NCT01695239

Brief Summary

This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis.

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
417

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2012

Longer than P75 for phase_3

Geographic Reach
14 countries

115 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

September 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

October 27, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

January 8, 2019

Status Verified

December 1, 2018

Enrollment Period

2 years

First QC Date

September 25, 2012

Results QC Date

April 20, 2016

Last Update Submit

December 16, 2018

Conditions

Psoriasis, Arthritic

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: American College of Rheumatology 20 Index [ACR20])

    ACR20 response is defined as a ≥20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).

    Week 24

Secondary Outcomes (30)

  • Percentage of Participants Achieving ACR20 Response

    Week 12

  • Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response

    Week 24

  • Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Score

    Week 24

  • Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])

    Baseline, Week 24

  • Change From Baseline in Modified Total Sharp Score (mTSS) (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: Modified Total Sharp Score [mTSS])

    Baseline, Week 24

  • +25 more secondary outcomes

Study Arms (4)

Ixekizumab Q2W

EXPERIMENTAL

Administered by 80 milligram (mg) subcutaneous (SC) injection every 2 weeks (Q2W).

Drug: Ixekizumab

Ixekizumab Q4W

EXPERIMENTAL

Administered by 80 mg SC injection every 4 weeks (Q4W).

Drug: Ixekizumab

Placebo

PLACEBO COMPARATOR

Placebo for ixekizumab and placebo for adalimumab administered by SC injection.

Drug: Placebo

Adalimumab Q2W

ACTIVE COMPARATOR

Administered by 40 mg SC injection Q2W.

Drug: Adalimumab

Interventions

IxekizumabDRUG

Administered SC

Also known as: LY2439821
Ixekizumab Q2WIxekizumab Q4W
PlaceboDRUG

Administered SC

Placebo
AdalimumabDRUG

Administered SC

Adalimumab Q2W

Eligibility Criteria

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

You may qualify if:

  • Presents with established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
  • Active psoriatic arthritis (PsA) defined as the presence of at least 3 tender and at least 3 swollen joints
  • Presence of active psoriatic skin lesion or a personal history of plaque psoriasis (Ps)
  • 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:

  • Current or prior use of biologic agents for treatment of Ps or PsA
  • Inadequate response to greater than or equal to 4 conventional disease-modifying antirheumatic drugs (DMARDs)
  • Current use of more than one conventional DMARD
  • Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
  • Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
  • Serious disorder or illness other than psoriatic arthritis
  • Serious infection within the last 3 months
  • Breastfeeding or nursing (lactating) women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (116)

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Birmingham, Alabama, 35205, United States

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Huntsville, Alabama, 35801, United States

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Tuscaloosa, Alabama, 35406, United States

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Little Rock, Arkansas, 72205, United States

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Upland, California, 91786, United States

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Trumbull, Connecticut, 06611, United States

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Boca Raton, Florida, 33486, United States

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Orange Park, Florida, 32073, United States

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Tampa, Florida, 33614, United States

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Zephyrhills, Florida, 33542, United States

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Atlanta, Georgia, 30342, United States

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Decatur, Georgia, 30033, United States

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Marietta, Georgia, 30060, United States

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Indianapolis, Indiana, 46227, United States

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Cedar Rapids, Iowa, 52403, United States

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Wichita, Kansas, 67207, United States

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Cumberland, Maryland, 21502, United States

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Hagerstown, Maryland, 21740, United States

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St Louis, Missouri, 63141, United States

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Toms River, New Jersey, 08753, United States

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Voorhees Township, New Jersey, 08043, United States

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Brooklyn, New York, 11201, United States

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Rochester, New York, 14642, United States

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Charlotte, North Carolina, 28210, United States

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Durham, North Carolina, 27704, United States

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Greensboro, North Carolina, 27408, United States

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Dayton, Ohio, 45417, United States

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Duncansville, Pennsylvania, 16635, United States

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Columbia, South Carolina, 29204, United States

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Orangeburg, South Carolina, 29118, United States

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Jackson, Tennessee, 38305, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77062, United States

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Kennewick, Washington, 99336, United States

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Seattle, Washington, 98122, United States

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Spokane, Washington, 99204, United States

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Clarksburg, West Virginia, 26301, United States

