Clinical trial NCT02584855: A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis
Official title: A Phase 3, Multicenter Study With a 36-Week Open-Label Period Followed by a Randomized Double-Blind Withdrawal Period From Week 36 to Week 104 to Evaluate the Long-Term Efficacy and Safety of Ixekizumab (LY2439821) 80 mg Every 2 Weeks in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients With Active Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriatic Arthritis
Keywords: Spondyloarthritis
Spondylarthropathy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2015-10-23
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Double-Blind Withdrawal Period: Time to Relapse (No Longer Meeting Coates Criteria for Minimal Disease Activity [MDA])
timeFrame: Double Blind Randomization through Week 104 (or Early Termination or Relapse)
Secondary outcomes:
measure: Double-Blind Withdrawal Period: Percentage of Participants Who Relapse in MDA
timeFrame: Double Blind Randomization through Week 104 (or Early Termination or Relapse)
measure: Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Tender Joint Count 68 (TJC)
timeFrame: Double Blind Randomization through Week 104 (or Early Termination or Relapse)
measure: Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Swollen Joint Count 66 (SJC)
timeFrame: Double Blind Randomization through Week 104 (or Early Termination or Relapse)
measure: Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Psoriasis Area and Severity Index (PASI)
timeFrame: Double Blind Randomization through Week 104 (or Early Termination or Relapse)
measure: Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: BSA
timeFrame: Double Blind Randomization through Week 104 (or Early Termination or Relapse)
measure: Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Pain Visual Analog Scale (VAS) Score
timeFrame: Double Blind Randomization through Week 104 (or Early Termination or Relapse)
measure: Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Patients Global Assessment of Disease Activity (PatGA) Visual Analog Scale (VAS) Score
timeFrame: Double Blind Randomization through Week 104 (or Early Termination or Relapse)
measure: Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Health Assessment Questionnaire-Disability Index (HAQ-DI)
timeFrame: Double Blind Randomization through Week 104 (or Early Termination or Relapse)
measure: Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Tender Entheseal Points
timeFrame: Double Blind Randomization through Week 104 (or Early Termination or Relapse)
measure: Open-Label Treatment Period: Time to Achieve Randomization Criteria (Meeting MDA for 3 Consecutive Months Over 4 Consecutive Visits)
timeFrame: Open Label Baseline through Double-Blind Randomization (Week 36 to 64)
measure: Double-Blind Withdrawal Period: Time to Re-Gain MDA Following Relapse in MDA
timeFrame: Relapse in MDA After Double Blind Randomization through Week 104 (or Early Termination)
measure: Double-Blind Withdrawal Period: Change From Baseline in Physical Functioning Assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI)
timeFrame: Baseline, 40 Weeks from Double Blind Randomization (Week 36 to 64)
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Arizona Arthritis & Rheumatology Research
state: Arizona
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis Research, PLC
state: Arizona
city: Sacramento
country: United States
facility: University of California, Davis - Health Systems
state: California
city: San Leandro
country: United States
facility: East Bay Rheumatology Medical Group
state: California
city: Orange Park
country: United States
facility: Arthritis & Osteoporosis Treatment Center, PA
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic PA
state: Florida
city: Cedar Rapids
country: United States
facility: Physicians Clinic of Iowa
state: Iowa
city: Wichita
country: United States
facility: Heartland Research Associates
state: Kansas
city: Cumberland
country: United States
facility: Klein and Associates MD, PA
state: Maryland
city: Hagerstown
country: United States
facility: Klein and Associates MD, PA
state: Maryland
city: Worcester
country: United States
facility: University of Massachusetts Medical Center
state: Massachusetts
city: Kalispell
country: United States
facility: Glacier View Research Institute
state: Montana
city: Voorhees
country: United States
facility: Arthritis, Rheumatic & Back Disease Associates
state: New Jersey
city: Brooklyn
country: United States
facility: Weill Cornell Physicians at Brooklyn Heights
state: New York
city: Durham
country: United States
facility: Robert A. Harrell, III, MD
state: North Carolina
city: Wyomissing
country: United States
facility: Pennsylvania Regional Center for Arthritis & Osteoarthritis
state: Pennsylvania
city: Cypress
country: United States
facility: Pioneer Research Solutions
state: Texas
city: Dallas
country: United States
facility: Arthritis Care & Diagnostic Center P.A.
