NCT01474512

Brief Summary

This study will assess the safety and efficacy of LY2439821 compared to 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
1,296

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_3

Geographic Reach
11 countries

104 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

November 15, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

November 16, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2014

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

May 27, 2016

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2018

Completed
Last Updated

October 3, 2019

Status Verified

January 18, 2019

Enrollment Period

2.6 years

First QC Date

November 15, 2011

Results QC Date

April 20, 2016

Last Update Submit

September 17, 2019

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA)

    The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were 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 ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: 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 of 0 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA)

    Week 12

  • Percentage of Participants Achieving PASI 90% (PASI90) or 100% (PASI100) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: PASI)

    Week 12

  • Percentage of Participants Maintaining sPGA 0 or 1 After Re-Randomization at Start of Maintenance Dosing Period

    Week 60

  • Percentage of Participants With Itch Numeric Rating Scale (Itch NRS) Score ≥4 Point Reduction From Baseline

    Baseline, Week 12

  • Change From Baseline in Dermatology-Specific Quality of Life Index (DLQI) Score

    Baseline, Week 12

  • +10 more secondary outcomes

Study Arms (4)

80 milligrams (mg) Ixekizumab Dosing Regimen 1 (Q2W)

EXPERIMENTAL

Administered as two 80-mg subcutaneous (SC) injections at Week 0, then one 80-mg SC injection per Dosing Regimen 1 \[every 2 weeks (Q2W)\] up to and including Week 10. At Week 12, arm is re-randomized to placebo, Dosing Regimen 2 \[every 4 weeks (Q4W)\] or Dosing Regimen 3 \[every 12 weeks Q12W)\].

Drug: 80 mg Ixekizumab Dosing Regimens 1, 2, and 3

80 mg Ixekizumab Dosing Regimen 2 (Q4W)

EXPERIMENTAL

Administered as two 80-mg SC injections at Week 0, then one 80-mg SC injection per Dosing Regimen 2 (Q4W) up to and including Week 10. At Week 12, arm is re-randomized to placebo, Dosing Regimen 2 (Q4W) or Dosing Regimen 3 (Q12W).

Drug: 80 mg Ixekizumab Dosing Regimens 1, 2, and 3

80 mg Ixekizumab Dosing Regimen 3 (Q12W)

EXPERIMENTAL

Dosing Regimen 3 (Q12W) is not used until Week 12. At Week 12, participants who were re-randomized to this arm were administered one 80-mg SC injection Q12W.

Drug: 80 mg Ixekizumab Dosing Regimens 1, 2, and 3

Placebo

PLACEBO COMPARATOR

Administered as 2 SC injections at Week 0, then 1 SC injection per Dosing Regimen 1 (Q2W) up to and including Week 10. At Week 12, arm is re-randomized to placebo or Dosing Regimen 2 (Q4W).

Drug: Placebo

Interventions

80 mg Ixekizumab Dosing Regimens 1, 2, and 3DRUG

Administered SC

Also known as: LY2439821
80 mg Ixekizumab Dosing Regimen 2 (Q4W)80 mg Ixekizumab Dosing Regimen 3 (Q12W)80 milligrams (mg) Ixekizumab Dosing Regimen 1 (Q2W)
PlaceboDRUG

Administered SC

Placebo

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 psoriasis vulgaris 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 during the study
  • Women must agree to use 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
  • Clinically significant flare of psoriasis during the 12 weeks prior to randomization
  • Concurrent or recent use of any biologic agent
  • Received systemic psoriasis therapy \[such as psoralen and ultraviolet A (PUVA) light therapy\] or phototherapy 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 (IL)-17 antagonists, including LY2439821
  • 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 (104)

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Birmingham, Alabama, 35233, United States

Location

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Anaheim, California, 92801, United States

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Bakersfield, California, 93309, United States

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Fremont, California, 94538, United States

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New Haven, Connecticut, 06511, United States

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Jacksonville, Florida, 32216, United States

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Miami, Florida, 33175, United States

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Miramar, Florida, 33027, 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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Pinellas Park, Florida, 33781, United States

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Tampa, Florida, 33624, United States

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West Palm Beach, Florida, 33409, United States

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Atlanta, Georgia, 30327, 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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Evansville, Indiana, 47714, United States

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Indianapolis, Indiana, 46256, United States

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South Bend, Indiana, 46617, United States

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Owensboro, Kentucky, 42303, United States

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Baton Rouge, Louisiana, 70809, United States

