A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy
Recruiting
Novartis Pharmaceuticals
Phase 3
2021-09-20
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.
Long-term Safety and Tolerability of Iptacopan in Patients With Paroxysmal Nocturnal Hemoglobinuria
Recruiting
Novartis Pharmaceuticals
Phase 3
2021-07-27
This study is an open-label, single arm, multicenter, roll-over extension study to
characterize long-term safety, tolerability and efficacy of iptacopan and to provide access
to iptacopan to patients with PNH who have completed Novartis-sponsored Phase 2 or 3 studies
with iptacopan
Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
Recruiting
Novartis Pharmaceuticals
Phase 3
2021-07-28
The study is designed as a multicenter, randomized, double-blind, parallel group,
placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in
complement 3 glomerulopathy.
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