Systemic Lupus ErythematosusPhase 2NCT07409181

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

A Phase 2 study testing BI 3000202 in people with Systemic Lupus Erythematosus, run by Boehringer Ingelheim at 139 sites in 21 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 74 years
Conditions the study is for: Systemic Lupus Erythematosus
What is being tested?: BI 3000202
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 405 participants
Where: 139 sitesin 21 countries
Study dates: 20 Apr 2026to 8 Jul 2029
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Drug-induced SLE
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
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
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)
Oral corticosteroids (prednisone or equivalent) >30 mg/day at screening Further exclusion criteria apply.

Trial locations and contacts

139 sites in 21 countries. Contact the study team or a site near you to ask about taking part.

Boehringer Ingelheim contact

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Country

City, postcode or hospital

Sites recruiting now only

139 sites in 21 countries

United States30 sites, 30 recruiting

Amarillo Center for Clinical Research
Amarillo, Texas, 79124
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
AARDS Research, Inc.
Aventura, Florida, 33180
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Wallace & Lee Center
Beverly Hills, California, 90210
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Meris Clinical Research-Brandon-69466
Brandon, Florida, 33511
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
DJL Clinical Research, PLLC
Charlotte, North Carolina, 28211
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33763
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Precision Comprehensive Clinical Research Solutions - Colleyville
Colleyville, Texas, 76034
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Denver Arthritis Clinic - Lowry
Denver, Colorado, 80230
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Altoona Arthritis & Osteoporosis Center - Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Precision Comprehensive Clinical Research Solutions
Euless, Texas, 76040
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Cross Creek Medical Clinic, PA
Fayetteville, North Carolina, 28304
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Arthritis & Rheumatology Institute - Frisco
Frisco, Texas, 75035
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
AA MRC LLC - Grand Blanc
Grand Blanc, Michigan, 48439
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Boeson Research - Great Falls
Great Falls, Montana, 59405
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Oscar Clinical Trials
Jackson, Mississippi, 39206
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
West Tennessee Research Institute
Jackson, Tennessee, 38305
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
R&H Clinical Research - Katy
Katy, Texas, 77449
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Arthritis & Osteoporosis Medical Center, Inc - La Palma
La Palma, California, 90623
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
June DO, PC
Lansing, Michigan, 48911
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Shelby Research LLC
Memphis, Tennessee, 38119
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
SouthWest Rheumatology Research
Mesquite, Texas, 75150
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Paramount Medical Research and Consulting
Middleburg Heights, Ohio, 44130
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Integral Rheumatology and Immunology Specialist
Plantation, Florida, 33324
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
University of California San Diego
San Diego, California, 92037
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Clinical Research of West Florida, Inc. - Tampa
Tampa, Florida, 33606
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
University of California Los Angeles
Torrance, California, 90509
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Inland Rheumatology Clinical Trials, Inc
Upland, California, 91786
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Focus Clinical Research
West Hills, California, 91307
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting

Other trials in United States

Japan15 sites, 15 recruiting

Japan Community Healthcare Organization Chukyo Hospital
Aichi, Nagoya, 457-8510
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Recruiting
National Hospital Organization Chibahigashi National Hospital
Chiba, Chiba, 260-8712
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Recruiting
Juntendo University Urayasu Hospital
Chiba, Urayasu, 279-0021
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Recruiting
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu, 807-8556
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Recruiting
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Recruiting
Tohoku Medical and Pharmaceutical University Hospital
Miyagi, Sendai, 983-8512
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Recruiting
University of Miyazaki Hospital
Miyazaki, Miyazaki, 889-1692
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Recruiting
Shinshu University Hospital
Nagano, Matsumoto, 390-8621
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Recruiting
Niigata University Medical and Dental Hospital
Niigata, Niigata, 951-8520
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Recruiting
Japanese Red Cross Okayama Hospital
Okayama, Okayama, 700-8607
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Recruiting
Saitama Medical University Hospital
Saitama, Iruma-gun, 350-0495
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Recruiting
Juntendo University Hospital
Tokyo, Bunkyo-ku, 113-8431
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Recruiting
Institute of Science Tokyo Hospital
Tokyo, Bunkyo-ku, 113-8519
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Recruiting
St. Luke's International Hospital
Tokyo, Chuo-ku, 104-8560
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Recruiting
Keio University Hospital
Tokyo, Shinjuku-ku, 160-8582
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Not yet recruiting

