LNP023 for Membranous Glomerulonephritis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Novartis Investigative Site, Montpellier, FranceMembranous GlomerulonephritisLNP023 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare LNP023 to rituximab to see if LNP023 is more effective and safe in treating MN.

Eligible Conditions
  • Membranous Glomerulonephritis

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Day 29 and Day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose)

Baseline, Week 24
Change in (eGFR) estimated Glomerular Filtration Rate from baseline to 24 weeks of treatment
Ratio between baseline Urine Protein Creatinine Ratio and Urine Protein Creatinine Ratio at 24 weeks of treatment (from 24h urine collection)
Day 113
Pharmacokinetic parameter AUClast in plasma
Pharmacokinetic parameter AUCtau in plasma
Pharmacokinetic parameter Tmax in plasma
Pharmakinetic parameter Cmax in plasma
Week 16
Pharmacokinetics in urine: renal plasma clearance derived from 24 hour urine sample
Week 24
Meausrement of Plasma levels of Bb and sC5b-9
Proportion of subjects with a complete remission
Proportion of subjects with a partial remission
Ratio between baseline (UPCR) Urine Proetin Creatinine Ratio and (UPCR) Urine Protein Creatinine Ratio at 24 weeks of treatment (from 24h urine collection)
Urine Protein Creatinine Ratio measured in first morning void

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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Side Effects for

LNP023 10mg Follow-up
5%Acute kidney injury
5%Asthenia
5%Diarrhoea
5%Upper respiratory tract infection
5%IgA nephropathy
5%Tooth disorder
5%Dizziness
5%Back pain
5%Influenza
5%Neck pain
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03373461) in the LNP023 10mg Follow-up ARM group. Side effects include: Acute kidney injury with 5%, Asthenia with 5%, Diarrhoea with 5%, Upper respiratory tract infection with 5%, IgA nephropathy with 5%.

Trial Design

2 Treatment Groups

Rituximab
1 of 2
LNP023
1 of 2

Active Control

Experimental Treatment

37 Total Participants · 2 Treatment Groups

Primary Treatment: LNP023 · No Placebo Group · Phase 2

LNP023
Drug
Experimental Group · 1 Intervention: LNP023 · Intervention Types: Drug
Rituximab
Drug
ActiveComparator Group · 1 Intervention: Rituximab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Iptacopan
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 29 and day 113 (pre-dose and 0.25 hours, 0.5 hours, 1 hour 2 hours, 4 hours and 6 hours post dose)

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,737 Previous Clinical Trials
3,544,098 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

What is the approximate number of participants engaged in this research project?

"Affirmative. The clinicaltrials.gov listings indicate that recruitment for this research has started and is ongoing, with the original posting dating back to November 23rd 2019. There are currently 4 sites searching for a total of 52 participants." - Anonymous Online Contributor

Unverified Answer

Are there any openings in this medical investigation that would accommodate a new participant?

"Clinicaltrials.gov verifies that this medical experiment is actively engaging participants. It was initially posted on the 23rd of November 2019 and the most recent iteration occurred on 18th of November 2022." - Anonymous Online Contributor

Unverified Answer

In which geographical areas is the trial being conducted?

"This clinical trial is presently being conducted in 4 different cities: Cleveland, New York, Temple and more. It would be beneficial to choose the closest medical centre for you to minimize your commuting needs should you participate." - Anonymous Online Contributor

Unverified Answer

Could you provide a summary of the research done on LNP023 thus far?

"The initial trials of LNP023 took place in 1993 at the National Institutes of Health Clinical Center, 9000 Rockville Pike. 809 studies have been conducted since then; presently 415 live experiments are taking place across the nation with a significant percentage based out of Cleveland, Ohio." - Anonymous Online Contributor

Unverified Answer

What health conditions is LNP023 commonly used to treat?

"LNP023 is an efficacious therapy for the treatment of diffuse large b-cell lymphoma, in addition to conditions such as polyangium and pemphigus vulgaris." - Anonymous Online Contributor

Unverified Answer

Has the FDA approved LNP023 for therapeutic use?

"The efficacy of LNP023 is yet to be proven, thus it scored a 2 on our team's safety scale. This Phase 2 trial has yielded some reassuring data regarding the drug's security profile." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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