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

May 28, 2026 updated by: Boehringer Ingelheim

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

405

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • CABA, Argentina, 1015
        • Not yet recruiting
        • Centro Medico Reumatologico - OMI
        • Contact:
      • CABA, Argentina, C1405BFN
        • Not yet recruiting
        • Instituto de Investigación Clínica TyT
        • Contact:
      • Capital Federal, Argentina, C1405BCH
        • Not yet recruiting
        • Instituto Médico Especializado
        • Contact:
      • General Paz, Argentina, 5000
        • Not yet recruiting
        • Consultora integral en Salud SRL.
        • Contact:
      • Maipu, Argentina, M5515DQA
      • Quilmes, Argentina, B1878
        • Not yet recruiting
        • Instituto de Investigaciones Clinicas Quilmes
        • Contact:
      • San Miguel de Tucumán, Argentina, 4000
        • Not yet recruiting
        • Centro de Investigaciones Médicas Tucumán
        • Contact:
  • Australia
    • Victoria
      • Heidelberg, Victoria, Australia, 3081
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
  • Brazil
      • Curitiba, Brazil, 80810-000
        • Not yet recruiting
        • SAPIENS - Instituto de Estudos e Pesquisa Clínica
        • Contact:
      • Juiz de Fora, Brazil, 36010-570
        • Not yet recruiting
        • Centro Mineiro de Pesquisa (CMIP)
        • Contact:
      • Porto Alegre, Brazil, 90035-001
        • Not yet recruiting
        • Hospitalar Moinhos de Vento
        • Contact:
      • Salvador, Brazil, 41820-000
        • Not yet recruiting
        • Inovace Pesquisa Clinica
        • Contact:
      • São José do Rio Preto, Brazil, 15090-000
        • Not yet recruiting
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto
        • Contact:
      • São Paulo, Brazil, 04266-010
        • Not yet recruiting
        • CEPIC - Centro Paulista de Investigacao Clinica
        • Contact:
      • Valinhos, Brazil, 13271-130
        • Not yet recruiting
        • Azidus Centro de Pesquisa Clinica Avancada
        • Contact:
  • Bulgaria
      • Haskovo, Bulgaria, 6304
        • Not yet recruiting
        • Medical Center MedTech Services Ltd.
        • Contact:
      • Pleven, Bulgaria, 5800
        • Not yet recruiting
        • Military medical academy - MHAT Pleven
        • Contact:
      • Plovdiv, Bulgaria, 4003
        • Not yet recruiting
        • Medical Complex Sveti Ivan Rilski EOOD
        • Contact:
      • Plovdiv, Bulgaria, 4027
      • Sofia, Bulgaria, 1510
      • Sofia, Bulgaria, 1431
        • Not yet recruiting
        • Diagnostic Consultative Center Alexandrovska
        • Contact:
      • Sofia, Bulgaria, 1113
        • Not yet recruiting
        • Medical center "Medici Sofia" Ltd.
        • Contact:
      • Sofia, Bulgaria, 1612
        • Not yet recruiting
        • University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD
        • Contact:
  • China
      • Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
      • Changchun, China, 130021
        • Not yet recruiting
        • Jilin Province People's Hospital
        • Contact:
      • Changsha, China, 410008
        • Not yet recruiting
        • Xiangya Hospital, Central South University
        • Contact:
      • Guangzhou, China, 510630
        • Not yet recruiting
        • The third affiliated hospital of Sun Yat-Sen University
        • Contact:
      • Linfen, China, 041000
        • Not yet recruiting
        • Linfen Central Hospital
        • Contact:
      • Nanjing, China, 210008
        • Not yet recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
      • Ningbo, China, 315010
        • Recruiting
        • The First Affiliated Hospital of Ningbo University
        • Contact:
      • Shanghai, China, 200040
        • Not yet recruiting
        • Huashan Hospital, Fudan University
        • Contact:
      • Shanghai, China, 200040
        • Not yet recruiting
        • Renji Hospital Shanghai Jiaotong Univesrity School of Medicine
        • Contact:
      • Suzhou, China, 215004
