Phase
Condition
Musculoskeletal Diseases
Lupus
Systemic Lupus Erythematosus
Treatment
Placebo
BI 3000202
Clinical Study ID
Ages 18-74 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male and female adult patients from ≥18 years (or alternative age for adults basedon local regulations) to <75 years
Confirmed Systemic Lupus Erythematosus (SLE) diagnosis meeting the European LeagueAgainst Rheumatism/American College of Rheumatology (EULAR/ACR) classificationcriteria at least 24 weeks prior to screening
At least one of the following positive at screening: Antinuclear Antibodies (ANA) ≥1:80 or anti-double-stranded Deoxyribonucleic Acid (dsDNA) antibody or anti-Smithantibody
- Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 points and clinical SLEDAI-2K score ≥4 points
At least 1 British Isles Lupus Assessment Group (BILAG) A and/or 1 BILAG B grade atscreening, with sufficient disease activity according to both investigator andadjudicator
On SLE background therapy with a maximum of 1 immunosuppressant and/or 1antimalarial for ≥8 weeks and at a stable dose for ≥4 weeks before screening and/ororal corticosteroids at a dose of ≤30 mg/day prednisone or equivalent, stable for ≥2weeks before screening (Visit 1) Further inclusion criteria apply.
Exclusion
Exclusion Criteria:
Drug-induced SLE
Scleroderma (except linear scleroderma that does not interfere with assessments ofSLE disease activity) or in the opinion of the investigator or adjudicator elementsof other connective tissue disease that would interfere with interpretation of testresults or SLE clinical assessments
Active or unstable lupus neuropsychiatric manifestations, including but not limitedto any condition as defined by BILAG A criteria in the neuropsychiatric system, withthe exception of mononeuritis/mononeuropathy multiplex, chorea, and polyneuropathy
Lupus nephritis that may require a change in immune-modulating treatment or whichdemonstrates serum creatinine that is unstable or >2 × Upper Limit of Normal (ULN)and/or Urine Protein Creatinine Ratio (UPCR) that is unstable or > 3mg/mg (339mg/mmol)
Oral corticosteroids (prednisone or equivalent) >30 mg/day at screening Furtherexclusion criteria apply.
Study Design
Connect with a study center
Centro Medico Reumatologico - OMI
CABA, 1015
ArgentinaSite Not Available
Instituto de Investigación Clínica TyT
CABA, C1405BFN
ArgentinaSite Not Available
Instituto Médico Especializado
Capital Federal, C1405BCH
ArgentinaSite Not Available
Consultora integral en Salud SRL.
General Paz, 5000
ArgentinaSite Not Available
Consultoría Integral en Salud SRL.
General Paz 3855078, 5000
ArgentinaSite Not Available
Sanatorio Maipú
Maipu, M5515DQA
ArgentinaSite Not Available
Instituto de Investigaciones Clinicas Quilmes
Quilmes, B1878
ArgentinaSite Not Available
Centro de Investigaciones Médicas Tucumán
San Miguel de Tucumán, 4000
ArgentinaSite Not Available
Austin Health
Heidelberg, Victoria 3081
AustraliaSite Not Available
Fiona Stanley Hospital
Murdoch, Western Australia 6150
AustraliaSite Not Available
SAPIENS - Instituto de Estudos e Pesquisa Clínica
Curitiba, 80810-000
BrazilSite Not Available
Centro Mineiro de Pesquisa (CMIP)
Juiz de Fora, 36010-570
BrazilSite Not Available
Hospitalar Moinhos de Vento
Porto Alegre, 90035-001
BrazilSite Not Available
Inovace Pesquisa Clínica
Salvador, 41820-000
BrazilSite Not Available
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, 15090-000
BrazilSite Not Available
CEPIC - Centro Paulista de Investigacao Clinica
São Paulo, 04266-010
BrazilSite Not Available
Azidus Centro de Pesquisa Clinica Avancada
Valinhos, 13271-130
BrazilSite Not Available
Medical Center MedTech Services Ltd.
Haskovo, 6304
BulgariaSite Not Available
Military medical academy - MHAT Pleven
Pleven, 5800
BulgariaSite Not Available
Hospital MHAT Plovdiv, AD
Plovdiv, 4027
BulgariaSite Not Available
Medical Complex Sveti Ivan Rilski EOOD
Plovdiv, 4003
BulgariaSite Not Available
Medical Complex Sveti Ivan Rilski EOOD
Plovdiv 728193, 4003
BulgariaSite Not Available
Diagnostic Consultative Center Alexandrovska
Sofia, 1431
BulgariaSite Not Available
Medical Center Excelsior OOD
Sofia, 1113
BulgariaSite Not Available
Medical Center Hera EOOD
Sofia, 1510
BulgariaSite Not Available
Medical center "Medici Sofia" Ltd.
