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NCT07409181PHASE2Recruiting

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

Boehringer Ingelheim

Start Date

4/20/2026

Completion Date

7/8/2029

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

Age Range: 18 years to 74 years

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.

Interventions

DRUG

BI 3000202

DRUG

Placebo

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Conditions

Systemic Lupus Erythematosus

Locations

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