A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Nipocalimab in Adult Participants with Active Lupus Nephritis

Janssen-Cilag International NV0 个研究点目标入组 80 人开始时间: 2021年7月14日最近更新: 2024年5月13日

研究概览

暂无简介。

•-Male or female, 18 to 75 years of age (inclusive) at the time of consent
•-Meets classification for SLE by the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria.
•-Kidney biopsy documentation of ISN/RPS proliferative nephritis: Class III-IV (with or without concomitant Class V) within the last 6 months prior to screening or performed during screening.
•-UPCR =1.0 mg/mg assessed on 2 first morning urine void specimens during screening.
•-Must have received MMF or MPA for at least 8 weeks at the time of randomization, and currently receiving MMF at a dose of =3g/day or MPA at dose of =2.2 g/day with stable dose for at least 4 weeks prior to first administration of study intervention.
•-Currently receiving prednisone equivalent dose of 1 mg/kg/day or =60 mg/day whichever is lower, or less. Must be receiving prednisone equivalent of 10 mg/day or more at screening and randomization. Treated for =6 weeks with stable dosing = 2 weeks prior to first administration of study intervention.
•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 65
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•-Current or history of, severe, progressive, or uncontrolled renal disease, with the exception of active LN.
•-Anticipated to require dialysis within 6 months.
•-Comorbidities (other than LN, eg, asthma, chronic obstructive pulmonary disease) which have required 3 or more courses of systemic glucocorticoids within the previous 12 months.
•-Has any unstable or progressive manifestation of SLE
•-Isolated Class V LN (ie, without coexistent/majority Class III or IV nephritis).
•-Has other inflammatory diseases that might confound the evaluations of efficacy, including but not limited to RA, PsA, RA/lupus overlap, psoriasis, Crohn’s disease, or active Lyme disease.

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