Clinical trial • Phase II • Immunology
BI 3000202 for Systemic lupus erythematosus
Phase II trial of BI 3000202 for Systemic lupus erythematosus.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Systemic lupus erythematosus
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 19-01-2026
- First CTIS Authorization Date
- 04-05-2026
Trial design
Randomised, placebo matching bi 3000202 (placebo). no dose or schedule for the comparator is specified in the available data.-controlled Phase II trial in Bulgaria, Croatia, Germany and others.
- Randomised
- Yes
- Comparator
- Placebo matching BI 3000202 (placebo). No dose or schedule for the comparator is specified in the available data.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 110
- Trial Duration For Participant
- 364
Eligibility
Recruits 110 Vulnerable population not selected (isVulnerablePopulationSelected=false). Trial enrolls adults (≥18 to <75). Informed consent provided by adult participants; no assent/consent procedures for minors or other vulnerable groups are described in the available data..
- Vulnerable Population
- Vulnerable population not selected (isVulnerablePopulationSelected=false). Trial enrolls adults (≥18 to <75). Informed consent provided by adult participants; no assent/consent procedures for minors or other vulnerable groups are described in the available data.
Inclusion criteria
- {"criterion_text":"- 1. Male and female adult patients from ≥18 years (or alternative age for adults based on local regulations) to <75 years\n- 2. Confirmed SLE diagnosis meeting the EULAR/ACR classification criteria at least 24 weeks prior to screening\n- 3. At least one of the following positive at screening: antinuclear antibodies (ANA) ≥1:80 or anti-dsDNA antibody or anti-Smith antibody\n- 4. Total SLEDAI-2K score ≥6 points and clinical SLEDAI-2K score ≥4 points\n- 5. At least 1 BILAG A and/or 1 BILAG B grade at screening, with sufficient disease activity according to both investigator and adjudicator\n- 6. 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)\n- 7. Further inclusion criteria apply."}
Exclusion criteria
- {"criterion_text":"- 1. Drug-induced SLE\n- 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\n- 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\n- 4. Lupus nephritis that may require a change in immune-modulating treatment or which demonstrates serum creatinine that is unstable or >2 × ULN and/or UPCR that is unstable or > 3mg/mg (339 mg/mmol)\n- 5. Oral corticosteroids (prednisone or equivalent) >30 mg/day at screening\n- 6. Further exclusion criteria apply."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Achievement of a Systemic Lupus Erythematosus Responder Index (SRI)-4 response at Week 32","definition_or_measurement_approach":"Defined as achievement of SRI-4 response at Week 32 (as stated in the protocol summary and objectives)."}
Secondary endpoints
- {"endpoint_text":"- Achievement of SRI-4 response at Week 52","definition_or_measurement_approach":"Defined as achievement of SRI-4 response at Week 52 (as stated)."}
- {"endpoint_text":"- Achievement of SRI-4 response and oral corticosteroid reduction to ≤5 mg/day prednisone or equivalent at Week 32","definition_or_measurement_approach":"Defined as achievement of SRI-4 response with oral corticosteroid dose reduced to ≤5 mg/day prednisone (or equivalent) at Week 32 (as stated)."}
- {"endpoint_text":"- Achievement of Lupus Low Disease Activity State (LLDAS) at Week 32","definition_or_measurement_approach":"Defined as achievement of LLDAS at Week 32 (as stated)."}
Recruitment
- Planned Sample Size
- 110
- Recruitment Window Months
- 38
- Consent Approach
- Informed consent to be provided by adult participants (patients ≥18). Subject information and ICF documents are available in multiple country/language-specific versions (examples in the public documents list: Bulgarian, English, Croatian, German, Hungarian, Romanian, Spanish, Polish and others). There are also partner/pregnant-subject information forms listed. Specific assent processes for minors or alternative consent processes are not described in the available data.
Geography
- Total Number Of Sites
- 29
- Total Number Of Participants
- 106
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 23-04-2026
- Latest Decision Or Authorization Date
- 07-05-2026
- Processing Time Days
- 14
- Number Of Sites
- 8
- Number Of Participants
- 30
Sites
- Site Name
- University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
- Department Name
- Clinic of Rheumatology
- Principal Investigator Name
- Valentina Reshkova
- Principal Investigator Email
- v_reshkova@abv.bg
- Contact Person Name
- Valentina Reshkova
- Contact Person Email
- v_reshkova@abv.bg
- Site Name
- Medical Center Hera EOOD
- Department Name
- Medical Center
- Principal Investigator Name
- Sarita Kostova
- Principal Investigator Email
- sarita.kostova@gmail.com
- Contact Person Name
- Sarita Kostova
- Contact Person Email
- sarita.kostova@gmail.com
- Site Name
- Medici Sofia Medical Centre Ltd.
