An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03385564
Recruitment Status : Recruiting
First Posted : December 28, 2017
Last Update Posted : February 6, 2019
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: BI 655064 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : January 9, 2018
Estimated Primary Completion Date : March 29, 2022
Estimated Study Completion Date : June 29, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BI 655064 Drug: BI 655064
subcutaneous injection

Placebo Comparator: Placebo Drug: Placebo
subcutaneous injection

Primary Outcome Measures :
  1. Proportion of patients with complete renal response (CRR) and without any renal flares [ Time Frame: Week 52 ]

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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03385564

Contact: Boehringer Ingelheim 1-800-243-0127

United States, New York
Northwell Health Recruiting
Great Neck, New York, United States, 11021
Contact: Sonali Narain    +001 (516) 708-2550   
Princess Alexandra Hospital Recruiting
Woolloongabba, Australia, 4102
Contact: Ross Francis    61 7 3176 5080   
CHU de Quebec-Universite Laval Research Centre Recruiting
Quebec, Canada, G1V 4G2
Contact: Paul Fortin    (418) 654-2178   
General University Hospital Prague 2, Nephrology Clinic Recruiting
Prague, Czechia, 12808
Contact: Vladimir Tesar    +420 224 962.664   
Institute of Rheumathology Prague Recruiting
Prague, Czechia, 12850
Contact: Jakub Zavada    +420 234 075 427   
University General Hospital Attikon Recruiting
Athens, Greece, 124 62
Contact: Dimitrios Boumpas    2105831990 / 1935   
Gen.Univ.Hosp. of Heraklion Recruiting
Heraklion, Crete, Greece, 711 10
Contact: Prodromos Sidiropoulos    +302810394783   
Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Lai-Shan Tam    852 3505 1429   
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Daniel Tak Mao Chan    852 2255 5977   
Tohoku University Hospital Recruiting
Miyagi, Sendai, Japan, 980-8574
Contact: Tomonori Ishii    022-717-7000   
Juntendo University Hospital Recruiting
Tokyo, Bunkyo-ku, Japan, 113-8431
Contact: Hirofumi Amano    03-3813-3111   
Instituto Nacional de Cardiologia Ignacio Chavez Recruiting
Ciudad de Mexico, Mexico, 14080
Contact: Magdalena Madero Rovalo    55 73 29 11 Ext.1264   
Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubiran" Recruiting
Ciudad de Mexico, Mexico, 14080
Contact: Juanita Romero Díaz    +52 5487 0900 Ext. 2604   
University Clinical Hospital in Bialystok I Recruiting
Bialystok, Poland, 15-540
Contact: Beata Naumnik    +48857409458   
Clinic Medical Center; Nowa Sol Recruiting
Nowa Sol, Poland, 67-100
Contact: Malgorzata Miakisz    0048684177519   
NZOZ Centrum Medyczne AESKULAP,Private Prac, Radom Recruiting
Radom, Poland, 26610
Contact: Antoni Sokalski    +48 361 5140   
CHLN, EPE - Hospital de Santa Maria Recruiting
Lisboa, Portugal, 1649-028
Contact: Carla Macieira    00351 217802769   
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Manuel Praga    +34913908383   
King Chulalongkorn Memorial Hospital Recruiting
Bangkok, Thailand, 10330
Contact: Yingyos Avihingsanon    +662-256-4251   
Chiangmai University Recruiting
Chiangmai, Thailand, 50200
Contact: Kajohnsak Noppakun    +6653- 934-451   
Pramongkutklao Hospital Recruiting
Rajathevee, Thailand, 10400
Contact: Bancha Satirapoj    +66 2 3547600 ext 94296   
United Kingdom
Guy's Hospital Recruiting
London, United Kingdom, SE1 9RT
Contact: David D'Cruz    02071 889 756    david.d'   
Sponsors and Collaborators
Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim Identifier: NCT03385564     History of Changes
Other Study ID Numbers: 1293-0013
2017-003101-17 ( EudraCT Number )
First Posted: December 28, 2017    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases