Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04181762
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This was a pivotal, randomized, double-blind, placebo-controlled trial evaluating at Week 52 the efficacy and safety of secukinumab versus placebo in patients with active lupus nephritis (ISN/RPS Class III or IV, with or without co-existing class V features) also receiving background standard of care therapy (SoC).

Key Dates

Start date
Jul 7, 2020
Status verified
May 2025
Primary completion
Sep 13, 2023
Completion
Sep 13, 2023

Study Design

Enrollment
275 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: secukinumab
    A blinded, weekly, subcutaneous (s.c.) secukinumab 300 mg loading regimen was administered for the first 4 weeks followed by a monthly maintenance dose in all randomized subjects thereafter.
  • Placebo Comparator: placebo
    A blinded, weekly, subcutaneous (s.c.) matching placebo loading regimen was administered for the first 4 weeks followed by a monthly maintenance dose in all randomized subjects thereafter.

Primary Outcome Measure

Percentage of Participants Achieving Complete Renal Response (CRR) at Week 52 [ Time Frame: Baseline, Week 52 ]

Locations (8)

FacilityCityStateZIPSite coordinators
University Of AlabamaBirminghamAlabama35294-
Kaiser Permanente FontanaFontanaCalifornia92335-
University of California LALos AngelesCalifornia90095-
Arthritis and Rheum Dise SpecAventuraFlorida33180-
Integral Rheumatology and Immunology Specialists IRISPlantationFlorida33324-
Piedmont Heart InstituteAtlantaGeorgia30309-
Beth Israel Deaconess HospitalBostonMassachusetts02215-
Ahmed Arif Medical Research CenterGrand BlancMichigan48439-

Find similar trials in Birmingham, AL

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
University Of Alabama· Birmingham, ALKaiser Permanente Fontana· Fontana, CAUniversity of California LA· Los Angeles, CAArthritis and Rheum Dise Spec· Aventura, FLIntegral Rheumatology and Immunology Specialists IRIS· Plantation, FLPiedmont Heart Institute· Atlanta, GA

Related Studies