CLINICAL TRIALS PROFILE FOR IPTACOPAN HYDROCHLORIDE
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All Clinical Trials for Iptacopan Hydrochloride
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT04557462 ↗ | 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. |
| NCT04747613 ↗ | 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 |
| NCT04817618 ↗ | 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. |
| NCT04820530 ↗ | Study of Efficacy and Safety of Twice Daily Oral Iptacopan (LNP023) in Adult PNH Patients Who Are Naive to Complement Inhibitor Therapy | Recruiting | Novartis Pharmaceuticals | Phase 3 | 2021-07-19 | The purpose of this Phase 3 study is to determine whether iptacopan is efficacious and safe for the treatment of PNH patients who are naive to complement inhibitor therapy |
| NCT04889430 ↗ | Efficacy and Safety of Iptacopan (LNP023) in Adult Patients With Atypical Hemolytic Uremic Syndrome Naive to Complement Inhibitor Therapy | Recruiting | Novartis Pharmaceuticals | Phase 3 | 2021-11-08 | The purpose of this Phase 3 study is to determine whether iptacopan (LNP023) is efficacious and safe for the treatment of aHUS in adult patients who are treatment naive to complement inhibitor therapy. |
| NCT05078580 ↗ | Pharmacokinetic (PK) and Safety Study of Iptacopan (LNP023) in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Matched Control Healthy Participants With Normal Hepatic Function. | Not yet recruiting | Novartis Pharmaceuticals | Phase 1 | 2021-10-29 | This is a an open-label, single dose, parallel group study to evaluate the PK of iptacopan in participants with mild, moderate, or severe hepatic impairment compared to matched healthy control participants |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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