A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Guselkumab in Subjects with Active Lupus Nephritis - ORCHID

Janssen-Cilag International NV0 个研究点目标入组 60 人开始时间: 2020年6月29日最近更新: 2022年5月16日

试验速览

暂无简介。

•1. 18 to 75 years of age, inclusive.
•2. Meets classification criteria for SLE by the 2019 European League Against Rheumatism (EULAR)/ACR.
•3. Kidney biopsy documentation of ISN/RPS proliferative nephritis: Class III-IV within the last 6 months prior to screening or performed during screening.
•4. Must have received MMF or MPA for at least 8 weeks at the time of randomization, and currently receiving MMF at a dose of =3 g/day or MPA at dose of =2.2 g/day.
•5. 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 before randomization.
•Please see section 5.1 in the protocol for all inclusion criteria.
•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 54
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 6

•1. Current or history of, severe, progressive, or uncontrolled renal disease, with the exception of active LN.
•2. Anticipated to require dialysis within 6 months.
•3. Comorbidities which have required 3 or more courses of systemic glucocorticoids within the previous 12 months.
•4. Isolated or predominant Class V LN.
•5. Has a history of catastrophic antiphospholipid syndrome (APS). Subjects with a history of non-catastrophic APS must be adequately controlled with anticoagulation and/or anti-platelet therapy in accordance with local guidelines. The suitability of the subject to participate in the study must be discussed with the medical monitor and/or sponsor before the subject is randomized.
•Please see section 5.2 in the protocol for all exclusion criteria.

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