A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)
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)
3 other identifiers
interventional
405
21 countries
138
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2026
Typical duration for phase_2
138 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2026
CompletedFirst Posted
Study publicly available on registry
February 13, 2026
CompletedStudy Start
First participant enrolled
April 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 8, 2029
July 23, 2026
July 1, 2026
2.8 years
February 9, 2026
July 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Achievement of a Systemic Lupus Erythematosus Responder Index (SRI)-4 response
At Week 32
Secondary Outcomes (3)
Achievement of SRI-4 response
At Week 52
Achievement of SRI-4 response and oral corticosteroid reduction to ≤5 mg/day prednisone or equivalent
At Week 32
Achievement of Lupus Low Disease Activity State (LLDAS)
At Week 32
Study Arms (5)
Arm 1: BI 3000202 dose 1
EXPERIMENTALArm 2: BI 3000202 dose 2
EXPERIMENTALArm 3: BI 3000202 dose 3
EXPERIMENTALArm 4: BI 3000202 dose 4
EXPERIMENTALArm 5: Placebo
PLACEBO COMPARATORInterventions
BI 3000202 at different doses
Eligibility Criteria
You may qualify if:
- Male and female adult patients from ≥18 years (or alternative age for adults based on local regulations) to \<75 years
- Confirmed Systemic Lupus Erythematosus (SLE) diagnosis meeting the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria 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-Smith antibody
- \- 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 at screening, with sufficient disease activity according to both investigator and adjudicator
You may not qualify if:
- Drug-induced SLE
- Scleroderma (except linear scleroderma that does not interfere with assessments of SLE disease activity) or in the opinion of the investigator or adjudicator elements of other connective tissue disease that would interfere with interpretation of test results or SLE clinical assessments
- Active or unstable lupus neuropsychiatric manifestations, including but not limited to any condition as defined by BILAG A criteria in the neuropsychiatric system, with the exception of mononeuritis/mononeuropathy multiplex, chorea, and polyneuropathy
- Lupus nephritis that may require a change in immune-modulating treatment or which demonstrates 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 (339 mg/mmol)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (138)
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2026
First Posted
February 13, 2026
Study Start
April 20, 2026
Primary Completion (Estimated)
February 4, 2029
Study Completion (Estimated)
July 8, 2029
Last Updated
July 23, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
- Access Criteria
- For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.