Clinical trial NCT03616912: A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Systemic Lupus Erythematosus
Keywords: SLE
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Incyte Corporation
First posted: 2018-08-06
Enrollment: 830
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 reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE).


Eligibility criteria: Inclusion Criteria:

* Have a clinical diagnosis of SLE at least 24 weeks prior to screening.
* Have documentation of having met at least 4 of 11 Revised Criteria for Classification of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 American College of Rheumatology (ACR) criteria for classification of SLE prior to randomization.
* Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA), and/or a positive anti-Smith (anti-Sm) as assessed by a central laboratory during screening.
* Have a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 during screening.
* Have a clinical SLEDAI-2K score ≥4 at randomization.
* Have at least 1 British Isles Lupus Assessment Group (BILAG) A score or 2 BILAG B scores during screening.
* Are receiving at least one of the following standard of care medications for SLE:

  * A single antimalarial at a stable dose for at least 8 weeks prior to screening
  * A single immunosuppressant at a stable dose for at least 8 weeks prior to screening
  * An oral corticosteroid, initiated at least 4 weeks prior to screening, at a stable dose ≤40 milligrams/day prednisone (or equivalent) for at least 2 weeks prior to screening. If the participant is not receiving an antimalarial or immunosuppressant, the dose of corticosteroid must be ≥7.5 milligrams/day prednisone (or equivalent)

Exclusion Criteria:

* Have severe active lupus nephritis.
* Have active central nervous system (CNS) lupus.
* Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.
* Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.
* Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.

Primary outcomes:
measure: Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib)
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants Achieving SRI-4 Response - 2 mg Baricitinib
timeFrame: Week 52
measure: Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)
timeFrame: Week 52
measure: Time to First Severe Flare
timeFrame: Baseline to Week 52
measure: Percentage of Participants Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Participants Receiving Greater Than 7.5 mg/Day at Baseline
timeFrame: Baseline, Week 40 through Week 52
measure: Change From Baseline in Worst Pain Numeric Rating Scale (NRS)
timeFrame: Baseline, Week 52
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Total Score
timeFrame: Baseline, Week 52
measure: Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Total Activity Score ≥10 at Baseline With ≥50% Reduction in CLASI Total Activity Score
timeFrame: Week 52
measure: Change From Baseline in Tender Joints Count
timeFrame: Baseline, Week 52
measure: Change From Baseline in Swollen Joint Count
timeFrame: Baseline, Week 52
measure: Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss)
timeFrame: Week 0 (Baseline): 15 minutes (min) and 60 min postdose; Week 4: 2 to 4 hours (hr) postdose; Week 8: 4 to 6 hr postdose; Week 12 and Week 16 predose
measure: Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss)
timeFrame: Week 0 (Baseline): 15 minutes (min) and 60 min postdose; Week 4: 2 to 4 hours (hr) postdose; Week 8: 4 to 6 hr postdose; Week 12 and Week 16 predose
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Glendale
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Fullerton
country: United States
facility: St. Joseph Heritage Medical Group
state: California
city: Hemet
country: United States
facility: MD Medical Corporation
state: California
city: Poway
country: United States
facility: ACRC Studies
state: California
city: Santa Barbara
country: United States
facility: Office: Hans R Barthel M.D.
state: California
city: Whittier
country: United States
facility: Medvin Clinical Research - Weidmann
state: California
city: Denver
country: United States
facility: Denver Arthritis Clinic - Lowry
state: Colorado
city: Bridgeport
country: United States
facility: New England Research Associates
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Aventura
country: United States
facility: Arthritis and Rheumatic Disease
state: Florida
city: Boca Raton
country: United States
facility: Rheumatology Associates of South Florida
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc. (Clearwater)
state: Florida
city: Margate
country: United States
facility: Arthritis and Rheumatology Center of South Florida
state: Florida
city: Miami Lakes
country: United States
facility: Lakes Research, LLC
state: Florida
city: Ormond Beach
country: United States
facility: Millennium Research
state: Florida
city: Plantation
country: United States
facility: IRIS Research and Development, LLC
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Atlanta
country: United States
facility: Piedmont Healthcare
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center for Clinical Research
state: Georgia
city: Boise
country: United States
facility: St Luke's Clinic - Intermountain Orthopaedics
state: Idaho
city: Rockford
country: United States
facility: Rockford Orthopedic Associates
state: Illinois
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Clair Shores
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Saint Louis
country: United States
facility: St. Louis Rheumatology
state: Missouri
city: Kalispell
country: United States
facility: Glacier View Research Institute - Endocrinology
state: Montana
city: Reno
country: United States
facility: Allied Clinical Research
state: Nevada
city: Albuquerque
country: United States
facility: Albuquerque Center for Rheumatology
state: New Mexico
city: Brooklyn
country: United States
facility: SUNY Health Science Center
state: New York
city: Canton
country: United States
facility: St. Lawrence Health System
state: New York
city: Great Neck
country: United States
facility: Northwell Health
state: New York
city: Manhasset
country: United States
facility: The Feinstein Institute for Medical Research
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Orchard Park
country: United States
facility: Buffalo Rheumatology
state: New York
city: Charlotte
country: United States
facility: Joint and Muscle Medical Care
state: North Carolina
city: Greensboro
country: United States
facility: Medication Management, LLC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Arthritis Associates
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Middleburg Heights
country: United States
facility: Paramount Medical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Arthritis & Rheumatology Center of Oklahoma PLLC
state: Oklahoma
city: Bethlehem
country: United States
facility: East Penn Rheumatology Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Lupus Center of Excellence
state: Pennsylvania
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Center for Clinical Research
state: Texas
city: Baytown
country: United States
facility: Accurate Clinical Management
state: Texas
city: Colleyville
country: United States
facility: Dr. Dhiman Basu Private Practice
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Fort Worth
country: United States
facility: Precision Comprehensive Clinical Research Solutions
state: Texas
city: Houston
country: United States
facility: Rheumatology Center of Houston
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology, P.A.
state: Texas
city: San Antonio
country: United States
facility: Accurate Clinical Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Univ of Texas Health Science Center at San Antonio
state: Texas
city: San Marcos
country: United States
facility: Arthritis Clinic Of Central Texas
state: Texas
city: Danville
country: United States
facility: Spectrum Medical Inc.
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Glendale
country: United States
facility: Rheumatic Disease Center
state: Wisconsin
city: Botany
country: Australia
facility: Emeritus Research
state: New South Wales
city: Maroochydore
country: Australia
facility: The Rheumatology Research Unit Sunshine Coast
state: Queensland
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincents Hospital Melbourne
state: Victoria
city: Southport
country: Australia
facility: Griffith University
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen
state: Oberösterreich
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Wien
country: Austria
facility: Klinik Hietzing
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
state: Brussel
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams Brabant
city: Liège
country: Belgium
facility: CHU de Liège
city: Salvador
country: Brazil
facility: SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
state: Bahia
city: Goiania
country: Brazil
facility: CIP-Centro Internacional de Pesquisa
state: Goiás
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericordia de Belo Horizonte
state: MG
city: Curitiba
country: Brazil
facility: Centro de Estudos em Terapias Inovadoras-CETI
state: Paraná
city: Curitiba
country: Brazil
facility: EDUMED - Educação em Saúde Ltda.
state: Paraná
city: Porto Alegre
country: Brazil
facility: LMK Serviços Médicos S/S
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
city: Campinas
country: Brazil
facility: Hospital de Clinicas UNICAMP
