Managed Access Programs for LNP023, Iptacopan

NCT05222412 | Unknown

• 1 other identifier: CLNP023B12004M
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

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

Keywords

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

Interventions

Iptacopan DRUG

Patients receive Iptacopan

Also known as: LNP023

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Hemoglobinuria, Paroxysmal

Interventions

iptacopan

Condition Hierarchy (Ancestors)

Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Myelodysplastic Syndromes; Bone Marrow Diseases

Central Study Contacts

MAP requests are initiated by a licensed physician.https:// www.novart is.com/healthcare-professionals/managed-access-programs

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 3, 2022
• Last Updated: December 5, 2025

Record last verified: 2025-12