A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-2)
NCT ID: NCT01597245
Last Updated: 2020-06-26
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
1224 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-05-18
Study Completion Date
2019-06-18
Brief Summary
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This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.
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Detailed Description
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Conditions
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Psoriasis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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80 mg ixekizumab Dosing Regimen 1
Administered by two 80 mg subcutaneous (SC) injections at Week 0, then one 80 mg SC injection per Dosing Regimen 1 until Week 12. At Week 12, ixekizumab responders are re-randomized to placebo, Dosing Regimen 2 or Dosing Regimen 3. Ixekizumab non-responders are assigned to Dosing Regimen 2.
Group Type
EXPERIMENTAL
80 mg ixekizumab Dosing Regimen
Intervention Type
DRUG
Administered SC
80 mg ixekizumab Dosing Regimen 2
Administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection per Dosing Regimen 2 until Week 12. At Week 12, ixekizumab responders are re-randomized to placebo, Dosing Regimen 2 or Dosing Regimen 3. Ixekizumab non-responders are assigned to Dosing Regimen 2.
Group Type
EXPERIMENTAL
80 mg ixekizumab Dosing Regimen
Intervention Type
DRUG
Administered SC
80 mg ixekizumab Dosing Regimen 3
Dosing Regimen 3 is not used until Week 12. At Week 12, ixekizumab responders re-randomized to this arm will receive Dosing Regimen 3.
Group Type
EXPERIMENTAL
80 mg ixekizumab Dosing Regimen
Intervention Type
DRUG
Administered SC
50 mg etanercept
Administered by one 50 mg SC injection twice weekly starting at Week 0 up to Week 12. At Week 12, etanercept responders are assigned to placebo, and nonresponders to Dosing Regimen 2.
Group Type
ACTIVE_COMPARATOR
50 mg etanercept
Intervention Type
DRUG
Administered SC
Placebo for ixekizumab
Placebo for ixekizumab administered by two SC injections at Week 0, then one SC injection per Dosing Regimen 1 until Week 12. At Week 12, placebo responders are assigned to placebo, and nonresponders to Dosing Regimen 2. Placebo for etanercept administered by one SC injection twice weekly starting at Week 0 up to Week 12 was used to blind etanercept injections for Dosing Regimen 1, Dosing Regimen 2, and Placebo Comparator groups.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Administered SC
Interventions
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80 mg ixekizumab Dosing Regimen
Administered SC
Intervention Type
DRUG
50 mg etanercept
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
* Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic plaque psoriasis for at least 6 months prior to first dose of study drug
* At least 10% Body Surface Area (BSA) of psoriasis at screening and at first dose of study drug
* Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at first dose of study drug
* Candidate for phototherapy and/or systemic therapy
* 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
* At least 10% Body Surface Area (BSA) of psoriasis at screening and at first dose of study drug
* Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at first dose of study drug
* Candidate for phototherapy and/or systemic therapy
* 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
Exclusion Criteria
* Pustular, erythrodermic, and/or guttate forms of psoriasis
* History of drug-induced psoriasis
* Prior use of etanercept
* Clinically significant flare of psoriasis during the 12 weeks prior to randomization
* Concurrent or recent use of any biologic agent
* Received non-biologic systemic psoriasis therapy or phototherapy (including psoralens and ultraviolet A \[PUVA\], ultraviolet B \[UVB\]) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization
* Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study
* Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
* Serious disorder or illness other than plaque psoriasis
* Serious infection within the last 3 months
* Breastfeeding or nursing (lactating) women
* History of drug-induced psoriasis
* Prior use of etanercept
* Clinically significant flare of psoriasis during the 12 weeks prior to randomization
* Concurrent or recent use of any biologic agent
* Received non-biologic systemic psoriasis therapy or phototherapy (including psoralens and ultraviolet A \[PUVA\], ultraviolet B \[UVB\]) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization
* Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study
* Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
* Serious disorder or illness other than plaque psoriasis
* 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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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Little Rock, Arkansas, United States
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Riverside, California, United States
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San Diego, California, United States
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Denver, Colorado, United States
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Farmington, Connecticut, United States
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DeLand, Florida, United States
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Andover, Massachusetts, United States
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San Antonio, Texas, United States
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Norfolk, Virginia, United States
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Phillip, Australian Capital Territory, Australia
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St Leonards, New South Wales, Australia
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Carlton, Victoria, Australia
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Feldkirch, , Austria
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Graz, , Austria
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Innsbruck, , Austria
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Vienna, , Austria
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Barrie, Ontario, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Markham, Ontario, Canada
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North Bay, Ontario, Canada
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Peterborough, Ontario, Canada
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Toronto, Ontario, Canada
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Sainte-Foy, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Brno, , Czechia
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Prague, , Czechia
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Amiens, , France
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Besançon, , France
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Boulogne, , France
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Cannes, , France
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Chambray-lès-Tours, , France
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Marseille, , France
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Nice, , France
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Paris, , France
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Poitiers, , France
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Rouen, , France
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Toulouse, , France
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Berlin, , Germany
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Darmstadt, , Germany
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Dresden, , Germany
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Essen, , Germany
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Giessen, , Germany
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Göttingen, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Jena, , Germany
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Osnabrück, , Germany
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Tübingen, , Germany
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Witten, , Germany
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Breda, , Netherlands
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Gdansk, , Poland
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Kielce, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Opole, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Bucharest, , Romania
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Craiova, , Romania
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Iași, , Romania
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Timișoara, , Romania
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Alcorcón, , Spain
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Alicante, , Spain
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Badalona, , Spain
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Barcelona, , Spain
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Las Palmas, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Seville, , Spain
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Dundee, Angus, United Kingdom
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London, Hampstead, United Kingdom
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Glasgow, Scotland, United Kingdom
Site Status
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Lanarkshire, , United Kingdom
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Salford, , United Kingdom
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Scunthorpe, , United Kingdom
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Sheffield, , United Kingdom
Site Status
Countries
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United States
Australia
Austria
Canada
Czechia
France
Germany
Netherlands
Poland
Romania
Spain
United Kingdom
References
Explore related publications, articles, or registry entries linked to this study.