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Genk, 3600, Belgium

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Ghent, 9000, Belgium

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Liège, 4000, Belgium

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Pleven, 5800, Bulgaria

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Plovdiv, 4002, Bulgaria

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Sliven, 8800, Bulgaria

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Sofia, 1233, Bulgaria

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Stara Zagora, 6000, Bulgaria

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Ottawa, Ontario, K1H 1A2, Canada

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Toronto, Ontario, M5T2S8, Canada

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Waterloo, Ontario, N2J 1C4, Canada

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Québec, G1V3M7, Canada

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Brno, 638 00, Czechia

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Bruntál, 79201, Czechia

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Hlučín, 748 01, Czechia

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Ostrava - Trebovice, 722 00, Czechia

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Prague, 15800, Czechia

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Zlín, 760 01, Czechia

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Tallinn, 13419, Estonia

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Bordeaux, 33076, France

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Nantes, 44093, France

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Orléans, 45032, France

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Toulouse, 31059, France

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Fukuoka, 810-8563, Japan

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Hokkaido, 078-8510, Japan

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Okayama, 700-8558, Japan

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Osaka, 545-8586, Japan

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Tokyo, 160-8582, Japan

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Chihuahua City, 31238, Mexico

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Guadalajara, 45040, Mexico

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Mexico City, 06700, Mexico

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Monterrey, 64000, Mexico

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San Luis Potosí City, 78213, Mexico

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Almelo, 7600SZ, Netherlands

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Amsterdam, 1105 AZ, Netherlands

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Maastricht, 6229 HX, Netherlands

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Nijmegen, 6522 JV, Netherlands

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Rotterdam, 3079 DZ, Netherlands

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Sneek, 8601 ZK, Netherlands

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Bialystok, 158-79, Poland

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Katowice, 40-635, Poland

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Krakow, 31-501, Poland

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Lublin, 20-582, Poland

Location

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Poznan, 60-539, Poland

Location

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Środa Wielkopolska, 63-000, Poland

Location

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Warsaw, 02-118, Poland

Location

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Wroclaw, 51-124, Poland

Location

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Barnaul, 656024, Russia

Location

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Kazan', 420097, Russia

Location

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Moscow, 115522, Russia

Location

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Petrozavodsk, 185019, Russia

Location

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Saint Petersburg, 193257, Russia

Location

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Yekaterinburg, 620102, Russia

Location

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Barcelona, 08034, Spain

Location

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Bilbao, 48013, Spain

Location

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Córdoba, 14004, Spain

Location

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Majadahonda, 28222, Spain

Location

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Málaga, 29009, Spain

Location

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Sabadell, 08208, Spain

Location

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Santander, 39008, Spain

Location

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Seville, 41009, Spain

Location

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Dnipropetrovsk, 49044, Ukraine

Location

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Donetsk, 83045, Ukraine

Location

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Ivano-Frankivsk, 76008, Ukraine

Location

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Kharkiv, 61176, Ukraine

Location

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Kyiv, 03680, Ukraine

Location

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Lutsk, 43024, Ukraine

Location

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Lviv, 79011, Ukraine

Location

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Odesa, 65026, Ukraine

Location

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Vinnytsia, 21029, Ukraine

Location

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Zaporizhzhia, 69600, Ukraine

Location

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Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

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Goodmayes, Essex, IG7 4DY, United Kingdom

Location

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London, Greater London, E11 1NR, United Kingdom

Location

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Headington, Oxford, OX3 7LE, United Kingdom

Location

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Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

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Bradford, West Yorkshire, BD5 0NA, United Kingdom

Location

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Leeds, West Yorkshire, LS7 4SA, United Kingdom

Location

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Liverpool, L9 7AL, United Kingdom

Location

Related Publications (18)

  • Kristensen LE, McGonagle D, Rudwaleit M, Kameda H, Wurtzen PA, Ngantcha M, Holzkamper T, Smolen J. Synergistic Improvements in Synovitis, Enthesitis, and Patient-Reported Outcomes for Patients with Psoriatic Arthritis Treated with Ixekizumab in SPIRIT Trials. Rheumatol Ther. 2025 Apr;12(2):381-395. doi: 10.1007/s40744-025-00748-8. Epub 2025 Feb 27.

