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Managed Access Programs for LNP023, Iptacopan

Managed Access Programs for LNP023, Iptacopan

Status
AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT05222412
Enrollment
Unknown
Registered
2022-02-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C3 Glomerulopathy (C3G), Paroxysmal Nocturnal Hemoglobinuria (PNH)

Keywords

C3 glomerulopathy (C3G), Paroxysmal nocturnal hemoglobinuria (PNH), MAP, Manage access program, Iptacopan, LNP023

Brief summary

The purpose of this registration form is to list all Managed Access Programs (MAPs) related to LNP023, Iptacopan

Detailed description

* CLNP023B12004M - Available - Managed Access Program (MAP) Cohort Treatment Plan CLNP023B12004M to Provide Access to Iptacopan (LNP023) for Complement 3 Glomerulopathy in Native and Transplanted Kidneys. * CLNP023N12001M - Available - Managed Access Program (MAP) Cohort Treatment Plan CLNP023N12001M to provide access to Iptacopan for patients with paroxysmal nocturnal hemoglobinuria (PNH).

Interventions

DRUGIptacopan

Patients receive Iptacopan

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* An independent request should be received from a licensed physician (in some instances from Health Authorities, Institutions or Governments). * The patient has a serious or life-threatening disease or condition and no comparable or satisfactory alternative therapy is available for diagnosis, monitoring or treatment; patient is not medically eligible for available treatment alternatives or has exhausted all available treatment options. * The patient is not eligible or able to enroll in a Novartis clinical trial or continue participation in a Novartis clinical trial. * There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated. * The patient must meet any other medical criteria established by the medical experts responsible for the product or by the Health Authority in a country (as applicable). * Provision of the product will not interfere with the initiation, conduct or completion of a Novartis clinical trial or overall development program. * Managed access provision is allowed per local laws/regulations.

Contacts

Primary ContactMAP requests are initiated by a licensed physician.https:// www.novart is.com/healthcare-professionals/managed-access-programs
novartis.email@novartis.com1-888-669-6682
Backup ContactNovartis Pharmaceuticals
+41613241111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026