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NCT05268289 · ClinicalTrials.gov registry record · Phase 2

Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V

A Phase 2 study of Lupus Nephritis, sponsored by Novartis Pharmaceuticals.

Recruiting
Registry status
Phase 2
Development phase
240
Enrollment target
20
Study locations

NCT05268289 is a Phase 2 study of Lupus Nephritis that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 240 participants, below the 302-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (21% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT05268289, a Phase 2 study of Lupus Nephritis, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.

RECRUITING
Registry status
Phase 2
Development phase
240 participants
Enrollment target
20
Study locations

Study Summary

The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.

Conditions Studied

Interventions

  • DRUG Iptacopan (part 1)
  • DRUG Iptacopan (part 2)
  • DRUG Placebo + standard of care
  • DRUG Iptacopan + placebo

Study Locations (20)

California

  • Kaiser Permanente Fontana - Fontana
  • Univ Calif Irvine - Irvine
  • Ronald Reagan UCLA Medical Center - Los Angeles
  • Loma Linda University - San Bernardino
  • Olive View UCLA Medical Center - Sylmar

Florida

  • Royal Research Corp - Hollywood
  • Mayo Clinic Jacksonville - Jacksonville
  • Nephrology Associates Of Central FL - Orlando
  • Florida Kidney Physicians - Riverview
  • Florida Kidney Physicians - Riverview

Arizona

  • AKDHC Medical Research ServicesLLC - Phoenix

Colorado

  • University of Colorado Denver - Aurora

Illinois

  • Nep Assoc of Northern Illinois - Hinsdale

Kansas

  • Wichita Community Clcl Onco Program - Wichita

Louisiana

  • Ochsner Health System - New Orleans

Maryland

  • Johns Hopkins Hospital - Baltimore

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2022-08-10
Est. Completion 2028-09-28
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT05268289

The ClinicalTrials.gov registry entry for NCT05268289 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 302-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (21% lower). 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 4 interventions - of which Iptacopan (part 1) is the first listed.

NCT05268289 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT05268289 about?

NCT05268289 is a clinical study titled "Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V". The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.

What is the current status of trial NCT05268289?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 2022-08-10. Estimated completion is 2028-09-28.

What conditions does trial NCT05268289 study?

This clinical trial studies the following conditions: Lupus Nephritis.

What interventions are being tested in trial NCT05268289?

The interventions under investigation include: Iptacopan (part 1) (DRUG), Iptacopan (part 2) (DRUG), Placebo + standard of care (DRUG), Iptacopan + placebo (DRUG).

Who is sponsoring clinical trial NCT05268289?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05268289 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. 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.