- Department Name
- Medical Center
- Principal Investigator Name
- Georgi Kotov
- Principal Investigator Email
- gnkotov1@gmail.com
- Contact Person Name
- Georgi Kotov
- Contact Person Email
- gnkotov1@gmail.com
- Site Name
- Medical Center Excelsior OOD
- Department Name
- Medical Center
- Principal Investigator Name
- Daniela Bichovska
- Principal Investigator Email
- ivdan@abv.bg
- Contact Person Name
- Daniela Bichovska
- Contact Person Email
- ivdan@abv.bg
- Site Name
- Military Medical Academy
- Department Name
- Department of Rheumatology
- Principal Investigator Name
- Tihomir Gorchev
- Principal Investigator Email
- dr.gorchev@gmail.com
- Contact Person Name
- Tihomir Gorchev
- Contact Person Email
- dr.gorchev@gmail.com
- Site Name
- Medical Center Medtech Services Ltd.
- Department Name
- Medical Center Medtech Services Ltd.
- Principal Investigator Name
- Krasimir Kraev
- Principal Investigator Email
- dr_k.kraev@abv.bg
- Contact Person Name
- Krasimir Kraev
- Contact Person Email
- dr_k.kraev@abv.bg
- Site Name
- Diagnostic-Consultative Center Alexandrovska EOOD
- Department Name
- DCC
- Principal Investigator Name
- Delina Ivanova
- Principal Investigator Email
- dr-delina@mail.bg
- Contact Person Name
- Delina Ivanova
- Contact Person Email
- dr-delina@mail.bg
- Site Name
- University Multiprofessional Hospital For Active Treatment Plovdiv AD
- Department Name
- Rheumatology department
- Principal Investigator Name
- Ivan Goranov
- Principal Investigator Email
- goranov_ivan@yahoo.com
- Contact Person Name
- Ivan Goranov
- Contact Person Email
- goranov_ivan@yahoo.com
Croatia
- Earliest CTIS Part Ii Submission Date
- 13-04-2026
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 25
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Klinicki Bolnicki Centar Osijek
- Department Name
- Department of Rheumatology, Clinical Immunology and Allergology
- Principal Investigator Name
- Jasminka Milas-Ahić
- Principal Investigator Email
- jmilasahic@gmail.com
- Contact Person Name
- Jasminka Milas-Ahić
- Contact Person Email
- jmilasahic@gmail.com
- Site Name
- Poliklinika Solmed d.o.o.
- Department Name
- Practice
- Principal Investigator Name
- Fanika Mrsić
- Principal Investigator Email
- fmrsic@yahoo.com
- Contact Person Name
- Fanika Mrsić
- Contact Person Email
- fmrsic@yahoo.com
- Site Name
- Specijalna Bolnica Medico
- Department Name
- Practice
- Principal Investigator Name
- Marija Rogoznica Pavlović
- Principal Investigator Email
- marija.rogoznica@gmail.com
- Contact Person Name
- Marija Rogoznica Pavlović
- Contact Person Email
- marija.rogoznica@gmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 02-04-2026
- Latest Decision Or Authorization Date
- 12-05-2026
- Processing Time Days
- 40
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Johannes Wesling Klinikum Minden
- Department Name
- Klinik für Rheumatologie und klinische Immunologie
- Principal Investigator Name
- Gunter Assmann
- Principal Investigator Email
- Gunter.Assmann@muehlenkreiskliniken.de
- Contact Person Name
- Gunter Assmann
- Contact Person Email
- Gunter.Assmann@muehlenkreiskliniken.de
- Site Name
- LMU Klinikum Muenchen AöR
- Department Name
- Medizinische Klinik und Poliklinik IV,
- Principal Investigator Name
- Hendrik Schulze-Koops
- Principal Investigator Email
- hendrik.schulze-koops@med.uni-muenchen.de
- Contact Person Name
- Hendrik Schulze-Koops
- Contact Person Email
- hendrik.schulze-koops@med.uni-muenchen.de
Hungary
- Earliest CTIS Part Ii Submission Date
- 17-03-2026
- Latest Decision Or Authorization Date
- 12-05-2026
- Processing Time Days
- 56
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Vita Verum Medical Bt.
- Department Name
- SMed Magankorhaz
- Principal Investigator Name
- Tunde Varga
- Principal Investigator Email
- vargatundedr1@gmail.com
- Contact Person Name
- Tunde Varga
- Contact Person Email
- vargatundedr1@gmail.com
- Site Name
- Semmelweis University
- Department Name
- Rheumatology
- Principal Investigator Name
- Gyorgy Nagy
- Principal Investigator Email
- gyorgyngy@gmail.com
- Contact Person Name
- Gyorgy Nagy
- Contact Person Email
- gyorgyngy@gmail.com
Romania
- Earliest CTIS Part Ii Submission Date
- 09-04-2026
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 32
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Spitalul Clinic Dr. I. Cantacuzino
- Department Name
- Internal Medicine and Rheumatology
- Principal Investigator Name
- Ana Maria Gheorghiu
- Principal Investigator Email
- ana.gherghe@gmail.com
- Contact Person Name
- Ana Maria Gheorghiu
- Contact Person Email
- ana.gherghe@gmail.com
- Site Name
- Centrul Clinic De Boli Reumatismale Dr. Ion Stoia
- Department Name
- Rheumatology
- Principal Investigator Name
- Catalin Codreanu
- Principal Investigator Email
- ccodreanu01@gmail.com
- Contact Person Name
- Catalin Codreanu
- Contact Person Email
- ccodreanu01@gmail.com
- Site Name
- Delta Health Care S.R.L.
