lupus nephritis MedDRA version: 21.1 Level: PT Classification code 10025140 Term: Lupus nephritis System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Product Name: BI 655064
Product Code: BI 655064 120 mg (180 mg/ml)
Pharmaceutical Form: Solution for infusion in pre-filled syringe
INN or Proposed INN: Not available
Current Sponsor code: BI 655064
O
Sponsors
Boehringer Ingelheim RCV GmbH & Co KG
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 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. 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 and for at least 90 days after cessation of MMF. * A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. - 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. ** Condoms are applied for both reproductively competent and vasectomised men, because the risks associated with the transfer of seminal fluid also apply to men who have had a vasectomy. In addition, female partners of male patients treated with MMF are recommended to use highly effective contraception during treatment and for a total of 90 days after the last dose of MMF. Definition of highly effective contraceptives: • The use of hormonal methods of contraception associated with inhibition of ovulation (either combined oestrogen and progestogen containing hormonal contraception, or progestogen-only hormonal contraception) • Placement of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) • Bilateral tubal occlusion • Vasectomised sexual partner • Complete sexual abstinence Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. - 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 CRR or a PRR or proteinuria = 1g/d (or UP/UC = 1) at the end of 1293.10. For Group 2 patients : Group 2 was cancelled, therefore all inclusion criteria were cancelled. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 69 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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 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 AST/ALT, bilirubin or alkaline phosphatase > 2 x 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 MMF or AZA or glucocorticoids. - The use of any restricted medications (see section 4.2.3.1) 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: Group 2 was cancelled, therefore all exclusion criteria were cancelled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 SOC during maintenance therapy for lupus nephritis. Since patients are randomized at the start of 1293.10 and on the same treatment in 1293-0013, the baseline of trial 1293.10 will be used as baseline for all assessments of change from baseline if not specified otherwise.;Secondary Objective: Not applicable;Primary end point(s): 1) proportion of patients with complete renal reponse (CRR) and without any renal flares ;Timepoint(s) of evaluation of this end point: 1) week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Proportion of patients with CRR at week 52 2) Proportion of patients with proteinuria <0.8g/d and without any renal flares at week 52. 3) Proportion of patients with CRR at week 52 and sustained steroid reduction to =5 mg/d from week 26 to week 52. 4) Proportion of patients experiencing at least one renal flare during 52 weeks. 5) Time to first renal flare over the course of 52 weeks. 6) Proportion of patients with confirmed CRR (defined as CRR at both week 42 and week 52 using UP/UC from spot urine) 7) Change from baseline in SLEDAI at weeks 12, 26, 42 and 52.;Timepoint(s) of evaluation of this end point: 1) week 52 2) week 52 3) at week 52 and from week 26 to week 52. 4) week 52 5) throughout the trial until week 52. 6) week 42 and week 52 7) at weeks 12, 26, 42 and 52. | — |
Countries
Australia, Canada, Czechia, Czech Republic, France, Germany, Greece, Hong Kong, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Philippines, Poland, Portugal, Spain, Thailand, United Kingdom, United States
Contacts
Public ContactCT Disclosure & Data Transparency
Boehringer Ingelheim Pharma GmbH and Co. KG
Outcome results
None listed