New lupus pill enters Mid-Stage trial – hope for better control?

NCT ID NCT07409181

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 13 times

Summary

This study tests an experimental oral drug called BI 3000202 in 405 adults with moderate to severe systemic lupus erythematosus (SLE). Participants are randomly assigned to one of four doses of the drug or a placebo, taken daily for a year alongside their usual lupus treatments. The goal is to see if the drug can reduce lupus activity and help lower steroid use. Results will help determine the best dose for future studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: BI 3000202 (oral tablet)
What this could lead to: If successful, this could point toward a new daily pill to better control lupus symptoms and reduce steroid use.
What could go wrong: This is an early Phase 2 trial with only 405 people. The drug may not work better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 405 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 74 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic lupus erythematosus

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

140 sites in 21 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

AA MRC LLC - Grand Blanc
NOT_YET_RECRUITING

Grand Blanc, Michigan, 48439, United States
AARDS Research, Inc.
RECRUITING

Aventura, Florida, 33180, United States
Addenbrooke's Hospital
NOT_YET_RECRUITING

Cambridge, CB2 0QQ, United Kingdom
All India Institute of Medical Sciences
NOT_YET_RECRUITING

New Delhi, 110029, India
Altoona Arthritis & Osteoporosis Center - Altoona Center for Clinical Research
RECRUITING

Duncansville, Pennsylvania, 16635, United States
Amarillo Center for Clinical Research
RECRUITING

Amarillo, Texas, 79124, United States
Arthritis & Osteoporosis Medical Center, Inc - La Palma
RECRUITING

La Palma, California, 90623, United States
Arthritis & Rheumatology Institute - Frisco
RECRUITING

Frisco, Texas, 75035, United States
Austin Health
RECRUITING

Heidelberg, Victoria, 3081, Australia
Azidus Centro de Pesquisa Clinica Avancada
RECRUITING

Valinhos, 13271-130, Brazil
Basingstoke and North Hampshire Hospital
RECRUITING

Basingstoke, RG24 9NA, United Kingdom
Belfast City Hospital
NOT_YET_RECRUITING

Belfast, BT9 7AB, United Kingdom
Boeson Research - Great Falls
RECRUITING

Great Falls, Montana, 59405, United States
CARE, Kochi
NOT_YET_RECRUITING

Kochi, 682040, India
CEPIC - Centro Paulista de Investigacao Clinica e Servicos
RECRUITING

São Paulo, 04266-010, Brazil
CIMAB
NOT_YET_RECRUITING

Torreón, 27000, Mexico
CIREEM SAS (Centro de Investigacion en Reumatologia y Especialidades Medicas)
NOT_YET_RECRUITING

Bogotá, 110231, Colombia
Cemdeicy, S.C.P.
NOT_YET_RECRUITING

Mérida, 97130, Mexico
Centro Medico Reumatologico - OMI
RECRUITING

CABA, 1015, Argentina
Centro Mineiro de Pesquisa (CMIP)
RECRUITING

Juiz de Fora, 36010-570, Brazil
Centro Médico ISSEMyM Ecatepec
NOT_YET_RECRUITING

Ecatepec, 55020, Mexico
Centro Médico del Angel SC
NOT_YET_RECRUITING

Mexicali, 21100, Mexico
Centro de Investigacion Farmacologica del Bajío, S.C.
NOT_YET_RECRUITING

León, 37160, Mexico
Centro de Investigaciones Medicas Tucuman
RECRUITING

San Miguel de Tucumán, 4000, Argentina
Centrul Clinic De Boli Reumatismale Dr. Ion Stoia
NOT_YET_RECRUITING

Bucharest, 020983, Romania
Chang Gung Memorial Hospital - Kaohsiung
RECRUITING

Kaohsiung City, 833, Taiwan
Chung Shan Medical University Hospital
RECRUITING

Taichung, 40201, Taiwan
Clinica de la Costa Ltda.
NOT_YET_RECRUITING

Barranquilla, 080020, Colombia
Clinical Research of West Florida, Inc.
NOT_YET_RECRUITING

