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RECRUITING Phase 2

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

NCT05268289 · View on ClinicalTrials.gov ↗

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

792 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05268289

The ClinicalTrials.gov registry entry for NCT05268289 describes a study currently listed as recruiting. It is categorized as Phase 2, 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 240 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 4 interventions — of which Iptacopan (part 1) 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: NCT05268289 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Arizona. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05268289?

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 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.

Related

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