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Complement Inhibitor

Iptacopan for IgA Nephropathy

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
All participants must be on supportive care regimen of ACEi or ARB* as per KDIGO guidelines
Be older than 18 years old
Must not have
Evidence of severe urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before dosing with LNP023
Participants treated with immunosuppressive or other immunmodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus and/or systemic corticosteroids exposure (>7.5 mg/d prednisone/prednisolone equivalent) within 5 half-lives of respective medication or 90 days prior to first study drug administration, whichever is shorter. Rituximab requires 180 days wash out
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening visit, months 1, 3, 6, 9, 12 and every 6 months thereafter
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will assess the safety and effectiveness of a new drug, iptacopan, to treat IgA nephropathy over a long period of time.

Who is the study for?
This trial is for people with a kidney condition called primary IgA nephropathy who finished earlier trials (CLNP023X2203 or CLNP023A2301). They should be up-to-date on certain vaccinations and judged by their doctor to benefit from the drug iptacopan. Participants must also follow specific guidelines for kidney care and have a minimum eGFR of 20 ml/min/1.73m2.
What is being tested?
The study tests the long-term safety and effects of iptacopan, an investigational drug, in patients with IgA nephropathy. It's open-label, meaning everyone knows they're getting iptacopan, and it continues until the drug is commercially available.
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions related to immune system suppression since iptacopan affects blood components involved in inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am taking ACE inhibitors or ARBs as part of my treatment plan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have severe problems urinating or other urinary tract issues not related to IgAN.
Select...
I haven't taken strong immune system affecting drugs recently.
Select...
My kidney function has declined by 50% in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening visit, months 1, 3, 6, 9, 12 and every 6 months thereafter
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening visit, months 1, 3, 6, 9, 12 and every 6 months thereafter for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number and percentage of participants with abnormalities in ECG
Number and percentage of participants with abnormalities in clinical laboratory evaluations
Number and percentage of participants with abnormalities in vital signs
+3 more
Secondary study objectives
Annualized total eGFR slope
Change from baseline in eGFR
Log transformed ratio to baseline in UPCR, UACR

Side effects data

From 2023 Phase 3 trial • 97 Patients • NCT04558918
20%
COVID-19
17%
Breakthrough haemolysis
9%
Pyrexia
9%
Nasopharyngitis
9%
Sinusitis
9%
Upper respiratory tract infection
9%
Blood lactate dehydrogenase increased
6%
Diarrhoea
6%
Back pain
3%
Sepsis
3%
Extravascular haemolysis
3%
Jaundice
3%
Arthritis bacterial
3%
Intervertebral discitis
3%
Pseudomonal sepsis
3%
Influenza A virus test positive
3%
Acute kidney injury
3%
Bilirubinuria
3%
Abdominal pain
3%
Nausea
3%
Vomiting
3%
Urinary tract infection
3%
Arthralgia
3%
Headache
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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: LNP023Experimental Treatment1 Intervention
All participants are receiving 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
2,921 Previous Clinical Trials
4,253,812 Total Patients Enrolled

Media Library

Iptacopan/LNP023 (Complement Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04557462 — Phase 3
IgA Nephropathy Research Study Groups: LNP023
IgA Nephropathy Clinical Trial 2023: Iptacopan/LNP023 Highlights & Side Effects. Trial Name: NCT04557462 — Phase 3
Iptacopan/LNP023 (Complement Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04557462 — Phase 3
~333 spots leftby Oct 2032
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