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NCT05126277 · ClinicalTrials.gov registry record · Phase 3
Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis
A Phase 3 study of Lupus Nephritis, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 462
- Enrollment target
- 20
- Study locations
NCT05126277: Recruiting Phase 3 study of Lupus Nephritis, sponsored by Novartis Pharmaceuticals.
NCT05126277 is a Phase 3 study of Lupus Nephritis that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 462 participants, above the 295-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (57% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05126277, a Phase 3 study of Lupus Nephritis, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 462 participants
- Enrollment target
- 20
- Study locations
Study Summary
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
Primary Outcome
The primary objective is to demonstrate superiority of ianalumab compared to placebo, in achieving stable CRR (defined as estimated glomerular filtration rate (eGFR) ≥90 ml/min/1.73 m2 or no less than 85% of baseline, AND, 24-hour UPCR \<0.5 g/g) at Week 72 in active lupus nephritis (ISN/RPS class III, IV active glomerulonephritis with or without co-existing class V features, or pure class V membranous) participants on background SoC therapy.
Conditions Studied
Interventions
- DRUG ianalumab s.c. q4w
- DRUG ianalumab s.c. q12w
- DRUG placebo s.c.
Study Locations (20)
California
- Advanced Medical Research - La Palma
- Wallace Rheumatic Study Center - Los Angeles
- University of California LA - Los Angeles
- University of California Irvine - Orange
- School Of Medicine - Sacramento
- University of California San Diego - San Diego
- Kaiser Permanente - San Diego
Georgia
- Emory University School of Medicine - Atlanta
- Fides Clinical Research - Atlanta
- Parris and Associates Rheumatology - Lawrenceville
Florida
- Mayo Clinic Jacksonville - Jacksonville
- University Of Miami - Miami
Louisiana
- Accurate Clinical Research - Lake Charles
- UMC New Orleans - New Orleans
Alabama
- University Of Alabama - Birmingham
Kansas
- University of Kansas Hospital - Kansas City
Michigan
- Wayne State University - Detroit
Nevada
- Univ of Nevada School of Med - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 462 participants |
| Start Date | 2022-07-14 |
| Est. Completion | 2031-02-11 |
| Phase | Phase 3 |
What NCT05126277 shows while recruiting
NCT05126277 is an interventional study that assigns participants to a tested intervention. The registered 462 participants enrollment target is mid-sized for trials with a published cap, above the 295-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (57% higher).
The record links to 1 condition, with Lupus Nephritis appearing as the primary indexed condition, and to 3 interventions - of which ianalumab s.c. q4w is the first listed.
NCT05126277 names 20 study sites across 10 states, led by California, Georgia, Florida.
Frequently Asked Questions
What is clinical trial NCT05126277 about?
NCT05126277 is a clinical study titled "Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis". 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
What is the current status of trial NCT05126277?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 462 participants. The study started on 2022-07-14. Estimated completion is 2031-02-11.
What conditions does trial NCT05126277 study?
This clinical trial studies the following conditions: Lupus Nephritis.
What interventions are being tested in trial NCT05126277?
The interventions under investigation include: ianalumab s.c. q4w (DRUG), ianalumab s.c. q12w (DRUG), placebo s.c. (DRUG).
Who is sponsoring clinical trial NCT05126277?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05126277 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lupus Nephritis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05126277's enrollment target sits among peer trials
462 3rd of 30 higher than 28 of 30 other Lupus Nephritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lupus Nephritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis
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-
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis
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Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V
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-
The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study
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