Other trials in Japan

China11 sites, 11 recruiting

Peking Union Medical College Hospital
Beijing, 100730
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Recruiting
Jilin Province People's Hospital
Changchun, 130021
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Recruiting
Xiangya Hospital, Central South University
Changsha, 410008
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Not yet recruiting
The third affiliated hospital of Sun Yat-Sen University
Guangzhou, 510630
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Recruiting
Linfen Central Hospital
Linfen, 041000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Recruiting
Nanjing Drum Tower Hospital
Nanjing, 210008
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, 315010
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Recruiting
Huashan Hospital, Fudan University
Shanghai, 200040
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Recruiting
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, 200040
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, 215004
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Recruiting

Other trials in China

Poland10 sites, 10 recruiting

Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Bydgoszcz, 85-168
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Not yet recruiting
Intercor
Bydgoszcz, 85605
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Not yet recruiting
Pratia S.A.
Krakow, 30-727
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Recruiting
Medical Center Hetmanska
Poznan, 60-218
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Recruiting
Prywatna Praktyka Lekarska Paweł Piesiak
Poznan, 61-397
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Recruiting
ai medical center LLC
Poznan, 61113
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Recruiting
Medicover Integrated Clinical Services Sp. z o.o.
Warsaw, 00874
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Not yet recruiting
Klinika Reuma Park Sp. z o.o. S.K.
Warsaw, 02665
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Not yet recruiting
Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy
Warsaw, 04-141
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Not yet recruiting
Pracownia Badan Klinicznych Salus
Wroclaw, 53034
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Not yet recruiting

Other trials in Poland

Bulgaria8 sites, 8 recruiting

Medical Center MedTech Services Ltd.
Haskovo, 6304
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
Recruiting
Military medical academy - MHAT Pleven
Pleven, 5800
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
Recruiting
Medical Complex Sveti Ivan Rilski EOOD
Plovdiv, 4003
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
Not yet recruiting
Hospital MHAT Plovdiv, AD
Plovdiv, 4027
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
Recruiting
Medical center "Medici Sofia" Ltd.
Sofia, 1113
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
Recruiting
Diagnostic Consultative Center Alexandrovska
Sofia, 1431
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
Recruiting
Medical Center Hera EOOD
Sofia, 1510
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
Recruiting
University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD
Sofia, 1612
Boehringer Ingelheim, 024903378, balgariya@bitrialsupport.com
Recruiting

Other trials in Bulgaria

Mexico8 sites, 8 recruiting

Investigacion y Biomedicina de Chihuahua S.C.
Chihuahua City, 31020
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
Not yet recruiting
Mediadvance Clinical S.A.P.I de C.V.
Chihuahua City, 31203
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
Not yet recruiting
Centro Médico ISSEMyM Ecatepec
Ecatepec, 55020
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
Not yet recruiting
Centro de Investigacion Farmacologica del Bajío, S.C.
León, 37160
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
Not yet recruiting
Cemdeicy, S.C.P.
Mérida, 97130
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
Not yet recruiting
Centro Médico del Angel SC
Mexicali, 21100
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
Not yet recruiting
Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
Not yet recruiting
CIMAB
Torreón, 27000
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
Not yet recruiting

Other trials in Mexico

Argentina7 sites, 7 recruiting

Centro Medico Reumatologico - OMI
CABA, 1015
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Recruiting
Instituto de Investigacion Clinica TyT
CABA, C1405BFN
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Recruiting
Instituto Medico Especializado
Capital Federal, C1405BCH
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Recruiting
Consultora integral en Salud SRL.
General Paz, 5000
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Recruiting
Sanatorio Maipu
Maipu, M5515DQA
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Recruiting
Instituto de Investigaciones Clinicas Quilmes
Quilmes, B1878
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Recruiting
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, 4000
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Recruiting

Other trials in Argentina

Brazil7 sites, 7 recruiting

SAPIENS - Instituto de Estudos e Pesquisa Clinica
Curitiba, 80810-000
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
Recruiting
Centro Mineiro de Pesquisa (CMIP)
Juiz de Fora, 36010-570
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
Recruiting
Hospitalar Moinhos de Vento
Porto Alegre, 90035-001
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
Recruiting
Inovace Pesquisa Clínica
Salvador, 41820-000
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
Recruiting
Fundaçao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, 15090-000
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
Recruiting
CEPIC - Centro Paulista de Investigacao Clinica e Servicos
São Paulo, 04266-010
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
Recruiting
A2Z Clinical Centro Avançado de Pesquisa Clinica
Valinhos, 13271-130
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
Recruiting

Other trials in Brazil

Colombia5 sites, 5 recruiting

Clinica de la Costa Ltda.
Barranquilla, 080020
Boehringer Ingelheim, 18005190813, colombia@bitrialsupport.com
Not yet recruiting
CIREEM SAS (Centro de Investigacion en Reumatologia y Especialidades Medicas)
Bogotá, 110231
Boehringer Ingelheim, 18005190813, colombia@bitrialsupport.com
Not yet recruiting
Hospital Universitario San Ignacio de Bogota
Bogotá, 110231
Boehringer Ingelheim, 18005190813, colombia@bitrialsupport.com
Not yet recruiting
IPS Centro Medico Julian Coronel S.A.
Cali, 760001
Boehringer Ingelheim, 18005190813, colombia@bitrialsupport.com
Not yet recruiting
Fundacion Oftalmologica de Santander FOSCAL
Floridablanca, 681001
Boehringer Ingelheim, 18005190813, colombia@bitrialsupport.com
Not yet recruiting

Other trials in Colombia

Spain5 sites, 5 recruiting

Hospital Germans Trias i Pujol
Badalona, 08916
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Recruiting
Hospital Santa Creu i Sant Pau
Barcelona, 08041
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Recruiting
Hospital de Galdakao
Galdakao, 48960
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Recruiting
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Recruiting
Hospital Universitario de Araba
Vitoria-Gasteiz, 01009
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Recruiting

Other trials in Spain

Taiwan5 sites, 5 recruiting

Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City, 833
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
Recruiting
Chung Shan Medical University Hospital
Taichung, 40201
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
Recruiting
National Taiwan University Hospital
Taipei, 100225
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
Recruiting
Taipei Medical University Hospital
Taipei, 110
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
Recruiting
Taipei Veterans General Hospital
Taipei, 112201
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
Recruiting

Other trials in Taiwan

Croatia4 sites, 4 recruiting

Klinicki Bolnicki Centar Osijek
Osijek, 31000
Boehringer Ingelheim, 08007744, hrvatska@bitrialsupport.com
Not yet recruiting
Specijalna Bolnica Medico
Rijeka, 51000
Boehringer Ingelheim, 08007744, hrvatska@bitrialsupport.com
Not yet recruiting
Poliklinika Bonifarm Zagreb
Zagreb, 10000
Boehringer Ingelheim, 08007744, hrvatska@bitrialsupport.com
Recruiting
Solmed Polyclinic
Zagreb, 1000
Boehringer Ingelheim, 08007744, hrvatska@bitrialsupport.com
Not yet recruiting

Other trials in Croatia

India4 sites, 4 recruiting

CARE, Kochi
Kochi, 682040
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
Not yet recruiting
IPGMER and SSKM Hospital
Kolkata, 700020
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
Not yet recruiting
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
Maharashtra, 400053
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
Not yet recruiting
All India Institute of Medical Sciences
New Delhi, 110029
Boehringer Ingelheim, 0008000501442, india@bitrialsupport.com
Not yet recruiting

Other trials in India

Romania4 sites, 4 recruiting

Delta Health Care
Bucharest, 014142
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
Recruiting
Spitalul Clinic Dr. I. Cantacuzino
Bucharest, 020475
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
Recruiting
Centrul Clinic De Boli Reumatismale Dr. Ion Stoia
Bucharest, 020983
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
Recruiting
Institutul Clinic Fundeni
Bucharest, 022328
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
Not yet recruiting

Other trials in Romania

United Kingdom4 sites, 4 recruiting

Basingstoke and North Hampshire Hospital
Basingstoke, RG24 9NA
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Recruiting
Belfast City Hospital
Belfast, BT9 7AB
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Recruiting
Addenbrooke's Hospital
Cambridge, CB2 0QQ
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Recruiting
Doncaster Royal Infirmary
Doncaster, DN2 5LTT
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Recruiting

Other trials in United Kingdom

South Africa3 sites, 3 recruiting

Cape Town - Arthritis Clinical Research Trial Unit
Cape Town, 7405
Boehringer Ingelheim, 0800988886, southafrica@bitrialsupport.com
Not yet recruiting
Umhlanga Medical Centre
Durban, 4319
Boehringer Ingelheim, 0800988886, southafrica@bitrialsupport.com
Not yet recruiting
Dr Gareth Scott Tarr
Stellenbosch, 7599
Boehringer Ingelheim, 0800988886, southafrica@bitrialsupport.com
Not yet recruiting