Clearwater, Florida, 33763, United States
Clinical Research of West Florida, Inc. - Tampa
RECRUITING

Tampa, Florida, 33606, United States
Consultora integral en Salud SRL.
RECRUITING

General Paz, 5000, Argentina
Cross Creek Medical Clinic, PA
NOT_YET_RECRUITING

Fayetteville, North Carolina, 28304, United States
DJL Clinical Research, PLLC
NOT_YET_RECRUITING

Charlotte, North Carolina, 28211, United States
Delta Health Care
NOT_YET_RECRUITING

Bucharest, 014142, Romania
Denver Arthritis Clinic - Lowry
NOT_YET_RECRUITING

Denver, Colorado, 80230, United States
Diagnostic Consultative Center Alexandrovska
RECRUITING

Sofia, 1431, Bulgaria
Doncaster Royal Infirmary
RECRUITING

Doncaster, DN2 5LTT, United Kingdom
Dr Gareth Scott Tarr
NOT_YET_RECRUITING

Stellenbosch, 7599, South Africa
Erasmus Medisch Centrum
NOT_YET_RECRUITING

Rotterdam, 3015 GD, Netherlands
Fiona Stanley Hospital
RECRUITING

Murdoch, Western Australia, 6150, Australia
Focus Clinical Research
RECRUITING

West Hills, California, 91307, United States
Fundacion Oftalmologica de Santander FOSCAL
NOT_YET_RECRUITING

Floridablanca, 681001, Colombia
Fundação Faculdade Regional de Medicina de São José do Rio Preto
RECRUITING

São José do Rio Preto, 15090-000, Brazil
General Hospital - Djordje Joanovic
NOT_YET_RECRUITING

Zrenjanin, 23101, Serbia
Guy's Hospital
NOT_YET_RECRUITING

London, SE1 9RT, United Kingdom
Hokkaido University Hospital
RECRUITING

Hokkaido, Sapporo, 060-8648, Japan
Hospital Germans Trias i Pujol
RECRUITING

Badalona, 08916, Spain
Hospital MHAT Plovdiv, AD
RECRUITING

Plovdiv, 4027, Bulgaria
Hospital Santa Creu i Sant Pau
RECRUITING

Barcelona, 08041, Spain
Hospital Universitario Ramon Y Cajal
RECRUITING

Madrid, 28034, Spain
Hospital Universitario San Ignacio de Bogota
NOT_YET_RECRUITING

Bogotá, 110231, Colombia
Hospital Universitario de Araba
RECRUITING

Vitoria-Gasteiz, 01009, Spain
Hospital de Galdakao
RECRUITING

Galdakao, 48960, Spain
Hospital of the University of Occupational and Environmental Health
RECRUITING

Fukuoka, Kitakyushu, 807-8556, Japan
Hospitalar Moinhos de Vento
NOT_YET_RECRUITING

Porto Alegre, 90035-001, Brazil
Huashan Hospital, Fudan University
RECRUITING

Shanghai, 200040, China
IPGMER and SSKM Hospital
NOT_YET_RECRUITING

Kolkata, 700020, India
IPS Centro Medico Julian Coronel S.A.
NOT_YET_RECRUITING

Cali, 760001, Colombia
Inland Rheumatology Clinical Trials, Inc
RECRUITING

Upland, California, 91786, United States
Inovace Pesquisa Clínica
NOT_YET_RECRUITING

Salvador, 41820-000, Brazil
Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
NOT_YET_RECRUITING

Mexico City, 14080, Mexico
Institute of Science Tokyo Hospital
RECRUITING

Tokyo, Bunkyo-ku, 113-8519, Japan
Instituto Medico Especializado
RECRUITING

Capital Federal, C1405BCH, Argentina
Instituto de Investigacion Clinica TyT
RECRUITING

