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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: Recruiting Phase 2 study of Lupus Nephritis, sponsored by Novartis Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Part 1: To evaluate the proportion of patients achieving complete renal response with iptacopan treatment "A" plus standard of care, compared to treatment alone Part 2: To evaluate the proportion of patients achieving complete renal response with Iptacopan treatment "B" plus standard of care, compared to treatment "D" alone Part 2: To evaluate the proportion of patients achieving complete renal response with Iptacopan treatment "C" plus standard of care, compared to treatment "D" alone Complete
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
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2022-08-10 |
| Est. Completion | 2028-09-28 |
| Phase | Phase 2 |
What NCT05268289 shows while recruiting
NCT05268289 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 302-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (21% lower).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
Similar trials for Lupus Nephritis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05268289's enrollment target sits among peer trials
240 9th of 30 higher than 22 of 30 other Lupus Nephritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lupus Nephritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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