Egeberg A, Hawkes JE, Somani N, Burge R, See K, Gallo G, McKean-Matthews M, Gooderham M, Han G, Armstrong A. Sustained Improvements in Clinical and Patient-Reported Outcomes and Quality of Life Through 5 Years Among Ixekizumab-Treated Patients with Complete Clearance of Scalp Psoriasis by Week 60. Dermatol Ther (Heidelb). 2024 Apr;14(4):1007-1018. doi: 10.1007/s13555-024-01147-7. Epub 2024 Apr 22.
Reference Type
DERIVED
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
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.
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
Rich P, Goldblum O, Disch D, Lin CY, Merola JF, Elewski B. Nail Psoriasis Does Not Affect Skin Response to Ixekizumab in Patients With Moderate-To-Severe Psoriasis. J Drugs Dermatol. 2020 Aug 1;19(8):741-746. doi: 10.36849/JDD.2020.5116.
Reference Type
DERIVED
Leonardi C, Reich K, Foley P, Torii H, Gerdes S, Guenther L, Gooderham M, Ferris LK, Griffiths CEM, ElMaraghy H, Crane H, Patel H, Burge R, Gallo G, Shrom D, Leung A, Lin CY, Papp K. Efficacy and Safety of Ixekizumab Through 5 Years in Moderate-to-Severe Psoriasis: Long-Term Results from the UNCOVER-1 and UNCOVER-2 Phase-3 Randomized Controlled Trials. Dermatol Ther (Heidelb). 2020 Jun;10(3):431-447. doi: 10.1007/s13555-020-00367-x. Epub 2020 Mar 21.
Reference Type
DERIVED
Yosipovitch G, Reich A, Steinhoff M, Beselin A, Kent T, Dossenbach M, Berggren L, Henneges C, Luger T. Impact of Ixekizumab Treatment on Itch and Psoriasis Area and Severity Index in Patients with Moderate-to-Severe Plaque Psoriasis: An Integrated Analysis of Two Phase III Randomized Studies. Dermatol Ther (Heidelb). 2018 Dec;8(4):621-637. doi: 10.1007/s13555-018-0267-9. Epub 2018 Nov 21.
Reference Type
DERIVED
Blauvelt A, Papp KA, Griffiths CEM, Puig L, Weisman J, Dutronc Y, Kerr LF, Ilo D, Mallbris L, Augustin M. Efficacy and Safety of Switching to Ixekizumab in Etanercept Non-Responders: A Subanalysis from Two Phase III Randomized Clinical Trials in Moderate-to-Severe Plaque Psoriasis (UNCOVER-2 and -3). Am J Clin Dermatol. 2017 Apr;18(2):273-280. doi: 10.1007/s40257-016-0246-9.
Reference Type
DERIVED
Gordon KB, Blauvelt A, Papp KA, Langley RG, Luger T, Ohtsuki M, Reich K, Amato D, Ball SG, Braun DK, Cameron GS, Erickson J, Konrad RJ, Muram TM, Nickoloff BJ, Osuntokun OO, Secrest RJ, Zhao F, Mallbris L, Leonardi CL; UNCOVER-1 Study Group; UNCOVER-2 Study Group; UNCOVER-3 Study Group. Phase 3 Trials of Ixekizumab in Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2016 Jul 28;375(4):345-56. doi: 10.1056/NEJMoa1512711. Epub 2016 Jun 8.
Reference Type
DERIVED
Armstrong AW, Lynde CW, McBride SR, Stahle M, Edson-Heredia E, Zhu B, Amato D, Nikai E, Yang FE, Gordon KB. Effect of Ixekizumab Treatment on Work Productivity for Patients With Moderate-to-Severe Plaque Psoriasis: Analysis of Results From 3 Randomized Phase 3 Clinical Trials. JAMA Dermatol. 2016 Jun 1;152(6):661-9. doi: 10.1001/jamadermatol.2016.0269.
Reference Type
DERIVED
Griffiths CE, Reich K, Lebwohl M, van de Kerkhof P, Paul C, Menter A, Cameron GS, Erickson J, Zhang L, Secrest RJ, Ball S, Braun DK, Osuntokun OO, Heffernan MP, Nickoloff BJ, Papp K; UNCOVER-2 and UNCOVER-3 investigators. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet. 2015 Aug 8;386(9993):541-51. doi: 10.1016/S0140-6736(15)60125-8. Epub 2015 Jun 10.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
I1F-MC-RHBA
Identifier Type: OTHER
Identifier Source: secondary_id
12973
Identifier Type: -
Identifier Source: org_study_id
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