NCT01597245

Brief Summary

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
1,224

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2012

Longer than P75 for phase_3

Geographic Reach
11 countries

111 active sites

Status
completed

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

May 10, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

May 18, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2014

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

October 20, 2016

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2019

Completed
Last Updated

June 26, 2020

Status Verified

August 1, 2019

Enrollment Period

1.9 years

First QC Date

May 10, 2012

Results QC Date

April 20, 2016

Last Update Submit

June 9, 2020

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants With a Static Physician Global Assessment (sPGA) of (0,1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])

    The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.

    Week 12

  • Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) ≥75% (PASI75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])

    The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor (head \[0.1\], upper limbs \[0.2\], trunk \[0.3\], lower limbs \[0.4\]). Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.

    Week 12

Secondary Outcomes (15)

  • Percentage of Participants Achieving an sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: [sPGA])

    Week 12

  • Percentage of Participants Achieving PASI 90% (PASI90) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: [PASI])

    Week 12

  • Percentage of Participants Achieving PASI 100% (PASI100)

    Week 12

  • Percentage of Participants Maintaining an sPGA (0,1) From Week 12 After Re-randomization at Start of Maintenance Dosing Period to Week 60

    Week 60

  • Percentage of Participants With Itching Severity (Itch Numeric Rating Scale [NRI]) Score ≥4 Point Reduction From Baseline

    Week 12

  • +10 more secondary outcomes

Study Arms (5)

80 mg ixekizumab Dosing Regimen 1

EXPERIMENTAL

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.

Drug: 80 mg ixekizumab Dosing Regimen

80 mg ixekizumab Dosing Regimen 2

EXPERIMENTAL

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.

Drug: 80 mg ixekizumab Dosing Regimen

80 mg ixekizumab Dosing Regimen 3

EXPERIMENTAL

Dosing Regimen 3 is not used until Week 12. At Week 12, ixekizumab responders re-randomized to this arm will receive Dosing Regimen 3.

Drug: 80 mg ixekizumab Dosing Regimen

50 mg etanercept

ACTIVE COMPARATOR

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.

Drug: 50 mg etanercept

Placebo for ixekizumab

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

80 mg ixekizumab Dosing RegimenDRUG

Administered SC

Also known as: LY2439821
80 mg ixekizumab Dosing Regimen 180 mg ixekizumab Dosing Regimen 280 mg ixekizumab Dosing Regimen 3
50 mg etanerceptDRUG

Administered SC

50 mg etanercept
PlaceboDRUG

Administered SC

Placebo for ixekizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (118)

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Phoenix, Arizona, 85032, United States

Location

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Scottsdale, Arizona, 85254, United States

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Little Rock, Arkansas, 72204, United States

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Riverside, California, 92505, United States

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San Diego, California, 92123, United States

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Denver, Colorado, 80220, United States

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Farmington, Connecticut, 06030, United States

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Washington D.C., District of Columbia, 20037, United States

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Boca Raton, Florida, 33431, United States

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DeLand, Florida, 32720, United States

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Jacksonville, Florida, 32204, United States

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Tampa, Florida, 33612, United States

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West Palm Beach, Florida, 33409, United States

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Alpharetta, Georgia, 30022, United States

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Atlanta, Georgia, 30327, United States

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Plainfield, Indiana, 46168, United States

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Overland Park, Kansas, 66215, United States

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Baton Rouge, Louisiana, 70809, United States

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Silver Spring, Maryland, 20902, United States

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Andover, Massachusetts, 01810, United States

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Worcester, Massachusetts, 01605, United States

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St Louis, Missouri, 63117, United States

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Paramus, New Jersey, 07652, United States

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Verona, New Jersey, 07044, United States

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New York, New York, 10029, United States

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Wilmington, North Carolina, 28403, United States

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Norman, Oklahoma, 73071, United States

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Philadelphia, Pennsylvania, 19103, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Greer, South Carolina, 29650, United States

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Bristol, Tennessee, 37620, United States

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Knoxville, Tennessee, 37922, United States

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Arlington, Texas, 76011, United States

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Austin, Texas, 78705, United States

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Dallas, Texas, 75230, United States

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San Antonio, Texas, 78229, United States

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Webster, Texas, 77598, United States

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Salt Lake City, Utah, 84132, United States

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Norfolk, Virginia, 23507, United States

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Richmond, Virginia, 23294, United States

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Spokane, Washington, 99204, United States

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Phillip, Australian Capital Territory, 02606, Australia

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St Leonards, New South Wales, 2065, Australia

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Sydney, New South Wales, 02000, Australia

