Systemic Lupus Erythematosus (SLE) Clinical Trials

Find Systemic Lupus Erythematosus (SLE) Clinical Trials Near You

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)

Status: Recruiting
Location: See all (140) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 74
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Wallace & Lee Center
NOT_YET_RECRUITING
Beverly Hills
Arthritis & Osteoporosis Medical Center, Inc - La Palma
NOT_YET_RECRUITING
La Palma
University of California San Diego
NOT_YET_RECRUITING
San Diego
University of California Los Angeles
NOT_YET_RECRUITING
Torrance
Inland Rheumatology Clinical Trials, Inc
RECRUITING
Upland
Focus Clinical Research
RECRUITING
West Hills
Colorado
Denver Arthritis Clinic - Lowry
NOT_YET_RECRUITING
Denver
Florida
AARDS Research, Inc.
RECRUITING
Aventura
Meris Clinical Research-Brandon-69466
NOT_YET_RECRUITING
Brandon
Clinical Research of West Florida, Inc.
NOT_YET_RECRUITING
Clearwater
Integral Rheumatology and Immunology Specialist
NOT_YET_RECRUITING
Plantation
Clinical Research of West Florida, Inc. - Tampa
RECRUITING
Tampa
Michigan
AA MRC LLC - Grand Blanc
NOT_YET_RECRUITING
Grand Blanc
June DO, PC
NOT_YET_RECRUITING
Lansing
Mississippi
Oscar Clinical Trials
RECRUITING
Jackson
Montana
Boeson Research - Great Falls
RECRUITING
Great Falls
North Carolina
DJL Clinical Research, PLLC
NOT_YET_RECRUITING
Charlotte
Cross Creek Medical Clinic, PA
NOT_YET_RECRUITING
Fayetteville
Ohio
Paramount Medical Research and Consulting
RECRUITING
Middleburg Heights
Oklahoma
Oklahoma Medical Research Foundation
NOT_YET_RECRUITING
Oklahoma City
Pennsylvania
Altoona Arthritis & Osteoporosis Center - Altoona Center for Clinical Research
RECRUITING
Duncansville
Tennessee
West Tennessee Research Institute
NOT_YET_RECRUITING
Jackson
Shelby Research LLC
RECRUITING
Memphis
Texas
Arthritis & Rheumatology Institute - Allen
NOT_YET_RECRUITING
Allen
Amarillo Center for Clinical Research
RECRUITING
Amarillo
Precision Comprehensive Clinical Research Solutions - Colleyville
NOT_YET_RECRUITING
Colleyville
Precision Comprehensive Clinical Research Solutions
RECRUITING
Euless
The University of Texas Health Science Center at Houston
NOT_YET_RECRUITING
Houston
R&H Clinical Research - Katy
RECRUITING
Katy
SouthWest Rheumatology Research
NOT_YET_RECRUITING
Mesquite
Other Locations
Argentina
Centro Medico Reumatologico - OMI
RECRUITING
Caba
Instituto de Investigacion Clinica TyT
RECRUITING
Caba
Instituto Medico Especializado
RECRUITING
Capital Federal
Consultora integral en Salud SRL.
RECRUITING
General Paz
Sanatorio Maipu
RECRUITING
Maipu
Instituto de Investigaciones Clinicas Quilmes
RECRUITING
Quilmes
Centro de Investigaciones Medicas Tucuman
RECRUITING
San Miguel De Tucumán
Australia
Austin Health
RECRUITING
Heidelberg
Fiona Stanley Hospital
NOT_YET_RECRUITING
Murdoch
Brazil
SAPIENS - Instituto de Estudos e Pesquisa Clínica
NOT_YET_RECRUITING
Curitiba
Centro Mineiro de Pesquisa (CMIP)
NOT_YET_RECRUITING
Juiz De Fora
Hospitalar Moinhos de Vento
NOT_YET_RECRUITING
Porto Alegre
Inovace Pesquisa Clínica
NOT_YET_RECRUITING
Salvador
Fundação Faculdade Regional de Medicina de São José do Rio Preto
RECRUITING
São José Do Rio Preto
CEPIC - Centro Paulista de Investigacao Clinica e Servicos
RECRUITING
São Paulo
Azidus Centro de Pesquisa Clinica Avancada
RECRUITING
Valinhos
Bulgaria
Medical Center MedTech Services Ltd.
