Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis
A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Effect of BI 655064 Administered as Sub-cutaneous Injections, on Renal Response After One Year of Treatment, in Patients With Active Lupus Nephritis
2 other identifiers
interventional
121
20 countries
74
Brief Summary
The overall purpose of the study is to assess the efficacy of three different doses of BI 655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus nephritis in order to characterize the dose-response relationship within the therapeutic range, and select the target dose for phase III development.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2016
Typical duration for phase_2
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2016
CompletedFirst Posted
Study publicly available on registry
May 12, 2016
CompletedStudy Start
First participant enrolled
May 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 18, 2020
CompletedResults Posted
Study results publicly available
July 12, 2021
CompletedOctober 16, 2025
October 1, 2025
4.1 years
May 11, 2016
June 18, 2021
October 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Patients With Complete Renal Response (CRR) at Week 52
Complete renal response (CRR) was defined as urine protein (UP) \< 0.5 g/day at Week 52 and either estimated glomerular filtration rate (eGFR) within normal range at Week 52 or decrease in eGFR \< 20% from baseline at Week 52 if eGFR was below normal range (below lower limit of normal \[LLN\], where LLN = 90 mL/min). CRR at Week 52 (derived using UP from the 24 h urine collections) was analyzed using a logistic regression model. Factors in the model included treatment and the covariates race (Asian/Non-Asian) and proteinuria at screening (UP/urine creatinine (UC) \<3 or \>=3 g/day). Pairwise comparisons of the modelled proportions of patients with CRR at each dose level to placebo were performed.
At week 52.
Secondary Outcomes (5)
Percentage of Patients With Complete Renal Response (CRR) at Week 26
At week 26.
Percentage of Patients With Partial Renal Response (PRR) at Week 26
At week 26.
Percentage of Patients With Partial Renal Response (PRR) at Week 52
At week 52.
Percentage of Patients With Major Renal Response (MRR) at Week 26
At week 26.
Percentage of Patients With Major Renal Response (MRR) at Week 52
At week 52.
Study Arms (4)
BI 655064 dose 1
EXPERIMENTALBI 655064 dose 2
EXPERIMENTALBI 655064 dose 3
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Males and females 18-70 years. Women of childbearing potential must be ready and able (as assessed by investigator) to use simultaneously two reliable methods of birth control, one of which must be highly effective. Highly effective method, per ICH M3(R2) is a method that result in a low failure rate of less than 1% per year when used consistently and correctly.
- Diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology (ACR) criteria 1997, at least 4 criteria must be documented, one of which must be a positive anti-dsDNA antibody OR a positive antinuclear antibody (ANA) at screening or around time of start of induction therapy
- Lupus Nephritis Class III or IV (International Society of Nephrology (ISN)/Renal Pathology Society (RPS) -2003 classification) with either active or active/chronic disease, co-existing class V permitted, proven by renal biopsy within 3 months prior to screening or during screening if induction therapy has not yet been started
- Active renal disease evidenced by proteinuria ≥ 1.0 g/day \[(Uprot/Ucrea) ≥ 1\]
- Signed and dated written informed consent
You may not qualify if:
- Clinically significant current other renal disease
- Glomerular Filtration Rate \<30ml/min/1.73m²
- Dialysis within 12m of screening
- Antiphospholipid syndrome
- Diabetes mellitus poorly controlled or known diabetic retinopathy or nephropathy
- Evidence of current or previous clinically significant disease, medical condition or finding in the medical examination that in the investigator's opinion would compromise the safety of the patient or the quality of the data
- Any induction therapy for Lupus Nephritis within the last 6 months prior to randomisation except induction with Mycophenolate Mofetil and high dose steroids started within 6 weeks prior to randomisation
- Treatment with any biologic B-cell depleting therapy (e.g. anti-CD20, anti-CD22,) within 12 months prior to randomisation
- Treatment with abatacept within 12 months prior to randomisation
- Treatment with tacrolimus or cyclosporin within 4 weeks prior to randomisation
- Treatment with cyclophosphamid within 6 months prior to randomisation
- Treatment with investigational drug within 6 months or 5 half-lives, whichever is greater before randomisation
- Contraindication for MMF or corticosteroids and/or known hypersensitivity to any constituents of the study drug.
