Available in Brazil
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
500Patients around the world