A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)
Start Date
4/20/2026
Completion Date
7/8/2029
Summary
This study is open to adults with systemic lupus erythematosus (SLE). The purpose of this study is to find out whether a medicine called BI 3000202 helps people with SLE. The study tests different doses of BI 3000202 and aims to find the best dose for people with this condition. Participants are put into 5 groups randomly, which means by chance. 4 groups get different doses of BI 3000202, and 1 group gets a placebo. Placebo tablets look like BI 3000202 tablets but do not contain any medicine. Participants take the tablets for 1 year. All participants also continue their regular treatment for SLE. Participants are in the study for a bit longer than 1 year. During this time, they visit the study site regularly. Doctors check the participants' health and take note of any unwanted effects. They also compare the results between the groups to see if the treatment works.
Eligibility Criteria
Age Range: 18 years to 74 years
Interventions
BI 3000202
Placebo
Conditions
Locations
Wallace & Lee Center
Beverly Hills, California 90210
United States
Arthritis & Osteoporosis Medical Center, Inc - La Palma
La Palma, California 90623
United States
University of California San Diego
San Diego, California 92037
United States
University of California Los Angeles
Torrance, California 90509
United States
Inland Rheumatology Clinical Trials, Inc
Upland, California 91786
United States
Focus Clinical Research
West Hills, California 91307
United States
Denver Arthritis Clinic - Lowry
Denver, Colorado 80230
United States
AARDS Research, Inc.
Aventura, Florida 33180
United States
Meris Clinical Research-Brandon-69466
Brandon, Florida 33511
United States
Clinical Research of West Florida, Inc.
Clearwater, Florida 33763
United States
Integral Rheumatology and Immunology Specialist
Plantation, Florida 33324
United States
Clinical Research of West Florida, Inc. - Tampa
Tampa, Florida 33606
United States
AA MRC LLC - Grand Blanc
Grand Blanc, Michigan 48439
United States
June DO, PC
Lansing, Michigan 48911
United States
Oscar Clinical Trials
Jackson, Mississippi 39206
United States
Boeson Research - Great Falls
Great Falls, Montana 59405
United States
DJL Clinical Research, PLLC
Charlotte, North Carolina 28211
United States
Cross Creek Medical Clinic, PA
Fayetteville, North Carolina 28304
United States
Paramount Medical Research and Consulting
Middleburg Heights, Ohio 44130
United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma 73104
United States
Altoona Arthritis & Osteoporosis Center - Altoona Center for Clinical Research
Duncansville, Pennsylvania 16635
United States
West Tennessee Research Institute
Jackson, Tennessee 38305
United States
Shelby Research LLC
Memphis, Tennessee 38119
United States
Arthritis & Rheumatology Institute - Allen
Allen, Texas 75013
United States
Amarillo Center for Clinical Research
Amarillo, Texas 79124
United States
Precision Comprehensive Clinical Research Solutions - Colleyville
Colleyville, Texas 76034
United States
Precision Comprehensive Clinical Research Solutions
Euless, Texas 76040
United States
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United States
R&H Clinical Research - Katy
Katy, Texas 77449
United States
SouthWest Rheumatology Research
Mesquite, Texas 75150
United States
Centro Medico Reumatologico - OMI
CABA, 1015
Argentina
Instituto de Investigación Clínica TyT
CABA, C1405BFN
Argentina
Instituto Médico Especializado
Capital Federal, C1405BCH
Argentina
Consultora integral en Salud SRL.
General Paz, 5000
Argentina
Sanatorio Maipú
Maipu, M5515DQA
Argentina
Instituto de Investigaciones Clinicas Quilmes
Quilmes, B1878
Argentina
Centro de Investigaciones Médicas Tucumán
San Miguel de Tucumán, 4000
Argentina
Austin Health
Heidelberg, Victoria 3081
Australia
Fiona Stanley Hospital
Murdoch, Western Australia 6150
Australia
SAPIENS - Instituto de Estudos e Pesquisa Clínica
Curitiba, 80810-000
Brazil
Centro Mineiro de Pesquisa (CMIP)
Juiz de Fora, 36010-570
Brazil
Hospitalar Moinhos de Vento
Porto Alegre, 90035-001
Brazil
Inovace Pesquisa Clínica
Salvador, 41820-000
Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, 15090-000
Brazil
CEPIC - Centro Paulista de Investigacao Clinica e Servicos
São Paulo, 04266-010
Brazil
Azidus Centro de Pesquisa Clinica Avancada
Valinhos, 13271-130
Brazil
Medical Center MedTech Services Ltd.
Haskovo, 6304
Bulgaria
Military medical academy - MHAT Pleven
Pleven, 5800
Bulgaria
Medical Complex Sveti Ivan Rilski EOOD
Plovdiv, 4003
Bulgaria
Hospital MHAT Plovdiv, AD
Plovdiv, 4027
Bulgaria
Medical center "Medici Sofia" Ltd.
Sofia, 1113
Bulgaria
Diagnostic Consultative Center Alexandrovska
Sofia, 1431
Bulgaria
Medical Center Hera EOOD
Sofia, 1510
Bulgaria
University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD
Sofia, 1612
Bulgaria
Peking Union Medical College Hospital
Beijing, 100730
China
Jilin Province People's Hospital
Changchun, 130021
China
Xiangya Hospital, Central South University
Changsha, 410008
China
The third affiliated hospital of Sun Yat-Sen University
Guangzhou, 510630
China
Linfen Central Hospital
Linfen, 041000
China
Nanjing Drum Tower Hospital
Nanjing, 210008
China
The First Affiliated Hospital of Ningbo University
Ningbo, 315010
China
Huashan Hospital, Fudan University
Shanghai, 200040
China
Renji Hospital Shanghai Jiaotong Univesrity School of Medicine
Shanghai, 200040
China
The Second Affiliated Hospital of Soochow University
Suzhou, 215004
China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000
China
Clínica de la Costa SAS
Barranquilla, 080020
Colombia
CIREEM SAS (Centro de Investigación en Reumatología y Especialidades Médicas)
Bogotá, 110231
Colombia
Hospital Universitario San Ignacio de Bogotá
Bogotá, 110231
Colombia
IPS Centro Medico Julián Coronel S.A.
