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

Last updated: May 28, 2026
Sponsor: Boehringer Ingelheim
Overall Status: Active - Recruiting

Phase

2

Condition

Musculoskeletal Diseases

Lupus

Systemic Lupus Erythematosus

Treatment

Placebo

BI 3000202

Clinical Study ID

NCT07409181
1509-0004
U1111-1329-5843
2025-523488-39
  • Ages 18-74
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  1. Male and female adult patients from ≥18 years (or alternative age for adults basedon local regulations) to <75 years

  2. Confirmed Systemic Lupus Erythematosus (SLE) diagnosis meeting the European LeagueAgainst Rheumatism/American College of Rheumatology (EULAR/ACR) classificationcriteria 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-Smithantibody

  • Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 points and clinical SLEDAI-2K score ≥4 points
  1. At least 1 British Isles Lupus Assessment Group (BILAG) A and/or 1 BILAG B grade atscreening, with sufficient disease activity according to both investigator andadjudicator

  2. On SLE background therapy with a maximum of 1 immunosuppressant and/or 1antimalarial for ≥8 weeks and at a stable dose for ≥4 weeks before screening and/ororal corticosteroids at a dose of ≤30 mg/day prednisone or equivalent, stable for ≥2weeks before screening (Visit 1) Further inclusion criteria apply.

Exclusion

Exclusion Criteria:

  1. Drug-induced SLE

  2. Scleroderma (except linear scleroderma that does not interfere with assessments ofSLE disease activity) or in the opinion of the investigator or adjudicator elementsof other connective tissue disease that would interfere with interpretation of testresults or SLE clinical assessments

  3. Active or unstable lupus neuropsychiatric manifestations, including but not limitedto any condition as defined by BILAG A criteria in the neuropsychiatric system, withthe exception of mononeuritis/mononeuropathy multiplex, chorea, and polyneuropathy

  4. Lupus nephritis that may require a change in immune-modulating treatment or whichdemonstrates 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 (339mg/mmol)

  5. Oral corticosteroids (prednisone or equivalent) >30 mg/day at screening Furtherexclusion criteria apply.

Study Design

Total Participants: 405
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
April 20, 2026
Estimated Completion Date:
July 08, 2029

Connect with a study center

  • Centro Medico Reumatologico - OMI

    CABA, 1015
    Argentina

    Site Not Available

  • Instituto de Investigación Clínica TyT

    CABA, C1405BFN
    Argentina

    Site Not Available

  • Instituto Médico Especializado

    Capital Federal, C1405BCH
    Argentina

    Site Not Available

  • Consultora integral en Salud SRL.

    General Paz, 5000
    Argentina

    Site Not Available

  • Consultoría Integral en Salud SRL.

    General Paz 3855078, 5000
    Argentina

    Site Not Available

  • Sanatorio Maipú

    Maipu, M5515DQA
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clinicas Quilmes

    Quilmes, B1878
    Argentina

    Site Not Available

  • Centro de Investigaciones Médicas Tucumán

    San Miguel de Tucumán, 4000
    Argentina

    Site Not Available

  • Austin Health

    Heidelberg, Victoria 3081
    Australia

    Site Not Available

  • Fiona Stanley Hospital

    Murdoch, Western Australia 6150
    Australia

    Site Not Available

  • SAPIENS - Instituto de Estudos e Pesquisa Clínica

    Curitiba, 80810-000
    Brazil

    Site Not Available

  • Centro Mineiro de Pesquisa (CMIP)

    Juiz de Fora, 36010-570
    Brazil

    Site Not Available

  • Hospitalar Moinhos de Vento

    Porto Alegre, 90035-001
    Brazil

    Site Not Available

  • Inovace Pesquisa Clínica

    Salvador, 41820-000
    Brazil

    Site Not Available

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    São José do Rio Preto, 15090-000
    Brazil

    Site Not Available

  • CEPIC - Centro Paulista de Investigacao Clinica

    São Paulo, 04266-010
    Brazil

    Site Not Available

  • Azidus Centro de Pesquisa Clinica Avancada

    Valinhos, 13271-130
    Brazil

    Site Not Available

  • Medical Center MedTech Services Ltd.

    Haskovo, 6304
    Bulgaria

    Site Not Available

  • Military medical academy - MHAT Pleven

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Hospital MHAT Plovdiv, AD

    Plovdiv, 4027
    Bulgaria

    Site Not Available

  • Medical Complex Sveti Ivan Rilski EOOD

    Plovdiv, 4003
    Bulgaria

    Site Not Available

  • Medical Complex Sveti Ivan Rilski EOOD

    Plovdiv 728193, 4003
    Bulgaria

    Site Not Available

  • Diagnostic Consultative Center Alexandrovska

    Sofia, 1431
    Bulgaria

    Site Not Available

  • Medical Center Excelsior OOD

    Sofia, 1113
    Bulgaria

    Site Not Available

  • Medical Center Hera EOOD

    Sofia, 1510
    Bulgaria

    Site Not Available

  • Medical center "Medici Sofia" Ltd.

