Clinical trial NCT02757352: A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis
Official title: A 52-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD Naive Patients With Nonradiographic Axial Spondyloarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Axial Spondyloarthritis
Keywords: ankylosing
nonradiographic spondyloarthritis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-05-02
Enrollment: 303
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 efficacy of the study drug known as ixekizumab in biologic disease modifying antirheumatic drug (bDMARD) naïve participants with nonradiographic axial spondyloarthritis (nonrad-axSpA).


Eligibility criteria: Inclusion Criteria:

* Are ambulatory.
* Diagnosis of nonradiographic axial spondyloarthritis (nr-axSpA) and fulfilling the 2009 Assessment of Spondyloarthritis International Society (ASAS) classification criteria.
* Have a history of back pain ≥3 months with age at onset \<45 years.
* Have active nr-axSpA defined as BASDAI ≥4 and total back pain ≥4 on a numeric rating scale (NRS) at screening and baseline.
* Have objective signs of inflammation by presence of sacroiliitis on MRI and/or presence of elevated C-reactive protein (CRP).
* In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDS) for duration of 4 weeks or cannot tolerate NSAIDS.
* If taking NSAIDS be on stable dose for at least 2 weeks prior to randomization.
* Have a history of prior therapy for axSpA for at least 12 weeks prior to screening.

Exclusion Criteria:

* Have radiographic sacroiliitis fulfilling the 1984 modified New York criteria.
* Have received any prior, or are currently receiving treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents.
* Have received a live vaccine within 12 weeks or have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year.
* Have an ongoing or serious infection within the last 12 weeks or evidence of active tuberculosis.
* Have a compromised immune system.
* Have any other serious and/or uncontrolled diseases.
* Have either a current diagnosis or a recent history of malignant disease.
* Have had major surgery within 8 weeks of baseline, or will require surgery during the study.
* Are pregnant or breastfeeding.
* Have evidence of active anterior uveitis (an acute episode) within the last 42 days prior to baseline randomization.

