Actively Recruiting
A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)
Led by Boehringer Ingelheim · Updated on 2026-05-14
405
Participants Needed
134
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female adults aged 18 to less than 75 years
- Confirmed diagnosis of systemic lupus erythematosus (SLE) meeting EULAR/ACR criteria at least 24 weeks before screening
- Positive for antinuclear antibodies (ANA) at 1:80 or higher, or anti-double-stranded DNA antibody, or anti-Smith antibody at screening
- Total SLEDAI-2K score of 6 points or more, with clinical SLEDAI-2K score of 4 points or more
- At least one BILAG A grade and/or one BILAG B grade at screening with sufficient disease activity
- Receiving stable SLE background therapy with up to one immunosuppressant and/or one antimalarial for at least 8 weeks
- Stable dose of oral corticosteroids at 30 mg/day prednisone or equivalent or less for at least 2 weeks before screening
You will not qualify if you...
- Drug-induced SLE
- Scleroderma (except linear scleroderma that does not affect SLE assessments) or other connective tissue diseases interfering with SLE evaluation
- Active or unstable neuropsychiatric lupus with BILAG A criteria, except mononeuritis/mononeuropathy multiplex, chorea, and polyneuropathy
- Lupus nephritis requiring immune-modulating treatment changes or with unstable serum creatinine above 2 times ULN or unstable urine protein creatinine ratio above 3 mg/mg
- Oral corticosteroids over 30 mg/day prednisone or equivalent at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 134 locations
1
Wallace & Lee Center
Beverly Hills, California, United States, 90210
Not Yet Recruiting
2
Arthritis & Osteoporosis Medical Center, Inc - La Palma
La Palma, California, United States, 90623
Not Yet Recruiting
3
University of California San Diego
San Diego, California, United States, 92037
Not Yet Recruiting
4
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Not Yet Recruiting
5
Inland Rheumatology Clinical Trials, Inc
Upland, California, United States, 91786
Not Yet Recruiting
6
Alliance Clinical West Hills
West Hills, California, United States, 91307
Not Yet Recruiting
7
Denver Arthritis Clinic - Lowry
Denver, Colorado, United States, 80230
Not Yet Recruiting
8
AARDS Research, Inc.
Aventura, Florida, United States, 33180
Not Yet Recruiting
9
Meris Clinical Research-Brandon-69466
Brandon, Florida, United States, 33511
Not Yet Recruiting
10
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States, 33763
Not Yet Recruiting
11
Integral Rheumatology and Immunology Specialist
Plantation, Florida, United States, 33324
Not Yet Recruiting
12
Clinical Research of West Florida, Inc. - Tampa
Tampa, Florida, United States, 33606
Not Yet Recruiting
13
Michigan Rheumatology Group, P.C. - Grand Blanc
Grand Blanc, Michigan, United States, 48439
Not Yet Recruiting
14
Great Lakes Center of Rheumatology
Lansing, Michigan, United States, 48911
Not Yet Recruiting
15
Oscar Clinical Trials
Jackson, Mississippi, United States, 39206
Not Yet Recruiting
16
Boeson Research - Great Falls
Great Falls, Montana, United States, 59405
Not Yet Recruiting
17
DJL Clinical Research, PLLC
Charlotte, North Carolina, United States, 28211
Not Yet Recruiting
18
Cross Creek Medical Clinic, PA
Fayetteville, North Carolina, United States, 28304
Not Yet Recruiting
19
Paramount Medical Research and Consulting
Middleburg Heights, Ohio, United States, 44130
Not Yet Recruiting
20
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
Not Yet Recruiting
21
Altoona Arthritis & Osteoporosis Center - Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Not Yet Recruiting
22
West Tennessee Research Institute
Jackson, Tennessee, United States, 38305
Not Yet Recruiting
23
Shelby Research LLC
Memphis, Tennessee, United States, 38119
Not Yet Recruiting
24
Arthritis & Rheumatology Institute - Allen
Allen, Texas, United States, 75013
Not Yet Recruiting
25
Amarillo Center for Clinical Research
Amarillo, Texas, United States, 79124
Not Yet Recruiting
26
Tekton Research, Inc - West Gate Boulevard
Austin, Texas, United States, 78745
Not Yet Recruiting
27
Heritage Rheumatology and Arthritis Care
Colleyville, Texas, United States, 76034
Not Yet Recruiting
28
Precision Comprehensive Clinical Research Solutions
Euless, Texas, United States, 76040
Not Yet Recruiting
29
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Not Yet Recruiting
30
R&H Clinical Research - Katy
Katy, Texas, United States, 77449
Not Yet Recruiting
31
SouthWest Rheumatology Research
Mesquite, Texas, United States, 75150
Not Yet Recruiting
32
Centro Medico Reumatologico - OMI
CABA, Argentina, 1015
Not Yet Recruiting
33
Instituto de Investigación Clínica TyT
CABA, Argentina, C1405BFN
Not Yet Recruiting
34
Instituto Médico Especializado
Capital Federal, Argentina, C1405BCH
Not Yet Recruiting
35
Consultora integral en Salud SRL.