state: SP
city: Cuiaba
country: Brazil
facility: Oncovida- Centro de Onco-Hematologia de Mato Grosso
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz
city: Guangzhou
country: China
facility: First affiliated Hospital of Sun Yat-Sen University
state: Guangdong
city: Harbin
country: China
facility: First Affiliated Hospital of the Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou Universtiy
state: Henan
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Pingxiang
country: China
facility: Jiangxi Pingxiang People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: China-Japan Union Hospital of Jilin University
state: Jilin
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Beijing Peking Union Medical College Hospital
city: Shanghai
country: China
facility: Shanghai Huashan Hospital Affil to Fu Dan University
city: Shenyang
country: China
facility: China Medical University (CMU) - First Affiliated Hospital
city: Suzhou Shi
country: China
facility: The First Affliated Hospital of Soochow University
city: Urumqi
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region
city: Rijeka
country: Croatia
facility: Klinicki Bolnicki Centar Rijeka
city: Split
country: Croatia
facility: University Hospital Split
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava
city: Praha 2
country: Czechia
facility: Revmatologicky ustav
state: Praha, Hlavní Mešto
city: Brno
country: Czechia
facility: Revmatologie.s.r.o.
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Pardubice
country: Czechia
facility: ARTHROHELP s.r.o.
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice
city: Tubingen
country: Germany
facility: Universitätsklinikum Tübingen
state: Baden-Wurttemberg
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
state: Baden-Württemberg
city: München
country: Germany
facility: Klinikum der Universität München
state: Bayern
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg A. ö. R.
state: Bayern
city: Köln
country: Germany
facility: Universitätsklinikum Köln
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
state: Rheinland-Pfalz
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
state: Sachsen
city: Leipzig
country: Germany
facility: Universität Leipzig - Universitätsklinikum
state: Sachsen
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin Campus Buch
city: Berlin
country: Germany
facility: Immanuel Krankenhaus Rheuma Klinik Berlin Buch
city: Berlin
country: Germany
facility: Schlosspark Klinik
city: Athens
country: Greece
facility: Gen Hospital of Athens G Gennimatas
state: Attiki
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
state: Crete
city: Larissa
country: Greece
facility: University General Hospital of Larissa
city: Thessaloniki
country: Greece
facility: Euromedica Kyanous Stavros General Hospital
city: Thessaloniki
country: Greece
facility: Hippokration University Hopsital
city: Gyula
country: Hungary
facility: Bekes Megyei Pandy Kalman Korhaz
state: Bekes
city: Veszprem
country: Hungary
facility: Vital Medical Center
state: Veszprém City
city: Budapest
country: Hungary
facility: Budai Irgalmasrendi Korhaz
city: Budapest
country: Hungary
facility: Qualiclinic Kft
city: Budapest
country: Hungary
facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointeze
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont Reumatologiai Tanszek
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika
city: Székesfehérvár
country: Hungary
facility: Vita Verum Egeszsegugyi Szolgaltato Bt
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Haifa
country: Israel
facility: Carmel Hospital
state: Ḥeifā
city: Torreon
country: Mexico
facility: CIMAB SA de CV
state: Coahuila
city: Mexico city
country: Mexico
facility: Hospital Angeles Lindavista
state: DF
city: Mexico City
country: Mexico
facility: Cliditer Sa de CV
state: Distrito Federal
city: Leon
country: Mexico
facility: Morales Vargas Centro de Investigacion, S.C.
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Centro Integral en Reumatologia SA de CV
state: Jalisco
city: Guadalajara
country: Mexico
facility: Clinica de Investigacion en Reumatologia y Obesidad S. C.
state: Jalisco
city: Guadalajara
country: Mexico
facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
state: Jalisco
city: Zapopan
country: Mexico
facility: Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
state: Jalisco
city: Merida
country: Mexico
facility: Köhler & Milstein Research
state: Yucatan
city: Merida
country: Mexico
facility: Centro Peninsular de Investigacion S.C.P
state: Yucatán
city: Merida
country: Mexico
facility: Cemdeicy S.C.P.
state: Yucatán
city: Ciudad De México
country: Mexico
facility: Centro de Investigación y Tratamiento Reumatológico S.C
city: Mexico City
country: Mexico
facility: Clinosar Mexico S.A. de C.V
city: San Luis Potosi
country: Mexico
facility: Centro de Alta Especialidad Reumatologia e Inv Potosi, S.C.
city: Leeuwarden
country: Netherlands
facility: Medische Centrum Leeuwarden
state: Fryslân
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum Amsterdam
city: St. Petersburg
country: Russian Federation
facility: LLC MK Med
state: Saint Petersburg
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Hospital
city: Kazan
country: Russian Federation
facility: City Hospital # 7
city: Kursk
country: Russian Federation
facility: Regional Clinical Hospital
city: Moscow
country: Russian Federation
facility: Russian State Medical University
city: Moscow
country: Russian Federation
facility: City Clinical Hospital 1 named after N.I. Pirogov
city: Moscow
country: Russian Federation
facility: Rheumatology Institute RAMS
city: Novosibirsk
country: Russian Federation
facility: Healthy Family
city: Novosibirsk
country: Russian Federation
facility: Reafan
city: Novosibirsk
country: Russian Federation
facility: Institute of Cytology and Genetics of Siberian Branch of Russian Academy of Medical Sciences
city: Omsk
country: Russian Federation
facility: Regional Hospital - Omsk
city: Orenburg
country: Russian Federation
facility: Orenburg State Medical Academy of Roszdrav
city: Ryazan
country: Russian Federation
facility: Ryazan State Medical University
city: Saint Petersburg
country: Russian Federation
facility: Russian Medical Military Academy n.a. S.M. Kirov
city: Smolensk
country: Russian Federation
facility: Departmental Hospital at Smolensk Station "rzhd" JSC
city: Ufa
country: Russian Federation
facility: Kuvatov Republican Clinical Hospital
city: Basel
country: Switzerland
facility: Universitätsspital Basel
state: Basel Stadt
city: st.Gallen
country: Switzerland
facility: Cantonal Hospital St.Gallen
state: Sankt Gallen
city: Kuei Shan Hsiang
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou
state: Taoyuan Hsien
city: Dalin Township
country: Taiwan
facility: Hualien Tzu-Chi Hospital
city: Kaohsiung City
country: Taiwan
facility: Chang Gung Memorial Hospital - Kaohsiung Branch
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan City
country: Taiwan
facility: Chi-Mei Medical Center
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital
state: Kent
city: London
country: United Kingdom
facility: Whipps Cross University Hospital
state: Surrey
city: Doncaster
country: United Kingdom
facility: Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Guy's Hospital
city: London
country: United Kingdom
facility: St. George's University Hospitals NHS Foundation Trust
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: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.