Primary outcomes:
measure: Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response
timeFrame: Week 16
measure: Percentage of Participants Achieving an ASAS40 Response
timeFrame: Week 52
Secondary outcomes:
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: Baseline, Week 16
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: Baseline, Week 52
measure: Number of Participants Without Clinically Meaningful Changes in Background Therapy
timeFrame: Baseline through Week 52
measure: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
timeFrame: Baseline, Week 16
measure: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
timeFrame: Baseline, Week 52
measure: Percentage of Participants Achieving ASDAS Low Disease Activity
timeFrame: Week 16
measure: Percentage of Participants Achieving ASDAS Low Disease Activity
timeFrame: Week 52
measure: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Baseline, Week 16
measure: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Baseline, Week 52
measure: Change From Baseline in Magnetic Resonance Imaging (MRI) of the Sacroiliac Joint (SIJ) Spondyloarthritis Research Consortium of Canada (SPARCC) Score
timeFrame: Baseline, Week 16
measure: Change From Baseline in SPARCC Enthesitis Score
timeFrame: Baseline, Week 52
measure: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: Baseline, Week 52
measure: Percentage of Participants Achieving ASDAS Inactive Disease
timeFrame: Week 52
measure: Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)
timeFrame: Baseline, Week 52
measure: Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
timeFrame: Baseline, Week 52
measure: Change From Baseline in Chest Expansion
timeFrame: Baseline, Week 52
measure: Change From Baseline in Occiput to Wall Distance
timeFrame: Baseline, Week 52
measure: Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
timeFrame: Baseline, Week 52
measure: Change From Baseline in Severity of Peripheral Arthritis by Tender (TJC) and Swollen Joint Count (SJC) Scores of 44 Joints
timeFrame: Baseline, Week 52
measure: Number of Participants With Anterior Uveitis
timeFrame: Baseline through Week 52
measure: Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score
timeFrame: Baseline, Week 52
measure: Change From Baseline in ASAS Health Index (ASAS HI)
timeFrame: Baseline, Week 52
measure: Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)
timeFrame: Baseline, Week 52
measure: Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores
timeFrame: Baseline, Week 52
measure: Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score
timeFrame: Baseline, Week 52
measure: Number of Participants With Treatment Emergent (TE) Anti-Ixekizumab Antibodies
timeFrame: Week 52
measure: Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough ss)
timeFrame: Week 52
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Arthritis Research, PLC
state: Arizona
city: El Cajon
country: United States
facility: TriWest Research Assocaites
state: California
city: Escondido
country: United States
facility: Rheumatology Center of San Diego
state: California
city: Huntington Beach
country: United States
facility: Care Access Research - Huntington Beach
state: California
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: Upland
country: United States
facility: Inlande Rheumatology Clinical Trials
state: California
city: Colorado Springs
country: United States
facility: Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC
state: Colorado
city: Danbury
country: United States
facility: Clinical Research Center of CT/NY
state: Connecticut
city: Sarasota
country: United States
facility: Sarasota Arthritis Center
state: Florida
city: Tamarac
country: United States
facility: West Broward Rheumatology Associates, Inc
state: Florida
city: Marietta
country: United States
facility: Marietta Rheumatology
state: Georgia
city: Idaho Falls
country: United States
facility: Institute of Arthritis Research
state: Idaho
city: Monroe
country: United States
facility: The Arthritis & Diabetes Clinic Inc.
state: Louisiana
city: Cumberland
country: United States
facility: Osteoporosis And Clinical Trial Center
state: Maryland
city: Hagerstown
country: United States
facility: Osteoporosis And Clinical Trial Center
state: Maryland
city: Kalispell
country: United States
facility: Glacier View Research Institute
state: Montana
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC
state: Nebraska
city: Brooklyn
country: United States
facility: Weill Cornell Physicians at Brooklyn Heights
state: New York
city: Raleigh
country: United States
facility: Shanahan Rheumatology & Immunotherapy
state: North Carolina
city: Wilmington
country: United States
facility: Carolina Arthritis Associates
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Columbia
country: United States
facility: Articularis Healthcare Group, INC dba Columbia Arthritis Ctr
state: South Carolina
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: Capital Federal
country: Argentina
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: Ciudad Autonoma de Buenos Aire
country: Argentina
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city: Quilmes
country: Argentina
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city: Rosario
country: Argentina
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city: Rosario
country: Argentina
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city: San Juan
country: Argentina
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city: San Miguel de Tucuman
country: Argentina
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city: San Miguel De Tucumán
country: Argentina
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city: Wien
country: Austria
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city: Wien
country: Austria
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city: Goiás
country: Brazil
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city: Juiz de Fora
country: Brazil
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city: Rio de Janeiro
country: Brazil
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city: Rio de Janeiro
country: Brazil
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city: Quebec
country: Canada
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city: St. John's
country: Canada
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city: Toronto
country: Canada
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city: Trois-Rivieres
country: Canada
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city: Brno
country: Czechia
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city: Ostrava
country: Czechia
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city: Pardubice
country: Czechia