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Woolloogabba, Queensland, 4120, Australia

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Hectorville, South Australia, 05073, Australia

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Box Hill, Victoria, 3128, Australia

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Carlton, Victoria, 3053, Australia

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Feldkirch, 6807, Austria

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Graz, 8036, Austria

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Innsbruck, 6020, Austria

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Vienna, A1090, Austria

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Calgary, Alberta, T3G 0B4, Canada

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Edmonton, Alberta, T5K 1X3, Canada

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Surrey, British Columbia, V3R 6A7, Canada

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Barrie, Ontario, L4M6L2, Canada

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Hamilton, Ontario, L8N1V6, Canada

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London, Ontario, N6A 3H7, Canada

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Markham, Ontario, L3P1A8, Canada

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North Bay, Ontario, P1B 3Z7, Canada

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Peterborough, Ontario, K9J 1Z2, Canada

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Toronto, Ontario, M5S 3B4, Canada

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Sainte-Foy, Quebec, G1V 3T6, Canada

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Sherbrooke, Quebec, J1J 2G2, Canada

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Brno, 602 00, Czechia

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Prague, 150 06, Czechia

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Amiens, 80054, France

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Besançon, 25030, France

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Boulogne, 92104, France

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Cannes, 06400, France

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Chambray-lès-Tours, 37170, France

Location

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Marseille, 13385, France

Location

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Nice, 06202, France

Location

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Paris, 75475, France

Location

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Poitiers, 86021, France

Location

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Rouen, 76036, France

Location

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Toulouse, 31059, France

Location

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Berlin, 14197, Germany

Location

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Darmstadt, 64283, Germany

Location

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Dresden, 01307, Germany

Location

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Essen, 45122, Germany

Location

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Giessen, 35390, Germany

Location

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Göttingen, 37075, Germany

Location

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Hamburg, 22143, Germany

Location

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Hanover, 30449, Germany

Location

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Jena, 07740, Germany

Location

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Osnabrück, 49078, Germany

Location

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Tübingen, 72076, Germany

Location

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Witten, 58453, Germany

Location

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Breda, 4818 CK, Netherlands

Location

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Nijmegen, 6525 GA, Netherlands

Location

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Rotterdam, Netherlands

Location

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Gdansk, 80-952, Poland

Location

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Kielce, 25-317, Poland

Location

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Lodz, 90-265, Poland

Location

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Lublin, 20-081, Poland

Location

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Opole, 48-080, Poland

Location

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Szczecin, 70-111, Poland

Location

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Warsaw, 02-507, Poland

Location

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Bucharest, 020125, Romania

Location

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Craiova, 200642, Romania

Location

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Iași, 700381, Romania

Location

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Timișoara, 300077, Romania

Location

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Alcorcón, 28922, Spain

Location

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Alicante, 03010, Spain

Location

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Badalona, 08916, Spain

Location

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Barcelona, 08025, Spain

Location

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Las Palmas, 35010, Spain

Location

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Madrid, 28041, Spain

Location

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Málaga, 29010, Spain

Location

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Seville, 41071, Spain

Location

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Dundee, Angus, DD1 9SY, United Kingdom

Location

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London, Hampstead, NW3 2QG, United Kingdom

Location

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Glasgow, Scotland, G11 6NT, United Kingdom

Location

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Lanarkshire, ML6 0JS, United Kingdom

Location

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Salford, M6 8HD, United Kingdom

Location

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Scunthorpe, DN15 7BA, United Kingdom

Location

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Sheffield, S10 2JF, United Kingdom

Location

Related Publications (11)

  • 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.

    PMID: 38647975DERIVED

  • 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.

    PMID: 38521874DERIVED

  • 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.

    PMID: 37400681DERIVED

  • 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.

    PMID: 35279805DERIVED

  • 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.

    PMID: 32845588DERIVED

  • 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.

    PMID: 32200512DERIVED

  • 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.

    PMID: 30465321DERIVED

  • 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.

    PMID: 28074446DERIVED

  • 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.

    PMID: 27299809DERIVED

  • 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.

    PMID: 26953848DERIVED

  • 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.

    PMID: 26072109DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

ixekizumabEtanercept

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2012

First Posted

May 14, 2012

Study Start

May 18, 2012

Primary Completion

March 25, 2014

Study Completion

June 18, 2019

Last Updated

June 26, 2020

Results First Posted

October 20, 2016

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share

Plan Description: 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.

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.
More information

Locations

RO(4)DE(12)CA(12)ES(8)PL(7)AU(4)US(41)NL(3)FR(11)GB(7)CZ(2)