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A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)
Sponsor: Boehringer Ingelheim
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.
Official title: Randomised, Placebo-controlled, Double-blind, Parallel-group Phase II Study to Evaluate the Efficacy and Safety of Oral BI 3000202 in Patients With Moderate to Severe Systemic Lupus Erythematosus (SLE)
Key Details
Gender
All
Age Range
18 Years - 74 Years
Study Type
INTERVENTIONAL
Enrollment
405
Start Date
2026-04-07
Completion Date
2029-06-24
Last Updated
2026-04-01
Healthy Volunteers
No
Conditions
Interventions
BI 3000202
BI 3000202 at different doses
Placebo
Placebo matching BI 3000202
Locations (129)
Wallace & Lee Center
Beverly Hills, California, United States
Arthritis & Osteoporosis Medical Center, Inc - La Palma
La Palma, California, United States
University of California San Diego
San Diego, California, United States
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
Inland Rheumatology and Osteoporosis Medical Group
Upland, California, United States
Alliance Clinical West Hills
West Hills, California, United States
Denver Arthritis Clinic - Lowry
Denver, Colorado, United States
Arthritis & Rheumatic Disease Specialties
Aventura, Florida, United States
Meris Clinical Research-Brandon-69466
Brandon, Florida, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Integral Rheumatology and Immunology Specialist
Plantation, Florida, United States
Clinical Research of West Florida, Inc. - Tampa
Tampa, Florida, United States
Michigan Rheumatology Group, P.C. - Grand Blanc
Grand Blanc, Michigan, United States
Great Lakes Center of Rheumatology
Lansing, Michigan, United States
Oscar Clinical Trials
Jackson, Mississippi, United States
Montana Arthritis Center
Great Falls, Montana, United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, United States
Cross Creek Medical Clinic, PA
Fayetteville, North Carolina, United States
Paramount Medical Research and Consulting
Middleburg Heights, Ohio, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Altoona Arthritis & Osteoporosis Center - Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Shelby Research LLC
Memphis, Tennessee, United States
Arthritis & Rheumatology Institute - Allen
Allen, Texas, United States
Amarillo Center for Clinical Research
Amarillo, Texas, United States
Tekton Research, Inc - West Gate Boulevard
Austin, Texas, United States
Heritage Rheumatology and Arthritis Care
Colleyville, Texas, United States
North Texas Center for Rheumatology
Euless, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
R&H Clinical Research - Katy
Katy, Texas, United States
SouthWest Rheumatology Research
Mesquite, Texas, United States
Centro Medico Reumatologico - OMI
CABA, Argentina
Instituto Médico Especializado
Capital Federal, Argentina
Consultora integral en Salud SRL.
General Paz, Argentina
Sanatorio Maipú
Maipú, Argentina
Instituto de Investigaciones Clinicas Quilmes
Quilmes, Argentina
Centro de Investigaciones Médicas Tucumán
San Miguel de Tucumán, Argentina
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
SAPIENS - Instituto de Estudos e Pesquisa Clínica
Curitiba, Brazil
Centro Mineiro de Pesquisa (CMIP)
Juiz de Fora, Brazil
Hospitalar Moinhos de Vento
Porto Alegre, Brazil
Inovace Pesquisa Clínica
Salvador, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, Brazil
CEPIC - Centro Paulista de Investigacao Clinica
São Paulo, Brazil
Azidus Centro de Pesquisa Clinica Avancada
Valinhos, Brazil
Medical Center MedTech Services Ltd.
Haskovo, Bulgaria
Military medical academy - MHAT Pleven
Pleven, Bulgaria
Medical Complex Sveti Ivan Rilski EOOD
Plovdiv, Bulgaria
Hospital MHAT Plovdiv, AD
Plovdiv, Bulgaria
Medical center "Medici Sofia" Ltd.
