A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis
NCT ID: NCT02584855
Last Updated: 2019-11-15
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
394 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-09-14
Study Completion Date
2018-10-30
Brief Summary
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The main purpose of this study is to evaluate the safety and long-term efficacy of ixekizumab compared to placebo in participants with active psoriatic arthritis.
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Detailed Description
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Conditions
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Psoriatic Arthritis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Ixekizumab Open Label
Open-Label Treatment Period: Starting dose of 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline (week 0) followed by 80 mg given as one SC injection every two weeks (Q2W) from week 2 to randomization (week 36 to 64).
Group Type
EXPERIMENTAL
Ixekizumab
Intervention Type
DRUG
Administered SC
Ixekizumab
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).
Group Type
EXPERIMENTAL
Ixekizumab
Intervention Type
DRUG
Administered SC
Placebo
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
Group Type
PLACEBO_COMPARATOR
Ixekizumab
Intervention Type
DRUG
Administered SC
Placebo
Intervention Type
DRUG
Administered SC
IXE80Q2W Non-randomized
Participants completed open label but did not meet criteria for randomization to the double-blind Withdrawal Period.
Participants continued to receive 80 mg given as one SC injection every two weeks during the double-blind withdrawal period.
Group Type
EXPERIMENTAL
Ixekizumab
Intervention Type
DRUG
Administered SC
Interventions
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Ixekizumab
Administered SC
Intervention Type
DRUG
Placebo
Administered SC
Intervention Type
DRUG
Other Intervention Names
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LY2439821
Eligibility Criteria
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Inclusion Criteria
* Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) 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)
* 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)
Exclusion Criteria
* Current or prior use of biologic agents for treatment of Ps or PsA
* Inadequate response to greater than or equal to 4 conventional disease-modifying antirheumatic drugs (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
* Inadequate response to greater than or equal to 4 conventional disease-modifying antirheumatic drugs (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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Arizona Arthritis & Rheumatology Research
Glendale, Arizona, United States
Site Status
Arizona Arthritis & Rheumatology Research, PLLC
Mesa, Arizona, United States
Site Status
Arizona Arthritis Research, PLC
Phoenix, Arizona, United States
Site Status
University of California, Davis - Health Systems
Sacramento, California, United States
Site Status
East Bay Rheumatology Medical Group
San Leandro, California, United States
Site Status
Arthritis & Osteoporosis Treatment Center, PA
Orange Park, Florida, United States
Site Status
Florida Medical Clinic PA
Zephyrhills, Florida, United States
Site Status
Physicians Clinic of Iowa
Cedar Rapids, Iowa, United States
Site Status
Heartland Research Associates
Wichita, Kansas, United States
Site Status
Klein and Associates MD, PA
Cumberland, Maryland, United States
Site Status
Klein and Associates MD, PA
Hagerstown, Maryland, United States
Site Status
University of Massachusetts Medical Center
Worcester, Massachusetts, United States
Site Status
Glacier View Research Institute
Kalispell, Montana, United States
Site Status
Arthritis, Rheumatic & Back Disease Associates
Voorhees Township, New Jersey, United States
Site Status
Weill Cornell Physicians at Brooklyn Heights
Brooklyn, New York, United States
Site Status
Robert A. Harrell, III, MD
Durham, North Carolina, United States
Site Status
Pennsylvania Regional Center for Arthritis & Osteoarthritis
Wyomissing, Pennsylvania, United States
Site Status
Pioneer Research Solutions
Cypress, Texas, United States
Site Status
Arthritis Care & Diagnostic Center P.A.
Dallas, Texas, United States
Site Status
Kadlec Clinic Rheumatology
Kennewick, Washington, United States
Site Status
Seattle Rheumatology Associates, P.L.L.C.
Seattle, Washington, United States
Site Status
Arthritis Northwest Rheumatology
Spokane, Washington, United States
Site Status
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Plovdiv, , Bulgaria
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Plovdiv, , Bulgaria
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Rousse, , Bulgaria
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Brno, , Czechia
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Tallinn, , Estonia
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Tartu, , Estonia
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Chihuahua City, , Mexico
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Guadalajara, , Mexico
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Monterrey, , Mexico
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Morelia, , Mexico
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San Luis Potosí City, , Mexico
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Bialystok, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Nowa Sól, , Poland
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Nowy Duninów, , Poland
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Poznan, , Poland
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Sochaczew, , Poland
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Torun, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Chelyabinsk, , Russia
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Kazan', , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Yekaterinburg, , Russia
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Považská Bystrica, , Slovakia
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Senica, , Slovakia
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Stará Ľubovňa, , Slovakia
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Svidník, , Slovakia
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Trnava, , Slovakia
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Zvolen, , Slovakia
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Cape Town, , South Africa
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Kempton Park, , South Africa
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Port Elizabeth, , South Africa
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Pretoria, , South Africa
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Pretoria, , South Africa
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Stellenbosch, , South Africa
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A Coruña, , Spain
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Málaga, , Spain
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Sabadell, , Spain
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Santander, , Spain
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Seville, , Spain
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
Site Status
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Lviv, , Ukraine
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Odesa, , Ukraine
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Vinnytsia, , Ukraine
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Vinnytsia, , Ukraine
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Vinnytsia, , Ukraine
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Zaporizhzhia, , Ukraine
Site Status
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Goodmayes, , United Kingdom
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Harlow, , United Kingdom
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London, , United Kingdom
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Truro, , United Kingdom
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Wolverhampton, , United Kingdom
Site Status
Countries
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United States
Bulgaria
Czechia
Estonia
Mexico
Poland
Russia
Slovakia
South Africa
Spain
Ukraine
United Kingdom
References
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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.
Reference Type
DERIVED
Coates LC, Pillai SG, Tahir H, Valter I, Chandran V, Kameda H, Okada M, Kerr L, Alves D, Park SY, Adams DH, Gallo G, Hufford MM, Hojnik M, Mease PJ, Kavanaugh A; SPIRIT-P3 Study Group. Withdrawing Ixekizumab in Patients With Psoriatic Arthritis Who Achieved Minimal Disease Activity: Results From a Randomized, Double-Blind Withdrawal Study. Arthritis Rheumatol. 2021 Sep;73(9):1663-1672. doi: 10.1002/art.41716. Epub 2021 Aug 6.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Provided Documents
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Document Type: Statistical Analysis Plan: Statistical Analysis Plan V3
Document Type: Statistical Analysis Plan: Statistical Analysis Plan Blinding and Unblinding Plan V3
Document Type: Study Protocol
Related Links
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http://www.lillytrialguide.com/EN/studies/arthritis/rhbf
Click here for more information about this study: A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis (SPIRIT P3)
Other Identifiers
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I1F-MC-RHBF
Identifier Type: OTHER
Identifier Source: secondary_id
2015-002433-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14518
Identifier Type: -
Identifier Source: org_study_id
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