General Paz, Argentina, 5000
Not Yet Recruiting
36
Sanatorio Maipú
Maipu, Argentina, M5515DQA
Not Yet Recruiting
37
Instituto de Investigaciones Clinicas Quilmes
Quilmes, Argentina, B1878
Not Yet Recruiting
38
Centro de Investigaciones Médicas Tucumán
San Miguel de Tucumán, Argentina, 4000
Not Yet Recruiting
39
Austin Health
Heidelberg, Victoria, Australia, 3081
Not Yet Recruiting
40
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Not Yet Recruiting
41
SAPIENS - Instituto de Estudos e Pesquisa Clínica
Curitiba, Brazil, 80810-000
Not Yet Recruiting
42
Centro Mineiro de Pesquisa (CMIP)
Juiz de Fora, Brazil, 36010-570
Not Yet Recruiting
43
Hospitalar Moinhos de Vento
Porto Alegre, Brazil, 90035-001
Not Yet Recruiting
44
Inovace Pesquisa Clínica
Salvador, Brazil, 41820-000
Not Yet Recruiting
45
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, Brazil, 15090-000
Not Yet Recruiting
46
CEPIC - Centro Paulista de Investigacao Clinica
São Paulo, Brazil, 04266-010
Not Yet Recruiting
47
Azidus Centro de Pesquisa Clinica Avancada
Valinhos, Brazil, 13271-130
Not Yet Recruiting
48
Medical Center MedTech Services Ltd.
Haskovo, Bulgaria, 6304
Not Yet Recruiting
49
Military medical academy - MHAT Pleven
Pleven, Bulgaria, 5800
Not Yet Recruiting
50
Medical Complex Sveti Ivan Rilski EOOD
Plovdiv, Bulgaria, 4003
Not Yet Recruiting
51
Hospital MHAT Plovdiv, AD
Plovdiv, Bulgaria, 4027
Not Yet Recruiting
52
Medical center "Medici Sofia" Ltd.
