An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis
2 other identifiers
interventional
69
16 countries
36
Brief Summary
The main objectives of this trial are to evaluate the long term efficacy and safety of different doses of BI 655064 versus placebo as add-on therapy to Standard of Care (SOC) during maintenance therapy for lupus nephritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2018
Typical duration for phase_2
36 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
December 21, 2017
CompletedFirst Posted
Study publicly available on registry
December 28, 2017
CompletedStudy Start
First participant enrolled
January 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2021
CompletedResults Posted
Study results publicly available
July 13, 2022
CompletedJuly 13, 2022
June 1, 2022
3.4 years
December 21, 2017
May 12, 2022
June 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Patients With Complete Renal Response (CRR) and Without Any Renal Flares
The adjusted (model-based, adjusted for race and proteinuria at screening) percentage of patients with complete renal response (CRR) and without any renal flares is reported. A logistic regression model was used including treatment and the covariates: race (Asian versus (vs.) non-Asian) and proteinuria \<3 gram (g)/day vs. ≥3 g/day (or Urine protein (UP)/ Urine creatinine (UC) \<3 vs. UP/UC ≥3) at screening. Complete renal response (CRR) was defined as urine protein (UP) \< 0.5 g/day and either estimated glomerular filtration rate (eGFR) within normal range or decrease in eGFR \< 20% from baseline if eGFR was below normal range (below lower limit of normal \[LLN\], where LLN = 90 mL/min.
At Week 52
Secondary Outcomes (10)
Percentage of Patients With Confirmed Complete Renal Response (CRR) and Without Any Renal Flares
At Week 52
Percentage of Patients With Proteinuria <0.8 Grams (g)/Day (d) and Without Any Renal Flares at Week 52
At Week 52
Percentage of Patients With Complete Renal Response (CRR) at Week 52 and Sustained Steroid Reduction to ≤5 Milligrams (mg)/Day (d) From Week 26 to Week 52
At Week 52 (Sustained Steroid Reduction to ≤5 mg/d was evaluated from Week 26 to Week 52).
Percentage of Patients Experiencing at Least One Renal Flare During 52 Weeks
At Week 52
Time to First Renal Flare Over the Course of 52 Weeks
Up to 52 weeks.
- +5 more secondary outcomes
Study Arms (4)
BI 655064 120 mg
EXPERIMENTAL120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
Placebo
PLACEBO COMPARATORMatching placebo were administered as solution for subcutaneous injection in a prefilled syringe once every week over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
BI 655064 180 mg
EXPERIMENTAL180 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every 2 weeks plus the administration of matching placebo as subcutaneous injection in a prefilled syringe once every 2 weeks (in the alternative weeks without BI 655064 administration) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
BI 655064 240 mg
EXPERIMENTAL120 milligrams (mg) BI 655064 were administered as solution for subcutaneous injection in a prefilled syringe once every week (240 mg every 2 weeks) over a treatment period of 52 weeks, followed by a 12-week follow-up period. The patients received 1 injection per week.
Interventions
Eligibility Criteria
You may qualify if:
- Male or female patients.
- Women of childbearing potential and men able to father a child must be ready and able to use two reliable methods of birth control simultaneously, one of which must be highly effective. Highly effective birth control per International Conference on Harmonisation (ICH) M3(R2) is a method that result in a low failure rate of less than 1% per year when used consistently and correctly. The reliable methods of birth control must be used before starting Mycophenolate mofetil/Azathioprine (MMF/AZA) and the trial drug; then continue during the trial period; and for at least 50 days after the last dose of MMF/AZA and trial medication. In case a female patient is treated with AZA the contraception shall continue for 90 days after treatment with AZA.A list of contraception methods meeting these criteria is provided in the patient information.
- Sexually active men must be ready to use condoms during treatment with MMF/AZA and for at least 90 days after cessation of MMF/AZA.
- Permanent sterilisation methods include hysterectomy, bilateral oophorectomy and bilateral salpingectomy.
- Tubal ligation is NOT a method of permanent sterilisation.
- A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- For Group 1 patients only:
- \- Achieved either a Complete renal Response (CRR) or a Partial Renal Response (PRR) or proteinuria ≤ 1g/d (or UP/UC ≤ 1) at the end of 1293.10.
You may not qualify if:
- Evidence of current or previous clinically significant diseases or medical conditions other than lupus, or findings of the medical examination (including vital signs and ECG) that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the data. This criterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other eligibility criteria are satisfied.
- Significant central nervous system symptoms related to Systemic Lupus Erythematosus (SLE) based on investigators assessment.
- Clinically important acute or chronic infections including but not limited to HIV, hepatitis B or C.
- Impaired hepatic function defined as serum Aspartate Aminotransferase/Alanine Aminotransferase (AST/ALT), bilirubin or alkaline phosphatase \> 2 x Upper Limit of Normal (ULN).
- Estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2 at screening (using CKD-EPI formula).
- Known hypersensitivity to any constituents of the trial medication; and/or contraindications to Mycophenolate mofetil (MMF) or Azathioprine (AZA) or glucocorticoids.
- The use of any restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
- Unable to comply with the protocol in the investigator's opinion.
- Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable trial patient or unlikely to complete the trial.
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Integral Rheumatology and Immunology Specialist
Plantation, Florida, 33324, 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
Princess Alexandra Hospital
Woolloongabba, 4102, Australia
CHU de Quebec-Universite Laval Research Centre
Québec, G1V 4G2, Canada
General University Hospital
Prague, 12808, Czechia
Institute of Rheumathology Prague
Prague, 12850, Czechia
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131, Germany
Robert-Bosch-Krankenhaus GmbH
Stuttgart, 70376, Germany
University General Hospital Attikon
Athens, 124 62, Greece
University General Hospital of Heraklion
Heraklion, Crete, 71500, Greece
Prince of Wales Hospital
Hong Kong, 999077, Hong Kong
Queen Mary Hospital
Hong Kong, 999077, Hong Kong
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648, 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
Hospital Tengku Ampuan Rahimah
Klang, 41200, Malaysia
Centenario Hospital Miguel Hidalgo
Aguascalientes, 20259, Mexico
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico City, 14080, Mexico
Instituto Nacional de Cs Médicas y Nutrición S Zubiran
Mexico City, 14080, Mexico
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
NZOZ Centrum Medyczne AESKULAP,Private Prac, Radom
Radom, 26610, Poland
Hospital Curry Cabral, EPE
Lisbon, 1069-166, Portugal
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria
Lisbon, 1649-028, Portugal
Ajou University Hospital
Suwon, 16499, South Korea
Siriraj Hospital
Bangkok, 10170, Thailand
King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
Chiangmai University
Chiang Mai, 50200, Thailand
Pramongkutklao Hospital
Rajathevee, 10400, Thailand
Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
Guy's Hospital
London, SE1 9RT, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- 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
December 21, 2017
First Posted
December 28, 2017
Study Start
January 9, 2018
Primary Completion
May 25, 2021
Study Completion
July 27, 2021
Last Updated
July 13, 2022
Results First Posted
July 13, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
- 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 both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this 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". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to 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. The data shared are the raw clinical study data sets.