Sofia, Bulgaria
Medical Center Excelsior OOD
Sofia, Bulgaria
Private Clinic of Dermatology Persenk
Sofia, Bulgaria
Diagnostic Consultative Center Alexandrovska
Sofia, Bulgaria
Medical Center Hera EOOD
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD
Sofia, Bulgaria
Peking Union Medical College Hospital
Beijing, China
Jilin Province People's Hospital
Changchun, China
Xiangya Hospital, Central South University
Changsha, China
The third affiliated hospital of Sun Yat-Sen University
Guangzhou, China
Linfen Central Hospital
Linfen, China
Nanjing Drum Tower Hospital
Nanjing, China
The First Affiliated Hospital of Ningbo University
Ningbo, China
Huashan Hospital, Fudan University
Shanghai, China
Renji Hospital Shanghai Jiaotong Univesrity School of Medicine
Shanghai, China
The Second Affiliated Hospital of Soochow University
Suzhou, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Clínica de la Costa SAS
Barranquilla, Colombia
CIREEM SAS (Centro de Investigación en Reumatología y Especialidades Médicas)
Bogotá, Colombia
Hospital Universitario San Ignacio de Bogotá
Bogotá, Colombia
IPS Centro Medico Julián Coronel S.A.
Cali, Colombia
Fundacion Oftalmologica de Santander FOSCAL
Floridablanca, Colombia
University Hospital Centre Osijek
Osijek, Croatia
Specialty Hospital Medico
Rijeka, Croatia
Solmed Polyclinic
Zagreb, Croatia
Rheumazentrum Prof. Dr. med. Gunther Neeck
Bad Doberan, Germany
Mühlenkreiskliniken AöR
Minden, Germany
Klinikum der Universität München AÖR
München, Germany
Semmelweis Egyetem Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika
Budapest, Hungary
Vita Verum Medical Bt.
Székesfehérvár, Hungary
IPGMER and SSKM Hospital
Kolkata, India
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
Maharashtra, India
Japan Community Healthcare Organization Chukyo Hospital
Aichi, Nagoya, Japan
National Hospital Organization Chibahigashi National Hospital
Chiba, Chiba, Japan
Juntendo University Urayasu Hospital
Chiba, Urayasu, Japan
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu, Japan
Hokkaido University Hospital
Hokkaido, Sapporo, Japan
Tohoku Medical and Pharmaceutical University Hospital
Miyagi, Sendai, Japan
University of Miyazaki Hospital
Miyazaki, Miyazaki, Japan
Shinshu University Hospital
Nagano, Matsumoto, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, Japan
Japanese Red Cross Okayama Hospital
Okayama, Okayama, Japan
Saitama Medical University Hospital
Saitama, Iruma-gun, Japan
Juntendo University Hospital
Tokyo, Bunkyo-ku, Japan
Institute of Science Tokyo Hospital
Tokyo, Bunkyo-ku, Japan
St. Luke's International Hospital
Tokyo, Chuo-ku, Japan
Keio University Hospital
Tokyo, Shinjuku-ku, Japan
Investigacion y Biomedicina de Chihuahua S.C.
Chihuahua City, Mexico
Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Bydgoszcz, Poland
Intercor
Bydgoszcz, Poland
Pratia S.A.
Krakow, Poland
Medical Center Hetmanska
Poznan, Poland
Prywatna Praktyka Lekarska Paweł Piesiak
Poznan, Poland
ai medical center LLC
Poznan, Poland
Medicover Integrated Clinical Services Sp. z o.o.
Warsaw, Poland
Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy
Warsaw, Poland
Pracownia Badan Klinicznych Salus
Wroclaw, Poland
Delta Health Care
Bucharest, Romania
Dr. Ion Cantacuzino Clinical Hospital
Bucharest, Romania
Center of Rheumatic Diseases Dr. Ioan Stoia Bucharest
Bucharest, Romania
Institutul Clinic Fundeni
Bucharest, Romania
Military Medical Academy
Belgrade, Serbia
Institute for Treatment and Rehabilitation, Niska Banja
Niška Banja, Serbia
General Hospital - Djordje Joanovic
Zrenjanin, Serbia
Dr Gareth Scott Tarr
Stellenbosch, South Africa
Durban Westville
Westville, South Africa
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital Santa Creu i Sant Pau
Barcelona, Spain
Hospital de Galdakao
Galdakao, Spain
Hospital Universitario Ramon Y Cajal
Madrid, Spain
Hospital Universitario de Araba
Vitoria-Gasteiz, Spain
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City, Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Belfast City Hospital
Belfast, United Kingdom
Doncaster Royal Infirmary
Doncaster, United Kingdom
Guy's Hospital
London, United Kingdom