Sofia, 1113
BulgariaSite Not Available
Private Clinic of Dermatology Persenk
Sofia, 1407
BulgariaSite Not Available
University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD
Sofia, 1612
BulgariaSite Not Available
Diagnostic Consultative Center Alexandrovska
Sofia 727011, 1431
BulgariaSite Not Available
Medical Center Hera EOOD
Sofia 727011, 1510
BulgariaSite Not Available
Medical center "Medici Sofia" Ltd.
Sofia 727011, 1113
BulgariaSite Not Available
Private Clinic of Dermatology Persenk
Sofia 727011, 1407
BulgariaSite Not Available
University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD
Sofia 727011, 1612
BulgariaSite Not Available
Peking Union Medical College Hospital
Beijing, 100730
ChinaActive - Recruiting
Jilin Province People's Hospital
Changchun, 130021
ChinaSite Not Available
Xiangya Hospital, Central South University
Changsha, 410008
ChinaSite Not Available
The third affiliated hospital of Sun Yat-Sen University
Guangzhou, 510630
ChinaSite Not Available
Linfen Central Hospital
Linfen, 041000
ChinaSite Not Available
Nanjing Drum Tower Hospital
Nanjing, 210008
ChinaSite Not Available
The First Affiliated Hospital of Ningbo University
Ningbo, 315010
ChinaActive - Recruiting
Huashan Hospital, Fudan University
Shanghai, 200040
ChinaSite Not Available
Renji Hospital Shanghai Jiaotong Univesrity School of Medicine
Shanghai, 200040
ChinaSite Not Available
Renji Hospital Shanghai Jiaotong Univesrity School of Medicine
Shanghai 1796236, 200040
ChinaSite Not Available
The Second Affiliated Hospital of Soochow University
Suzhou, 215004
ChinaSite Not Available
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000
ChinaSite Not Available
Clínica de la Costa SAS
Barranquilla, 080020
ColombiaSite Not Available
CIREEM SAS (Centro de Investigación en Reumatología y Especialidades Médicas)
Bogotá, 110231
ColombiaSite Not Available
Hospital Universitario San Ignacio de Bogotá
Bogotá, 110231
ColombiaSite Not Available
Hospital Universitario San Ignacio de Bogotá
Bogotá 3688689, 110231
ColombiaSite Not Available
IPS Centro Medico Julián Coronel S.A.
Cali, 760001
ColombiaSite Not Available
Fundacion Oftalmologica de Santander FOSCAL
Floridablanca, 681001
ColombiaSite Not Available
Klinicki Bolnicki Centar Osijek
Osijek, 31000
CroatiaSite Not Available
University Hospital Centre Osijek
Osijek, 31000
CroatiaSite Not Available
Specialty Hospital Medico
Rijeka, 51000
CroatiaSite Not Available
Specijalna Bolnica Medico
Rijeka, 51000
CroatiaSite Not Available
Poliklinika Bonifarm Zagreb
Zagreb, 10000
CroatiaSite Not Available
Solmed Polyclinic
Zagreb, 1000
CroatiaSite Not Available
Rheumazentrum Prof. Dr. med. Gunther Neeck
Bad Doberan, 18209
GermanySite Not Available
Mühlenkreiskliniken AöR
Minden, 32429
GermanySite Not Available
Klinikum der Universität München AÖR
München, 80336
GermanySite Not Available
Semmelweis Egyetem Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika
Budapest, 1021
HungarySite Not Available
Vita Verum Medical Bt.