RECRUITING
Haskovo
Military medical academy - MHAT Pleven
NOT_YET_RECRUITING
Pleven
Hospital MHAT Plovdiv, AD
NOT_YET_RECRUITING
Plovdiv
Medical Complex Sveti Ivan Rilski EOOD
NOT_YET_RECRUITING
Plovdiv
Diagnostic Consultative Center Alexandrovska
RECRUITING
Sofia
Medical Center Hera EOOD
RECRUITING
Sofia
Medical center Medici Sofia Ltd.
NOT_YET_RECRUITING
Sofia
University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD
RECRUITING
Sofia
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Jilin Province People's Hospital
RECRUITING
Changchun
Xiangya Hospital, Central South University
NOT_YET_RECRUITING
Changsha
The third affiliated hospital of Sun Yat-Sen University
RECRUITING
Guangzhou
Linfen Central Hospital
RECRUITING
Linfen
Nanjing Drum Tower Hospital
RECRUITING
Nanjing
The First Affiliated Hospital of Ningbo University
RECRUITING
Ningbo
Huashan Hospital, Fudan University
RECRUITING
Shanghai
Renji Hospital Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
The Second Affiliated Hospital of Soochow University
RECRUITING
Suzhou
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Colombia
Clinica de la Costa Ltda.
NOT_YET_RECRUITING
Barranquilla
CIREEM SAS (Centro de Investigacion en Reumatologia y Especialidades Medicas)
NOT_YET_RECRUITING
Bogotá
Hospital Universitario San Ignacio de Bogota
NOT_YET_RECRUITING
Bogotá
IPS Centro Medico Julian Coronel S.A.
NOT_YET_RECRUITING
Cali
Fundacion Oftalmologica de Santander FOSCAL
NOT_YET_RECRUITING
Floridablanca
Croatia
Klinicki Bolnicki Centar Osijek
NOT_YET_RECRUITING
Osijek
Specijalna Bolnica Medico
NOT_YET_RECRUITING
Rijeka
Poliklinika Bonifarm Zagreb
NOT_YET_RECRUITING
Zagreb
Solmed Polyclinic
NOT_YET_RECRUITING
Zagreb
Germany
Rheumazentrum Prof. Dr. med. Gunther Neeck
NOT_YET_RECRUITING
Bad Doberan
Mühlenkreiskliniken AöR
NOT_YET_RECRUITING
Minden
Klinikum der Universität München AÖR
RECRUITING
München
Hungary
Semmelweis University
NOT_YET_RECRUITING
Budapest
Vita Verum Medical Bt.
NOT_YET_RECRUITING
Székesfehérvár
India
CARE, Kochi
NOT_YET_RECRUITING
Kochi
IPGMER and SSKM Hospital
NOT_YET_RECRUITING
Kolkata
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
NOT_YET_RECRUITING
Maharashtra
All India Institute of Medical Sciences
NOT_YET_RECRUITING
New Delhi
Japan
Japan Community Healthcare Organization Chukyo Hospital
RECRUITING
Aichi, Nagoya
National Hospital Organization Chibahigashi National Hospital
RECRUITING
Chiba, Chiba
Juntendo University Urayasu Hospital
RECRUITING
Chiba, Urayasu
Hospital of the University of Occupational and Environmental Health
RECRUITING
Fukuoka, Kitakyushu
Hokkaido University Hospital
RECRUITING
Hokkaido, Sapporo
Tohoku Medical and Pharmaceutical University Hospital
RECRUITING
Miyagi, Sendai
University of Miyazaki Hospital
RECRUITING
Miyazaki, Miyazaki
Shinshu University Hospital
RECRUITING
Nagano, Matsumoto
Niigata University Medical and Dental Hospital
RECRUITING
Niigata, Niigata
Japanese Red Cross Okayama Hospital
RECRUITING
Okayama, Okayama
Saitama Medical University Hospital
RECRUITING
Saitama, Iruma-gun
Institute of Science Tokyo Hospital
RECRUITING
Tokyo, Bunkyo-ku
Juntendo University Hospital
RECRUITING
Tokyo, Bunkyo-ku
St. Luke's International Hospital
RECRUITING
Tokyo, Chuo-ku
Keio University Hospital
NOT_YET_RECRUITING
Tokyo, Shinjuku-ku
Mexico
Investigacion y Biomedicina de Chihuahua S.C.
