A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis
NCT ID: NCT02561806
Last Updated: 2020-06-17
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
302 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-10-31
Study Completion Date
2017-10-31
Brief Summary
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The main purpose of this study is to evaluate the efficacy of the study drug ixekizumab compared to ustekinumab in participants with moderate-to-severe-plaque psoriasis.
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Detailed Description
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Conditions
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Plaque Psoriasis
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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Ustekinumab
45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
Group Type
ACTIVE_COMPARATOR
Ustekinumab
Intervention Type
DRUG
Administered SC
Placebo
Intervention Type
DRUG
Administered SC
Ixekizumab
160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52.Placebo for ustekinumab injections will be used for blinding.
Group Type
EXPERIMENTAL
Ixekizumab
Intervention Type
DRUG
Administered SC
Placebo
Intervention Type
DRUG
Administered SC
Interventions
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Ixekizumab
Administered SC
Intervention Type
DRUG
Ustekinumab
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
* Chronic plaque psoriasis for at least 6 months before baseline
* Failure, contraindication, or intolerability to at least 1 systemic therapy (including cyclosporine, methotrexate, or phototherapy)
* Psoriasis Area Severity Index (PASI) score at least 10 at screening and at baseline
* Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 15 weeks after stopping treatment
* Failure, contraindication, or intolerability to at least 1 systemic therapy (including cyclosporine, methotrexate, or phototherapy)
* Psoriasis Area Severity Index (PASI) score at least 10 at screening and at baseline
* Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 15 weeks after stopping treatment
Exclusion Criteria
* Predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis
* History of drug-induced psoriasis
* Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks before baseline and during the study
* Have received systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks of baseline, or have had topical psoriasis treatment within the 2 weeks of baseline
* Concurrent or recent use of any biologic agent within the following washout periods: etanercept \<28 days; infliximab, adalimumab, or alefacept \<60 days; golimumab \<90 days; rituximab \<12 months; or any other biologic agent \<5 half-lives prior to baseline
* Have prior use of ustekinumab, or have any condition or contraindication to ustekinumab that would preclude the participant from participating in this protocol
* Have previously completed or withdrawn from this study, participated in any other study with ixekizumab, have participated in any study investigating other interleukin (IL)-17 or IL-12/23 antagonists, or have received treatment with other IL-17 or IL-12/23 antagonists
* Have had a live vaccination within 12 weeks of baseline, or intend to have a live vaccination during the course of the study or within 15 weeks of completing treatment in this study
* Have had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months of baseline or intend to have vaccination with BCG during the course of the study or within 12 months of completing treatment in this study
* Have a known allergy or hypersensitivity to latex
* Have had any major surgery within 8 weeks of baseline or will require such during the study
* Have active or history of malignant disease within 5 years prior to baseline
* Significant uncontrolled disorder
* Ongoing infection or serious infection within 12 weeks of baseline; serious bone or joint infection within 24 weeks of baseline
* Are women who are lactating or breast-feeding
* History of drug-induced psoriasis
* Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks before baseline and during the study
* Have received systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks of baseline, or have had topical psoriasis treatment within the 2 weeks of baseline
* Concurrent or recent use of any biologic agent within the following washout periods: etanercept \<28 days; infliximab, adalimumab, or alefacept \<60 days; golimumab \<90 days; rituximab \<12 months; or any other biologic agent \<5 half-lives prior to baseline
* Have prior use of ustekinumab, or have any condition or contraindication to ustekinumab that would preclude the participant from participating in this protocol
* Have previously completed or withdrawn from this study, participated in any other study with ixekizumab, have participated in any study investigating other interleukin (IL)-17 or IL-12/23 antagonists, or have received treatment with other IL-17 or IL-12/23 antagonists
* Have had a live vaccination within 12 weeks of baseline, or intend to have a live vaccination during the course of the study or within 15 weeks of completing treatment in this study
* Have had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months of baseline or intend to have vaccination with BCG during the course of the study or within 12 months of completing treatment in this study
* Have a known allergy or hypersensitivity to latex
* Have had any major surgery within 8 weeks of baseline or will require such during the study
* Have active or history of malignant disease within 5 years prior to baseline
* Significant uncontrolled disorder
* Ongoing infection or serious infection within 12 weeks of baseline; serious bone or joint infection within 24 weeks of baseline
* Are women who are lactating or breast-feeding
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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Wein, , Austria
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Brussels, , Belgium
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Ghent, , Belgium
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Calgary, , Canada
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Edmonton, , Canada
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Mississauga, , Canada
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North Bay, , Canada
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St. John's, , Canada
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Toronto, , Canada
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Marseille, , France
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Martigues, , France
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Nice, , France
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Rouen, , France
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Toulouse, , France
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Frankfurt am Main, , Germany
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Giessen, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Kiel, , Germany
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Lübeck, , Germany
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München, , Germany
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Tübingen, , Germany
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Witten, , Germany
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Budapest, , Hungary
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Kecskemét, , Hungary
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Szeged, , Hungary
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Szolnok, , Hungary
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Catania, , Italy
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Pisa, , Italy
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Nijmegen, , Netherlands
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Bialystok, , Poland
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Lodz, , Poland
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Świdnik, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Badalona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Seville, , Spain
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Malmo, , Sweden
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Stockholm, , Sweden
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Geneva, , Switzerland
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Lausanne, , Switzerland
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Zurich, , Switzerland
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Dundee, , United Kingdom
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Salford, , United Kingdom
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Countries
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Austria
Belgium
Canada
France
Germany
Hungary
Italy
Netherlands
Poland
Spain
Sweden
Switzerland
United Kingdom
References
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Armstrong A, Gonzalez-Cantero A, Khattri S, Muzy G, Malatestinic WN, Lampropoulou A, Feely M, See SK, Mert C, Blauvelt A. Comparing Achievement of National Psoriasis Foundation Treatment Targets among Patients with Plaque Psoriasis Treated with Ixekizumab versus Other Biologics in Clinical and Real-World Studies. Dermatol Ther (Heidelb). 2024 Apr;14(4):933-952. doi: 10.1007/s13555-024-01136-w. Epub 2024 Mar 23.
Reference Type
DERIVED
Elewski BE, Blauvelt A, Gallo G, Wolf E, McKean-Matthews M, Burge R, Merola JF, Gottlieb AB, Guenther LC. Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Dermatol Ther (Heidelb). 2022 Apr;12(4):911-920. doi: 10.1007/s13555-022-00704-2. Epub 2022 Mar 13.
Reference Type
DERIVED
Wasel N, Thaci D, French LE, Conrad C, Dutronc Y, Gallo G, Berggren L, Lacour JP. Ixekizumab and Ustekinumab Efficacy in Nail Psoriasis in Patients with Moderate-to-Severe Psoriasis: 52-Week Results from a Phase 3, Head-to-Head Study (IXORA-S). Dermatol Ther (Heidelb). 2020 Aug;10(4):663-670. doi: 10.1007/s13555-020-00383-x. Epub 2020 May 15.
Reference Type
DERIVED
Related Links
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http://www.lillytrialguide.com/EN-us/studies/psoriasis/rhbs
Click here for more information about this study: A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis
Other Identifiers
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I1F-MC-RHBS
Identifier Type: OTHER
Identifier Source: secondary_id
2015-000892-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16012
Identifier Type: -
Identifier Source: org_study_id
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