A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)
Recruiting · NCT07409181 · Interventional (participants receive a specific treatment) · Lead sponsor: Boehringer Ingelheim
View the official record on ClinicalTrials.gov →Interventions studied
BI 3000202Placebo
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.
Who can take part
Age range
18 Years to 74 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
60 locations listed across 12 US states.
- Wallace & Lee Center - Beverly Hills, California, United States
- Arthritis & Osteoporosis Medical Center, Inc - La Palma - La Palma, California, United States
- University of California San Diego - San Diego, California, United States
- University of California Los Angeles - Torrance, California, United States
- Inland Rheumatology Clinical Trials, Inc - Upland, California, United States
- Focus Clinical Research - West Hills, California, United States
- Denver Arthritis Clinic - Lowry - Denver, Colorado, United States
- AARDS Research, Inc. - Aventura, Florida, United States
- Meris Clinical Research-Brandon-69466 - Brandon, Florida, United States
- Clinical Research of West Florida, Inc. - Clearwater, Florida, United States
- Integral Rheumatology and Immunology Specialist - Plantation, Florida, United States
- Clinical Research of West Florida, Inc. - Tampa - Tampa, Florida, United States
- AA MRC LLC - Grand Blanc - Grand Blanc, Michigan, United States
- June DO, PC - Lansing, Michigan, United States
- Oscar Clinical Trials - Jackson, Mississippi, United States
- Boeson Research - Great Falls - Great Falls, Montana, United States
- DJL Clinical Research, PLLC - Charlotte, North Carolina, United States
- Cross Creek Medical Clinic, PA - Fayetteville, North Carolina, United States
- Paramount Medical Research and Consulting - Middleburg Heights, Ohio, United States
- Oklahoma Medical Research Foundation - Oklahoma City, Oklahoma, United States
- Altoona Arthritis & Osteoporosis Center - Altoona Center for Clinical Research - Duncansville, Pennsylvania, United States
- West Tennessee Research Institute - Jackson, Tennessee, United States
- Shelby Research LLC - Memphis, Tennessee, United States
- Amarillo Center for Clinical Research - Amarillo, Texas, United States
- Precision Comprehensive Clinical Research Solutions - Colleyville - Colleyville, Texas, United States
- Precision Comprehensive Clinical Research Solutions - Euless, Texas, United States
- Arthritis & Rheumatology Institute - Frisco - Frisco, Texas, United States
- The University of Texas Health Science Center at Houston - Houston, Texas, United States
- R&H Clinical Research - Katy - Katy, Texas, United States
- SouthWest Rheumatology Research - Mesquite, Texas, United States
- Japan Community Healthcare Organization Chukyo Hospital - Aichi, Nagoya, Japan
- Rheumazentrum Prof. Dr. med. Gunther Neeck - Bad Doberan, Germany
- Hospital Germans Trias i Pujol - Badalona, Spain
- Hospital Santa Creu i Sant Pau - Barcelona, Spain
- Clinica de la Costa Ltda. - Barranquilla, Colombia
- Basingstoke and North Hampshire Hospital - Basingstoke, United Kingdom
- Peking Union Medical College Hospital - Beijing, China
- Belfast City Hospital - Belfast, United Kingdom
- Military Medical Academy - Belgrade, Serbia
- CIREEM SAS (Centro de Investigacion en Reumatologia y Especialidades Medicas) - Bogotá, Colombia
- Hospital Universitario San Ignacio de Bogota - Bogotá, Colombia
- Delta Health Care - Bucharest, Romania
- Spitalul Clinic Dr. I. Cantacuzino - Bucharest, Romania
- Centrul Clinic De Boli Reumatismale Dr. Ion Stoia - Bucharest, Romania
- Institutul Clinic Fundeni - Bucharest, Romania
- Semmelweis University - Budapest, Hungary
- Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy - Bydgoszcz, Poland
- Intercor - Bydgoszcz, Poland
- Centro Medico Reumatologico - OMI - CABA, Argentina
- Instituto de Investigacion Clinica TyT - CABA, Argentina
- IPS Centro Medico Julian Coronel S.A. - Cali, Colombia
- Addenbrooke's Hospital - Cambridge, United Kingdom
- Instituto Medico Especializado - Capital Federal, Argentina
- Jilin Province People's Hospital - Changchun, China
- Xiangya Hospital, Central South University - Changsha, China
- National Hospital Organization Chibahigashi National Hospital - Chiba, Chiba, Japan
- Juntendo University Urayasu Hospital - Chiba, Urayasu, Japan
- Investigacion y Biomedicina de Chihuahua S.C. - Chihuahua City, Mexico
- Mediadvance Clinical S.A.P.I de C.V. - Chihuahua City, Mexico
- SAPIENS - Instituto de Estudos e Pesquisa Clínica - Curitiba, Brazil
Showing 60 of 140 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →