NCT02584855

Brief Summary

The main purpose of this study is to evaluate the safety and long-term efficacy of ixekizumab 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
394

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2015

Typical duration for phase_3

Geographic Reach
11 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

Study Start

First participant enrolled

September 14, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 16, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
1 year until next milestone

Results Posted

Study results publicly available

November 15, 2019

Completed
Last Updated

November 15, 2019

Status Verified

November 1, 2018

Enrollment Period

3.1 years

First QC Date

October 16, 2015

Results QC Date

October 25, 2019

Last Update Submit

October 25, 2019

Conditions

Psoriatic Arthritis

Keywords

SpondyloarthritisSpondylarthropathy

Outcome Measures

Primary Outcomes (1)

  • Double-Blind Withdrawal Period: Time to Relapse (No Longer Meeting Coates Criteria for Minimal Disease Activity [MDA])

    Relapse is loss of MDA response. MDA is achieved if 5 of 7 outcome measures are fulfilled:TJC ≤1;SJC ≤1;psoriasis activity \& severity index(PASI total score) ≤1 or body surface area(BSA) ≤3;participant pain VAS score of ≤15;participant global disease activity VAS score of ≤20;HAQ-DI score ≤0.5;and tender entheseal points ≤1.Participants met the randomization criteria if they had MDA for 3 consecutive months over 4 consecutive visits.Time-to relapse was calculated in weeks as follows:((Date of Relapse) - Date of first injection of randomized study treatment in period 3)+1) divided by 7.If the date of first dose is missing,the date of randomization will be used.Participants completing Period 3 will be censored at date of completion(the date of the last scheduled visit in the period).Participants without a date of completion or discontinuation for Period 3 will be censored at latest non-missing date out of the following dates:date of last dose \& date of last attended visit in Period 3.

    Double Blind Randomization through Week 104 (or Early Termination or Relapse)

Secondary Outcomes (12)

  • Double-Blind Withdrawal Period: Percentage of Participants Who Relapse in MDA

    Double Blind Randomization through Week 104 (or Early Termination or Relapse)

  • Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Tender Joint Count 68 (TJC)

    Double Blind Randomization through Week 104 (or Early Termination or Relapse)

  • Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Swollen Joint Count 66 (SJC)

    Double Blind Randomization through Week 104 (or Early Termination or Relapse)

  • Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Psoriasis Area and Severity Index (PASI)

    Double Blind Randomization through Week 104 (or Early Termination or Relapse)

  • Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: BSA

    Double Blind Randomization through Week 104 (or Early Termination or Relapse)

  • +7 more secondary outcomes

Study Arms (4)

Ixekizumab Open Label

EXPERIMENTAL

Open-Label Treatment Period: Starting dose of 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline (week 0) followed by 80 mg given as one SC injection every two weeks (Q2W) from week 2 to randomization (week 36 to 64).

Drug: Ixekizumab

Ixekizumab

EXPERIMENTAL

Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).

Drug: Ixekizumab

Placebo

PLACEBO COMPARATOR

Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)

Drug: IxekizumabDrug: Placebo

IXE80Q2W Non-randomized

EXPERIMENTAL

Participants completed open label but did not meet criteria for randomization to the double-blind Withdrawal Period. Participants continued to receive 80 mg given as one SC injection every two weeks during the double-blind withdrawal period.

Drug: Ixekizumab

Interventions

IxekizumabDRUG

Administered SC

Also known as: LY2439821
IXE80Q2W Non-randomizedIxekizumabIxekizumab Open LabelPlacebo
PlaceboDRUG

Administered SC

Placebo

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 (PsA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
  • Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints
  • Presence of active psoriatic skin lesion or a 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
  • Have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs)

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 cDMARDs
  • Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
  • Have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonal antibody (MAb) therapy
  • 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 (106)

Arizona Arthritis & Rheumatology Research

Glendale, Arizona, 85306, United States

Location

Arizona Arthritis & Rheumatology Research, PLLC

Mesa, Arizona, 85202, United States

Location

Arizona Arthritis Research, PLC

Phoenix, Arizona, 85032, United States

Location

University of California, Davis - Health Systems

Sacramento, California, 95817, United States

Location

East Bay Rheumatology Medical Group

San Leandro, California, 94578, United States

Location

Arthritis & Osteoporosis Treatment Center, PA

Orange Park, Florida, 32073, United States

Location

Florida Medical Clinic PA

Zephyrhills, Florida, 33542, United States

Location

Physicians Clinic of Iowa

Cedar Rapids, Iowa, 54203, United States

Location

Heartland Research Associates

Wichita, Kansas, 67207, United States

Location

Klein and Associates MD, PA

Cumberland, Maryland, 21502, United States

Location

Klein and Associates MD, PA

Hagerstown, Maryland, 21740, United States

Location

University of Massachusetts Medical Center

Worcester, Massachusetts, 01605, United States

Location

Glacier View Research Institute

Kalispell, Montana, 59901, United States

Location

Arthritis, Rheumatic & Back Disease Associates

Voorhees Township, New Jersey, 08043, United States

Location

Weill Cornell Physicians at Brooklyn Heights

Brooklyn, New York, 11201, United States

Location

Robert A. Harrell, III, MD

Durham, North Carolina, 27704, United States

Location

Pennsylvania Regional Center for Arthritis & Osteoarthritis

Wyomissing, Pennsylvania, 19610, United States

Location

Pioneer Research Solutions

Cypress, Texas, 77429, United States

Location

Arthritis Care & Diagnostic Center P.A.

