NCT01646177

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
1,346

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2012

Longer than P75 for phase_3

Geographic Reach
10 countries

101 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

July 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

July 28, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2014

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

October 21, 2016

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2019

Completed
Last Updated

July 28, 2020

Status Verified

November 1, 2019

Enrollment Period

1.8 years

First QC Date

July 18, 2012

Results QC Date

April 20, 2016

Last Update Submit

July 17, 2020

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (2)

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

    The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1.

    Week 12

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

    The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 was defined as having an improvement of at least 75% in the PASI scores compared to baseline.

    Week 12

Secondary Outcomes (16)

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

    Week 12

  • Number of Participants Achieving ≥90% (PASI 90) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)

    Week 12

  • Number of Participants Achieving 100% (PASI 100) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)

    Week 12

  • Number of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]

    Week 12

  • Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score

    Baseline, Week 12

  • +11 more secondary outcomes

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo for ixekizumab administered by two SC injections at Week 0, then one SC injection per Dosing Regimen 1 until Week 12. Placebo for etanercept administered by one SC injection twice weekly starting at Week 0 up to Week 12. At Week 12, participants are assigned to Dosing Regimen 2.

Drug: Placebo

50 mg etanercept

ACTIVE COMPARATOR

Administered by SC injections twice weekly starting at Week 0 up to Week 12. At Week 12, arm is assigned to Dosing Regimen 2

Drug: 50 mg etanercept

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 264.

Drug: 80 mg ixekizumab

80 mg ixekizumab Dosing Regimen 1

EXPERIMENTAL

Administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection per Dosing Regimen 1 until Week 12. At Week 12, arm is assigned to Dosing Regimen 2.

Drug: 80 mg ixekizumab

Interventions

PlaceboDRUG

Administered SC

Placebo
50 mg etanerceptDRUG

Administered SC

50 mg etanercept
80 mg ixekizumabDRUG

Administered SC

Also known as: LY2439821
80 mg ixekizumab Dosing Regimen 180 mg ixekizumab Dosing Regimen 2

Eligibility Criteria

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

You may qualify if:

  • Presents with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis for at least 6 months prior to randomization
  • At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization
  • 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 randomization
  • 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 (101)

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Anaheim, California, 92801, United States

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Bakersfield, California, 93309, United States

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Bell Gardens, California, 90201, United States

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Beverly Hills, California, 90212, United States

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Irvine, California, 92697, United States

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Los Angeles, California, 90045, United States

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Oceanside, California, 92056, United States

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San Diego, California, 92123, United States

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Santa Monica, California, 90404, United States

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Aurora, Colorado, 80045, United States

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New Haven, Connecticut, 06511, United States

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Edgewater, Florida, 32132, United States

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Jacksonville, Florida, 32216, United States

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Miami, Florida, 33144, United States

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Ocala, Florida, 34471, United States

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Ormond Beach, Florida, 32174, United States

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Arlington Heights, Illinois, 60005, United States

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Chicago, Illinois, 60611, United States

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Skokie, Illinois, 60077, United States

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Indianapolis, Indiana, 46256, United States

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West Des Moines, Iowa, 50265, United States

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Louisville, Kentucky, 40217, United States

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Owensboro, Kentucky, 42303, United States

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Boston, Massachusetts, 02111, United States

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Ann Arbor, Michigan, 48109, United States

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Omaha, Nebraska, 68144, United States

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Henderson, Nevada, 89074, United States

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Newington, New Hampshire, 03801, United States

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East Windsor, New Jersey, 08520, United States

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Albuquerque, New Mexico, 87106, United States

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New York, New York, 10075, United States

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Stony Brook, New York, 11790, United States

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High Point, North Carolina, 27262, United States

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Winston-Salem, North Carolina, 27157, United States

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Portland, Oregon, 97223, United States

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Hazleton, Pennsylvania, 18201, United States

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Anderson, South Carolina, 29621, United States

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Dallas, Texas, 75246, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84132, United States

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West Jordan, Utah, 84088, United States

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Buenos Aires, C1055AA0, Argentina

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Ciudad Autónoma de Buenosaire, C1199ABD, Argentina

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Plovdiv, 4000, Bulgaria

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Sofia, 1632, Bulgaria

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Varna, 9010, Bulgaria

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Calgary, Alberta, T3A 2N1, Canada

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Vancouver, British Columbia, V5Z-3Y1, Canada

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Halifax, Nova Scotia, B3H0A2, Canada

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Brampton, Ontario, L6R 0W3, Canada