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Troy, Michigan, 48084, United States

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St Louis, Missouri, 63117, United States

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New York, New York, 10021, United States

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Rochester, New York, 14623, United States

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The Bronx, New York, 10467, United States

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Raleigh, North Carolina, 27612, United States

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Cleveland, Ohio, 44106, United States

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Portland, Oregon, 97223, United States

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Johnston, Rhode Island, 02919, United States

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Knoxville, Tennessee, 37922, United States

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Salt Lake City, Utah, 84132, United States

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Bellingham, Washington, 98225, United States

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Seattle, Washington, 98101, United States

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Kogarah, New South Wales, 2217, Australia

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Benowa, Queensland, 4217, Australia

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Woolloogabba, Queensland, 4120, Australia

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Adelaide, South Australia, 5000, Australia

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Carlton, Victoria, 3053, Australia

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Parkville, Victoria, 3050, Australia

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Fremantle, Western Australia, 6160, Australia

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Surrey, British Columbia, V3R 6A7, Canada

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Winnipeg, Manitoba, R3C 1R4, Canada

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Moncton, New Brunswick, E1C8X3, Canada

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Halifax, Nova Scotia, B5H1Z4, Canada

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Ajax, Ontario, L1S7K8, Canada

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Barrie, Ontario, L4M6L2, Canada

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London, Ontario, N6A 3H7, Canada

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Newmarket, Ontario, L3Y6P5, 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, N8W 1E6, Canada

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Montreal, Quebec, H3Z 2S6, Canada

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Aarhus, 8000, Denmark

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Copenhagen, 2400, Denmark

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Hellerup, 2900, Denmark

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Berlin, 13125, Germany

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Cologne, 50937, Germany

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Darmstadt, 64283, Germany

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Frankfurt, 60596, Germany

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Hamburg, 22143, Germany

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Hanau, 63450, Germany

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Hanover, 30449, Germany

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Kiel, 24105, Germany

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Mahlow, 39110, Germany

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Mainz, 55131, Germany

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Münster, 48149, Germany

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Quedlinburg, 06484, Germany

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Wuppertal, 42275, Germany

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Budapest, 1036, Hungary

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Debrecen, 4032, Hungary

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Miskolc, 3529, Hungary

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Szeged, H-6720, Hungary

Location

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Szolnok, H-5000, Hungary

Location

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Szombathely, H-9700, Hungary

Location

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Bergamo, 24128, Italy

Location

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Bologna, 40100, Italy

Location

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Padua, 35128, Italy

Location

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Pisa, 56126, Italy

Location

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Aichi, 467-0001, Japan

Location

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Fukuoka, 814-0180, Japan

Location

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Kochi, 783-8505, Japan

Location

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Kyoto, 602-0841, Japan

Location

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Shiga, 520-2192, Japan

Location

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Shizuoka, 431-3125, Japan

Location

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Tochigi, 329- 0498, Japan

Location

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Tokyo, 169-0073, Japan

Location

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Bialystok, 15-017, Poland

Location

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Elblag, 82-300, Poland

Location

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Krakow, 30-510, Poland

Location

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Lodz, 90-265, Poland

Location

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Lublin, 20-081, Poland

Location

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Szczecin, 70-111, Poland

Location

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Torun, 87-100, Poland

Location

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Warsaw, 04-749, Poland

Location

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Baia Mare, 430193, Romania

Location

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Bucharest, 21155, Romania

Location

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Craiova, 200642, Romania

Location

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Iași, 700125, Romania

Location

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Salford, Manchester, M6 8HD, United Kingdom

Location

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Scunthorpe, North Lincolnshire, DN15 7BH, United Kingdom

Location

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Dundee, Scotland, DD1 9SY, United Kingdom

Location

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Nuneaton, Warwickshire, CV10 7BL, United Kingdom

Location

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Lanarkshire, ML6 0JS, United Kingdom

Location

Related Publications (6)

  • 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

  • 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

  • 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

  • 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

MeSH Terms

Conditions

Psoriasis

Interventions

ixekizumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

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

November 15, 2011

First Posted

November 18, 2011

Study Start

November 16, 2011

Primary Completion

June 24, 2014

Study Completion

September 20, 2018

Last Updated

October 3, 2019

Results First Posted

May 27, 2016

Record last verified: 2019-01-18

Locations

RO(4)CA(12)US(34)DK(3)IT(4)GB(5)AU(7)JP(8)DE(13)HU(6)PL(8)