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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 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.
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
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 462 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 295-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (57% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.