    Sofia, 1113
    Bulgaria

    Site Not Available

  • Private Clinic of Dermatology Persenk

    Sofia, 1407
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD

    Sofia, 1612
    Bulgaria

    Site Not Available

  • Diagnostic Consultative Center Alexandrovska

    Sofia 727011, 1431
    Bulgaria

    Site Not Available

  • Medical Center Hera EOOD

    Sofia 727011, 1510
    Bulgaria

    Site Not Available

  • Medical center "Medici Sofia" Ltd.

    Sofia 727011, 1113
    Bulgaria

    Site Not Available

  • Private Clinic of Dermatology Persenk

    Sofia 727011, 1407
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD

    Sofia 727011, 1612
    Bulgaria

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing, 100730
    China

    Active - Recruiting

  • Jilin Province People's Hospital

    Changchun, 130021
    China

    Site Not Available

  • Xiangya Hospital, Central South University

    Changsha, 410008
    China

    Site Not Available

  • The third affiliated hospital of Sun Yat-Sen University

    Guangzhou, 510630
    China

    Site Not Available

  • Linfen Central Hospital

    Linfen, 041000
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing, 210008
    China

    Site Not Available

  • The First Affiliated Hospital of Ningbo University

    Ningbo, 315010
    China

    Active - Recruiting

  • Huashan Hospital, Fudan University

    Shanghai, 200040
    China

    Site Not Available

  • Renji Hospital Shanghai Jiaotong Univesrity School of Medicine

    Shanghai, 200040
    China

    Site Not Available

  • Renji Hospital Shanghai Jiaotong Univesrity School of Medicine

    Shanghai 1796236, 200040
    China

    Site Not Available

  • The Second Affiliated Hospital of Soochow University

    Suzhou, 215004
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000
    China

    Site Not Available

  • Clínica de la Costa SAS

    Barranquilla, 080020
    Colombia

    Site Not Available

  • CIREEM SAS (Centro de Investigación en Reumatología y Especialidades Médicas)

    Bogotá, 110231
    Colombia

    Site Not Available

  • Hospital Universitario San Ignacio de Bogotá

    Bogotá, 110231
    Colombia

    Site Not Available

  • Hospital Universitario San Ignacio de Bogotá

    Bogotá 3688689, 110231
    Colombia

    Site Not Available

  • IPS Centro Medico Julián Coronel S.A.

    Cali, 760001
    Colombia

    Site Not Available

  • Fundacion Oftalmologica de Santander FOSCAL

    Floridablanca, 681001
    Colombia

    Site Not Available

  • Klinicki Bolnicki Centar Osijek

    Osijek, 31000
    Croatia

    Site Not Available

  • University Hospital Centre Osijek

    Osijek, 31000
    Croatia

    Site Not Available

  • Specialty Hospital Medico

    Rijeka, 51000
    Croatia

    Site Not Available

  • Specijalna Bolnica Medico

    Rijeka, 51000
    Croatia

    Site Not Available

  • Poliklinika Bonifarm Zagreb

    Zagreb, 10000
    Croatia

    Site Not Available

  • Solmed Polyclinic

    Zagreb, 1000
    Croatia

    Site Not Available

  • Rheumazentrum Prof. Dr. med. Gunther Neeck

    Bad Doberan, 18209
    Germany

    Site Not Available

  • Mühlenkreiskliniken AöR

    Minden, 32429
    Germany

    Site Not Available

  • Klinikum der Universität München AÖR

    München, 80336
    Germany

    Site Not Available

  • Semmelweis Egyetem Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika

    Budapest, 1021
    Hungary

    Site Not Available

  • Vita Verum Medical Bt.

    Székesfehérvár, 8000
    Hungary

    Site Not Available

  • CARE, Kochi

    Kochi, 682040
    India

    Site Not Available

  • IPGMER and SSKM Hospital

    Kolkata, 700020
    India

    Site Not Available

  • Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute

    Maharashtra, 400053
    India

    Site Not Available

  • Japan Community Healthcare Organization Chukyo Hospital

    Aichi, Nagoya, 457-8510
    Japan

    Site Not Available

  • National Hospital Organization Chibahigashi National Hospital

    Chiba, Chiba, 260-8712
    Japan

    Site Not Available

  • Juntendo University Urayasu Hospital

    Chiba, Urayasu, 279-0021
    Japan

    Site Not Available

  • Hospital of the University of Occupational and Environmental Health

    Fukuoka, Kitakyushu, 807-8556
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Hokkaido, Sapporo, 060-8648
    Japan

