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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.

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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

FieldValue
Enrollment Target 462 participants
Start Date 2022-07-14
Est. Completion 2031-02-11
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.