Dallas, Texas, 75231, United States

Location

Kadlec Clinic Rheumatology

Kennewick, Washington, 99336, United States

Location

Seattle Rheumatology Associates, P.L.L.C.

Seattle, Washington, 98122, United States

Location

Arthritis Northwest Rheumatology

Spokane, Washington, 99204, United States

Location

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Plovdiv, 4000, Bulgaria

Location

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Plovdiv, 4002, Bulgaria

Location

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Rousse, 7002, Bulgaria

Location

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Sofia, 1784, Bulgaria

Location

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Brno, 60200, Czechia

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Brno, 638 00, Czechia

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Česká Lípa, 470 01, Czechia

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Ostrava, 722 00, Czechia

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Pardubice, 53002, Czechia

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Prague, 128 50, Czechia

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Prague, 13000, Czechia

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Prague, 15800, Czechia

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Praha 4 Nusle, 140 00, Czechia

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Uherské Hradiště, 686 01, Czechia

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Zlín, 760 01, Czechia

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Tallinn, 10117, Estonia

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Tallinn, 10128, Estonia

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Tallinn, 10138, Estonia

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Tallinn, 13419, Estonia

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Tartu, 50107, Estonia

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Chihuahua City, 03100, Mexico

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Cuautitlán Izcalli, 54769, Mexico

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Durango, 34000, Mexico

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Guadalajara, 45040, Mexico

Location

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Monterrey, 64610, Mexico

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Morelia, 58260, Mexico

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San Luis Potosí City, 78213, Mexico

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Bialystok, 15879, Poland

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Krakow, 30-510, Poland

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Krakow, 31-023, Poland

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Krakow, 31-501, Poland

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Lublin, 20-582, Poland

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Nowa Sól, 67100, Poland

Location

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Nowy Duninów, 09505, Poland

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Poznan, 61-113, Poland

Location

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Sochaczew, 96500, Poland

Location

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Torun, 87-100, Poland

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Warsaw, 00-465, Poland

Location

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Warsaw, 00660, Poland

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Warsaw, 01-868, Poland

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Warsaw, 02-118, Poland

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Wroclaw, 51-124, Poland

Location

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Chelyabinsk, 454076, Russia

Location

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Kazan', 420012, Russia

Location

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Moscow, 119333, Russia

Location

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Novosibirsk, 630061, Russia

Location

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Saint Petersburg, 190068, Russia

Location

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Saint Petersburg, 191186, Russia

Location

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Saint Petersburg, 194291, Russia

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Yekaterinburg, 620043, Russia

Location

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Bratislava, 83103, Slovakia

Location

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Bratislava, 84231, Slovakia

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Košice, 040 15, Slovakia

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Považská Bystrica, 01701, Slovakia

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Senica, 90501, Slovakia

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Stará Ľubovňa, 06401, Slovakia

Location

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Svidník, 08901, Slovakia

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Trnava, 91701, Slovakia

Location

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Zvolen, 96001, Slovakia

Location

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Cape Town, 7405, South Africa

Location

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Kempton Park, 1619, South Africa

Location

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Port Elizabeth, 6057, South Africa

Location

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Pretoria, 0002, South Africa

Location

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Pretoria, 0084, South Africa

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Stellenbosch, 7600, South Africa

Location

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A Coruña, 15006, 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, 41010, Spain

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Kharkiv, 61039, Ukraine

Location

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Kharkiv, 61176, Ukraine

Location

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Kyiv, 03151, Ukraine

Location

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Lviv, 79011, Ukraine

Location

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Odesa, 65026, Ukraine

Location

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Vinnytsia, 21018, Ukraine

Location

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Vinnytsia, 21029, Ukraine

Location

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Vinnytsia, 21030, Ukraine

Location

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Zaporizhzhia, 69600, Ukraine

Location

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Goodmayes, IG7 4DY, United Kingdom

Location

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Harlow, CM20 1QX, United Kingdom

Location

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London, E11 1NR, United Kingdom

Location

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Truro, TR1 3LJ, United Kingdom

Location

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Wolverhampton, WV10 0QP, United Kingdom

Location

Related Publications (3)

  • 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

  • Coates LC, Pillai SG, Tahir H, Valter I, Chandran V, Kameda H, Okada M, Kerr L, Alves D, Park SY, Adams DH, Gallo G, Hufford MM, Hojnik M, Mease PJ, Kavanaugh A; SPIRIT-P3 Study Group. Withdrawing Ixekizumab in Patients With Psoriatic Arthritis Who Achieved Minimal Disease Activity: Results From a Randomized, Double-Blind Withdrawal Study. Arthritis Rheumatol. 2021 Sep;73(9):1663-1672. doi: 10.1002/art.41716. Epub 2021 Aug 6.

    PMID: 33682378DERIVED

  • 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

Related Links

MeSH Terms

Conditions

Arthritis, PsoriaticSpondylarthritisSpondylarthropathies

Interventions

ixekizumab

Condition Hierarchy (Ancestors)

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

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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2015

First Posted

October 23, 2015

Study Start

September 14, 2015

Primary Completion

October 30, 2018

Study Completion

October 30, 2018

Last Updated

November 15, 2019

Results First Posted

November 15, 2019

Record last verified: 2018-11

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 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

PL(15)GB(5)SL(9)ES(5)ME(7)BU(4)US(22)RU(8)CZ(11)ZA(6)UA(9)