A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label LNP023 in Patients With Primary IgA Nephropathy

A Multicenter Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label LNP023 in Patients With Primary IgA Nephropathy Who Have Completed Study CLNP023X2203 or CLNP023A2301

ClinicalTrials.gov Identifier: NCT04557462

Novartis Reference Number: CLNP023A2002B

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this study is to evaluate the long-term safety and tolerability, of open label LNP023 in IgA nephropathy patients who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with LNP023 until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate the clinical effects of LNP023 on long-term disease progression.

Condition 
IgA Nephropathy
Phase 
Phase 3
Overall status 
Not yet recruiting
Enrollment count 
410 participants
Start date 
Feb 17, 2021
Completion date 
May 26, 2028
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
LNP023
Capsule 200mg (b.i.d.) taken orally twice a day

Eligibility Criteria

Inclusion Criteria:

For LNP023X2203, patients must have completed part 1 or part 2 of the trial. For LNP023A2301, patients must have completed the entire core trial defined as the full 24 month treatment period.

eGFR* ≥ 20 ml/min/1.73m2

*eGFR calculated using the CKD-EPI formula (or modified MDRD formula according to specific ethnic groups and local practice guidelines)

Per investigator's clinical judgement, the patient may benefit from receiving the open-label treatment of LNP023 200 mg b.i.d.
Prior Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections should be up to date (i.e. any boosters required administered according to local regulations.

All patients must be on supportive care regimen of ACEi or ARB* as per KDIGO guidelines.

Patients who are not taking KDIGO guideline doses because they have documented allergies or intolerance to ACEi and ARB are eligible for the study

Exclusion Criteria:

Patients who screen or baseline failed in the CLNP023X2203 Part 1 or Part 2, or CLNP023A2301 studies or who prematurely withdrew from either study for any reason.
Evidence of severe urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before dosing with LNP023.
Current (within 4 weeks of study drug administration in the REP) acute kidney injury (AKI)
Presence of Rapidly Progressive Glomerulonephritis (RPGN) as defined by 50% decline in eGFR within the last 3 months.
Patients previously treated with immunosuppressive or other immunmodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, hydroxychloroquine, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus and/or systemic corticosteroids exposure (>10 mg/d prednisone/prednisolone equivalent) within 90 days (or 180 days for rituximab) prior to first study drug administration
Use of other investigational drugs at the time of enrolment, or within 5 half-lives of enrolment or within 30 days whichever is longer.
History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus and pneumococcus.

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Name: 
Novartis Pharmaceuticals
Phone: 
Email: 

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