Cali, 760001
Colombia
Fundacion Oftalmologica de Santander FOSCAL
Floridablanca, 681001
Colombia
Klinicki Bolnicki Centar Osijek
Osijek, 31000
Croatia
Specijalna Bolnica Medico
Rijeka, 51000
Croatia
Poliklinika Bonifarm Zagreb
Zagreb, 10000
Croatia
Solmed Polyclinic
Zagreb, 1000
Croatia
Rheumazentrum Prof. Dr. med. Gunther Neeck
Bad Doberan, 18209
Germany
Mühlenkreiskliniken AöR
Minden, 32429
Germany
Klinikum der Universität München AÖR
München, 80336
Germany
Semmelweis University
Budapest, 1021
Hungary
Vita Verum Medical Bt.
Székesfehérvár, 8000
Hungary
CARE, Kochi
Kochi, 682040
India
IPGMER and SSKM Hospital
Kolkata, 700020
India
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
Maharashtra, 400053
India
Japan Community Healthcare Organization Chukyo Hospital
Aichi, Nagoya, 457-8510
Japan
National Hospital Organization Chibahigashi National Hospital
Chiba, Chiba, 260-8712
Japan
Juntendo University Urayasu Hospital
Chiba, Urayasu, 279-0021
Japan
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu, 807-8556
Japan
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648
Japan
Tohoku Medical and Pharmaceutical University Hospital
Miyagi, Sendai, 983-8512
Japan
University of Miyazaki Hospital
Miyazaki, Miyazaki, 889-1692
Japan
Shinshu University Hospital
Nagano, Matsumoto, 390-8621
Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, 951-8520
Japan
Japanese Red Cross Okayama Hospital
Okayama, Okayama, 700-8607
Japan
Saitama Medical University Hospital
Saitama, Iruma-gun, 350-0495
Japan
Juntendo University Hospital
Tokyo, Bunkyo-ku, 113-8431
Japan
Institute of Science Tokyo Hospital
Tokyo, Bunkyo-ku, 113-8519
Japan
St. Luke's International Hospital
Tokyo, Chuo-ku, 104-8560
Japan
Keio University Hospital
Tokyo, Shinjuku-ku, 160-8582
Japan
Investigacion y Biomedicina de Chihuahua S.C.
Chihuahua City, 31020
Mexico
Mediadvance Clinical S.A.P.I de C.V.
Chihuahua City, 31203
Mexico
Centro Médico ISSEMyM Ecatepec
Ecatepec, 55020
Mexico
Centro de Investigacion Farmacologica del Bajío, S.C.
León, 37160
Mexico
Centro Médico del Angel SC
Mexicali, 21100
Mexico
Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080
Mexico
Cemdeicy, S.C.P.
Mérida, 97130
Mexico
CIMAB S.A. de C.V
Torreón, 27000
Mexico
Erasmus Medisch Centrum
Rotterdam, 3015 GD
Netherlands
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Bydgoszcz, 85-168
Poland
Intercor
Bydgoszcz, 85605
Poland
Pratia S.A.
Krakow, 30-727
Poland
Medical Center Hetmanska
Poznan, 60-218
Poland
Prywatna Praktyka Lekarska Paweł Piesiak
Poznan, 61-397
Poland
ai medical center LLC
Poznan, 61113
Poland
Medicover Integrated Clinical Services Sp. z o.o.
Warsaw, 00874
Poland
Klinika Reuma Park Sp. z o.o. S.K.
Warsaw, 02665
Poland
Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy
Warsaw, 04-141
Poland
Pracownia Badan Klinicznych Salus
Wroclaw, 53034
Poland
Delta Health Care
Bucharest, 014142
Romania
Spitalul Clinic Dr. I. Cantacuzino
Bucharest, 020475
Romania
Centrul Clinic De Boli Reumatismale Dr. Ion Stoia
Bucharest, 020983
Romania
Institutul Clinic Fundeni
Bucharest, 022328
Romania
Military Medical Academy
Belgrade, 11000
Serbia
General Hospital - Djordje Joanovic
Zrenjanin, 23101
Serbia
Dr Gareth Scott Tarr
Stellenbosch, 7599
South Africa
Hospital Germans Trias i Pujol
Badalona, 08916
Spain
Hospital Santa Creu i Sant Pau
Barcelona, 08041
Spain
Hospital de Galdakao
Galdakao, 48960
Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Spain
Hospital Universitario de Araba
Vitoria-Gasteiz, 01009
Spain
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City, 833
Taiwan
Chung Shan Medical University Hospital
Taichung, 40201
Taiwan
National Taiwan University Hospital
Taipei, 100225
Taiwan
Taipei Medical University Hospital
Taipei, 110
Taiwan
Taipei Veterans General Hospital
Taipei, 112201
Taiwan
Basingstoke and North Hampshire Hospital
Basingstoke, RG24 9NA
United Kingdom
Belfast City Hospital
Belfast, BT9 7AB
United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 0QQ
United Kingdom
Doncaster Royal Infirmary
Doncaster, DN2 5LTT
United Kingdom
Guy's Hospital
London, SE1 9RT
United Kingdom