        • Not yet recruiting
        • The Second Affiliated Hospital of Soochow University
        • Contact:
      • Wenzhou, China, 325000
        • Not yet recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
  • Colombia
      • Barranquilla, Colombia, 080020
        • Not yet recruiting
        • Clínica de la Costa SAS
        • Contact:
      • Bogotá, Colombia, 110231
        • Not yet recruiting
        • CIREEM SAS (Centro de Investigación en Reumatología y Especialidades Médicas)
        • Contact:
      • Bogotá, Colombia, 110231
        • Not yet recruiting
        • Hospital Universitario San Ignacio de Bogotá
        • Contact:
      • Cali, Colombia, 760001
        • Not yet recruiting
        • IPS Centro Medico Julián Coronel S.A.
        • Contact:
      • Floridablanca, Colombia, 681001
        • Not yet recruiting
        • Fundacion Oftalmologica de Santander FOSCAL
        • Contact:
  • Croatia
      • Osijek, Croatia, 31000
        • Not yet recruiting
        • Klinicki Bolnicki Centar Osijek
        • Contact:
      • Rijeka, Croatia, 51000
      • Zagreb, Croatia, 1000
      • Zagreb, Croatia, 10000
        • Not yet recruiting
        • Poliklinika Bonifarm Zagreb
        • Contact:
  • Germany
      • Bad Doberan, Germany, 18209
        • Not yet recruiting
        • Rheumazentrum Prof. Dr. med. Gunther Neeck
        • Contact:
      • Minden, Germany, 32429
      • München, Germany, 80336
        • Not yet recruiting
        • Klinikum der Universität München AÖR
        • Contact:
  • Hungary
      • Budapest, Hungary, 1021
        • Not yet recruiting
        • Semmelweis Egyetem Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika
        • Contact:
      • Székesfehérvár, Hungary, 8000
  • India
      • Kochi, India, 682040
        • Not yet recruiting
        • CARE, Kochi
        • Contact:
      • Kolkata, India, 700020
        • Not yet recruiting
        • IPGMER and SSKM Hospital
        • Contact:
      • Maharashtra, India, 400053
        • Not yet recruiting
        • Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
        • Contact:
  • Japan
      • Aichi, Nagoya, Japan, 457-8510
        • Not yet recruiting
        • Japan Community Healthcare Organization Chukyo Hospital
        • Contact:
      • Chiba, Chiba, Japan, 260-8712
        • Not yet recruiting
        • National Hospital Organization Chibahigashi National Hospital
        • Contact:
      • Chiba, Urayasu, Japan, 279-0021
        • Not yet recruiting
        • Juntendo University Urayasu Hospital
        • Contact:
      • Fukuoka, Kitakyushu, Japan, 807-8556
        • Not yet recruiting
        • Hospital of the University of Occupational and Environmental Health
        • Contact:
      • Hokkaido, Sapporo, Japan, 060-8648
        • Not yet recruiting
        • Hokkaido University Hospital
        • Contact:
      • Miyagi, Sendai, Japan, 983-8512
        • Not yet recruiting
        • Tohoku Medical and Pharmaceutical University Hospital
        • Contact:
      • Miyazaki, Miyazaki, Japan, 889-1692
        • Not yet recruiting
        • University of Miyazaki Hospital
        • Contact:
      • Nagano, Matsumoto, Japan, 390-8621
        • Not yet recruiting
        • Shinshu University Hospital
        • Contact:
      • Niigata, Niigata, Japan, 951-8520
        • Not yet recruiting
        • Niigata University Medical and Dental Hospital
        • Contact:
      • Okayama, Okayama, Japan, 700-8607
        • Not yet recruiting
        • Japanese Red Cross Okayama Hospital
        • Contact:
      • Saitama, Iruma-gun, Japan, 350-0495
        • Not yet recruiting
        • Saitama Medical University Hospital
        • Contact:
      • Tokyo, Bunkyo-ku, Japan, 113-8431
        • Not yet recruiting
        • Juntendo University Hospital
        • Contact:
      • Tokyo, Bunkyo-ku, Japan, 113-8519
        • Not yet recruiting
        • Institute of Science Tokyo Hospital
        • Contact:
      • Tokyo, Chuo-ku, Japan, 104-8560
        • Not yet recruiting
        • St. Luke's International Hospital
        • Contact:
      • Tokyo, Shinjuku-ku, Japan, 160-8582
