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

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)

Overview

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.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (3)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 30 centers

• Wallace & Lee Center — Beverly Hills
• Arthritis & Osteoporosis Medical Center, Inc - La Palma — La Palma
• University of California San Diego — San Diego
• University of California Los Angeles — Torrance
• Inland Rheumatology Clinical Trials, Inc — Upland
• Focus Clinical Research — West Hills
• Denver Arthritis Clinic - Lowry — Denver
• AARDS Research, Inc. — Aventura
• … and 22 more centers

Japan · 15 centers

Center list to be confirmed — check the primary protocol.

China · 11 centers

• Peking Union Medical College Hospital — Beijing
• Jilin Province People's Hospital — Changchun
• Xiangya Hospital, Central South University — Changsha
• The third affiliated hospital of Sun Yat-Sen University — Guangzhou
• Linfen Central Hospital — Linfen
• Nanjing Drum Tower Hospital — Nanjing
• The First Affiliated Hospital of Ningbo University — Ningbo
• Huashan Hospital, Fudan University — Shanghai
• … and 3 more centers

Poland · 10 centers

Center list to be confirmed — check the primary protocol.

Bulgaria · 8 centers

• Medical Center MedTech Services Ltd. — Haskovo
• Military medical academy - MHAT Pleven — Pleven
• Medical Complex Sveti Ivan Rilski EOOD — Plovdiv
• Hospital MHAT Plovdiv, AD — Plovdiv
• Medical center "Medici Sofia" Ltd. — Sofia
• Diagnostic Consultative Center Alexandrovska — Sofia
• Medical Center Hera EOOD — Sofia
• University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD — Sofia

Mexico · 8 centers

Center list to be confirmed — check the primary protocol.

Argentina · 7 centers

• Centro Medico Reumatologico - OMI — CABA
• Instituto de Investigación Clínica TyT — CABA
• Instituto Médico Especializado — Capital Federal
• Consultora integral en Salud SRL. — General Paz
• Sanatorio Maipú — Maipu
• Instituto de Investigaciones Clinicas Quilmes — Quilmes
• Centro de Investigaciones Médicas Tucumán — San Miguel de Tucumán

Brazil · 7 centers

• SAPIENS - Instituto de Estudos e Pesquisa Clínica — Curitiba
• Centro Mineiro de Pesquisa (CMIP) — Juiz de Fora
• Hospitalar Moinhos de Vento — Porto Alegre
• Inovace Pesquisa Clínica — Salvador
• Fundação Faculdade Regional de Medicina de São José do Rio Preto — São José do Rio Preto
• CEPIC - Centro Paulista de Investigacao Clinica e Servicos — São Paulo
• Azidus Centro de Pesquisa Clinica Avancada — Valinhos

Colombia · 5 centers

• Clínica de la Costa SAS — Barranquilla
• CIREEM SAS (Centro de Investigación en Reumatología y Especialidades Médicas) — Bogotá
• Hospital Universitario San Ignacio de Bogotá — Bogotá
• IPS Centro Medico Julián Coronel S.A. — Cali
• Fundacion Oftalmologica de Santander FOSCAL — Floridablanca

Spain · 5 centers

Center list to be confirmed — check the primary protocol.

Taiwan · 5 centers

Center list to be confirmed — check the primary protocol.

United Kingdom · 5 centers

Center list to be confirmed — check the primary protocol.

Croatia · 4 centers

• Klinicki Bolnicki Centar Osijek — Osijek
• Specijalna Bolnica Medico — Rijeka
• Poliklinika Bonifarm Zagreb — Zagreb
• Solmed Polyclinic — Zagreb

Romania · 4 centers

Center list to be confirmed — check the primary protocol.

Germany · 3 centers

• Rheumazentrum Prof. Dr. med. Gunther Neeck — Bad Doberan
• Mühlenkreiskliniken AöR — Minden
• Klinikum der Universität München AÖR — München

India · 3 centers

• CARE, Kochi — Kochi
• … and 2 more centers

Australia · 2 centers

• Austin Health — Heidelberg
• Fiona Stanley Hospital — Murdoch

Hungary · 2 centers

• Semmelweis University — Budapest
• Vita Verum Medical Bt. — Székesfehérvár

Serbia · 2 centers

Center list to be confirmed — check the primary protocol.

Netherlands · 1 center

Center list to be confirmed — check the primary protocol.

South Africa · 1 center

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07409181 · 1509-0004 · 2025-523488-39-00 · U1111-1329-5843

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