RecruitingRecruiting
A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)
NCT07409181 · Boehringer Ingelheim
In plain English
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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)
About this study
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
Inclusion Criteria:
1. Male and female adult patients from ≥18 years (or alternative age for adults based on local regulations) to \<75 years
2. 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
3. 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
4. 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
5. On SLE background therapy with a maximum of 1 immunosuppressant and/or 1 antimalarial for ≥8 weeks and at a stable dose for ≥4 weeks before screening and/or oral corticosteroids at a dose of ≤30 mg/day prednisone or equivalent, stable for ≥2 weeks before screening (Visit 1) Further inclusion criteria apply.
Exclusion Criteria:
1. Drug-induced SLE
2. 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
3. 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
4. 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)
5. Oral corticosteroids (prednisone or equivalent) \>30 mg/day at screening Further exclusion criteria apply.
Study design
Enrollment target: 405 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-04-20
Estimated completion: 2029-07-08
Last updated: 2026-05-29
Interventions
Drug: BI 3000202Drug: Placebo
Primary outcomes
- • Achievement of a Systemic Lupus Erythematosus Responder Index (SRI)-4 response (At Week 32)
Sponsor
Boehringer Ingelheim · industry
Contacts & investigators
ContactBoehringer Ingelheim · contact · clintriage.rdg@boehringer-ingelheim.com · 1-800-243-0127
All locations (134)
Wallace & Lee CenterNot Yet Recruiting
Beverly Hills, California, United States
Arthritis & Osteoporosis Medical Center, Inc - La PalmaNot Yet Recruiting
La Palma, California, United States
University of California San DiegoNot Yet Recruiting
San Diego, California, United States
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterNot Yet Recruiting
Torrance, California, United States
Inland Rheumatology Clinical Trials, IncNot Yet Recruiting
Upland, California, United States
Focus Clinical ResearchNot Yet Recruiting
West Hills, California, United States
Denver Arthritis Clinic - LowryNot Yet Recruiting
Denver, Colorado, United States
AARDS Research, Inc.Not Yet Recruiting
Aventura, Florida, United States
Meris Clinical Research-Brandon-69466Not Yet Recruiting
Brandon, Florida, United States
Clinical Research of West Florida, Inc.Not Yet Recruiting
Clearwater, Florida, United States
Integral Rheumatology and Immunology SpecialistNot Yet Recruiting
Plantation, Florida, United States
Clinical Research of West Florida, Inc. - TampaNot Yet Recruiting
Tampa, Florida, United States
Michigan Rheumatology Group, P.C. - Grand BlancNot Yet Recruiting
Grand Blanc, Michigan, United States
Great Lakes Center of RheumatologyNot Yet Recruiting
Lansing, Michigan, United States
Oscar Clinical TrialsNot Yet Recruiting
Jackson, Mississippi, United States
Boeson Research - Great FallsNot Yet Recruiting
Great Falls, Montana, United States
DJL Clinical Research, PLLCNot Yet Recruiting
Charlotte, North Carolina, United States
Cross Creek Medical Clinic, PANot Yet Recruiting
Fayetteville, North Carolina, United States
Paramount Medical Research and ConsultingNot Yet Recruiting
Middleburg Heights, Ohio, United States
Oklahoma Medical Research FoundationNot Yet Recruiting
Oklahoma City, Oklahoma, United States
Altoona Arthritis & Osteoporosis Center - Altoona Center for Clinical ResearchNot Yet Recruiting
Duncansville, Pennsylvania, United States
West Tennessee Research InstituteNot Yet Recruiting
Jackson, Tennessee, United States
Shelby Research LLCNot Yet Recruiting
Memphis, Tennessee, United States
Arthritis & Rheumatology Institute - AllenNot Yet Recruiting
Allen, Texas, United States
Amarillo Center for Clinical ResearchNot Yet Recruiting
Amarillo, Texas, United States
Tekton Research, Inc - West Gate BoulevardNot Yet Recruiting
Austin, Texas, United States
Precision Comprehensive Clinical Research Solutions - ColleyvilleNot Yet Recruiting
Colleyville, Texas, United States
Precision Comprehensive Clinical Research SolutionsNot Yet Recruiting
Euless, Texas, United States
The University of Texas Health Science Center at HoustonNot Yet Recruiting
Houston, Texas, United States
R&H Clinical Research - KatyNot Yet Recruiting
Katy, Texas, United States
SouthWest Rheumatology ResearchNot Yet Recruiting
Mesquite, Texas, United States
Centro Medico Reumatologico - OMINot Yet Recruiting
CABA, Argentina
Instituto de Investigación Clínica TyTNot Yet Recruiting
CABA, Argentina
Instituto Médico EspecializadoNot Yet Recruiting
Capital Federal, Argentina
Consultora integral en Salud SRL.Not Yet Recruiting
General Paz, Argentina
Sanatorio MaipúNot Yet Recruiting
Maipu, Argentina
Instituto de Investigaciones Clinicas QuilmesNot Yet Recruiting
Quilmes, Argentina
Centro de Investigaciones Médicas TucumánNot Yet Recruiting
San Miguel de Tucumán, Argentina
Austin HealthNot Yet Recruiting
Heidelberg, Victoria, Australia
Fiona Stanley HospitalNot Yet Recruiting
Murdoch, Western Australia, Australia
SAPIENS - Instituto de Estudos e Pesquisa ClínicaNot Yet Recruiting
Curitiba, Brazil
Centro Mineiro de Pesquisa (CMIP)Not Yet Recruiting
Juiz de Fora, Brazil
Hospitalar Moinhos de VentoNot Yet Recruiting
Porto Alegre, Brazil
Inovace Pesquisa ClínicaNot Yet Recruiting
Salvador, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio PretoNot Yet Recruiting
São José do Rio Preto, Brazil
CEPIC - Centro Paulista de Investigacao ClinicaNot Yet Recruiting
São Paulo, Brazil
Azidus Centro de Pesquisa Clinica AvancadaNot Yet Recruiting
Valinhos, Brazil
Medical Center MedTech Services Ltd.Not Yet Recruiting
Haskovo, Bulgaria
Military medical academy - MHAT PlevenNot Yet Recruiting
Pleven, Bulgaria
Medical Complex Sveti Ivan Rilski EOODNot Yet Recruiting
Plovdiv, Bulgaria
Hospital MHAT Plovdiv, ADNot Yet Recruiting
Plovdiv, Bulgaria
Medical center "Medici Sofia" Ltd.Not Yet Recruiting
Sofia, Bulgaria
Diagnostic Consultative Center AlexandrovskaNot Yet Recruiting
Sofia, Bulgaria
Medical Center Hera EOODNot Yet Recruiting
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment St. Ivan Rilski EADNot Yet Recruiting
Sofia, Bulgaria
Peking Union Medical College HospitalRecruiting
Beijing, China
Jilin Province People's HospitalNot Yet Recruiting
Changchun, China
Xiangya Hospital, Central South UniversityNot Yet Recruiting
Changsha, China
The third affiliated hospital of Sun Yat-Sen UniversityNot Yet Recruiting
Guangzhou, China
Linfen Central HospitalNot Yet Recruiting
Linfen, China
Nanjing Drum Tower HospitalNot Yet Recruiting
Nanjing, China
The First Affiliated Hospital of Ningbo UniversityRecruiting
Ningbo, China
Huashan Hospital, Fudan UniversityNot Yet Recruiting
Shanghai, China
Renji Hospital Shanghai Jiaotong Univesrity School of MedicineNot Yet Recruiting
Shanghai, China
The Second Affiliated Hospital of Soochow UniversityNot Yet Recruiting
Suzhou, China
The First Affiliated Hospital of Wenzhou Medical UniversityNot Yet Recruiting
Wenzhou, China
Clínica de la Costa SASNot Yet Recruiting
Barranquilla, Colombia
CIREEM SAS (Centro de Investigación en Reumatología y Especialidades Médicas)Not Yet Recruiting
Bogotá, Colombia
Hospital Universitario San Ignacio de BogotáNot Yet Recruiting
Bogotá, Colombia
IPS Centro Medico Julián Coronel S.A.Not Yet Recruiting
Cali, Colombia
Fundacion Oftalmologica de Santander FOSCALNot Yet Recruiting
Floridablanca, Colombia
Klinicki Bolnicki Centar OsijekNot Yet Recruiting
Osijek, Croatia
Specijalna Bolnica MedicoNot Yet Recruiting
Rijeka, Croatia
Poliklinika Bonifarm ZagrebNot Yet Recruiting
Zagreb, Croatia
Solmed PolyclinicNot Yet Recruiting
Zagreb, Croatia
Rheumazentrum Prof. Dr. med. Gunther NeeckNot Yet Recruiting
Bad Doberan, Germany
Mühlenkreiskliniken AöRNot Yet Recruiting
Minden, Germany
Klinikum der Universität München AÖRNot Yet Recruiting
München, Germany
