Submitted by: Raymond Val Padua 2017-12-01 00:00:00 Last Updated by: Jeverly Ann S. Principe 2018-01-12 14:51:14 Export to PDF

Dose-finding, efficacy and safety of BI 655064 in patients with active lupus nephritis

PHRR180112-001736

1293.10

2017-CT0406

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

This study is a Multi-national, randomized, double-blind, placebo-controlled, 4 parallel group in patients with Lupus Nephritis

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2017-12-01 12 2018-12-01 0000-00-00

Ongoing

Institution Classification Region LTO #
Boehringer Ingelheim (Philippines), Inc. Private Business NCR LTO-3000001365916
Institution Amount Region
Boehringer Ingelheim Singapore, Pte. Ltd. N/A Singapore
Name E-Mail Phone Number Postal Address
Dr. Greta Cortez MEDROPUSEASKRregistry.SG@boehringer-ingelheim.com +63 2 867 0943 Boehringer Ingelheim Phil., 23rd Floor Citibank Tower, 8741 Paseo de Roxas, Makati City
Name E-Mail Phone Number Postal Address
Dr. Greta Cortez MEDROPUSEASKRregistry.SG@boehringer-ingelheim.com +63 2 867 0943 Boehringer Ingelheim Phil., 23rd Floor Citibank Tower, 8741 Paseo de Roxas, Makati City
Name Expertise Affiliation
Harold Michael P. Gomez, MD Rhuematology Angeles University Foundation Medical Center
Rhona Laylo Recto, MD Rhuematology Mary Mediatrix Medical Center
Edgar Ramiterre, MD Rhuematology Southern Philippines Medical Center
James Bermas, MD Rhuematology Chong Hua Hospital
Merle Y. Barba, MD Rhuematology Cebu Doctors' University Hospital
Project Location Institutional Ethics Review Board
Angeles University Foundation Medical Center Angeles University Foundation Medical Center Institutional Ethics Review Committee
Mary Mediatrix Medical Center Mary Mediatrix Medical Center Institutional Ethics Review Board
Southern Philippines Medical Center SPMC Hospital Research Committee
Chong Hua Hospital Chong Hua Hospital Ethics Review Committee
Cebu Doctors' University Hospital Cebu Doctors' University Hospital - Institutional Ethics Review Committee

Active Lupus Nephritis

Primary endpoint : Proportion of patients with Complete Renal Response at
week 52

Secondary endpoints :
Proportion of patients with Complete renal response at week 26
Proportion of patients with Partial renal response at week 26 and 52
Proportion of patients with Major renal response at week 26 and 52

Pending

  • Canada
  • France
  • Germany
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Philippines
  • South Korea
  • Thailand

Clinical Trial

20170324113728

2017-09-08

None

Inclusion Criteria:

1. Males and females, age 18 –70 (inclusive) years at visit 1
2. Diagnosis of systemic lupus erythematosus (SLE) by ACR criteria 1997, at
least 4 criteria must be documented, one of which must be a positive antidsDNA
antibody at screening or around time of start of induction therapy
3. Lupus Nephritis Class III or IV (ISN/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 in case induction
therapy for LN has not yet been started
4. Active renal disease evidenced by proteinuria ≥ 1.0 g/day (Uprot/Ucrea ≥ 1)

Exclusion Criteria:

1. Clinically significant current other renal diseases, based on investigator’s judgement.
E.g.: post-infectious glomerulonephritis, pyelonephritis, interstitial nephitis,
glomerulosclerosis
2. GFR < 30 ml/min/1.73m2 at screening
3. Acute presence of oliguria (
4. Dialysis within 12 months of screening
5. Antiphospholipid syndrome, defined as positive antiphospholipid antibodies and
either history of any thrombotic event or history of miscarriage
6. Diabetes mellitus if poorly controlled according to investigator or known diabetic
retinopathy or diabetic nephropathy
7. Evidence of current or previous clinically significant disease, medical condition other
than lupus, or finding 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 toexclude patients based on clinical judgment, even if other eligibility criteria are
satisfied.
8. With regards to previous treatments the following applies.
 Any induction therapy for LN within the last 6 months prior to
randomization except induction with MMF and high dose steroids
(maximal amount of i.v. steroids 1.5g prednisone equivalent) started within
6 weeks prior to randomization. If a higher dose of iv steroids is
considered necessary by the investigator a total dose of up to 3g is
acceptable.
 Treatment with any biologic B-cell depleting therapy (e.g. anti-CD20, anti-
CD22,) within 12 months prior to randomisation
 Treatment with Belimumab or other anti BLyS: when used for treatment of
non-renal SLE 3 months or 5 half-lives whichever is longer, prior to
randomisation ; when used for treatment of Lupus nephrits: 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
9. Contraindications for SOC medication used in this trial : mycophenolate mofetil or
corticosteroids and/or known hypersensitivity to any constituents of the study drug.
10. Live vaccination within 6 weeks before randomisation
11. Clinically important as assessed by investigator acute or chronic infections including
but not limited to HIV, hepatitis B or C.
12. Patients who are not eligible according to the following tuberculosis 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 at least 6
months prior to the first administration of study agent.
 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 agent.
13. 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 and squamous cell carcinomas
14. Patients unable to comply with the protocol in the investigator’s opinion.
15. Alcohol abuse or active drug abuse in the opinion of the investigator.
16. Women who are pregnant, nursing, or who plan to become pregnant while in the trial
17. Impaired hepatic function, defined as serum AST/ALT, bilirubin or alkaline
phosphatase levels > 2 x ULN
18. Patients with significant central nervous system (CNS) symptoms related to SLE
based on investigators assessment

Observational

Unspecified

Unspecified

Randomized

Double Blind

Randomization of subjects in the following treatment group (worldwide scope) 20 patients in group 1 (120mg) 20 patients in group 2 (180 mg) 40 patients in group 3 (240 mg) 40 patients in placebo group

Single Arm

The overall purpose of this trial 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.

Other objectives of this study are safety, tolerability, pharmacokinetics, and
pharmacodynamics of BI 655064.

Phase II

6

Unspecified

Unspecified

01 Dec 2017

Utilization Utilization Info
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