Székesfehérvár, 8000
HungarySite Not Available
CARE, Kochi
Kochi, 682040
IndiaSite Not Available
IPGMER and SSKM Hospital
Kolkata, 700020
IndiaSite Not Available
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
Maharashtra, 400053
IndiaSite Not Available
Japan Community Healthcare Organization Chukyo Hospital
Aichi, Nagoya, 457-8510
JapanSite Not Available
National Hospital Organization Chibahigashi National Hospital
Chiba, Chiba, 260-8712
JapanSite Not Available
Juntendo University Urayasu Hospital
Chiba, Urayasu, 279-0021
JapanSite Not Available
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu, 807-8556
JapanSite Not Available
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648
JapanSite Not Available
Tohoku Medical and Pharmaceutical University Hospital
Miyagi, Sendai, 983-8512
JapanSite Not Available
University of Miyazaki Hospital
Miyazaki, Miyazaki, 889-1692
JapanSite Not Available
Shinshu University Hospital
Nagano, Matsumoto, 390-8621
JapanSite Not Available
Niigata University Medical and Dental Hospital
Niigata, Niigata, 951-8520
JapanSite Not Available
Japanese Red Cross Okayama Hospital
Okayama, Okayama, 700-8607
JapanSite Not Available
Saitama Medical University Hospital
Saitama, Iruma-gun, 350-0495
JapanSite Not Available
Institute of Science Tokyo Hospital
Tokyo, Bunkyo-ku, 113-8519
JapanSite Not Available
Juntendo University Hospital
Tokyo, Bunkyo-ku, 113-8431
JapanSite Not Available
St. Luke's International Hospital
Tokyo, Chuo-ku, 104-8560
JapanSite Not Available
Keio University Hospital
Tokyo, Shinjuku-ku, 160-8582
JapanSite Not Available
Investigacion y Biomedicina de Chihuahua S.C.
Chihuahua City, 31020
MexicoSite Not Available
Centro Médico ISSEMyM Ecatepec
Ecatepec, 55020
MexicoSite Not Available
Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080
MexicoSite Not Available
Erasmus Medisch Centrum
Rotterdam, 3015 GD
NetherlandsSite Not Available
Intercor
Bydgoszcz, 85605
PolandSite Not Available
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Bydgoszcz, 85-168
PolandSite Not Available
Intercor
Bydgoszcz 3102014, 85605
PolandSite Not Available
Pratia S.A.
Krakow, 30-727
PolandSite Not Available
Medical Center Hetmanska
Poznan, 60-218
PolandSite Not Available
Prywatna Praktyka Lekarska Paweł Piesiak
Poznan, 61-397
PolandSite Not Available
ai medical center LLC
Poznan, 61113
PolandSite Not Available
Prywatna Praktyka Lekarska Paweł Piesiak
Poznan 3088171, 61-397
PolandSite Not Available
ai medical center LLC
Poznan 3088171, 61113
PolandSite Not Available
Klinika Reuma Park
Warsaw, 02665
PolandSite Not Available
Medicover Integrated Clinical Services Sp. z o.o.
Warsaw, 00874
PolandSite Not Available
Medycyna Kliniczna
Warsaw, 00874
PolandSite Not Available
Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy
Warsaw, 04-141
PolandSite Not Available
Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy
Warsaw 756135, 04-141
PolandSite Not Available
Pracownia Badan Klinicznych Salus
Wroclaw, 53034
PolandSite Not Available
Center of Rheumatic Diseases Dr. Ioan Stoia Bucharest
Bucharest, 020983
RomaniaSite Not Available
Center of Rheumatic Diseases Dr. Ion Stoia Bucharest
Bucharest, 020983
RomaniaSite Not Available
Centrul Clinic De Boli Reumatismale Dr. Ion Stoia
Bucharest, 020983
RomaniaSite Not Available
Delta Health Care
Bucharest, 014142
RomaniaSite Not Available
Dr. Ion Cantacuzino Clinical Hospital
Bucharest, 020475
RomaniaSite Not Available
Institutul Clinic Fundeni
Bucharest, 022328
RomaniaSite Not Available
Spitalul Clinic Dr. I. Cantacuzino
Bucharest, 020475
RomaniaSite Not Available
Delta Health Care
Bucharest 683506, 014142
RomaniaSite Not Available
Dr. Ion Cantacuzino Clinical Hospital
Bucharest 683506, 020475
RomaniaSite Not Available
Military Medical Academy
Belgrade, 11000
SerbiaSite Not Available
General Hospital - Djordje Joanovic
Zrenjanin, 23101
SerbiaSite Not Available
Dr Gareth Scott Tarr
Stellenbosch, 7599
South AfricaSite Not Available
Durban Westville
Westville, 3630
South AfricaSite Not Available
Hospital Germans Trias i Pujol
Badalona, 08916
SpainSite Not Available
Hospital Santa Creu i Sant Pau
Barcelona, 08041
SpainSite Not Available
Hospital de Galdakao
Galdakao, 48960
SpainSite Not Available
Hospital Universitario Ramon Y Cajal
Madrid, 28034
SpainSite Not Available
Hospital Universitario de Araba
Vitoria-Gasteiz, 01009
SpainSite Not Available
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City, 833
TaiwanSite Not Available