- Department Name
- Rheumatology
- Principal Investigator Name
- Bogdan Chicos
- Principal Investigator Email
- b_chicos@yahoo.com
- Contact Person Name
- Bogdan Chicos
- Contact Person Email
- b_chicos@yahoo.com
Spain
- Earliest CTIS Part Ii Submission Date
- 27-04-2026
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 7
- Number Of Sites
- 5
- Number Of Participants
- 7
Sites
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Servicio de Reumatologia
- Principal Investigator Name
- Anne Riveros Frutos
- Principal Investigator Email
- amriveros.germanstrias@gencat.cat
- Contact Person Name
- Anne Riveros Frutos
- Contact Person Email
- amriveros.germanstrias@gencat.cat
- Site Name
- Hospital De Galdakao Usansolo
- Department Name
- Servicio de Reumatología
- Principal Investigator Name
- Irati Urionagüena Onaindia
- Principal Investigator Email
- irati.urionaguenaonaindia@osakidetza.eus
- Contact Person Name
- Irati Urionagüena Onaindia
- Contact Person Email
- irati.urionaguenaonaindia@osakidetza.eus
- Site Name
- Hospital Universitario Araba
- Department Name
- Servicio de Reumatología -Sede Txagorritxu
- Principal Investigator Name
- Jaime Calvo Alen
- Principal Investigator Email
- JAIME.CALVOALEN@osakidetza.eus
- Contact Person Name
- Jaime Calvo Alen
- Contact Person Email
- JAIME.CALVOALEN@osakidetza.eus
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Servicio de Reumatología
- Principal Investigator Name
- Sandra Garrote Corral
- Principal Investigator Email
- sandteco@hotmail.com
- Contact Person Name
- Sandra Garrote Corral
- Contact Person Email
- sandteco@hotmail.com
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Servicio de Reumatología
- Principal Investigator Name
- Berta Magallares
- Principal Investigator Email
- bmagallares@santpau.cat
- Contact Person Name
- Berta Magallares
- Contact Person Email
- bmagallares@santpau.cat
Poland
- Earliest CTIS Part Ii Submission Date
- 13-04-2026
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 25
- Number Of Sites
- 6
- Number Of Participants
- 39
Sites
- Site Name
- Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
- Department Name
- Department of Rheumatology and Connective Tissue Diseases
- Principal Investigator Name
- Iwona Dankiewicz-Fares
- Principal Investigator Email
- iwonafares@wp.pl
- Contact Person Name
- Iwona Dankiewicz-Fares
- Contact Person Email
- iwonafares@wp.pl
- Site Name
- Ai Centrum Medyczne Sp. z o.o.
- Department Name
- Practice
- Principal Investigator Name
- Anna Rychlewska-Hanczewska
- Principal Investigator Email
- a.hanczewska@wp.pl
- Contact Person Name
- Anna Rychlewska-Hanczewska
- Contact Person Email
- a.hanczewska@wp.pl
- Site Name
- Prywatna Praktyka Lekarska
- Department Name
- Prywatna Praktyka Lekarska
- Principal Investigator Name
- Paweł Hrycaj
- Principal Investigator Email
- pawel.hrycaj@gmail.com
- Contact Person Name
- Paweł Hrycaj
- Contact Person Email
- pawel.hrycaj@gmail.com
- Site Name
- Pratia S.A.
- Department Name
- Pratia MCM Krakow
- Principal Investigator Name
- Piotr Gluszko
- Principal Investigator Email
- zruj@mp.pl
- Contact Person Name
- Piotr Gluszko
- Contact Person Email
- zruj@mp.pl
- Site Name
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
- Department Name
- Department of Internal Diseases and Rheumatology
- Principal Investigator Name
- Joanna Kur-Zalewska
- Principal Investigator Email
- jkur-zalewska@wim.mil.pl
- Contact Person Name
- Joanna Kur-Zalewska
- Contact Person Email
- jkur-zalewska@wim.mil.pl
- Site Name
- Medyczne Centrum Hetmanska
- Department Name
- Medyczne Centrum Hetmańska
- Principal Investigator Name
- Piotr Leszczynski
- Principal Investigator Email
- piotr.leszczynski@centrum-hetmanska.pl
- Contact Person Name
- Piotr Leszczynski
- Contact Person Email
- piotr.leszczynski@centrum-hetmanska.pl
Sponsor
Primary sponsor
- Full Name
- Boehringer Ingelheim International GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- sponsorDuties codes: 1, 12; contact josephine.kench@iqvia.com
Third parties
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1, 12","organisation_type":"Pharmaceutical company"}
Co-sponsors
- Boehringer Ingelheim Espana S.A.
Investigational products
- Investigational Product Name
- BI 3000202
- Active Substance
- BI 3000202
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Authorised (prodAuthStatus=1)
- Investigational Product Name
- Placebo matching BI 3000202
- Modality
- Other
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