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Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis
NCT05126277 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05126277
The ClinicalTrials.gov registry entry for NCT05126277 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 462 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05126277 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Georgia, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05126277?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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