A Study of Guselkumab in Participants With Active Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of guselkumab in participants with
      active lupus nephritis (LN).
    

Detailed description: 
      Guselkumab is a monoclonal antibody (mAb) that binds to human interleukin (IL)-23 with high
      affinity and blocks binding of extracellular IL-23 to cell surface IL-23 receptor, inhibiting
      IL 23 specific intracellular signaling and subsequent activation and cytokine production. It
      is used in treatment of plaque psoriasis, psoriatic arthritis, generalized pustular
      psoriasis, erythrodermic psoriasis. Lupus is a heterogeneous autoimmune disease with lesions
      confined to skin (cutaneous lupus erythematosus [CLE]) to others that involve 1 or more vital
      internal organs (systemic lupus erythematosus [SLE]). Renal involvement due to SLE is termed
      lupus nephritis (LN). There is a high unmet need for new treatment options in LN that are
      safe and effective, especially new therapies that can provide improved long-term efficacy
      over currently available therapies. This study will evaluate safety and efficacy of
      guselkumab added to standard-of-care compared to placebo added to standard-of-care. Total
      duration of study is up to 68 weeks: a less than or equal to 8 week screening period, a 48
      week double-blind treatment period, a 12 week safety follow-up period after last dose.
      Participants who complete the assessments at Week 52 and have achieved complete renal
      response (CRR) may have the option to participate in the long-term extension (LTE) of study
      through Week 152 and the 12-week safety follow-up visit. Hypothesis of this study is that
      guselkumab plus standard-of-care is superior to placebo plus standard-of-care in participants
      with active LN as measured by the proportion of participants inducing at least a 50
      percentage reduction of proteinuria with protocol specified steroid tapering regimen at Week
      24. Safety assessments include Adverse events (AEs), clinical laboratory tests (hematology
      and chemistry), systolic and diastolic blood pressures over time, monitoring for
      hypersensitivity reactions, AEs temporally associated with infusion, injection-site
      reactions, suicidality assessment, and early detection of active tuberculosis (TB).
    

Intervention name(s): Guselkumab Dose 1; Placebo; Guselkumab Dose 2; Standard-of-care treatment
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive guselkumab Dose 1 via IV administration.; Participants will receive placebo IV at Weeks 0, 4 and 8 (that is, 3 IV doses) and placebo SC q4w from Week 12 through Week 48.; Participants will receive guselkumab Dose 2 via SC route.; Participants will receive standard of care treatment including MMF/MPA and glucocorticoids from Week 12 through Week 48.
Other intervention name(s): CNTO 1959; CNTO1959
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment