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Набира участници Фаза 2 NCT07409181

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

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Systemic Lupus Erythematosus

Спонсор: Boehringer Ingelheim

Налично на: БГ
Обобщение
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.
Кой може да участва
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.
Интервенции
BI 3000202
DRUG
Placebo
DRUG
Места на провеждане 132
Argentina (6)
Centro Medico Reumatologico - OMI
CABA
NOT_YET_RECRUITING
Instituto Médico Especializado
Capital Federal
NOT_YET_RECRUITING
Consultora integral en Salud SRL.
General Paz
NOT_YET_RECRUITING
Sanatorio Maipú
Maipu
NOT_YET_RECRUITING
Instituto de Investigaciones Clinicas Quilmes
Quilmes
NOT_YET_RECRUITING
Centro de Investigaciones Médicas Tucumán
San Miguel de Tucumán
NOT_YET_RECRUITING
Австралия (1)
Fiona Stanley Hospital
Murdoch , Western Australia
NOT_YET_RECRUITING
Бразилия (7)
SAPIENS - Instituto de Estudos e Pesquisa Clínica
Curitiba
NOT_YET_RECRUITING
Centro Mineiro de Pesquisa (CMIP)
Juiz de Fora
NOT_YET_RECRUITING
Hospitalar Moinhos de Vento
Porto Alegre
NOT_YET_RECRUITING
Inovace Pesquisa Clínica
Salvador
NOT_YET_RECRUITING
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto
NOT_YET_RECRUITING
CEPIC - Centro Paulista de Investigacao Clinica
São Paulo
NOT_YET_RECRUITING
Azidus Centro de Pesquisa Clinica Avancada
Valinhos
NOT_YET_RECRUITING
България (10)
Medical Center MedTech Services Ltd.
Haskovo
NOT_YET_RECRUITING
Military medical academy - MHAT Pleven
Pleven
NOT_YET_RECRUITING
Medical Complex Sveti Ivan Rilski EOOD
Plovdiv
NOT_YET_RECRUITING
Hospital MHAT Plovdiv, AD
Plovdiv
NOT_YET_RECRUITING
Medical center "Medici Sofia" Ltd.
Sofia
NOT_YET_RECRUITING
Medical Center Excelsior OOD
Sofia
NOT_YET_RECRUITING
Private Clinic of Dermatology Persenk
Sofia
NOT_YET_RECRUITING
Diagnostic Consultative Center Alexandrovska
Sofia
NOT_YET_RECRUITING
Medical Center Hera EOOD
Sofia
NOT_YET_RECRUITING
University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD
Sofia
NOT_YET_RECRUITING
Китай (11)
Peking Union Medical College Hospital
Beijing
NOT_YET_RECRUITING
Jilin Province People's Hospital
Changchun
NOT_YET_RECRUITING
Xiangya Hospital, Central South University
Changsha
NOT_YET_RECRUITING
The third affiliated hospital of Sun Yat-Sen University
Guangzhou
NOT_YET_RECRUITING
Linfen Central Hospital
Linfen
NOT_YET_RECRUITING
Nanjing Drum Tower Hospital
Nanjing
NOT_YET_RECRUITING
The First Affiliated Hospital of Ningbo University
Ningbo
Huashan Hospital, Fudan University
Shanghai
NOT_YET_RECRUITING
Renji Hospital Shanghai Jiaotong Univesrity School of Medicine
Shanghai
NOT_YET_RECRUITING
The Second Affiliated Hospital of Soochow University
Suzhou
NOT_YET_RECRUITING
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
NOT_YET_RECRUITING
Colombia (5)
Clínica de la Costa SAS
Barranquilla
NOT_YET_RECRUITING
CIREEM SAS (Centro de Investigación en Reumatología y Especialidades Médicas)
Bogotá
NOT_YET_RECRUITING
Hospital Universitario San Ignacio de Bogotá
Bogotá
NOT_YET_RECRUITING
IPS Centro Medico Julián Coronel S.A.
