N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 2 ClinicalTrials.gov

A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)

Sponsor: Boehringer Ingelheim • ClinicalTrials.gov ID: NCT07409181

Registry updated: 2026-10-14
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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.

Interventions

  • BI 3000202 (Drug)
    BI 3000202 at different doses
  • Placebo (Drug)
    Placebo matching BI 3000202

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.

Conditions

Systemic Lupus Erythematosus

Locations

  • 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
  • University of California Los Angeles — Torrance, California, United States
  • Inland Rheumatology Clinical Trials, Inc — Upland, California, United States
  • Focus Clinical Research — West Hills, California, United States
  • Denver Arthritis Clinic - Lowry — Denver, Colorado, United States
  • AARDS Research, Inc. — 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
  • AA MRC LLC - Grand Blanc — Grand Blanc, Michigan, United States
  • June DO, PC — Lansing, Michigan, United States
  • Oscar Clinical Trials — Jackson, Mississippi, United States
  • Boeson Research - Great Falls — 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
  • Amarillo Center for Clinical Research — Amarillo, Texas, United States
  • Precision Comprehensive Clinical Research Solutions - Colleyville — Colleyville, Texas, United States
  • Precision Comprehensive Clinical Research Solutions — Euless, Texas, United States
  • Arthritis & Rheumatology Institute - Frisco — Frisco, 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 de Investigacion Clinica TyT — CABA, Argentina
  • Instituto Medico Especializado — Capital Federal, Argentina
  • Consultora integral en Salud SRL. — General Paz, Argentina
  • Sanatorio Maipu — Maipu, Argentina
  • Instituto de Investigaciones Clinicas Quilmes — Quilmes, Argentina
  • Centro de Investigaciones Medicas Tucuman — San Miguel de Tucumán, Argentina
  • Austin Health — Heidelberg, Victoria, Australia
  • Fiona Stanley Hospital — Murdoch, Western Australia, Australia
  • SAPIENS - Instituto de Estudos e Pesquisa Clinica — Curitiba, Brazil
  • Centro Mineiro de Pesquisa (CMIP) — Juiz de Fora, Brazil
  • Hospitalar Moinhos de Vento — Porto Alegre, Brazil
  • Inovace Pesquisa Clínica — Salvador, Brazil
  • Fundaçao Faculdade Regional de Medicina de Sao Jose do Rio Preto — São José do Rio Preto, Brazil
  • CEPIC - Centro Paulista de Investigacao Clinica e Servicos — São Paulo, Brazil
  • A2Z Clinical Centro Avançado de Pesquisa Clinica — 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
  • 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 University School of Medicine — Shanghai, China
  • The Second Affiliated Hospital of Soochow University — Suzhou, China
  • The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, China
  • Clinica de la Costa Ltda. — Barranquilla, Colombia
  • CIREEM SAS (Centro de Investigacion en Reumatologia y Especialidades Medicas) — Bogotá, Colombia
  • Hospital Universitario San Ignacio de Bogota — Bogotá, Colombia
  • IPS Centro Medico Julian Coronel S.A. — Cali, Colombia
  • Fundacion Oftalmologica de Santander FOSCAL — Floridablanca, Colombia
  • Klinicki Bolnicki Centar Osijek — Osijek, Croatia
  • Specijalna Bolnica Medico — Rijeka, Croatia
  • Poliklinika Bonifarm Zagreb — Zagreb, Croatia
  • Solmed Polyclinic — Zagreb, Croatia
  • Mühlenkreiskliniken AöR — Minden, Germany
  • Klinikum der Universität München AÖR — München, Germany
  • Semmelweis University — Budapest, Hungary
  • Vita Verum Medical Bt. — Székesfehérvár, Hungary
  • CARE, Kochi — Kochi, India
  • IPGMER and SSKM Hospital — Kolkata, India
  • Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute — Maharashtra, India
  • All India Institute of Medical Sciences — New Delhi, 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
  • Mediadvance Clinical S.A.P.I de C.V. — Chihuahua City, Mexico
  • Centro Médico ISSEMyM Ecatepec — Ecatepec, Mexico
  • Centro de Investigacion Farmacologica del Bajío, S.C. — León, Mexico
  • Centro Médico del Angel SC — Mexicali, Mexico
  • Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran — Mexico City, Mexico
  • Cemdeicy, S.C.P. — Mérida, Mexico
  • CIMAB — Torreón, Mexico
  • Erasmus Medisch Centrum — Rotterdam, Netherlands
  • 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
  • Klinika Reuma Park Sp. z o.o. S.K. — Warsaw, Poland
  • Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy — Warsaw, Poland
  • Pracownia Badan Klinicznych Salus — Wroclaw, Poland
  • Delta Health Care — Bucharest, Romania
  • Spitalul Clinic Dr. I. Cantacuzino — Bucharest, Romania
  • Centrul Clinic De Boli Reumatismale Dr. Ion Stoia — Bucharest, Romania
  • Institutul Clinic Fundeni — Bucharest, Romania
  • Military Medical Academy — Belgrade, Serbia
  • General Hospital - Djordje Joanovic — Zrenjanin, Serbia
  • Cape Town - Arthritis Clinical Research Trial Unit — Cape Town, South Africa
  • Umhlanga Medical Centre — Durban, South Africa
  • Dr Gareth Scott Tarr — Stellenbosch, 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
  • Basingstoke and North Hampshire Hospital — Basingstoke, United Kingdom
  • Belfast City Hospital — Belfast, United Kingdom
  • Addenbrooke's Hospital — Cambridge, United Kingdom
  • Doncaster Royal Infirmary — Doncaster, United Kingdom
  • Guy's Hospital — London, United Kingdom
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record