The sponsor electively terminated the study because the risk mitigation measures, deemed necessary after an unforeseen safety event, could not be effectively implemented within this protocol while maintaining study timelines within a reasonable time frame.
This study will evaluate atacicept's effects in subjects who have lupus nephritis, at least 2 g/day of protein in the urine, and are already taking mycophenolate mofetil. The evaluations will include the concentrations of atacicept in the blood, the effects of atacicept on immunoglobulins (antibodies), and any side effects. The first subjects will be given a low dose. Following periodic reviews of the trial data, subsequent subjects are planned to receive one of 2 progressively higher doses of atacicept.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
1. Regimen 1: Atacicept 25 mg weekly for 12 weeks 2. Regimen 2: Atacicept 75 mg weekly for 12 weeks 3. Regimen 3: Atacicept 150 mg weekly for 12 weeks
EMD Serono Inc., One Technology Place
Rockland, Massachusetts, United States
The nature (preferred terms) and incidence of AEs
Frequency tables summarizing the observed number of AEs by System Organ Class (SOC) and preferred term will be presented per regimen.
Time frame: 12 weeks
Proportion of subjects fulfilling criteria for an Atacicept dose modification due to an IgG decrease
Percentages of subjects fulfilling the criteria (prespecified in the protocol) for an atacicept dose modification due to a decrease in IgG will be presented.
Time frame: 12 weeks
The frequency and severity of laboratory abnormalities
The incidence of subjects given each atacicept regimen who have shifts from Baseline in serum creatinine, serum albumin, urinary protein, or Hematology test (counts of white blood cells, neutrophils, lymphocytes, platelets) of at least 2 grades will be presented. Grading will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 toxicity grading, using the worst grade post-baseline during the 12-week treatment period.
Time frame: 12 weeks
The nature (preferred terms) and incidence of AEs
Frequency tables summarizing the observed number of AEs by System Organ Class (SOC) and preferred term will be presented per regimen.
Time frame: 36 weeks
Proportion of subjects fulfilling criteria for an Atacicept dose modification due to an IgG decrease
Percentages of subjects fulfilling the criteria (prespecified in the protocol) for an atacicept dose modification due to a decrease in IgG will be presented.
Time frame: 36 weeks
The frequency and severity of laboratory abnormalities
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The incidence of subjects given each atacicept regimen who have shifts from Baseline in serum creatinine, serum albumin, urinary protein, or Hematology test (counts of white blood cells, neutrophils, lymphocytes, platelets) of at least 2 grades will be presented. Grading will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 toxicity grading, using the worst grade post-baseline during the 12-week treatment period.
Time frame: 36 weeks