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city: Praha 2
country: Czechia
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city: Uherske Hradiste
country: Czechia
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city: Helsinki
country: Finland
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city: Helsinki
country: Finland
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city: Hyvinkaa
country: Finland
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city: Kuopio
country: Finland
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city: Oulu
country: Finland
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city: Halle (Saale)
country: Germany
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state: Sachsen-Anhalt
city: Bad Doberan
country: Germany
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city: Berlin
country: Germany
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city: Hamburg
country: Germany
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city: Hamburg
country: Germany
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city: Herne
country: Germany
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city: Bunkyo-ku
country: Japan
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city: Chuo-Ku
country: Japan
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city: Kita-gun
country: Japan
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city: Kuwana
country: Japan
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city: Nankoku
country: Japan
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city: Nishinomiya
country: Japan
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city: Okayama
country: Japan
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city: Osaka
country: Japan
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city: Osaka
country: Japan
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city: Sapporo
country: Japan
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city: Sasebo
country: Japan
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city: Suita-shi
country: Japan
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city: Tenri
country: Japan
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city: Yamagata
country: Japan
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city: Ōsaka
country: Japan
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city: Daejeon
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Chihuahua
country: Mexico
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city: Guadalajara
country: Mexico
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city: Guadalajara
country: Mexico
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city: Merida
country: Mexico
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city: Mexicali
country: Mexico
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: Monterrey
country: Mexico
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city: San Luis Potosí
country: Mexico
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city: Amsterdam
country: Netherlands
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city: Elblag
country: Poland
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city: Lodz
country: Poland
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city: Nadarzyn
country: Poland
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city: Poznan
country: Poland
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city: Swidnik
country: Poland
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: Warsaw
country: Poland
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: Caguas
country: Puerto Rico
facility: Office: Perez-De Jesus, Amarilis
city: Ponce
country: Puerto Rico
facility: Ponce School of Medicine CAIMED Center
city: San Juan
country: Puerto Rico
facility: Mindful Medical Research
city: Santurce
country: Puerto Rico
facility: Latin Clinical Trial Center
city: Bucuresti
country: Romania
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: Bucuresti
country: Romania
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: Constanta
country: Romania
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: Moscow
country: Russian Federation
facility: V.A. Nasonova Research Institute of Rheumatology
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #1
city: Ryazan
country: Russian Federation
facility: Ryazan State Medical University/Ryazan Clinical Regional Cardiological Dispensary
city: Saratov
country: Russian Federation
facility: Saratov Regional Clinical Hospital
city: St. Petersburg
country: Russian Federation
facility: Clinical Rheumatology Hospital # 25
city: Yaroslavl
country: Russian Federation
facility: Clinical Hospital for Emergency Care
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: van der Horst-Bruinsma IE, de Vlam K, Walsh JA, Bolce R, Hunter T, Sandoval D, Zhu D, Geneus V, Soriano ER, Magrey M. Baseline Characteristics and Treatment Response to Ixekizumab Categorised by Sex in Radiographic and Non-radiographic Axial Spondylarthritis Through 52 Weeks: Data from Three Phase III Randomised Controlled Trials. Adv Ther. 2022 Jun;39(6):2806-2819. doi: 10.1007/s12325-022-02132-2. Epub 2022 Apr 16.
citation: Deodhar A, Mease P, Marzo-Ortega H, Hunter T, Sandoval D, Kronbergs A, Lauzon S, Leung A, Navarro-Compan V. Ixekizumab improves sleep and work productivity in patients with non-radiographic axial spondyloarthritis: results from the COAST-X trial at 52 weeks. BMC Rheumatol. 2021 Sep 25;5(1):50. doi: 10.1186/s41927-021-00218-y.
citation: Deodhar A, Mease P, Rahman P, Navarro-Compan V, Marzo-Ortega H, Hunter T, Sandoval D, Kronbergs A, Leon L, Shan M, Leung A, De Vlam K, Strand V. Ixekizumab Improves Patient-Reported Outcomes in Non-Radiographic Axial Spondyloarthritis: Results from the Coast-X Trial. Rheumatol Ther. 2021 Mar;8(1):135-150. doi: 10.1007/s40744-020-00254-z. Epub 2020 Dec 7.
citation: Walsh JA, Magrey MN, Baraliakos X, Inui K, Weng MY, Lubrano E, van der Heijde D, Boonen A, Gensler LS, Strand V, Braun J, Hunter T, Li X, Zhu B, Leon L, Calderon DMS, Kiltz U. Improvement of Functioning and Health With Ixekizumab in the Treatment of Active Nonradiographic Axial Spondyloarthritis in a 52-Week, Randomized, Controlled Trial. Arthritis Care Res (Hoboken). 2022 Mar;74(3):451-460. doi: 10.1002/acr.24482. Epub 2022 Jan 26.
citation: Deodhar A, van der Heijde D, Gensler LS, Kim TH, Maksymowych WP, Ostergaard M, Poddubnyy D, Marzo-Ortega H, Bessette L, Tomita T, Leung A, Hojnik M, Gallo G, Li X, Adams D, Carlier H, Sieper J; COAST-X Study Group. Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X): a randomised, placebo-controlled trial. Lancet. 2020 Jan 4;395(10217):53-64. doi: 10.1016/S0140-6736(19)32971-X. Epub 2019 Dec 5.