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Ottawa, Ontario, K2G 6E2, Canada

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Richmond Hill, Ontario, L4B 1A5, Canada

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Waterloo, Ontario, N2J 1C4, Canada

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Windsor, Ontario, N8W5L7, Canada

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Drummondville, Quebec, J2B 5L4, Canada

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Montreal, Quebec, H2K4L5, Canada

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Santiago, 8420383, Chile

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Augsburg, 86179, Germany

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Berlin, 13125, Germany

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Bonn, 53111, Germany

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Dresden, 01069, Germany

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Erfurt, 99084, Germany

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Ergolding, 84038, Germany

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Frankfurt, 60596, Germany

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Freiburg im Breisgau, 79100, Germany

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Freising, 85354, Germany

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Friedrichshafen, 88045, Germany

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Gera, 07548, Germany

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Hamburg, 20253, Germany

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Hanau, 63450, Germany

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Kiel, 24148, Germany

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Leipzig, 04103, Germany

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Mahlow, 15831, Germany

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Mainz, 55131, Germany

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Mannheim, 68167, Germany

Location

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Mönchengladbach, 41236, Germany

Location

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Münster, 48159, Germany

Location

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Northeim, 37154, Germany

Location

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Schwerin, 19055, Germany

Location

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Würzburg, 97080, Germany

Location

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Budapest, 1036, Hungary

Location

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Debrecen, 4032, Hungary

Location

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Kecskemét, 6000, Hungary

Location

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Makó, 6900, Hungary

Location

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Miskolc, 3529, Hungary

Location

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Orosháza, 5900, Hungary

Location

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Pécs, 7632, Hungary

Location

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Szeged, H-6720, Hungary

Location

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Szolnok, H-5000, Hungary

Location

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Szombathely, 9700, Hungary

Location

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Veszprém, 8200, Hungary

Location

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Monterrey, 64460, Mexico

Location

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Bialystok, 15-017, Poland

Location

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Krakow, 30-510, Poland

Location

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Warsaw, 02-201, Poland

Location

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Krasnodar, 350020, Russia

Location

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Moscow, 127473, Russia

Location

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Saint Petersburg, 194356, Russia

Location

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Saint Petersburg, 195112, Russia

Location

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Smolensk, 214019, Russia

Location

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Yaroslavl, 150002, Russia

Location

Related Publications (13)

  • 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

  • Blauvelt A, Lebwohl MG, Mabuchi T, Leung A, Garrelts A, Crane H, ElMaraghy H, Patel H, Ridenour T, See K, Gallo G, Paul C. Long-term efficacy and safety of ixekizumab: A 5-year analysis of the UNCOVER-3 randomized controlled trial. J Am Acad Dermatol. 2021 Aug;85(2):360-368. doi: 10.1016/j.jaad.2020.11.022. Epub 2020 Nov 28.

    PMID: 33253833DERIVED

  • 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

  • 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

  • Reich K, Jackson K, Ball S, Garces S, Kerr L, Chua L, Muram TM, Blauvelt A. Ixekizumab Pharmacokinetics, Anti-Drug Antibodies, and Efficacy through 60 Weeks of Treatment of Moderate to Severe Plaque Psoriasis. J Invest Dermatol. 2018 Oct;138(10):2168-2173. doi: 10.1016/j.jid.2018.04.019. Epub 2018 May 8.

    PMID: 29751001DERIVED

  • 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

  • van de Kerkhof P, Guenther L, Gottlieb AB, Sebastian M, Wu JJ, Foley P, Morita A, Goldblum O, Zhang L, Erickson J, Ball S, Rich P. Ixekizumab treatment improves fingernail psoriasis in patients with moderate-to-severe psoriasis: results from the randomized, controlled and open-label phases of UNCOVER-3. J Eur Acad Dermatol Venereol. 2017 Mar;31(3):477-482. doi: 10.1111/jdv.14033. Epub 2016 Dec 2.

    PMID: 27910156DERIVED

  • 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

Etanerceptixekizumab

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
ClinicalTrials.gov@lilly.com
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

July 18, 2012

First Posted

July 20, 2012

Study Start

July 28, 2012

Primary Completion

May 22, 2014

Study Completion

July 22, 2019

Last Updated

July 28, 2020

Results First Posted

October 21, 2016

Record last verified: 2019-11-01

Data Sharing

IPD Sharing
Will share

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 European Union (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

AR(2)PL(3)ME(1)CL(1)DE(23)CA(10)BU(3)HU(11)US(41)RU(6)