Atacicept in Lupus Nephritis Patients Taking Stable Regimen of Mycophenolate Mofetil
A Phase Ib, Multicenter, Open Label, Dose-Escalating, Repeat-Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Atacicept When Administered to Subjects With Lupus Nephritis on a Stable Regimen of Mycophenolate Mofetil (MMF) With or Without Corticosteroids
Sponsor: EMD Serono
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
The nature (preferred terms) and incidence of AEs
Time frame: 12 weeks
Proportion of subjects fulfilling criteria for an Atacicept dose modification due to an IgG decrease
Time frame: 12 weeks
The frequency and severity of laboratory abnormalities
Time frame: 12 weeks
Secondary Endpoints
The nature (preferred terms) and incidence of AEs
Proportion of subjects fulfilling criteria for an Atacicept dose modification due to an IgG decrease
The frequency and severity of laboratory abnormalities
Eligibility Criteria
Inclusion Criteria: * Male or female subjects, ≥ 18 years of age, who provide written informed consent * Subjects must have a diagnosis of SLE satisfying ≥ 4 of 11 ACR criteria, and must have had a renal biopsy during screening or within the previous 18 months demonstrating class III (A or A/C), IV (A or A/C), V, or concomitant III/V or IV/V LN as defined by the International Society of Nephrology/Renal Pathology Society (ISN/RPS). * Subjects must have a urine protein: creatinine ratio ≥ 2 mg/mg (≥ 226.2 mg/mmol), and either a positive test for antinuclear antibody (ANA) (HEp-2 ANA ≥ 1:80) and/or anti-double stranded deoxyribonucleic acid (dsDNA) (≥ 30 IU/mL) at screening. * Subjects must have started induction therapy for LN at least 5 months prior to Trial Day 1, be considered to have received continuous treatment for LN during the 5 months prior to Trial Day 1, and have received a stable dose of MMF ≥ 1 g/day, with or without corticosteroids, for at least 8 weeks prior to Trial Day…
Read full criteria on CT.gov →✦ Analyst Commentary
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