← Back to Search

Iptacopan for Lupus Nephritis

Verified Trial
Phase 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
First presentation or flare of lupus nephritis.
You have been diagnosed with class III or IV lupus nephritis
Timeline
Screening 34 days
Treatment 52 weeks
Follow Up 30 days
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is effective, safe, and well tolerated when used in addition to standard care for treating patients.

Who is the study for?
This trial is for people who are experiencing their first or a recurring episode of lupus nephritis, specifically class III or IV. Participants must have active kidney disease and be vaccinated against certain infections. Those who've had recent kidney treatments or biopsies, or specific medications like cyclophosphamide, cannot join.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of iptacopan (LNP023) in treating lupus nephritis when added to standard care. It's divided into two parts: one where participants get iptacopan plus placebo, and another with just iptacopan.See study design
What are the potential side effects?
While not specified here, potential side effects may include reactions at the site of injection, increased risk of infection due to immune system suppression, liver issues, blood disorders, and gastrointestinal symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My kidney problems are due to a first-time or worsening lupus.
Select...
I have been diagnosed with severe lupus affecting my kidneys.
Select...
I have had a kidney biopsy in the last 3 months or am willing to get one.
Select...
I am willing to get vaccinated for the study.

Timeline

Screening ~ 34 days
Treatment ~ 52 weeks
Follow Up ~30 days
This trial's timeline: 34 days for screening, 52 weeks for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1 and 2: Proportion of patients achieving Complete Renal Response (CRR) at week 24 in the absence of renal flares
Secondary outcome measures
Change from baseline FACIT-Fatigue Score
Change from baseline in BILAG-2004 score at weeks 24 and 52
Change from baseline in SLEDAI-2K score at weeks 24 and 52
+4 more

Trial Design

5Treatment groups
Active Control
Placebo Group
Group I: Placebo matching iptacopan + standard of care (part 2)Active Control1 Intervention
Placebo matching iptacopan + standard of care
Group II: Iptacopan + standard of care (part 2)Active Control1 Intervention
Iptacopan + standard of care
Group III: Iptacopan + placebo (part 2)Active Control1 Intervention
Iptacopan + placebo standard of care
Group IV: Iptacopan + standard of care (part 1)Active Control1 Intervention
Iptacopan + standard of care
Group V: Placebo matching iptacopan + standard of care (part 1)Placebo Group1 Intervention
Placebo matching iptacopan standard of care

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,858 Previous Clinical Trials
4,197,616 Total Patients Enrolled
7 Trials studying Lupus Nephritis
951 Patients Enrolled for Lupus Nephritis

Media Library

Iptacopan + standard of care (part 2) Clinical Trial Eligibility Overview. Trial Name: NCT05268289 — Phase 2
Lupus Nephritis Research Study Groups: Placebo matching iptacopan + standard of care (part 2), Iptacopan + standard of care (part 2), Iptacopan + placebo (part 2), Placebo matching iptacopan + standard of care (part 1), Iptacopan + standard of care (part 1)
Lupus Nephritis Clinical Trial 2023: Iptacopan + standard of care (part 2) Highlights & Side Effects. Trial Name: NCT05268289 — Phase 2
Iptacopan + standard of care (part 2) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05268289 — Phase 2
Lupus Nephritis Patient Testimony for trial: Trial Name: NCT05268289 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree can combining Iptacopan and the established treatment protocol be detrimental to a patient's health?

"Our assessment of Iptacopan + standard of care (part 2) yielded a score of 2; this is because there are no known efficacy data, but safety has been partially verified."

Answered by AI

Is there currently an enrollment period for this investigation?

"Confirmed. Medical data available on clinicaltrials.gov states that this trial is still open for participants and was first posted to the site on August 10th 2022, with its latest edit occuring on November 18th 2022."

Answered by AI

What is the aggregate number of individuals participating in this scientific investigation?

"Affirmative. Data from clinicaltrials.gov confirms that this trial, whose first posting was on August 10th 2022 is actively recruiting for participants. A total of 240 patients need to be enrolled at 2 distinct medical centres."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
Illinois
What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
3+
0

Why did patients apply to this trial?

I have lupus and i could really use the money I lost my husband recently. I was born with Chronic Renal Failure 1973 at birth. I have been on Dialysis and have had a Kidney Transplant 1992.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Novartis Investigative Site: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V
2022. "Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05268289.
All > Lupus Nephritis > Lupus
~46 spots leftby Oct 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top