
New Cross Hospital
Wolverhampton, West Midlands, United Kingdom
Chapel Allerton Hospital
Leeds, West Yorkshire, United Kingdom
Countries
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References
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Kristensen LE, McGonagle D, Rudwaleit M, Kameda H, Wurtzen PA, Ngantcha M, Holzkamper T, Smolen J. Synergistic Improvements in Synovitis, Enthesitis, and Patient-Reported Outcomes for Patients with Psoriatic Arthritis Treated with Ixekizumab in SPIRIT Trials. Rheumatol Ther. 2025 Apr;12(2):381-395. doi: 10.1007/s40744-025-00748-8. Epub 2025 Feb 27.
Tillett W, Birt J, Vadhariya A, Ross S, Ngantcha M, Ng KJ. Filling the "GAP" in Real-World Assessment of Psoriatic Arthritis Disease Activity: Performance Characteristics of a Global/Pain Composite Endpoint. Rheumatol Ther. 2024 Oct;11(5):1101-1114. doi: 10.1007/s40744-024-00690-1. Epub 2024 Jul 2.
Armstrong AW, Jaleel T, Merola JF, Gottlieb AB, Khattri S, Helt CC, Malatestinic WN, Ross SE, Ngantcha ME, de Vlam K. Ixekizumab Demonstrates Rapid and Consistent Efficacy for Patients with Psoriatic Arthritis, Regardless of Psoriasis Severity. Dermatol Ther (Heidelb). 2024 Jun;14(6):1615-1631. doi: 10.1007/s13555-024-01188-y. Epub 2024 May 30.
Kirkham BW, Egeberg A, Behrens F, Pinter A, Merola JF, Holzkamper T, Gallo G, Ng KJ, Bolce R, Schuster C, Nash P, Puig L. A Comprehensive Review of Ixekizumab Efficacy in Nail Psoriasis from Clinical Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Rheumatol Ther. 2023 Oct;10(5):1127-1146. doi: 10.1007/s40744-023-00553-1. Epub 2023 Jul 3.
Eder L, Tony HP, Odhav S, Agirregoikoa EG, Korkosz M, Schwartzman S, Sprabery AT, Gellett AM, Park SY, Bertram CC, Ogdie A. Responses to Ixekizumab in Male and Female Patients with Psoriatic Arthritis: Results from Two Randomized, Phase 3 Clinical Trials. Rheumatol Ther. 2022 Jun;9(3):919-933. doi: 10.1007/s40744-022-00445-w. Epub 2022 Apr 9.
Deodhar AA, Combe B, Accioly AP, Bolce R, Zhu D, Gellett AM, Sprabery AT, Burmester GR. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022 Jul;81(7):944-950. doi: 10.1136/annrheumdis-2021-222027. Epub 2022 Apr 7.
Combe B, Tsai TF, Huffstutter JE, Sprabery AT, Lin CY, Park SY, Kronbergs A, Hufford MM, Nash P. Ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of PsA: week 52 results from Spirit-P1 and Spirit-P2 studies. Arthritis Res Ther. 2021 Jan 27;23(1):41. doi: 10.1186/s13075-020-02388-5.
Orbai AM, Gratacos J, Turkiewicz A, Hall S, Dokoupilova E, Combe B, Nash P, Gallo G, Bertram CC, Gellett AM, Sprabery AT, Birt J, Macpherson L, Geneus VJ, Constantin A. Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2). Rheumatol Ther. 2021 Mar;8(1):199-217. doi: 10.1007/s40744-020-00261-0. Epub 2020 Dec 5.
Schweikert B, Malmberg C, Nunez M, Dilla T, Sapin C, Hartz S. Cost-effectiveness analysis of ixekizumab versus secukinumab in patients with psoriatic arthritis and concomitant moderate-to-severe psoriasis in Spain. BMJ Open. 2020 Aug 13;10(8):e032552. doi: 10.1136/bmjopen-2019-032552.
Combe B, Rahman P, Kameda H, Canete JD, Gallo G, Agada N, Xu W, Genovese MC. Safety results of ixekizumab with 1822.2 patient-years of exposure: an integrated analysis of 3 clinical trials in adult patients with psoriatic arthritis. Arthritis Res Ther. 2020 Jan 21;22(1):14. doi: 10.1186/s13075-020-2099-0.
Tillett W, Lin CY, Zbrozek A, Sprabery AT, Birt J. A Threshold of Meaning for Work Disability Improvement in Psoriatic Arthritis Measured by the Work Productivity and Activity Impairment Questionnaire. Rheumatol Ther. 2019 Sep;6(3):379-391. doi: 10.1007/s40744-019-0155-5. Epub 2019 Jun 1.
Coates LC, Orbai AM, Morita A, Benichou O, Kerr L, Adams DH, Shuler CL, Birt J, Helliwell PS. Achieving minimal disease activity in psoriatic arthritis predicts meaningful improvements in patients' health-related quality of life and productivity. BMC Rheumatol. 2018 Aug 13;2:24. doi: 10.1186/s41927-018-0030-y. eCollection 2018.
Gladman DD, Orbai AM, Klitz U, Wei JC, Gallo G, Birt J, Rathmann S, Shrom D, Marzo-Ortega H. Ixekizumab and complete resolution of enthesitis and dactylitis: integrated analysis of two phase 3 randomized trials in psoriatic arthritis. Arthritis Res Ther. 2019 Jan 29;21(1):38. doi: 10.1186/s13075-019-1831-0.
Genovese MC, Combe B, Kremer JM, Tsai TF, Behrens F, Adams DH, Lee C, Kerr L, Nash P. Safety and efficacy of ixekizumab in patients with PsA and previous inadequate response to TNF inhibitors: week 52 results from SPIRIT-P2. Rheumatology (Oxford). 2018 Nov 1;57(11):2001-2011. doi: 10.1093/rheumatology/key182.
Nash P, Kirkham B, Okada M, Rahman P, Combe B, Burmester GR, Adams DH, Kerr L, Lee C, Shuler CL, Genovese M; SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017 Jun 10;389(10086):2317-2327. doi: 10.1016/S0140-6736(17)31429-0. Epub 2017 May 24.
Related Links
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Click here for more information about this study: A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis
Other Identifiers
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I1F-MC-RHBE
Identifier Type: OTHER
Identifier Source: secondary_id
2011-002328-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14310
Identifier Type: -
Identifier Source: org_study_id
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