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Complement inhibitor

LNP023 for Complement 3 Glomerulopathy

Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 66 months for participants from clnp023x2202 and up to 36 months for participants from clnp023b12301
Awards & highlights

Study Summary

This trial will evaluate the long-term effects of the drug LNP023 in people with a kidney disease called C3 glomerulopathy.

Who is the study for?
This trial is for patients who have completed the CLNP023X2202 trial for C3 glomerulopathy. It's not open to those with HIV, severe diseases like advanced heart disease or pulmonary hypertension, active infections close to screening time, fever shortly before screening, or certain ECG abnormalities.Check my eligibility
What is being tested?
The study tests the long-term effects of a drug called LNP023 on people with C3 glomerulopathy. As an open-label extension study, all participants know they are receiving LNP023 and its impact over a longer period will be observed.See study design
What are the potential side effects?
While specific side effects aren't listed here, 'safety and tolerability' suggests monitoring for any adverse reactions from prolonged use of LNP023 which could include typical drug-related issues such as digestive discomfort, allergic reactions or other organ-specific impacts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 66 months for participants from clnp023x2202 and up to 36 months for participants from clnp023b12301
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 66 months for participants from clnp023x2202 and up to 36 months for participants from clnp023b12301 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CLNP023X2202 Cohort A-native C3G: Number of participants who achieve the composite renal endpoint
CLNP023X2202 Cohort B - kidney transplant and recurrent C3G: Change from baseline in the C3 Deposit Score
Number of AEs of special interest
+2 more
Secondary outcome measures
CLNP023B12301: Change from Day 180 in log-transformed UPCR over time (placebo arm of study CLNP023B12301)
CLNP023B12301: Change from Day 180 in study CLNP023B12301 in eGFR over time (placebo arm of study CLNP023B12301)
CLNP023B12301: Change from baseline in eGFR over time
+11 more

Side effects data

From 2023 Phase 3 trial • 97 Patients • NCT04558918
20%
COVID-19
17%
Breakthrough haemolysis
9%
Blood lactate dehydrogenase increased
9%
Pyrexia
9%
Sinusitis
9%
Nasopharyngitis
9%
Upper respiratory tract infection
6%
Diarrhoea
6%
Back pain
3%
Pseudomonal sepsis
3%
Vomiting
3%
Headache
3%
Abdominal pain
3%
Nausea
3%
Extravascular haemolysis
3%
Bilirubinuria
3%
Arthralgia
3%
Jaundice
3%
Sepsis
3%
Intervertebral discitis
3%
Influenza A virus test positive
3%
Arthritis bacterial
3%
Acute kidney injury
3%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anti-C5 Antibody (Randomized Treatment Period)
Any LNP023 200mg b.i.d. (Randomized Treatment Period + Extension Treatment Period)
LNP023 200mg b.i.d. (Randomized Treatment Period)
LNP023 200mg b.i.d. (Randomized Treatment Period + Extension Treatment Period)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort C: Participants with native C3G from CLNP023B12301Experimental Treatment1 Intervention
Participants from CLNP023B12301 study receiving LNP023 capsules 200 mg b.i.d
Group II: Cohort B: participants with transplanted kidneys from CLNP023X2202Experimental Treatment1 Intervention
C3G participants from study CLNP023X2202 who have undergone kidney transplant and have recurrence of C3G receiving LNP023 capsules 200 mg b.i.d
Group III: Cohort A: participants with native kidneys from CLNP023X2202Experimental Treatment1 Intervention
C3G participants from study CLNP023X2202 with native kidneys receiving LNP023 capsules 200 mg b.i.d
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LNP023
2019
Completed Phase 3
~260

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,856 Previous Clinical Trials
4,197,611 Total Patients Enrolled

Media Library

LNP023 (Complement inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03955445 — Phase 3
Complement 3 Glomerulopathy Research Study Groups: Cohort A: participants with native kidneys from CLNP023X2202, Cohort B: participants with transplanted kidneys from CLNP023X2202, Cohort C: Participants with native C3G from CLNP023B12301
Complement 3 Glomerulopathy Clinical Trial 2023: LNP023 Highlights & Side Effects. Trial Name: NCT03955445 — Phase 3
LNP023 (Complement inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03955445 — Phase 3

Frequently Asked Questions

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

Has LNP023 been approved for use by the Food and Drug Administration?

"LNP023 has had some safety studies conducted, thus granting it a rating of 2 on the 1-3 scale. Unfortunately, there is no data to back up its efficacy yet as this is still in Phase 2 trials."

Answered by AI

Have there been prior explorations into the therapeutic properties of LNP023?

"Currently, 10 clinical trials are underway exploring the efficacy of LNP023. 7 out of these studies have reached Phase 3 with Praha and Antwerp as primary locations for research. Ultimately there are 475 sites across the world running this trial."

Answered by AI

Is there presently space for enrolment in this research study?

"The information on clinicaltrials.gov suggests that the research is actively seeking participants. The study was posted online on October 3rd 2019 and recently revised on November 15th 2022."

Answered by AI

What are the overarching goals of this trial?

"This 9-month study is designed to assess the number of patients with adverse events. Secondary goals include measuring changes in serum creatinine, evaluating progression of C3G disease (based on glomerular histopathology), and assessing change in Urine albumin/creatinine ratio relative to baseline readings prior to treatment."

Answered by AI

Is this experiment a pioneering venture in its field?

"As of this moment, 10 ongoing trials involving LNP023 are being conducted in 169 cities and 39 countries. Novartis Pharmaceuticals initiated the initial trial for LNP023 back in 2019 with 95 participants; it received phase 2 drug approval before concluding. Since then, an additional 5 studies have been completed."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Long-term Efficacy, Safety and Tolerability of LNP023 in C3G
2019. "Long-term Efficacy, Safety and Tolerability of LNP023 in C3G". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03955445.
~9 spots leftby Oct 2024
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