NOT_YET_RECRUITING
Chihuahua City
Mediadvance Clinical S.A.P.I de C.V.
NOT_YET_RECRUITING
Chihuahua City
Centro Médico ISSEMyM Ecatepec
NOT_YET_RECRUITING
Ecatepec
Centro de Investigacion Farmacologica del Bajío, S.C.
NOT_YET_RECRUITING
León
Cemdeicy, S.C.P.
NOT_YET_RECRUITING
Mérida
Centro Médico del Angel SC
NOT_YET_RECRUITING
Mexicali
Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
NOT_YET_RECRUITING
Mexico City
CIMAB
NOT_YET_RECRUITING
Torreón
Netherlands
Erasmus Medisch Centrum
NOT_YET_RECRUITING
Rotterdam
Poland
Intercor
NOT_YET_RECRUITING
Bydgoszcz
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
NOT_YET_RECRUITING
Bydgoszcz
Pratia S.A.
NOT_YET_RECRUITING
Krakow
ai medical center LLC
RECRUITING
Poznan
Medical Center Hetmanska
RECRUITING
Poznan
Prywatna Praktyka Lekarska Paweł Piesiak
NOT_YET_RECRUITING
Poznan
Klinika Reuma Park Sp. z o.o. S.K.
NOT_YET_RECRUITING
Warsaw
Medicover Integrated Clinical Services Sp. z o.o.
NOT_YET_RECRUITING
Warsaw
Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy
NOT_YET_RECRUITING
Warsaw
Pracownia Badan Klinicznych Salus
NOT_YET_RECRUITING
Wroclaw
Romania
Centrul Clinic De Boli Reumatismale Dr. Ion Stoia
NOT_YET_RECRUITING
Bucharest
Delta Health Care
NOT_YET_RECRUITING
Bucharest
Institutul Clinic Fundeni
NOT_YET_RECRUITING
Bucharest
Spitalul Clinic Dr. I. Cantacuzino
NOT_YET_RECRUITING
Bucharest
Serbia
Military Medical Academy
NOT_YET_RECRUITING
Belgrade
General Hospital - Djordje Joanovic
NOT_YET_RECRUITING
Zrenjanin
South Africa
Umhlanga Medical Centre
NOT_YET_RECRUITING
Durban
Dr Gareth Scott Tarr
NOT_YET_RECRUITING
Stellenbosch
Spain
Hospital Germans Trias i Pujol
RECRUITING
Badalona
Hospital Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital de Galdakao
RECRUITING
Galdakao
Hospital Universitario Ramon Y Cajal
RECRUITING
Madrid
Hospital Universitario de Araba
RECRUITING
Vitoria-gasteiz
Taiwan
Chang Gung Memorial Hospital - Kaohsiung
RECRUITING
Kaohsiung City
Chung Shan Medical University Hospital
RECRUITING
Taichung
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Medical University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
United Kingdom
Basingstoke and North Hampshire Hospital
RECRUITING
Basingstoke
Belfast City Hospital
NOT_YET_RECRUITING
Belfast
Addenbrooke's Hospital
NOT_YET_RECRUITING
Cambridge
Doncaster Royal Infirmary
NOT_YET_RECRUITING
Doncaster
Guy's Hospital
NOT_YET_RECRUITING
London
Contact Information
Primary
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127
Time Frame
Start Date: 2026-04-20
Estimated Completion Date: 2029-07-08
Participants
Target number of participants: 405
Treatments
Experimental: Arm 1: BI 3000202 dose 1
Experimental: Arm 2: BI 3000202 dose 2
Experimental: Arm 3: BI 3000202 dose 3
Experimental: Arm 4: BI 3000202 dose 4
Placebo_comparator: Arm 5: Placebo
Related Therapeutic Areas
Sponsors
Leads: Boehringer Ingelheim

This content was sourced from clinicaltrials.gov