Managed Access Programs for INC424, Ruxolitinib

NCT04745637 | Unknown

• 1 other identifier: CINC424A2405
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this registration is to list Managed Access Programs (MAPs) related to INC424, Ruxolitinib

Conditions

Primary Myelofibrosis (PMF); Post Polycythemia Myelofibrosis (PPV MF); Thrombocythemia Myelofibrosis (PET-MF); Severe/Very Severe COVID-19 Illness; Polycythemia Vera (PV); Steroid Refractory Acute Graft Versus Host Disease (SR aGVHD); Steroid Refractory Chronic Graft Versus Host Disease (SR cGVHD)

Keywords

MAP; Manage Access Program; Primary Myelofibrosis (PMF); Post Polycythemia Myelofibrosis (PPV MF); Thrombocythemia Myelofibrosis (PET-MF); Severe/very severe COVID-19 illness; Polycythemia Vera (PV); Steroid refractory acute Graft versus Host Disease (SR aGVHD); Steroid refractory chronic Graft versus Host Disease (SR cGVHD); INC424; Ruxolitinib

Interventions

Ruxolitinib DRUG

Patients receive Ruxolitinib

Also known as: INC424

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• An independent request was received from a licensed physician.
• The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
• The patient is not eligible or able to enroll in a clinical trial or continue participation in such 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 the country of request (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

Primary Myelofibrosis; Polycythemia Vera

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms

Central Study Contacts

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

CONTACT

1-88-669-6682; 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: February 5, 2021
• First Posted: February 9, 2021
• Last Updated: November 18, 2025

Record last verified: 2025-10