Cali
NOT_YET_RECRUITING
Fundacion Oftalmologica de Santander FOSCAL
Floridablanca
NOT_YET_RECRUITING
Хърватия (3)
University Hospital Centre Osijek
Osijek
NOT_YET_RECRUITING
Specialty Hospital Medico
Rijeka
NOT_YET_RECRUITING
Solmed Polyclinic
Zagreb
NOT_YET_RECRUITING
Германия (3)
Rheumazentrum Prof. Dr. med. Gunther Neeck
Bad Doberan
NOT_YET_RECRUITING
Mühlenkreiskliniken AöR
Minden
NOT_YET_RECRUITING
Klinikum der Universität München AÖR
München
NOT_YET_RECRUITING
Унгария (2)
Semmelweis Egyetem Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika
Budapest
NOT_YET_RECRUITING
Vita Verum Medical Bt.
Székesfehérvár
NOT_YET_RECRUITING
Индия (3)
CARE, Kochi
Kochi
NOT_YET_RECRUITING
IPGMER and SSKM Hospital
Kolkata
NOT_YET_RECRUITING
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
Maharashtra
NOT_YET_RECRUITING
Япония (15)
Japan Community Healthcare Organization Chukyo Hospital
Aichi, Nagoya
NOT_YET_RECRUITING
National Hospital Organization Chibahigashi National Hospital
Chiba, Chiba
NOT_YET_RECRUITING
Juntendo University Urayasu Hospital
Chiba, Urayasu
NOT_YET_RECRUITING
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu
NOT_YET_RECRUITING
Hokkaido University Hospital
Hokkaido, Sapporo
NOT_YET_RECRUITING
Tohoku Medical and Pharmaceutical University Hospital
Miyagi, Sendai
NOT_YET_RECRUITING
University of Miyazaki Hospital
Miyazaki, Miyazaki
NOT_YET_RECRUITING
Shinshu University Hospital
Nagano, Matsumoto
NOT_YET_RECRUITING
Niigata University Medical and Dental Hospital
Niigata, Niigata
NOT_YET_RECRUITING
Japanese Red Cross Okayama Hospital
Okayama, Okayama
NOT_YET_RECRUITING
Saitama Medical University Hospital
Saitama, Iruma-gun
NOT_YET_RECRUITING
Juntendo University Hospital
Tokyo, Bunkyo-ku
NOT_YET_RECRUITING
Institute of Science Tokyo Hospital
Tokyo, Bunkyo-ku
NOT_YET_RECRUITING
St. Luke's International Hospital
Tokyo, Chuo-ku
NOT_YET_RECRUITING
Keio University Hospital
Tokyo, Shinjuku-ku
NOT_YET_RECRUITING
Mexico (2)
Investigacion y Biomedicina de Chihuahua S.C.
Chihuahua City
NOT_YET_RECRUITING
Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City
NOT_YET_RECRUITING
Нидерландия (1)
Erasmus Medisch Centrum
Rotterdam
NOT_YET_RECRUITING
Полша (9)
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Bydgoszcz
NOT_YET_RECRUITING
Intercor
Bydgoszcz
NOT_YET_RECRUITING
Pratia S.A.
Krakow
NOT_YET_RECRUITING
Medical Center Hetmanska
Poznan
NOT_YET_RECRUITING
Prywatna Praktyka Lekarska Paweł Piesiak
Poznan
NOT_YET_RECRUITING
ai medical center LLC
Poznan
NOT_YET_RECRUITING
Medicover Integrated Clinical Services Sp. z o.o.