Sofia, Bulgaria, 1113
Not Yet Recruiting
53
Diagnostic Consultative Center Alexandrovska
Sofia, Bulgaria, 1431
Not Yet Recruiting
54
Medical Center Hera EOOD
Sofia, Bulgaria, 1510
Not Yet Recruiting
55
University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD
Sofia, Bulgaria, 1612
Not Yet Recruiting
56
Peking Union Medical College Hospital
Beijing, China, 100730
Actively Recruiting
57
Jilin Province People's Hospital
Changchun, China, 130021
Not Yet Recruiting
58
Xiangya Hospital, Central South University
Changsha, China, 410008
Not Yet Recruiting
59
The third affiliated hospital of Sun Yat-Sen University
Guangzhou, China, 510630
Not Yet Recruiting
60
Linfen Central Hospital
Linfen, China, 041000
Not Yet Recruiting
61
Nanjing Drum Tower Hospital
Nanjing, China, 210008
Not Yet Recruiting
62
The First Affiliated Hospital of Ningbo University
Ningbo, China, 315010
Actively Recruiting
63
Huashan Hospital, Fudan University
Shanghai, China, 200040
Not Yet Recruiting
64
Renji Hospital Shanghai Jiaotong Univesrity School of Medicine
Shanghai, China, 200040
Not Yet Recruiting
65
The Second Affiliated Hospital of Soochow University
Suzhou, China, 215004
Not Yet Recruiting
66
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China, 325000
Not Yet Recruiting
67
Clínica de la Costa SAS
Barranquilla, Colombia, 080020
Not Yet Recruiting
68
CIREEM SAS (Centro de Investigación en Reumatología y Especialidades Médicas)
Bogotá, Colombia, 110231
Not Yet Recruiting
69
Hospital Universitario San Ignacio de Bogotá
Bogotá, Colombia, 110231
Not Yet Recruiting
70
IPS Centro Medico Julián Coronel S.A.
Cali, Colombia, 760001
Not Yet Recruiting
71
Fundacion Oftalmologica de Santander FOSCAL
Floridablanca, Colombia, 681001
Not Yet Recruiting
72
University Hospital Centre Osijek
Osijek, Croatia, 31000
Not Yet Recruiting
73
Specialty Hospital Medico
Rijeka, Croatia, 51000
Not Yet Recruiting
74
Poliklinika Bonifarm Zagreb
Zagreb, Croatia, 10000
Not Yet Recruiting
75
Solmed Polyclinic
Zagreb, Croatia, 1000
Not Yet Recruiting
76
Rheumazentrum Prof. Dr. med. Gunther Neeck
Bad Doberan, Germany, 18209
Not Yet Recruiting
77
Mühlenkreiskliniken AöR
Minden, Germany, 32429
Not Yet Recruiting
78
Klinikum der Universität München AÖR
München, Germany, 80336
Not Yet Recruiting
79
Semmelweis Egyetem Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika
Budapest, Hungary, 1021
Not Yet Recruiting
80
Vita Verum Medical Bt.
Székesfehérvár, Hungary, 8000
Not Yet Recruiting
81
CARE, Kochi
Kochi, India, 682040
Not Yet Recruiting
82
IPGMER and SSKM Hospital
Kolkata, India, 700020
Not Yet Recruiting
83
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
Maharashtra, India, 400053
Not Yet Recruiting
84
Japan Community Healthcare Organization Chukyo Hospital
Aichi, Nagoya, Japan, 457-8510
Not Yet Recruiting
85
National Hospital Organization Chibahigashi National Hospital
Chiba, Chiba, Japan, 260-8712
Not Yet Recruiting
86
Juntendo University Urayasu Hospital
Chiba, Urayasu, Japan, 279-0021
Not Yet Recruiting
87
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu, Japan, 807-8556
Not Yet Recruiting
88
Hokkaido University Hospital
Hokkaido, Sapporo, Japan, 060-8648
Not Yet Recruiting
89
Tohoku Medical and Pharmaceutical University Hospital
Miyagi, Sendai, Japan, 983-8512
Not Yet Recruiting
90
University of Miyazaki Hospital
Miyazaki, Miyazaki, Japan, 889-1692
Not Yet Recruiting
91
Shinshu University Hospital
Nagano, Matsumoto, Japan, 390-8621
Not Yet Recruiting
92
Niigata University Medical and Dental Hospital
Niigata, Niigata, Japan, 951-8520
Not Yet Recruiting
93
Japanese Red Cross Okayama Hospital
Okayama, Okayama, Japan, 700-8607
Not Yet Recruiting
94
Saitama Medical University Hospital
Saitama, Iruma-gun, Japan, 350-0495
Not Yet Recruiting
95
Juntendo University Hospital
Tokyo, Bunkyo-ku, Japan, 113-8431
Not Yet Recruiting
96
Institute of Science Tokyo Hospital
Tokyo, Bunkyo-ku, Japan, 113-8519
Not Yet Recruiting
97
St. Luke's International Hospital
Tokyo, Chuo-ku, Japan, 104-8560
Not Yet Recruiting
98
Keio University Hospital
Tokyo, Shinjuku-ku, Japan, 160-8582
Not Yet Recruiting
99
Investigacion y Biomedicina de Chihuahua S.C.
