Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05126277
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • ianalumab s.c. q4w — DRUG
    ianalumab s.c. q4w in addition to SoC
  • ianalumab s.c. q12w — DRUG
    ianalumab s.c. q12w in addition to SoC
  • placebo s.c. — DRUG
    placebo s.c. q4w in addition to SoC

Study Details

This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN

Key Dates

Start date
Jul 14, 2022
Status verified
May 2026
Primary completion
Jun 22, 2027
Completion
Feb 11, 2031

Study Design

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

Arms

  • Experimental: Arm 1 - ianalumab s.c. q4w
    ianalumab s.c. q4w in addition to standard of care (SoC)
  • Experimental: Arm 2 - ianalumab s.c. q12w
    ianalumab s.c. q12w in addition to SoC
  • Placebo Comparator: Arm 3 - placebo s.c. q4w
    Placebo s.c. q4w in addition to SoC

Primary Outcome Measure

Frequency and percentage of participants achieving stable Complete Renal Response (CRR) [ Time Frame: Week 72 ]

Locations (27)

FacilityCityStateZIPSite coordinators
University Of AlabamaBirminghamAlabama35294-
Advanced Medical ResearchLa PalmaCalifornia90623-
University of California IrvineOrangeCalifornia92868-
School Of MedicineSacramentoCalifornia95817-
Kaiser PermanenteSan DiegoCalifornia92111-
University of California San DiegoSan DiegoCalifornia92037-
Mayo Clinic JacksonvilleJacksonvilleFlorida32224-
University Of MiamiMiamiFlorida33136-
Emory University School of MedicineAtlantaGeorgia30303-
Fides Clinical ResearchAtlantaGeorgia30342-
Parris and Associates RheumatologyLawrencevilleGeorgia30044-
Accurate Clinical ResearchLake CharlesLouisiana70601-
UMC New OrleansNew OrleansLouisiana70112-
Wayne State UniversityDetroitMichigan48201-
Univ of Nevada School of MedLas VegasNevada89102-
NY NephrologyClifton ParkNew York12065-
Hospital for Special SurgeryNew YorkNew York10021-
Northwell HealthNew YorkNew York10028-
Circuit ClinicalOrchard ParkNew York14127-
James J Peters VA Medical CenterThe BronxNew York10468-
University Of CincinnatiCincinnatiOhio45267-
Univ of Pennsylvania Medical CenterPhiladelphiaPennsylvania19104-
Precision Comprehensive ResearchColleyvilleTexas76034-
Univof Texas Southwestern Med CntrDallasTexas75235-
Uni of Texas Health Science CenterSan AntonioTexas78229-
Northern Assoc of Northern VAFairfaxVirginia22033-
Uni Wisconsin School Med Pub HealthMadisonWisconsin53792-

Find similar trials in Birmingham, AL

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
University Of Alabama· Birmingham, ALAdvanced Medical Research· La Palma, CAUniversity of California Irvine· Orange, CASchool Of Medicine· Sacramento, CAKaiser Permanente· San Diego, CAUniversity of California San Diego· San Diego, CA

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