Semmelweis Egyetem Sebeszeti, Transzplantacios es Gasztroenterologiai KlinikaNot Yet Recruiting
Budapest, Hungary
Vita Verum Medical Bt.Not Yet Recruiting
Székesfehérvár, Hungary
CARE, KochiNot Yet Recruiting
Kochi, India
IPGMER and SSKM HospitalNot Yet Recruiting
Kolkata, India
Kokilaben Dhirubhai Ambani Hospital & Medical Research InstituteNot Yet Recruiting
Maharashtra, India
Japan Community Healthcare Organization Chukyo HospitalNot Yet Recruiting
Aichi, Nagoya, Japan
National Hospital Organization Chibahigashi National HospitalNot Yet Recruiting
Chiba, Chiba, Japan
Juntendo University Urayasu HospitalNot Yet Recruiting
Chiba, Urayasu, Japan
Hospital of the University of Occupational and Environmental HealthNot Yet Recruiting
Fukuoka, Kitakyushu, Japan
Hokkaido University HospitalNot Yet Recruiting
Hokkaido, Sapporo, Japan
Tohoku Medical and Pharmaceutical University HospitalNot Yet Recruiting
Miyagi, Sendai, Japan
University of Miyazaki HospitalNot Yet Recruiting
Miyazaki, Miyazaki, Japan
Shinshu University HospitalNot Yet Recruiting
Nagano, Matsumoto, Japan
Niigata University Medical and Dental HospitalNot Yet Recruiting
Niigata, Niigata, Japan
Japanese Red Cross Okayama HospitalNot Yet Recruiting
Okayama, Okayama, Japan
Saitama Medical University HospitalNot Yet Recruiting
Saitama, Iruma-gun, Japan
Juntendo University HospitalNot Yet Recruiting
Tokyo, Bunkyo-ku, Japan
Institute of Science Tokyo HospitalNot Yet Recruiting
Tokyo, Bunkyo-ku, Japan
St. Luke's International HospitalNot Yet Recruiting
Tokyo, Chuo-ku, Japan
Keio University HospitalNot Yet Recruiting
Tokyo, Shinjuku-ku, Japan
Investigacion y Biomedicina de Chihuahua S.C.Not Yet Recruiting
Chihuahua City, Mexico
Centro Médico ISSEMyM EcatepecNot Yet Recruiting
Ecatepec, Mexico
Inst Nac de Ciencias Medicas y Nutricion Salvador ZubiranNot Yet Recruiting
Mexico City, Mexico
Erasmus Medisch CentrumNot Yet Recruiting
Rotterdam, Netherlands
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W BydgoszczyNot Yet Recruiting
Bydgoszcz, Poland
IntercorNot Yet Recruiting
Bydgoszcz, Poland
Pratia S.A.Not Yet Recruiting
Krakow, Poland
Medical Center HetmanskaNot Yet Recruiting
Poznan, Poland
Prywatna Praktyka Lekarska Paweł PiesiakNot Yet Recruiting
Poznan, Poland
ai medical center LLCNot Yet Recruiting
Poznan, Poland
Medicover Integrated Clinical Services Sp. z o.o.Not Yet Recruiting
Warsaw, Poland
Klinika Reuma ParkNot Yet Recruiting
Warsaw, Poland
Wojskowy Instytut Medyczny - Państwowy Instytut BadawczyNot Yet Recruiting
Warsaw, Poland
Pracownia Badan Klinicznych SalusNot Yet Recruiting
Wroclaw, Poland
Delta Health CareNot Yet Recruiting
Bucharest, Romania
Spitalul Clinic Dr. I. CantacuzinoNot Yet Recruiting
Bucharest, Romania
Centrul Clinic De Boli Reumatismale Dr. Ion StoiaNot Yet Recruiting
Bucharest, Romania
Institutul Clinic FundeniNot Yet Recruiting
Bucharest, Romania
Military Medical AcademyNot Yet Recruiting
Belgrade, Serbia
General Hospital - Djordje JoanovicNot Yet Recruiting
Zrenjanin, Serbia
Dr Gareth Scott TarrNot Yet Recruiting
Stellenbosch, South Africa
Durban WestvilleNot Yet Recruiting
Westville, South Africa
Hospital Germans Trias i PujolNot Yet Recruiting
Badalona, Spain
Hospital Santa Creu i Sant PauNot Yet Recruiting
Barcelona, Spain
Hospital de GaldakaoNot Yet Recruiting
Galdakao, Spain
Hospital Universitario Ramon Y CajalNot Yet Recruiting
Madrid, Spain
Hospital Universitario de ArabaNot Yet Recruiting
Vitoria-Gasteiz, Spain
Chang Gung Memorial Hospital - KaohsiungNot Yet Recruiting
Kaohsiung City, Taiwan
Chung Shan Medical University HospitalNot Yet Recruiting
Taichung, Taiwan
National Taiwan University HospitalNot Yet Recruiting
Taipei, Taiwan
Taipei Medical University HospitalNot Yet Recruiting
Taipei, Taiwan
Taipei Veterans General HospitalNot Yet Recruiting
Taipei, Taiwan
Basingstoke and North Hampshire HospitalNot Yet Recruiting
Basingstoke, United Kingdom
Belfast City HospitalNot Yet Recruiting
Belfast, United Kingdom
Doncaster Royal InfirmaryNot Yet Recruiting
Doncaster, United Kingdom
Guy's HospitalNot Yet Recruiting
London, United Kingdom