- Chronic or relevant acute infections, including but not limited to HIV, Hepatitis B and C and tuberculosis (including a history of clinical tuberculosis (TB) and/or a positive QuantiFERON TB-Gold test
- Any active or suspected malignancy or history of documented malignancy within the last 5 years before screening, except appropriately treated carcinoma in situ and treated basal cell carcinoma.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (74)
Academic Medical Research Institute
Los Angeles, California, 90022, United States
Integrity Clinical Research, LLC
Doral, Florida, 33166, United States
Hope Clinical Research
Kissimmee, Florida, 34741, United States
Integral Rheumatology and Immunology Specialist
Plantation, Florida, 33324, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwell Health
Great Neck, New York, 11021, United States
Feinstein Institute for Medical Research
Manhasset, New York, 11030, United States
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, 10032, United States
Office of Dr. Ramesh C. Gupta
Memphis, Tennessee, 38119, United States
The Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Princess Alexandra Hospital
Woolloongabba, 4102, Australia
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
CHU de Quebec-Universite Laval Research Centre
Québec, G1V 4G2, Canada
Hospital Hradec Kralove
Hradec Králové, 50005, Czechia
General University Hospital Prague 2, Nephrology Clinic
Prague, 12808, Czechia
Institute of Rheumathology Prague
Prague, 12850, Czechia
HOP Henri Mondor
Créteil, 94010, France
HOP La Pitié Salpêtrière
Paris, 75013, France
Universitätsklinikum Köln (AöR)
Cologne, 50937, Germany
Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen, 37075, Germany
Asklepios Klinik Altona
Hamburg, 22763, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, 23538, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131, Germany
Robert-Bosch-Krankenhaus GmbH
Stuttgart, 70376, Germany
General Hospital of Athens "Laiko"
Athens, 115 27, Greece
University General Hospital Attikon
Athens, 124 62, Greece
University General Hospital of Heraklion
Heraklion, Crete, 711 10, Greece
Prince of Wales Hospital
Hong Kong, 999077, Hong Kong
Queen Mary Hospital
Hong Kong, 999077, Hong Kong
Azienda Ospedaliera Universitaria di Padova
Padua, 35128, Italy
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu, 807-8556, Japan
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648, Japan
St. Marianna University School of Medicine Hospital
Kanagawa, Kawasaki, 216-8511, Japan
Tohoku University Hospital
Miyagi, Sendai, 980-8574, Japan
Okayama University Hospital
Okayama, Okayama, 700-8558, Japan
Juntendo University Hospital
Tokyo, Bunkyo-ku, 113-8431, Japan
Keio University Hospital
Tokyo, Shinjuku-ku, 160-8582, Japan
Hospital Raja Permaisuri Bainun
Ipoh, 30990, Malaysia
Hospital Tengku Ampuan Rahimah
Klang, 41200, Malaysia
Hospital Cardiologica Aguascalientes
Aguascalientes, 20230, Mexico
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico City, 14080, Mexico
Instituto Nacional de Cs Médicas y Nutrición S Zubiran
Mexico City, 14080, Mexico
H. Central Dr Ignacio M. P.
San Luis Potosí City, 78240, Mexico
Angeles University Foundation Medical Center
Angeles City, 2009, Philippines
Chong Hua Hospital
Cebu City, 6000, Philippines
Cebu Doctors Hospital
Cebu City, Cebu, 6000, Philippines
Southern Philippines Medical Center
Davao City, 8000, Philippines
Mary Mediatrix Medical Center
Lipa City, Batangas, 4217, Philippines
University Clinical Hospital in Bialystok I
Bialystok, 15-540, Poland
Norbert Barlicki University Clinical Hospital No.1, Lodz
Lodz, 90-153, Poland
Cent.Clin.Hosp.Med.Univ.Lodz,Electrocard
Lodz, 92-213, Poland
Clinic Medical Center; Nowa Sol
Nowa Sól, 67-100, Poland
NZOZ Centrum Medyczne AESKULAP,Private Prac, Radom
Radom, 26610, Poland
John Paul II Regional Hospital, Zamosc
Zamość, 22-400, Poland
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, 3000-075, Portugal
Hospital Curry Cabral, EPE
Lisbon, 1069-166, Portugal
CHULN, EPE - Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Centro Hospitalar Universitário São João,EPE
Porto, 4200-319, Portugal
Institute of Rheumatology, Belgrade
Belgrade, 11000, Serbia
Military Medical Academy
Belgrade, 11000, Serbia
Clinical Centre Nis
Niš, 18000, Serbia
Ajou University Hospital
Suwon, 16499, South Korea
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Dr. Peset
Valencia, 46017, Spain
King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
Pramongkutklao Hospital
Bangkok, 10400, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Chiangmai University
Chiang Mai, 50200, Thailand
Naresuan University Hospital
Muang, 65000, Thailand
Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
Leicester General Hospital
Leicester, LE5 4PW, United Kingdom
Guy's Hospital
London, SE1 9RT, United Kingdom
Related Publications (1)
Jayne DR, Steffgen J, Romero-Diaz J, Bajema I, Boumpas DT, Noppakun K, Amano H, Gomez HM, Satirapoj B, Avihingsanon Y, Chawanasuntorapoj R, Madero M, Naumnik B, Recto R, Fagan N, Revollo I, Wu J, Visvanathan S, Furie R. Clinical and Biomarker Responses to BI 655064, an Antagonistic Anti-CD40 Antibody, in Patients With Active Lupus Nephritis: A Randomized, Double-Blind, Placebo-Controlled, Phase II Trial. Arthritis Rheumatol. 2023 Nov;75(11):1983-1993. doi: 10.1002/art.42557. Epub 2023 Aug 17.
PMID: 37192040DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2016
First Posted
May 12, 2016
Study Start
May 16, 2016
Primary Completion
June 23, 2020
Study Completion
August 18, 2020
Last Updated
October 16, 2025
Results First Posted
July 12, 2021
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
- Access Criteria
- For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.