    Site Not Available

  • Tohoku Medical and Pharmaceutical University Hospital

    Miyagi, Sendai, 983-8512
    Japan

    Site Not Available

  • University of Miyazaki Hospital

    Miyazaki, Miyazaki, 889-1692
    Japan

    Site Not Available

  • Shinshu University Hospital

    Nagano, Matsumoto, 390-8621
    Japan

    Site Not Available

  • Niigata University Medical and Dental Hospital

    Niigata, Niigata, 951-8520
    Japan

    Site Not Available

  • Japanese Red Cross Okayama Hospital

    Okayama, Okayama, 700-8607
    Japan

    Site Not Available

  • Saitama Medical University Hospital

    Saitama, Iruma-gun, 350-0495
    Japan

    Site Not Available

  • Institute of Science Tokyo Hospital

    Tokyo, Bunkyo-ku, 113-8519
    Japan

    Site Not Available

  • Juntendo University Hospital

    Tokyo, Bunkyo-ku, 113-8431
    Japan

    Site Not Available

  • St. Luke's International Hospital

    Tokyo, Chuo-ku, 104-8560
    Japan

    Site Not Available

  • Keio University Hospital

    Tokyo, Shinjuku-ku, 160-8582
    Japan

    Site Not Available

  • Investigacion y Biomedicina de Chihuahua S.C.

    Chihuahua City, 31020
    Mexico

    Site Not Available

  • Centro Médico ISSEMyM Ecatepec

    Ecatepec, 55020
    Mexico

    Site Not Available

  • Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, 14080
    Mexico

    Site Not Available

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • Intercor

    Bydgoszcz, 85605
    Poland

    Site Not Available

  • Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy

    Bydgoszcz, 85-168
    Poland

    Site Not Available

  • Intercor

    Bydgoszcz 3102014, 85605
    Poland

    Site Not Available

  • Pratia S.A.

    Krakow, 30-727
    Poland

    Site Not Available

  • Medical Center Hetmanska

    Poznan, 60-218
    Poland

    Site Not Available

  • Prywatna Praktyka Lekarska Paweł Piesiak

    Poznan, 61-397
    Poland

    Site Not Available

  • ai medical center LLC

    Poznan, 61113
    Poland

    Site Not Available

  • Prywatna Praktyka Lekarska Paweł Piesiak

    Poznan 3088171, 61-397
    Poland

    Site Not Available

  • ai medical center LLC

    Poznan 3088171, 61113
    Poland

    Site Not Available

  • Klinika Reuma Park

    Warsaw, 02665
    Poland

    Site Not Available

  • Medicover Integrated Clinical Services Sp. z o.o.

    Warsaw, 00874
    Poland

    Site Not Available

  • Medycyna Kliniczna

    Warsaw, 00874
    Poland

    Site Not Available

  • Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy

    Warsaw, 04-141
    Poland

    Site Not Available

  • Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy

    Warsaw 756135, 04-141
    Poland

    Site Not Available

  • Pracownia Badan Klinicznych Salus

    Wroclaw, 53034
    Poland

    Site Not Available

  • Center of Rheumatic Diseases Dr. Ioan Stoia Bucharest

    Bucharest, 020983
    Romania

    Site Not Available

  • Center of Rheumatic Diseases Dr. Ion Stoia Bucharest

    Bucharest, 020983
    Romania

    Site Not Available

  • Centrul Clinic De Boli Reumatismale Dr. Ion Stoia

    Bucharest, 020983
    Romania

    Site Not Available

  • Delta Health Care

    Bucharest, 014142
    Romania

    Site Not Available

  • Dr. Ion Cantacuzino Clinical Hospital

    Bucharest, 020475
    Romania

    Site Not Available

  • Institutul Clinic Fundeni

    Bucharest, 022328
    Romania

    Site Not Available

  • Spitalul Clinic Dr. I. Cantacuzino

    Bucharest, 020475
    Romania

    Site Not Available

  • Delta Health Care

    Bucharest 683506, 014142
    Romania

    Site Not Available

  • Dr. Ion Cantacuzino Clinical Hospital

    Bucharest 683506, 020475
    Romania

    Site Not Available

  • Military Medical Academy

    Belgrade, 11000
    Serbia

    Site Not Available

  • General Hospital - Djordje Joanovic

    Zrenjanin, 23101
    Serbia

    Site Not Available

  • Dr Gareth Scott Tarr

    Stellenbosch, 7599
    South Africa

    Site Not Available

  • Durban Westville

    Westville, 3630
    South Africa

    Site Not Available

  • Hospital Germans Trias i Pujol

    Badalona, 08916
    Spain

    Site Not Available

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    Barcelona, 08041
    Spain