Chihuahua City, Mexico, 31020
Not Yet Recruiting
100
Centro Médico ISSEMyM Ecatepec
Ecatepec, Mexico, 55020
Not Yet Recruiting
101
Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico, 14080
Not Yet Recruiting
102
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 GD
Not Yet Recruiting
103
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Bydgoszcz, Poland, 85-168
Not Yet Recruiting
104
Intercor
Bydgoszcz, Poland, 85605
Not Yet Recruiting
105
Pratia S.A.
Krakow, Poland, 30-727
Not Yet Recruiting
106
Medical Center Hetmanska
Poznan, Poland, 60-218
Not Yet Recruiting
107
Prywatna Praktyka Lekarska Paweł Piesiak
Poznan, Poland, 61-397
Not Yet Recruiting
108
ai medical center LLC
Poznan, Poland, 61113
Not Yet Recruiting
109
Medicover Integrated Clinical Services Sp. z o.o.
Warsaw, Poland, 00874
Not Yet Recruiting
110
Klinika Reuma Park
Warsaw, Poland, 02665
Not Yet Recruiting
111
Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy
Warsaw, Poland, 04-141
Not Yet Recruiting
112
Pracownia Badan Klinicznych Salus
Wroclaw, Poland, 53034
Not Yet Recruiting
113
Delta Health Care
Bucharest, Romania, 014142
Not Yet Recruiting
114
Spitalul Clinic Dr. I. Cantacuzino
Bucharest, Romania, 020475
Not Yet Recruiting
115
Centrul Clinic De Boli Reumatismale Dr. Ion Stoia
Bucharest, Romania, 020983
Not Yet Recruiting
116
Institutul Clinic Fundeni
Bucharest, Romania, 022328
Not Yet Recruiting
117
Military Medical Academy
Belgrade, Serbia, 11000
Not Yet Recruiting
118
General Hospital - Djordje Joanovic
Zrenjanin, Serbia, 23101
Not Yet Recruiting
119
Dr Gareth Scott Tarr
Stellenbosch, South Africa, 7599
Not Yet Recruiting
120
Durban Westville
Westville, South Africa, 3630
Not Yet Recruiting
121
Hospital Germans Trias i Pujol
Badalona, Spain, 08916
Not Yet Recruiting
122
Hospital Santa Creu i Sant Pau
Barcelona, Spain, 08041
Not Yet Recruiting
123
Hospital de Galdakao
Galdakao, Spain, 48960
Not Yet Recruiting
124
Hospital Universitario Ramon Y Cajal
Madrid, Spain, 28034
Not Yet Recruiting
125
Hospital Universitario de Araba
Vitoria-Gasteiz, Spain, 01009
Not Yet Recruiting
126
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City, Taiwan, 833
Not Yet Recruiting
127
Chung Shan Medical University Hospital
Taichung, Taiwan, 40201
Not Yet Recruiting
128
National Taiwan University Hospital
Taipei, Taiwan, 100225
Not Yet Recruiting
129
Taipei Medical University Hospital
Taipei, Taiwan, 110
Not Yet Recruiting
130
Taipei Veterans General Hospital
Taipei, Taiwan, 112201
Not Yet Recruiting
131
Basingstoke and North Hampshire Hospital
Basingstoke, United Kingdom, RG24 9NA
Not Yet Recruiting
132
Belfast City Hospital
Belfast, United Kingdom, BT9 7AB
Not Yet Recruiting
133
Doncaster Royal Infirmary
Doncaster, United Kingdom, DN2 5LTT
Not Yet Recruiting
134
Guy's Hospital
London, United Kingdom, SE1 9RT
Not Yet Recruiting
Research Team
B
Boehringer Ingelheim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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