state: Texas
city: Kennewick
country: United States
facility: Kadlec Clinic Rheumatology
state: Washington
city: Seattle
country: United States
facility: Seattle Rheumatology Associates, P.L.L.C.
state: Washington
city: Spokane
country: United States
facility: Arthritis Northwest Rheumatology
state: Washington
city: Plovdiv
country: Bulgaria
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city: Plovdiv
country: Bulgaria
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city: Ruse
country: Bulgaria
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city: Sofia
country: Bulgaria
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city: Brno
country: Czechia
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city: Brno
country: Czechia
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city: Ceska Lipa
country: Czechia
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city: Ostrava
country: Czechia
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city: Pardubice
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city: Praha 2
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city: Praha 4 Nusle
country: Czechia
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city: Praha 5
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city: Praha
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city: Uherske Hradiste
country: Czechia
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city: Zlin
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city: Tallinn
country: Estonia
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country: Estonia
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city: Tallinn
country: Estonia
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city: Tallinn
country: Estonia
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city: Tartu
country: Estonia
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city: Chihuahua
country: Mexico
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city: Cuautitlan Izcalli
country: Mexico
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city: Durango
country: Mexico
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city: Guadalajara
country: Mexico
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city: Monterrey
country: Mexico
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city: Morelia
country: Mexico
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city: San Luis Potosi
country: Mexico
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city: Bialystok
country: Poland
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city: Krakow
country: Poland
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city: Krakow
country: Poland
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city: Krakow
country: Poland
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city: Lublin
country: Poland
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city: Nowa Sol
country: Poland
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city: Nowy Duninow
country: Poland
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city: Poznan
country: Poland
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city: Sochaczew
country: Poland
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city: Torun
country: Poland
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city: Warsaw
country: Poland
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city: Warszawa
country: Poland
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city: Warszawa
country: Poland
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city: Warszawa
country: Poland
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city: Wroclaw
country: Poland
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city: Chelyabinsk
country: Russian Federation
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city: Ekaterinburg
country: Russian Federation
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city: Kazan
country: Russian Federation
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city: Moscow
country: Russian Federation
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city: Novosibirsk
country: Russian Federation
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city: St. Petersburg
country: Russian Federation
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city: St. Petersburg
country: Russian Federation
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city: St. Petersburg
country: Russian Federation
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city: Bratislava
country: Slovakia
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city: Bratislava
country: Slovakia
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city: Kosice
country: Slovakia
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city: Povazska Bystrica
country: Slovakia
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city: Senica
country: Slovakia
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city: Stara Lubovna
country: Slovakia
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city: Svidnik
country: Slovakia
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country: Slovakia
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city: Zvolen
country: Slovakia
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city: Cape Town
country: South Africa
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city: Kempton Park
country: South Africa
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city: Port Elizabeth
country: South Africa
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city: Pretoria
country: South Africa
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city: Pretoria
country: South Africa
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city: Stellenbosch
country: South Africa
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city: La Coruna
country: Spain
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city: Malaga
country: Spain
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city: Sabadell
country: Spain
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city: Santander
country: Spain
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city: Sevilla
country: Spain
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city: Kharkiv
country: Ukraine
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city: Kharkiv
country: Ukraine
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city: Kyiv
country: Ukraine
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city: Lviv
country: Ukraine
facility: 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.
city: Odesa
country: Ukraine
facility: 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.
city: Vinnytsia
country: Ukraine
facility: 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.
city: Vinnytsia
country: Ukraine
facility: 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.
city: Vinnytsya
country: Ukraine
facility: 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.
city: Zaporizhzhia
country: Ukraine
facility: 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.
city: Goodmayes
country: United Kingdom
facility: 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.
city: Harlow
country: United Kingdom
facility: 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.
city: London
country: United Kingdom
facility: 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.
city: Truro
country: United Kingdom
facility: 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.
city: Wolverhampton
country: United Kingdom
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.