CABA, C1405BFN, Argentina
Instituto de Investigaciones Clinicas Quilmes
RECRUITING

Quilmes, B1878, Argentina
Institutul Clinic Fundeni
NOT_YET_RECRUITING

Bucharest, 022328, Romania
Integral Rheumatology and Immunology Specialist
NOT_YET_RECRUITING

Plantation, Florida, 33324, United States
Intercor
NOT_YET_RECRUITING

Bydgoszcz, 85605, Poland
Investigacion y Biomedicina de Chihuahua S.C.
NOT_YET_RECRUITING

Chihuahua City, 31020, Mexico
Japan Community Healthcare Organization Chukyo Hospital
RECRUITING

Aichi, Nagoya, 457-8510, Japan
Japanese Red Cross Okayama Hospital
RECRUITING

Okayama, Okayama, 700-8607, Japan
Jilin Province People's Hospital
RECRUITING

Changchun, 130021, China
June DO, PC
NOT_YET_RECRUITING

Lansing, Michigan, 48911, United States
Juntendo University Hospital
RECRUITING

Tokyo, Bunkyo-ku, 113-8431, Japan
Juntendo University Urayasu Hospital
RECRUITING

Chiba, Urayasu, 279-0021, Japan
Keio University Hospital
NOT_YET_RECRUITING

Tokyo, Shinjuku-ku, 160-8582, Japan
Klinicki Bolnicki Centar Osijek
NOT_YET_RECRUITING

Osijek, 31000, Croatia
Klinika Reuma Park Sp. z o.o. S.K.
NOT_YET_RECRUITING

Warsaw, 02665, Poland
Klinikum der Universität München AÖR
RECRUITING

München, 80336, Germany
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
NOT_YET_RECRUITING

Maharashtra, 400053, India
Linfen Central Hospital
RECRUITING

Linfen, 041000, China
Mediadvance Clinical S.A.P.I de C.V.
NOT_YET_RECRUITING

Chihuahua City, 31203, Mexico
Medical Center Hera EOOD
RECRUITING

Sofia, 1510, Bulgaria
Medical Center Hetmanska
RECRUITING

Poznan, 60-218, Poland
Medical Center MedTech Services Ltd.
RECRUITING

Haskovo, 6304, Bulgaria
Medical Complex Sveti Ivan Rilski EOOD
NOT_YET_RECRUITING

Plovdiv, 4003, Bulgaria
Medical center "Medici Sofia" Ltd.
RECRUITING

Sofia, 1113, Bulgaria
Medicover Integrated Clinical Services Sp. z o.o.
NOT_YET_RECRUITING

Warsaw, 00874, Poland
Meris Clinical Research-Brandon-69466
NOT_YET_RECRUITING

Brandon, Florida, 33511, United States
Military Medical Academy
NOT_YET_RECRUITING

Belgrade, 11000, Serbia
Military medical academy - MHAT Pleven
NOT_YET_RECRUITING

Pleven, 5800, Bulgaria
Mühlenkreiskliniken AöR
NOT_YET_RECRUITING

Minden, 32429, Germany
Nanjing Drum Tower Hospital
RECRUITING

Nanjing, 210008, China
National Hospital Organization Chibahigashi National Hospital
RECRUITING

Chiba, Chiba, 260-8712, Japan
National Taiwan University Hospital
RECRUITING

Taipei, 100225, Taiwan
Niigata University Medical and Dental Hospital
RECRUITING

Niigata, Niigata, 951-8520, Japan
Oklahoma Medical Research Foundation
NOT_YET_RECRUITING

Oklahoma City, Oklahoma, 73104, United States
Oscar Clinical Trials
RECRUITING

Jackson, Mississippi, 39206, United States
Paramount Medical Research and Consulting
RECRUITING

Middleburg Heights, Ohio, 44130, United States
Peking Union Medical College Hospital
RECRUITING