Other trials in South Africa

Australia2 sites, 2 recruiting

Austin Health
Heidelberg, Victoria, 3081
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
Recruiting

Other trials in Australia

Germany2 sites, 2 recruiting

Mühlenkreiskliniken AöR
Minden, 32429
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Not yet recruiting
Klinikum der Universität München AÖR
München, 80336
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Recruiting

Other trials in Germany

Hungary2 sites, 2 recruiting

Semmelweis University
Budapest, 1021
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
Not yet recruiting
Vita Verum Medical Bt.
Székesfehérvár, 8000
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
Not yet recruiting

Other trials in Hungary

Serbia2 sites, 2 recruiting

Military Medical Academy
Belgrade, 11000
Boehringer Ingelheim, 0800800636, srbija@bitrialsupport.com
Not yet recruiting
General Hospital - Djordje Joanovic
Zrenjanin, 23101
Boehringer Ingelheim, 0800800636, srbija@bitrialsupport.com
Not yet recruiting

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Netherlands1 site, 1 recruiting

Erasmus Medisch Centrum
Rotterdam, 3015 GD
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
Not yet recruiting

Other trials in Netherlands

About this study

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)

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.

Conditions: Systemic Lupus Erythematosus
Being tested: BI 3000202, Placebo
Keywords: Lupus
Medical subject headings: Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 3000202Drug
BI 3000202 at different doses
PlaceboDrug
Placebo matching BI 3000202

Study groups in NCT07409181
Study group	Role	What they receive
Arm 1: BI 3000202 dose 1	Experimental	Not described Receives: Drug: BI 3000202
Arm 2: BI 3000202 dose 2	Experimental	Not described Receives: Drug: BI 3000202
Arm 3: BI 3000202 dose 3	Experimental	Not described Receives: Drug: BI 3000202
Arm 4: BI 3000202 dose 4	Experimental	Not described Receives: Drug: BI 3000202
Arm 5: Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Achievement of a Systemic Lupus Erythematosus Responder Index (SRI)-4 response
Measured: At Week 32

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Apr 20268 Jul 2029

First posted13 Feb 2026
Study start20 Apr 2026
Primary completion4 Feb 2029 (estimated)
Study completion8 Jul 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 405 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07409181
Sponsor's protocol ID: 1509-0004
Other IDs: 2025-523488-39-00, U1111-1329-5843, 2025
Status last verified: Oct 2026
First submitted: 9 Feb 2026
Last updated: 28 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Interested in taking part?

Boehringer Ingelheim

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Active, not recruitingPhase 3
A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
Active, not recruitingPhase 3
A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic

All Systemic Lupus Erythematosus trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT07409181
Acronym / sponsor ID: 1509-0004
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 405 participants (estimated)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 20 Apr 2026 (actual)
Primary completion: 4 Feb 2029 (estimated)
Study completion: 8 Jul 2029 (estimated)
First posted: 13 Feb 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Arm 1: BI 3000202 dose 1	Experimental	Drug: BI 3000202
Arm 2: BI 3000202 dose 2	Experimental	Drug: BI 3000202
Arm 3: BI 3000202 dose 3	Experimental	Drug: BI 3000202
Arm 4: BI 3000202 dose 4	Experimental	Drug: BI 3000202
Arm 5: Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

Drug-induced SLE
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
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
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)
Oral corticosteroids (prednisone or equivalent) >30 mg/day at screening Further exclusion criteria apply.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BI 3000202BI 3000202 at different doses	Drug	Arm 1: BI 3000202 dose 1, Arm 2: BI 3000202 dose 2, Arm 3: BI 3000202 dose 3, Arm 4: BI 3000202 dose 4
PlaceboPlacebo matching BI 3000202	Drug	Arm 5: Placebo

Primary outcome

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

3 secondary outcomes

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

Related trials for Systemic Lupus Erythematosus

Active, not recruitingPhase 3
A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
Active, not recruitingPhase 3
A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Boehringer Ingelheim contact

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

139 sites in 21 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 3000202 in people with Systemic Lupus Erythematosus, run by Boehringer Ingelheim at 139 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 139 sites in United States, Japan, China, Poland, Bulgaria and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Achievement of a Systemic Lupus Erythematosus Responder Index (SRI)-4 response (time frame: At Week 32). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07409181.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.