Chung Shan Medical University Hospital
Taichung, 40201
TaiwanSite Not Available
National Taiwan University Hospital
Taipei, 100225
TaiwanSite Not Available
Taipei Medical University Hospital
Taipei, 110
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei, 112201
TaiwanSite Not Available
Taipei Medical University Hospital
Taipei 1668341, 110
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei 1668341, 112201
TaiwanSite Not Available
Basingstoke and North Hampshire Hospital
Basingstoke, RG24 9NA
United KingdomSite Not Available
Belfast City Hospital
Belfast, BT9 7AB
United KingdomSite Not Available
Doncaster Royal Infirmary
Doncaster, DN2 5LTT
United KingdomSite Not Available
Guy's Hospital
London, SE1 9RT
United KingdomSite Not Available
Wallace & Lee Center
Beverly Hills, California 90210
United StatesSite Not Available
Arthritis & Osteoporosis Medical Center, Inc - La Palma
La Palma, California 90623
United StatesSite Not Available
University of California San Diego
San Diego, California 92037
United StatesSite Not Available
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California 90502
United StatesSite Not Available
Inland Rheumatology Clinical Trials, Inc
Upland, California 91786
United StatesSite Not Available
Inland Rheumatology and Osteoporosis Medical Group
Upland, California 91786
United StatesSite Not Available
Alliance Clinical West Hills
West Hills, California 91307
United StatesSite Not Available
Focus Clinical Research
West Hills, California 91307
United StatesSite Not Available
Denver Arthritis Clinic - Lowry
Denver, Colorado 80230
United StatesSite Not Available
AARDS Research, Inc.
Aventura, Florida 33180
United StatesSite Not Available
Arthritis & Rheumatic Disease Specialties
Aventura, Florida 33180
United StatesSite Not Available
Meris Clinical Research-Brandon-69466
Brandon, Florida 33511
United StatesSite Not Available
Clinical Research of West Florida, Inc.
Clearwater, Florida 33763
United StatesSite Not Available
Integral Rheumatology and Immunology Specialist
Plantation, Florida 33324
United StatesSite Not Available
Clinical Research of West Florida, Inc. - Tampa
Tampa, Florida 33606
United StatesSite Not Available
Michigan Rheumatology Group, P.C. - Grand Blanc
Grand Blanc, Michigan 48439
United StatesSite Not Available
Great Lakes Center of Rheumatology
Lansing, Michigan 48911
United StatesSite Not Available
Oscar Clinical Trials
Jackson, Mississippi 39206
United StatesSite Not Available
Boeson Research
Great Falls, Montana 59405
United StatesSite Not Available
Boeson Research - Great Falls
Great Falls, Montana 59405
United StatesSite Not Available
Montana Arthritis Center
Great Falls, Montana 59405
United StatesSite Not Available
DJL Clinical Research, PLLC
Charlotte, North Carolina 28211
United StatesSite Not Available
Cross Creek Medical Clinic, PA
Fayetteville, North Carolina 28304
United StatesSite Not Available
Paramount Medical Research and Consulting
Middleburg Heights, Ohio 44130
United StatesSite Not Available
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Altoona Arthritis & Osteoporosis Center - Altoona Center for Clinical Research
Duncansville, Pennsylvania 16635
United StatesSite Not Available
West Tennessee Research Institute
Jackson, Tennessee 38305
United StatesSite Not Available
Office of Dr. Ramesh C. Gupta I
Memphis, Tennessee 38119
United StatesSite Not Available
Shelby Research LLC
Memphis, Tennessee 38119
United StatesSite Not Available
Arthritis & Rheumatology Institute - Allen
Allen, Texas 75013
United StatesSite Not Available
Amarillo Center for Clinical Research
Amarillo, Texas 79124
United StatesSite Not Available
Tekton Research, Inc - West Gate Boulevard
Austin, Texas 78745
United StatesSite Not Available
Heritage Rheumatology and Arthritis Care
Colleyville, Texas 76034
United StatesSite Not Available
Precision Comprehensive Clinical Research Solutions - Colleyville
Colleyville, Texas 76034
United StatesSite Not Available
North Texas Center for Rheumatology
Euless, Texas 76040
United StatesSite Not Available
Precision Comprehensive Clinical Research Solutions
Euless, Texas 76040
United StatesSite Not Available
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United StatesSite Not Available
R&H Clinical Research - Katy
Katy, Texas 77449
United StatesSite Not Available
SouthWest Rheumatology Research
Mesquite, Texas 75150
United StatesSite Not Available

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