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  • Hospital de Galdakao

    Galdakao, 48960
    Spain

    Site Not Available

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Universitario de Araba

    Vitoria-Gasteiz, 01009
    Spain

    Site Not Available

  • Chang Gung Memorial Hospital - Kaohsiung

    Kaohsiung City, 833
    Taiwan

    Site Not Available

  • Chung Shan Medical University Hospital

    Taichung, 40201
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 100225
    Taiwan

    Site Not Available

  • Taipei Medical University Hospital

    Taipei, 110
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 112201
    Taiwan

    Site Not Available

  • Taipei Medical University Hospital

    Taipei 1668341, 110
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei 1668341, 112201
    Taiwan

    Site Not Available

  • Basingstoke and North Hampshire Hospital

    Basingstoke, RG24 9NA
    United Kingdom

    Site Not Available

  • Belfast City Hospital

    Belfast, BT9 7AB
    United Kingdom

    Site Not Available

  • Doncaster Royal Infirmary

    Doncaster, DN2 5LTT
    United Kingdom

    Site Not Available

  • Guy's Hospital

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • Wallace & Lee Center

    Beverly Hills, California 90210
    United States

    Site Not Available

  • Arthritis & Osteoporosis Medical Center, Inc - La Palma

    La Palma, California 90623
    United States

    Site Not Available

  • University of California San Diego

    San Diego, California 92037
    United States

    Site Not Available

  • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California 90502
    United States

    Site Not Available

  • Inland Rheumatology Clinical Trials, Inc

    Upland, California 91786
    United States

    Site Not Available

  • Inland Rheumatology and Osteoporosis Medical Group

    Upland, California 91786
    United States

    Site Not Available

  • Alliance Clinical West Hills

    West Hills, California 91307
    United States

    Site Not Available

  • Focus Clinical Research

    West Hills, California 91307
    United States

    Site Not Available

  • Denver Arthritis Clinic - Lowry

    Denver, Colorado 80230
    United States

    Site Not Available

  • AARDS Research, Inc.

    Aventura, Florida 33180
    United States

    Site Not Available

  • Arthritis & Rheumatic Disease Specialties

    Aventura, Florida 33180
    United States

    Site Not Available

  • Meris Clinical Research-Brandon-69466

    Brandon, Florida 33511
    United States

    Site Not Available

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida 33763
    United States

    Site Not Available

  • Integral Rheumatology and Immunology Specialist

    Plantation, Florida 33324
    United States

    Site Not Available

  • Clinical Research of West Florida, Inc. - Tampa

    Tampa, Florida 33606
    United States

    Site Not Available

  • Michigan Rheumatology Group, P.C. - Grand Blanc

    Grand Blanc, Michigan 48439
    United States

    Site Not Available

  • Great Lakes Center of Rheumatology

    Lansing, Michigan 48911
    United States

    Site Not Available

  • Oscar Clinical Trials

    Jackson, Mississippi 39206
    United States

    Site Not Available

  • Boeson Research

    Great Falls, Montana 59405
    United States

    Site Not Available

  • Boeson Research - Great Falls

    Great Falls, Montana 59405
    United States

    Site Not Available

  • Montana Arthritis Center

    Great Falls, Montana 59405
    United States

    Site Not Available

  • DJL Clinical Research, PLLC

    Charlotte, North Carolina 28211
    United States

    Site Not Available

  • Cross Creek Medical Clinic, PA

    Fayetteville, North Carolina 28304
    United States

    Site Not Available

  • Paramount Medical Research and Consulting

    Middleburg Heights, Ohio 44130
    United States

    Site Not Available

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Altoona Arthritis & Osteoporosis Center - Altoona Center for Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • West Tennessee Research Institute

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Office of Dr. Ramesh C. Gupta I

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Shelby Research LLC

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Arthritis & Rheumatology Institute - Allen

    Allen, Texas 75013
    United States

    Site Not Available

  • Amarillo Center for Clinical Research

    Amarillo, Texas 79124
    United States

    Site Not Available

  • Tekton Research, Inc - West Gate Boulevard

    Austin, Texas 78745
    United States

    Site Not Available

  • Heritage Rheumatology and Arthritis Care

    Colleyville, Texas 76034
    United States

    Site Not Available

  • Precision Comprehensive Clinical Research Solutions - Colleyville

    Colleyville, Texas 76034
    United States

    Site Not Available

  • North Texas Center for Rheumatology

    Euless, Texas 76040
    United States

    Site Not Available

  • Precision Comprehensive Clinical Research Solutions

    Euless, Texas 76040
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • R&H Clinical Research - Katy

    Katy, Texas 77449
    United States

    Site Not Available

  • SouthWest Rheumatology Research

    Mesquite, Texas 75150
    United States

    Site Not Available

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