Beijing, 100730, China
Poliklinika Bonifarm Zagreb
NOT_YET_RECRUITING

Zagreb, 10000, Croatia
Pracownia Badan Klinicznych Salus
NOT_YET_RECRUITING

Wroclaw, 53034, Poland
Pratia S.A.
RECRUITING

Krakow, 30-727, Poland
Precision Comprehensive Clinical Research Solutions
RECRUITING

Euless, Texas, 76040, United States
Precision Comprehensive Clinical Research Solutions - Colleyville
RECRUITING

Colleyville, Texas, 76034, United States
Prywatna Praktyka Lekarska Paweł Piesiak
RECRUITING

Poznan, 61-397, Poland
R&H Clinical Research - Katy
RECRUITING

Katy, Texas, 77449, United States
Renji Hospital Shanghai Jiaotong University School of Medicine
RECRUITING

Shanghai, 200040, China
Rheumazentrum Prof. Dr. med. Gunther Neeck
NOT_YET_RECRUITING

Bad Doberan, 18209, Germany
SAPIENS - Instituto de Estudos e Pesquisa Clínica
RECRUITING

Curitiba, 80810-000, Brazil
Saitama Medical University Hospital
RECRUITING

Saitama, Iruma-gun, 350-0495, Japan
Sanatorio Maipu
RECRUITING

Maipu, M5515DQA, Argentina
Semmelweis University
NOT_YET_RECRUITING

Budapest, 1021, Hungary
Shelby Research LLC
RECRUITING

Memphis, Tennessee, 38119, United States
Shinshu University Hospital
RECRUITING

Nagano, Matsumoto, 390-8621, Japan
Solmed Polyclinic
NOT_YET_RECRUITING

Zagreb, 1000, Croatia
SouthWest Rheumatology Research
NOT_YET_RECRUITING

Mesquite, Texas, 75150, United States
Specijalna Bolnica Medico
NOT_YET_RECRUITING

Rijeka, 51000, Croatia
Spitalul Clinic Dr. I. Cantacuzino
RECRUITING

Bucharest, 020475, Romania
St. Luke's International Hospital
RECRUITING

Tokyo, Chuo-ku, 104-8560, Japan
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
NOT_YET_RECRUITING

Bydgoszcz, 85-168, Poland
Taipei Medical University Hospital
RECRUITING

Taipei, 110, Taiwan
Taipei Veterans General Hospital
RECRUITING

Taipei, 112201, Taiwan
The First Affiliated Hospital of Ningbo University
RECRUITING

Ningbo, 315010, China
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING

Wenzhou, 325000, China
The Second Affiliated Hospital of Soochow University
RECRUITING

Suzhou, 215004, China
The University of Texas Health Science Center at Houston
NOT_YET_RECRUITING

Houston, Texas, 77030, United States
The third affiliated hospital of Sun Yat-Sen University
RECRUITING

Guangzhou, 510630, China
Tohoku Medical and Pharmaceutical University Hospital
RECRUITING

Miyagi, Sendai, 983-8512, Japan
Umhlanga Medical Centre
NOT_YET_RECRUITING

Durban, 4319, South Africa
University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD
RECRUITING

Sofia, 1612, Bulgaria
University of California Los Angeles
NOT_YET_RECRUITING

Torrance, California, 90509, United States
University of California San Diego
NOT_YET_RECRUITING

San Diego, California, 92037, United States
University of Miyazaki Hospital
RECRUITING

Miyazaki, Miyazaki, 889-1692, Japan
Vita Verum Medical Bt.
NOT_YET_RECRUITING

Székesfehérvár, 8000, Hungary
Wallace & Lee Center
NOT_YET_RECRUITING

Beverly Hills, California, 90210, United States
West Tennessee Research Institute
NOT_YET_RECRUITING

Jackson, Tennessee, 38305, United States
Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy
NOT_YET_RECRUITING

Warsaw, 04-141, Poland
Xiangya Hospital, Central South University
NOT_YET_RECRUITING

Changsha, 410008, China
ai medical center LLC
RECRUITING

Poznan, 61113, Poland

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