    PMID: 40014255DERIVED

  • Tillett W, Birt J, Vadhariya A, Ross S, Ngantcha M, Ng KJ. Filling the "GAP" in Real-World Assessment of Psoriatic Arthritis Disease Activity: Performance Characteristics of a Global/Pain Composite Endpoint. Rheumatol Ther. 2024 Oct;11(5):1101-1114. doi: 10.1007/s40744-024-00690-1. Epub 2024 Jul 2.

    PMID: 38955921DERIVED

  • Armstrong AW, Jaleel T, Merola JF, Gottlieb AB, Khattri S, Helt CC, Malatestinic WN, Ross SE, Ngantcha ME, de Vlam K. Ixekizumab Demonstrates Rapid and Consistent Efficacy for Patients with Psoriatic Arthritis, Regardless of Psoriasis Severity. Dermatol Ther (Heidelb). 2024 Jun;14(6):1615-1631. doi: 10.1007/s13555-024-01188-y. Epub 2024 May 30.

    PMID: 38814433DERIVED

  • Kameda H, Hagimori K, Morisaki Y, Holzkamper T, Konomi A, Dobashi H. Ixekizumab Efficacy in Patients with Severe Peripheral Psoriatic Arthritis: A Post Hoc Analysis of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (SPIRIT-P1). Rheumatol Ther. 2023 Dec;10(6):1683-1703. doi: 10.1007/s40744-023-00605-6. Epub 2023 Oct 19.

    PMID: 37858007DERIVED

  • Coates LC, Smolen JS, Mease PJ, Husni ME, Merola JF, Lespessailles E, Kishimoto M, Macpherson L, Bradley AJ, Bolce R, Helliwell PS. Comparative performance of composite measures from two phase III clinical trials of ixekizumab in psoriatic arthritis. RMD Open. 2022 Sep;8(2):e002457. doi: 10.1136/rmdopen-2022-002457.

    PMID: 36171019DERIVED

  • Eder L, Tony HP, Odhav S, Agirregoikoa EG, Korkosz M, Schwartzman S, Sprabery AT, Gellett AM, Park SY, Bertram CC, Ogdie A. Responses to Ixekizumab in Male and Female Patients with Psoriatic Arthritis: Results from Two Randomized, Phase 3 Clinical Trials. Rheumatol Ther. 2022 Jun;9(3):919-933. doi: 10.1007/s40744-022-00445-w. Epub 2022 Apr 9.

    PMID: 35397092DERIVED

  • Deodhar AA, Combe B, Accioly AP, Bolce R, Zhu D, Gellett AM, Sprabery AT, Burmester GR. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022 Jul;81(7):944-950. doi: 10.1136/annrheumdis-2021-222027. Epub 2022 Apr 7.

    PMID: 35393269DERIVED

  • Combe B, Tsai TF, Huffstutter JE, Sprabery AT, Lin CY, Park SY, Kronbergs A, Hufford MM, Nash P. Ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of PsA: week 52 results from Spirit-P1 and Spirit-P2 studies. Arthritis Res Ther. 2021 Jan 27;23(1):41. doi: 10.1186/s13075-020-02388-5.

    PMID: 33499913DERIVED

  • Schweikert B, Malmberg C, Nunez M, Dilla T, Sapin C, Hartz S. Cost-effectiveness analysis of ixekizumab versus secukinumab in patients with psoriatic arthritis and concomitant moderate-to-severe psoriasis in Spain. BMJ Open. 2020 Aug 13;10(8):e032552. doi: 10.1136/bmjopen-2019-032552.

    PMID: 32792421DERIVED

  • Chandran V, van der Heijde D, Fleischmann RM, Lespessailles E, Helliwell PS, Kameda H, Burgos-Vargas R, Erickson JS, Rathmann SS, Sprabery AT, Birt JA, Shuler CL, Gallo G. Ixekizumab treatment of biologic-naive patients with active psoriatic arthritis: 3-year results from a phase III clinical trial (SPIRIT-P1). Rheumatology (Oxford). 2020 Oct 1;59(10):2774-2784. doi: 10.1093/rheumatology/kez684.

