Study Description
The purpose of this study is to evaluate the long-term safety and tolerability, of open
label iptacopan in primary IgA nephropathy participants 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
iptacopan 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 iptacopan on
long-term disease progression. This is an open-label, non-randomized, multicenter roll-over extension program (REP) to:
- CLNP023X2203, a Phase II trial investigating the dose ranging effects of LNP023 on
efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability in
primary IgAN patients, and
- CLNP023A2301, a Phase III trial, investigating the efficacy, pharmacokinetics (PK),
pharmacodynamics (PD), safety and tolerability of LNP023 in patients with primary
IgAN.
Subjects completing the CLNP023X2203 and CLNP023A2301 trials on study drug, who want to
continue treatment and who meet the inclusion/exclusion requirements of the roll over
extension program, will have the opportunity to receive iptacopan until:
- 3 years from LPFV of this study CLNP023A2002B, or
- the participant no longer derives benefit from iptacopan according to the
Investigator, or
- the benefit-risk profile of the product in IgAN is no longer positive, or
- initiation of maintenance hemodialysis, kidney transplantation or eGFR < 15
mL/min/1.73m2 , or
- the product becomes commercially available in a specific country following product
launch and subsequent reimbursement for IgAN, where applicable, or
- if a marketing application or reimbursement of an investigational product is
rejected/not pursued in a region/country for the indication under study or which
ever is sooner
Interventions
LNP023
Eligibility Criteria
Inclusion Criteria:
- For LNP023X2203, participants must have completed part 1 or part 2 of the trial. For
LNP023A2301, participants 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 participant may benefit from receiving
the open-label treatment of iptacopan 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 participants must be on supportive care regimen of ACEi or ARB* as per KDIGO
guidelines.
- participants 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:
- participants 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.
- 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.
- 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.
Worldwide Contacts
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