        • Not yet recruiting
        • Keio University Hospital
        • Contact:
  • Mexico
      • Chihuahua City, Mexico, 31020
        • Not yet recruiting
        • Investigacion y Biomedicina de Chihuahua S.C.
        • Contact:
      • Ecatepec, Mexico, 55020
        • Not yet recruiting
        • Centro Médico ISSEMyM Ecatepec
        • Contact:
      • Mexico City, Mexico, 14080
        • Not yet recruiting
        • Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
        • Contact:
  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Not yet recruiting
        • Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
        • Contact:
      • Bydgoszcz, Poland, 85605
      • Krakow, Poland, 30-727
      • Poznan, Poland, 60-218
        • Not yet recruiting
        • Medical Center Hetmanska
        • Contact:
      • Poznan, Poland, 61-397
        • Not yet recruiting
        • Prywatna Praktyka Lekarska Paweł Piesiak
        • Contact:
      • Poznan, Poland, 61113
        • Not yet recruiting
        • ai medical center LLC
        • Contact:
      • Warsaw, Poland, 00874
        • Not yet recruiting
        • Medicover Integrated Clinical Services Sp. z o.o.
        • Contact:
      • Warsaw, Poland, 04-141
        • Not yet recruiting
        • Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy
        • Contact:
      • Warsaw, Poland, 02665
        • Not yet recruiting
        • Klinika Reuma Park
        • Contact:
      • Wroclaw, Poland, 53034
        • Not yet recruiting
        • Pracownia Badan Klinicznych Salus
        • Contact:
  • Romania
      • Bucharest, Romania, 014142
      • Bucharest, Romania, 022328
        • Not yet recruiting
        • Institutul Clinic Fundeni
        • Contact:
      • Bucharest, Romania, 020475
        • Not yet recruiting
        • Spitalul Clinic Dr. I. Cantacuzino
        • Contact:
      • Bucharest, Romania, 020983
        • Not yet recruiting
        • Centrul Clinic De Boli Reumatismale Dr. Ion Stoia
        • Contact:
  • Serbia
      • Belgrade, Serbia, 11000
        • Not yet recruiting
        • Military Medical Academy
        • Contact:
      • Zrenjanin, Serbia, 23101
        • Not yet recruiting
        • General Hospital - Djordje Joanovic
        • Contact:
  • South Africa
      • Stellenbosch, South Africa, 7599
      • Westville, South Africa, 3630
  • Spain
      • Badalona, Spain, 08916
        • Not yet recruiting
        • Hospital Germans Trias I Pujol
        • Contact:
      • Barcelona, Spain, 08041
        • Not yet recruiting
        • Hospital Santa Creu i Sant Pau
        • Contact:
      • Galdakao, Spain, 48960
        • Not yet recruiting
        • Hospital de Galdakao
        • Contact:
      • Madrid, Spain, 28034
        • Not yet recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
      • Vitoria-Gasteiz, Spain, 01009
        • Not yet recruiting
        • Hospital Universitario de Araba
        • Contact:
  • Taiwan
      • Kaohsiung City, Taiwan, 833
        • Not yet recruiting
        • Chang Gung Memorial Hospital - Kaohsiung
        • Contact:
      • Taichung, Taiwan, 40201
        • Not yet recruiting
        • Chung Shan Medical University Hospital
        • Contact:
      • Taipei, Taiwan, 110
        • Not yet recruiting
        • Taipei Medical University Hospital
        • Contact:
      • Taipei, Taiwan, 112201
        • Not yet recruiting
        • Taipei Veterans General Hospital
        • Contact:
      • Taipei, Taiwan, 100225
        • Not yet recruiting
        • National Taiwan University Hospital
        • Contact:
  • United Kingdom
      • Basingstoke, United Kingdom, RG24 9NA
      • Belfast, United Kingdom, BT9 7AB
      • Doncaster, United Kingdom, DN2 5LTT
      • London, United Kingdom, SE1 9RT
  • United States
    • California
      • Beverly Hills, California, United States, 90210
      • La Palma, California, United States, 90623
        • Not yet recruiting
        • Arthritis & Osteoporosis Medical Center, Inc - La Palma
        • Contact:
      • San Diego, California, United States, 92037
      • Torrance, California, United States, 90502
