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Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02770170
Recruitment Status : Active, not recruiting
First Posted : May 12, 2016
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE May 11, 2016
First Posted Date  ICMJE May 12, 2016
Last Update Posted Date October 2, 2019
Actual Study Start Date  ICMJE May 16, 2016
Estimated Primary Completion Date December 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
Proportion of patients with complete renal response [ Time Frame: week 52 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02770170 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
  • Proportion of patients with complete renal response [ Time Frame: week 26 ]
  • Proportion of patients with partial renal response [ Time Frame: week 26 and 52 ]
  • Proportion of patients with major renal response [ Time Frame: week 26 and 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 Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis
Official Title  ICMJE 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
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.
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 dose 1
  • Drug: BI 655064 dose 2
  • Drug: BI 655064 dose 3
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: BI 655064 dose 1
    Intervention: Drug: BI 655064 dose 1
  • Experimental: BI 655064 dose 2
    Intervention: Drug: BI 655064 dose 2
  • Experimental: BI 655064 dose 3
    Intervention: Drug: BI 655064 dose 3
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 16, 2019)
121
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2016)
120
Estimated Study Completion Date  ICMJE August 25, 2020
Estimated Primary Completion Date December 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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.
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Czechia,   France,   Germany,   Greece,   Hong Kong,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   Philippines,   Poland,   Portugal,   Serbia,   Spain,   Thailand,   United Kingdom,   United States
Removed Location Countries Austria,   Czech Republic,   Turkey
 
Administrative Information
NCT Number  ICMJE NCT02770170
Other Study ID Numbers  ICMJE 1293.10
2015-001750-15 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date September 2019

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