Warsaw
NOT_YET_RECRUITING
Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy
Warsaw
NOT_YET_RECRUITING
Pracownia Badan Klinicznych Salus
Wroclaw
NOT_YET_RECRUITING
Румъния (4)
Delta Health Care
Bucharest
NOT_YET_RECRUITING
Dr. Ion Cantacuzino Clinical Hospital
Bucharest
NOT_YET_RECRUITING
Center of Rheumatic Diseases Dr. Ion Stoia Bucharest
Bucharest
NOT_YET_RECRUITING
Institutul Clinic Fundeni
Bucharest
NOT_YET_RECRUITING
Сърбия (3)
Military Medical Academy
Belgrade
NOT_YET_RECRUITING
Institute for Treatment and Rehabilitation, Niska Banja
Niška Banja
NOT_YET_RECRUITING
General Hospital - Djordje Joanovic
Zrenjanin
NOT_YET_RECRUITING
South Africa (2)
Dr Gareth Scott Tarr
Stellenbosch
NOT_YET_RECRUITING
Durban Westville
Westville
NOT_YET_RECRUITING
Испания (5)
Hospital Germans Trias i Pujol
Badalona
NOT_YET_RECRUITING
Hospital Santa Creu i Sant Pau
Barcelona
NOT_YET_RECRUITING
Hospital de Galdakao
Galdakao
NOT_YET_RECRUITING
Hospital Universitario Ramon Y Cajal
Madrid
NOT_YET_RECRUITING
Hospital Universitario de Araba
Vitoria-Gasteiz
NOT_YET_RECRUITING
Taiwan (5)
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City
NOT_YET_RECRUITING
Chung Shan Medical University Hospital
Taichung
NOT_YET_RECRUITING
National Taiwan University Hospital
Taipei
NOT_YET_RECRUITING
Taipei Medical University Hospital
Taipei
NOT_YET_RECRUITING
Taipei Veterans General Hospital
Taipei
NOT_YET_RECRUITING
Великобритания (4)
Basingstoke and North Hampshire Hospital
Basingstoke
NOT_YET_RECRUITING
Belfast City Hospital
Belfast
NOT_YET_RECRUITING
Doncaster Royal Infirmary
Doncaster
NOT_YET_RECRUITING
Guy's Hospital
London
NOT_YET_RECRUITING
САЩ (31)
Arthritis & Rheumatology Institute - Allen
Allen , Texas
NOT_YET_RECRUITING
Amarillo Center for Clinical Research
Amarillo , Texas
NOT_YET_RECRUITING
Tekton Research, Inc - West Gate Boulevard
Austin , Texas
NOT_YET_RECRUITING
AARDS Research, Inc.
Aventura , Florida
NOT_YET_RECRUITING
Wallace & Lee Center
Beverly Hills , California
NOT_YET_RECRUITING
Meris Clinical Research-Brandon-69466
Brandon , Florida
NOT_YET_RECRUITING
DJL Clinical Research, PLLC
Charlotte , North Carolina
NOT_YET_RECRUITING
Clinical Research of West Florida, Inc.
Clearwater , Florida
NOT_YET_RECRUITING
Heritage Rheumatology and Arthritis Care
Colleyville , Texas
NOT_YET_RECRUITING
Denver Arthritis Clinic - Lowry
Denver , Colorado
NOT_YET_RECRUITING
Altoona Arthritis & Osteoporosis Center - Altoona Center for Clinical Research
Duncansville , Pennsylvania
NOT_YET_RECRUITING
Precision Comprehensive Clinical Research Solutions
Euless , Texas
NOT_YET_RECRUITING
Cross Creek Medical Clinic, PA
Fayetteville , North Carolina
NOT_YET_RECRUITING
Michigan Rheumatology Group, P.C. - Grand Blanc
Grand Blanc , Michigan
NOT_YET_RECRUITING
Boeson Research
Great Falls , Montana
NOT_YET_RECRUITING
The University of Texas Health Science Center at Houston
Houston , Texas
NOT_YET_RECRUITING
Oscar Clinical Trials
Jackson , Mississippi
NOT_YET_RECRUITING
West Tennessee Research Institute
Jackson , Tennessee
NOT_YET_RECRUITING
R&H Clinical Research - Katy
Katy , Texas
NOT_YET_RECRUITING
Arthritis & Osteoporosis Medical Center, Inc - La Palma
La Palma , California
NOT_YET_RECRUITING
Great Lakes Center of Rheumatology
Lansing , Michigan
NOT_YET_RECRUITING
Shelby Research LLC
Memphis , Tennessee
NOT_YET_RECRUITING
SouthWest Rheumatology Research
Mesquite , Texas
NOT_YET_RECRUITING
Paramount Medical Research and Consulting
Middleburg Heights , Ohio
NOT_YET_RECRUITING
Oklahoma Medical Research Foundation
Oklahoma City , Oklahoma
NOT_YET_RECRUITING
Integral Rheumatology and Immunology Specialist
Plantation , Florida
NOT_YET_RECRUITING
University of California San Diego
San Diego , California
NOT_YET_RECRUITING
Clinical Research of West Florida, Inc. - Tampa
Tampa , Florida
NOT_YET_RECRUITING
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance , California
NOT_YET_RECRUITING
Inland Rheumatology Clinical Trials, Inc
Upland , California
NOT_YET_RECRUITING
Alliance Clinical West Hills
West Hills , California
NOT_YET_RECRUITING
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
74 Years
Здрави доброволци
Не
Начална дата
20.04.2026
Крайна дата
24.06.2029
Регистрационен номер
NCT07409181
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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