        • Not yet recruiting
        • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
        • Contact:
      • Upland, California, United States, 91786
        • Not yet recruiting
        • Inland Rheumatology Clinical Trials, Inc
        • Contact:
      • West Hills, California, United States, 91307
    • Colorado
      • Denver, Colorado, United States, 80230
    • Florida
      • Aventura, Florida, United States, 33180
      • Brandon, Florida, United States, 33511
      • Clearwater, Florida, United States, 33763
        • Not yet recruiting
        • Clinical Research of West Florida, Inc.
        • Contact:
      • Plantation, Florida, United States, 33324
        • Not yet recruiting
        • Integral Rheumatology and Immunology Specialist
        • Contact:
      • Tampa, Florida, United States, 33606
        • Not yet recruiting
        • Clinical Research of West Florida, Inc. - Tampa
        • Contact:
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Not yet recruiting
        • Michigan Rheumatology Group, P.C. - Grand Blanc
        • Contact:
      • Lansing, Michigan, United States, 48911
    • Mississippi
      • Jackson, Mississippi, United States, 39206
    • Montana
      • Great Falls, Montana, United States, 59405
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
      • Fayetteville, North Carolina, United States, 28304
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Not yet recruiting
        • Paramount Medical Research and Consulting
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Not yet recruiting
        • Altoona Arthritis & Osteoporosis Center - Altoona Center for Clinical Research
        • Contact:
    • Tennessee
      • Jackson, Tennessee, United States, 38305
      • Memphis, Tennessee, United States, 38119
    • Texas
      • Allen, Texas, United States, 75013
        • Not yet recruiting
        • Arthritis & Rheumatology Institute - Allen
        • Contact:
      • Amarillo, Texas, United States, 79124
      • Austin, Texas, United States, 78745
        • Not yet recruiting
        • Tekton Research, Inc - West Gate Boulevard
        • Contact:
      • Colleyville, Texas, United States, 76034
        • Not yet recruiting
        • Precision Comprehensive Clinical Research Solutions - Colleyville
        • Contact:
      • Euless, Texas, United States, 76040
        • Not yet recruiting
        • Precision Comprehensive Clinical Research Solutions
        • Contact:
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • The University of Texas Health Science Center at Houston
        • Contact:
      • Katy, Texas, United States, 77449
      • Mesquite, Texas, United States, 75150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: BI 3000202 dose 1
Drug: BI 3000202
BI 3000202 at different doses
Experimental: Arm 2: BI 3000202 dose 2
Drug: BI 3000202
BI 3000202 at different doses
Experimental: Arm 3: BI 3000202 dose 3
Drug: BI 3000202
BI 3000202 at different doses
Experimental: Arm 4: BI 3000202 dose 4
Drug: BI 3000202
BI 3000202 at different doses
Placebo Comparator: Arm 5: Placebo
Drug: Placebo
Placebo matching BI 3000202

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Achievement of a Systemic Lupus Erythematosus Responder Index (SRI)-4 response
Time Frame: At Week 32
At Week 32

Secondary Outcome Measures

Outcome Measure
Time Frame
Achievement of SRI-4 response
Time Frame: At Week 52
At Week 52
Achievement of SRI-4 response and oral corticosteroid reduction to ≤5 mg/day prednisone or equivalent
Time Frame: At Week 32
At Week 32
Achievement of Lupus Low Disease Activity State (LLDAS)
Time Frame: At Week 32
At Week 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2026

Primary Completion (Estimated)

February 4, 2029

Study Completion (Estimated)

July 8, 2029

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1509-0004
  • 2025-523488-39 (Registry Identifier: CTIS)
  • U1111-1329-5843 (Registry Identifier: WHO - International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Systemic Lupus Erythematosus

Clinical Trials on BI 3000202

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe