Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02770170




Registration number
NCT02770170
Ethics application status
Date submitted
11/05/2016
Date registered
12/05/2016
Date last updated
12/07/2021

Titles & IDs
Public title
Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis
Scientific title
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
Secondary ID [1] 0 0
2015-001750-15
Secondary ID [2] 0 0
1293.10
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
Experimental: BI 655064 dose 1 -

Experimental: BI 655064 dose 2 -

Experimental: BI 655064 dose 3 -

Placebo comparator: Placebo -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Patients With Complete Renal Response (CRR) at Week 52
Timepoint [1] 0 0
At week 52.
Secondary outcome [1] 0 0
Percentage of Patients With Complete Renal Response (CRR) at Week 26
Timepoint [1] 0 0
At week 26.
Secondary outcome [2] 0 0
Percentage of Patients With Partial Renal Response (PRR) at Week 26
Timepoint [2] 0 0
At week 26.
Secondary outcome [3] 0 0
Percentage of Patients With Partial Renal Response (PRR) at Week 52
Timepoint [3] 0 0
At week 52.
Secondary outcome [4] 0 0
Percentage of Patients With Major Renal Response (MRR) at Week 26
Timepoint [4] 0 0
At week 26.
Secondary outcome [5] 0 0
Percentage of Patients With Major Renal Response (MRR) at Week 52
Timepoint [5] 0 0
At week 52.

Eligibility
Key inclusion criteria
Inclusion criteria:

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

* 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.
* Live vaccination within 6 weeks before randomisation
* Patients unable to comply with the protocol in the investigator's opinion.
* Alcohol abuse in the opinion of the investigator or active drug abuse .
* Women who are pregnant, nursing, or who plan to become pregnant while in the trial
* Impaired hepatic function, defined as serum Aspartate Transferase/Alanine Transferase, bilirubin or alkaline phosphatase levels > 2 x Upper Limit of Normal
* Further exclusion criteria apply.

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
16/05/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/08/2020
Sample size
Target
Accrual to date
Final
121
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The Prince of Wales Hospital - Randwick
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
Czechia
State/province [8] 0 0
Hradec Kralove
Country [9] 0 0
Czechia
State/province [9] 0 0
Prague
Country [10] 0 0
France
State/province [10] 0 0
Creteil
Country [11] 0 0
France
State/province [11] 0 0
Paris
Country [12] 0 0
Germany
State/province [12] 0 0
Göttingen
Country [13] 0 0
Germany
State/province [13] 0 0
Hamburg
Country [14] 0 0
Germany
State/province [14] 0 0
Köln
Country [15] 0 0
Germany
State/province [15] 0 0
Lübeck
Country [16] 0 0
Germany
State/province [16] 0 0
Mainz
Country [17] 0 0
Germany
State/province [17] 0 0
Stuttgart
Country [18] 0 0
Greece
State/province [18] 0 0
Athens
Country [19] 0 0
Greece
State/province [19] 0 0
Heraklion, Crete
Country [20] 0 0
Hong Kong
State/province [20] 0 0
HK
Country [21] 0 0
Hong Kong
State/province [21] 0 0
Hong Kong
Country [22] 0 0
Italy
State/province [22] 0 0
Padova
Country [23] 0 0
Japan
State/province [23] 0 0
Fukuoka, Kitakyushu
Country [24] 0 0
Japan
State/province [24] 0 0
Hokkaido, Sapporo
Country [25] 0 0
Japan
State/province [25] 0 0
Kanagawa, Kawasaki
Country [26] 0 0
Japan
State/province [26] 0 0
Miyagi, Sendai
Country [27] 0 0
Japan
State/province [27] 0 0
Okayama, Okayama
Country [28] 0 0
Japan
State/province [28] 0 0
Tokyo, Bunkyo-ku
Country [29] 0 0
Japan
State/province [29] 0 0
Tokyo, Shinjuku-ku
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Suwon
Country [31] 0 0
Malaysia
State/province [31] 0 0
Ipoh
Country [32] 0 0
Malaysia
State/province [32] 0 0
Klang
Country [33] 0 0
Mexico
State/province [33] 0 0
Aguascalientes
Country [34] 0 0
Mexico
State/province [34] 0 0
Ciudad de Mexico
Country [35] 0 0
Mexico
State/province [35] 0 0
San Luis Potosi
Country [36] 0 0
Philippines
State/province [36] 0 0
Angeles City
Country [37] 0 0
Philippines
State/province [37] 0 0
Cebu City, Cebu
Country [38] 0 0
Philippines
State/province [38] 0 0
Cebu City
Country [39] 0 0
Philippines
State/province [39] 0 0
Davao
Country [40] 0 0
Philippines
State/province [40] 0 0
Lipa City, Batangas
Country [41] 0 0
Poland
State/province [41] 0 0
Bialystok
Country [42] 0 0
Poland
State/province [42] 0 0
Lodz
Country [43] 0 0
Poland
State/province [43] 0 0
Nowa Sol
Country [44] 0 0
Poland
State/province [44] 0 0
Radom
Country [45] 0 0
Poland
State/province [45] 0 0
Zamosc
Country [46] 0 0
Portugal
State/province [46] 0 0
Coimbra
Country [47] 0 0
Portugal
State/province [47] 0 0
Lisboa
Country [48] 0 0
Portugal
State/province [48] 0 0
Porto
Country [49] 0 0
Serbia
State/province [49] 0 0
Belgrade
Country [50] 0 0
Serbia
State/province [50] 0 0
Nis
Country [51] 0 0
Spain
State/province [51] 0 0
Barcelona
Country [52] 0 0
Spain
State/province [52] 0 0
Madrid
Country [53] 0 0
Spain
State/province [53] 0 0
Valencia
Country [54] 0 0
Thailand
State/province [54] 0 0
Bangkok
Country [55] 0 0
Thailand
State/province [55] 0 0
Chiangmai
Country [56] 0 0
Thailand
State/province [56] 0 0
Muang
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Cambridge
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Leicester
Country [59] 0 0
United Kingdom
State/province [59] 0 0
London

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

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT02770170
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02770170