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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 : May 15, 2019
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE December 21, 2017
First Posted Date  ICMJE December 28, 2017
Last Update Posted Date May 15, 2019
Actual Study Start Date  ICMJE January 9, 2018
Estimated Primary Completion Date March 29, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2017)
Proportion of patients with complete renal response (CRR) and without any renal flares [ Time Frame: Week 52 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03385564 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2017)
  • Proportion of patients with proteinuria <0.8g/d and without any renal flares at week 52 [ Time Frame: Week 52 ]
  • 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 ]
  • Proportion of patients experiencing at least one renal flare during 52 weeks [ Time Frame: 52 weeks ]
  • Time to first renal flare over the course of 52 weeks [ Time Frame: 52 weeks ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Lupus Nephritis
Intervention  ICMJE
  • Drug: BI 655064
    subcutaneous injection
  • Drug: Placebo
    subcutaneous injection
Study Arms  ICMJE
  • Experimental: BI 655064
    Intervention: Drug: BI 655064
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 24, 2018)
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2017)
Estimated Study Completion Date  ICMJE June 29, 2022
Estimated Primary Completion Date March 29, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Boehringer Ingelheim 1-800-243-0127
Listed Location Countries  ICMJE Australia,   Canada,   Czechia,   Germany,   Greece,   Hong Kong,   Japan,   Mexico,   Poland,   Portugal,   Spain,   Thailand,   United Kingdom,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03385564
Other Study ID Numbers  ICMJE 1293-0013
2017-003101-17 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP