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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03385564
Ethics application status
Date submitted
21/12/2017
Date registered
28/12/2017
Date last updated
7/08/2019

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 -

Placebo Comparator: Placebo -


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
Proportion of patients with complete renal response (CRR) and without any renal flares
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Proportion of patients with proteinuria <0.8g/d and without any renal flares at week 52
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Proportion of patients with complete renal response (CRR) at week 52 and sustained steroid reduction to =5 mg/d from week 26 to week 52
Timepoint [2] 0 0
up to Week 52
Secondary outcome [3] 0 0
Proportion of patients experiencing at least one renal flare during 52 weeks
Timepoint [3] 0 0
52 weeks
Secondary outcome [4] 0 0
Time to first renal flare over the course of 52 weeks
Timepoint [4] 0 0
52 weeks
Secondary outcome [5] 0 0
Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at weeks 12, 26, 42 and 52
Timepoint [5] 0 0
Baseline and Weeks 12, 26, 42 , 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.

For Group 2 patients only:

- Age 18 -70 years at screening. For patients in Japan, age 20 - 70 years at screening.

- Diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology
(ACR) criteria 1997 with at least 4 criteria documented, one of which must either be a
positive Antinuclear Antibody (ANA) or a positive anti-double strand DeoxyriboNucleic
Acid (dsDNA) antibody at the time of starting induction therapy (historical data).

- Lupus Nephritis Class III or IV (co-existing class V permitted) based on International
Society of Nephrology / Renal Pathology Society (ISN/RPS) 2003 classification with
either active or active/chronic disease, proven by renal biopsy before the start of
induction therapy (historical data).

- Achieved either a CRR or a PRR or proteinuria = 1.5g/d (or UP/UC = 1.5) after at least
6 months of induction treatment (either with Standard of Care (SOC) (Cyclophosphamide
(CYC) or MMF-based) or SOC in combination with other available therapies used for
induction treatment of Lupus Nephritis (LN) e.g. tacrolimus, cyclosporin, experimental
drug etc.); and within 12 months after initiating induction therapy outside of 1293.10
trial.

- Steroid dose = 15 mg/d prednisone-equivalent at baseline.
Minimum age
18 Years
Maximum age
70 Years
Gender
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.

For Group 2 patients only:

- Clinically significant current non-SLE related renal diseases based on investigator's
judgment (e.g. post-infectious glomerulonephritis, pyelonephritis, interstitial
nephritis, glomerulosclerosis).

- Dialysis within 12 months of screening.

- Live vaccination within 6 weeks prior to randomisation.

- Antiphospholipid syndrome defined as positive antiphospholipid antibodies and either
history of any thrombotic event or history of miscarriage.

- Diabetes mellitus if poorly controlled or accompanied by known diabetic retinopathy or
diabetic nephropathy.It is in the investigator's judgment if the diabetes is
sufficiently controlled for the patient to enter the trial.

- With regard to previous induction treatments, the following applies:

-- Treatment with tacrolimus or cyclosporine or mizoribine within 1 month prior to
randomisation.

- Treatment with belimumab or other "BLyS antagonists" or another investigational drug
within 3 months or 5 half-lives, whichever is greater, prior to randomisation.

- Treatment with abatacept or cyclophosphamide within 3 months prior to randomisation.

- Treatment with any biologic B-cell depleting therapy (e.g. anti-CD20) within 6 months
prior to randomisation.

- Are not eligible according to the following tuberculosis (TB) screening criteria:

- Have signs or symptoms suggestive of current active or latent TB upon medical
history, physical examination and/or a chest radiograph (both posterior-anterior
and lateral views, taken within 3 months prior to the first administration of
study drug and read by a qualified radiologist).

- Have history of latent or active TB prior to screening, except for patients who
have documentation of having completed an adequate treatment regimen according to
local guidelines within the past 3 years and at least 6 months prior to the first
administration of study drug.

- Have positive QuantiFERON-TB Gold In-Tube test within 2 months prior to or during
screening, in which latent or active TB has not been ruled out, except for
patients with history of TB and documentation of having completed an adequate
treatment regimen at least 6 months prior to the first administration of study
drug.

- Any documented active or suspected malignancy or history of malignancy within 5 years
prior to screening, except appropriately treated basal cell carcinoma of the skin or
in situ carcinoma of uterine cervix.

- Previous enrolment in 1293.10 and did not complete 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
New York
Country [2] 0 0
Canada
State/province [2] 0 0
Quebec
Country [3] 0 0
Czechia
State/province [3] 0 0
Prague
Country [4] 0 0
Germany
State/province [4] 0 0
Mainz
Country [5] 0 0
Germany
State/province [5] 0 0
Stuttgart
Country [6] 0 0
Greece
State/province [6] 0 0
Athens
Country [7] 0 0
Greece
State/province [7] 0 0
Heraklion, Crete
Country [8] 0 0
Hong Kong
State/province [8] 0 0
Hong Kong
Country [9] 0 0
Japan
State/province [9] 0 0
Miyagi, Sendai
Country [10] 0 0
Japan
State/province [10] 0 0
Okayama, Okayama
Country [11] 0 0
Japan
State/province [11] 0 0
Tokyo, Bunkyo-ku
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Suwon
Country [13] 0 0
Mexico
State/province [13] 0 0
Ciudad de Mexico
Country [14] 0 0
Philippines
State/province [14] 0 0
Lipa City, Batangas
Country [15] 0 0
Poland
State/province [15] 0 0
Bialystok
Country [16] 0 0
Poland
State/province [16] 0 0
Lodz
Country [17] 0 0
Poland
State/province [17] 0 0
Nowa Sol
Country [18] 0 0
Poland
State/province [18] 0 0
Radom
Country [19] 0 0
Portugal
State/province [19] 0 0
Lisboa
Country [20] 0 0
Spain
State/province [20] 0 0
Madrid
Country [21] 0 0
Thailand
State/province [21] 0 0
Bangkok
Country [22] 0 0
Thailand
State/province [22] 0 0
Chiangmai
Country [23] 0 0
Thailand
State/province [23] 0 0
Rajathevee
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Cambridge
Country [25] 0 0
United Kingdom
State/province [25] 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 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 website
https://clinicaltrials.gov/show/NCT03385564
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
Boehringer Ingelheim
Address 0 0
Country 0 0
Phone 0 0
1-800-243-0127
Fax 0 0
Email 0 0
clintriage.rdg@boehringer-ingelheim.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03385564