    PMID: 32031665DERIVED

  • Combe B, Rahman P, Kameda H, Canete JD, Gallo G, Agada N, Xu W, Genovese MC. Safety results of ixekizumab with 1822.2 patient-years of exposure: an integrated analysis of 3 clinical trials in adult patients with psoriatic arthritis. Arthritis Res Ther. 2020 Jan 21;22(1):14. doi: 10.1186/s13075-020-2099-0.

    PMID: 31964419DERIVED

  • Tillett W, Lin CY, Zbrozek A, Sprabery AT, Birt J. A Threshold of Meaning for Work Disability Improvement in Psoriatic Arthritis Measured by the Work Productivity and Activity Impairment Questionnaire. Rheumatol Ther. 2019 Sep;6(3):379-391. doi: 10.1007/s40744-019-0155-5. Epub 2019 Jun 1.

    PMID: 31154634DERIVED

  • Coates LC, Orbai AM, Morita A, Benichou O, Kerr L, Adams DH, Shuler CL, Birt J, Helliwell PS. Achieving minimal disease activity in psoriatic arthritis predicts meaningful improvements in patients' health-related quality of life and productivity. BMC Rheumatol. 2018 Aug 13;2:24. doi: 10.1186/s41927-018-0030-y. eCollection 2018.

    PMID: 30886974DERIVED

  • Gladman DD, Orbai AM, Klitz U, Wei JC, Gallo G, Birt J, Rathmann S, Shrom D, Marzo-Ortega H. Ixekizumab and complete resolution of enthesitis and dactylitis: integrated analysis of two phase 3 randomized trials in psoriatic arthritis. Arthritis Res Ther. 2019 Jan 29;21(1):38. doi: 10.1186/s13075-019-1831-0.

    PMID: 30696483DERIVED

  • Gottlieb AB, Strand V, Kishimoto M, Mease P, Thaci D, Birt J, Lee CH, Shuler CL, Lin CY, Gladman DD. Ixekizumab improves patient-reported outcomes up to 52 weeks in bDMARD-naive patients with active psoriatic arthritis (SPIRIT-P1). Rheumatology (Oxford). 2018 Oct 1;57(10):1777-1788. doi: 10.1093/rheumatology/key161.

    PMID: 29945203DERIVED

  • Coates LC, Kishimoto M, Gottlieb A, Shuler CL, Lin CY, Lee CH, Mease PJ. Ixekizumab efficacy and safety with and without concomitant conventional disease-modifying antirheumatic drugs (cDMARDs) in biologic DMARD (bDMARD)-naive patients with active psoriatic arthritis (PsA): results from SPIRIT-P1. RMD Open. 2017 Dec 22;3(2):e000567. doi: 10.1136/rmdopen-2017-000567. eCollection 2017.

    PMID: 29299340DERIVED

  • van der Heijde D, Gladman DD, Kishimoto M, Okada M, Rathmann SS, Moriarty SR, Shuler CL, Carlier H, Benichou O, Mease PJ. Efficacy and Safety of Ixekizumab in Patients with Active Psoriatic Arthritis: 52-week Results from a Phase III Study (SPIRIT-P1). J Rheumatol. 2018 Mar;45(3):367-377. doi: 10.3899/jrheum.170429. Epub 2017 Dec 15.

    PMID: 29247148DERIVED

  • Mease PJ, van der Heijde D, Ritchlin CT, Okada M, Cuchacovich RS, Shuler CL, Lin CY, Braun DK, Lee CH, Gladman DD; SPIRIT-P1 Study Group. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Ann Rheum Dis. 2017 Jan;76(1):79-87. doi: 10.1136/annrheumdis-2016-209709. Epub 2016 Aug 23.

    PMID: 27553214DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

ixekizumabAdalimumab

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

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

September 25, 2012

First Posted

September 27, 2012

Study Start

December 1, 2012

Primary Completion

December 1, 2014

Study Completion

September 1, 2017

Last Updated

January 8, 2019

Results First Posted

October 27, 2016

Record last verified: 2018-12

Locations

FR(4)NL(6)JP(5)GB(8)CA(4)PL(8)ES(8)CZ(6)BE(3)BU(5)US(37)UA(10)RU(6)ME(5)