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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03385564




Registration number
NCT03385564
Ethics application status
Date submitted
21/12/2017
Date registered
28/12/2017

Titles & IDs
Public title
An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis
Scientific title
An Exploratory Maintenance Trial Evaluating the Effect of BI 655064 in Lupus Nephritis Patients Who Have Achieved a Meaningful Response Either at the End of 1293.10 or After an Induction Treatment Outside of 1293.10
Secondary ID [1] 0 0
2017-003101-17
Secondary ID [2] 0 0
1293-0013
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lupus Nephritis 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BI 655064
Treatment: Drugs - Placebo

Experimental: BI 655064 120 mg - 120 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 comparator: Placebo - Matching 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.

Experimental: BI 655064 180 mg - 180 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.

Experimental: BI 655064 240 mg - 120 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.


Treatment: Drugs: BI 655064
subcutaneous injection

Treatment: Drugs: Placebo
subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Patients With Complete Renal Response (CRR) and Without Any Renal Flares
Timepoint [1] 0 0
At Week 52
Secondary outcome [1] 0 0
Percentage of Patients With Confirmed Complete Renal Response (CRR) and Without Any Renal Flares
Timepoint [1] 0 0
At Week 52
Secondary outcome [2] 0 0
Percentage of Patients With Proteinuria <0.8 Grams (g)/Day (d) and Without Any Renal Flares at Week 52
Timepoint [2] 0 0
At Week 52
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
At Week 52 (Sustained Steroid Reduction to =5 mg/d was evaluated from Week 26 to Week 52).
Secondary outcome [4] 0 0
Percentage of Patients Experiencing at Least One Renal Flare During 52 Weeks
Timepoint [4] 0 0
At Week 52
Secondary outcome [5] 0 0
Time to First Renal Flare Over the Course of 52 Weeks
Timepoint [5] 0 0
Up to 52 weeks.
Secondary outcome [6] 0 0
Percentage of Patients With Partial Renal Response (PRR) and Without Any Renal Flares Derived From Urine Protein (UP) 24 Hours (h) Collection at Week 52
Timepoint [6] 0 0
At Week 52
Secondary outcome [7] 0 0
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 12
Timepoint [7] 0 0
At baseline and at Week 12
Secondary outcome [8] 0 0
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 26
Timepoint [8] 0 0
At baseline and at Week 26
Secondary outcome [9] 0 0
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 42
Timepoint [9] 0 0
At baseline and at Week 42
Secondary outcome [10] 0 0
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Total Score at Week 52
Timepoint [10] 0 0
At baseline and at Week 52

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/07/2021
Sample size
Target
Accrual to date
Final
69
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec
Country [4] 0 0
Czechia
State/province [4] 0 0
Prague
Country [5] 0 0
Germany
State/province [5] 0 0
Mainz
Country [6] 0 0
Germany
State/province [6] 0 0
Stuttgart
Country [7] 0 0
Greece
State/province [7] 0 0
Athens
Country [8] 0 0
Greece
State/province [8] 0 0
Heraklion, Crete
Country [9] 0 0
Hong Kong
State/province [9] 0 0
Hong Kong
Country [10] 0 0
Japan
State/province [10] 0 0
Hokkaido, Sapporo
Country [11] 0 0
Japan
State/province [11] 0 0
Miyagi, Sendai
Country [12] 0 0
Japan
State/province [12] 0 0
Okayama, Okayama
Country [13] 0 0
Japan
State/province [13] 0 0
Tokyo, Bunkyo-ku
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Suwon
Country [15] 0 0
Malaysia
State/province [15] 0 0
Klang
Country [16] 0 0
Mexico
State/province [16] 0 0
Aguascalientes
Country [17] 0 0
Mexico
State/province [17] 0 0
Ciudad de Mexico
Country [18] 0 0
Philippines
State/province [18] 0 0
Davao
Country [19] 0 0
Philippines
State/province [19] 0 0
Lipa City, Batangas
Country [20] 0 0
Poland
State/province [20] 0 0
Bialystok
Country [21] 0 0
Poland
State/province [21] 0 0
Lodz
Country [22] 0 0
Poland
State/province [22] 0 0
Radom
Country [23] 0 0
Portugal
State/province [23] 0 0
Lisboa
Country [24] 0 0
Thailand
State/province [24] 0 0
Bangkok
Country [25] 0 0
Thailand
State/province [25] 0 0
Chiangmai
Country [26] 0 0
Thailand
State/province [26] 0 0
Rajathevee
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Cambridge
Country [28] 0 0
United Kingdom
State/province [28] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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'.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03385564