ClinicalTrials.gg
AvailableNCT04745637Updated Nov 18, 2025

Managed Access Programs for INC424, Ruxolitinib

An expanded access record providing Ruxolitinib in Primary Myelofibrosis (PMF), Post Polycythemia Myelofibrosis (PPV MF) and Thrombocythemia Myelofibrosis (PET-MF), sponsored by Novartis Pharmaceuticals. Available. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2025-11-18.

Sponsored by Novartis Pharmaceuticals (part of Novartis) · Expanded access

Study type
Expanded access
Access type
Intermediate-size population
Ages
2 Years and older
Sex
All
01

Study summary

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

Read the detailed description

CINC424A2405 - No longer available- Managed Access Program (MAP) Cohort Treatment Plan CINC424A2405 to provide access to Ruxolitinib for patients with Primary Myelofibrosis (PMF) or Post Polycythemia Myelofibrosis (PPV MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF)

CINC424A2001M - No longer available - Ruxolitinib Managed Access Program (MAP) for patients diagnosed with severe/very severe COVID-19 illness

CINC424B2002I - No longer available- Managed Access Program (MAP) Cohort Treatment Plan CINC424B2002I to provide access to Ruxolitinib for patients with Polycythemia Vera (PV)

CINC424C2001M - Available - Managed Access Program (MAP) Cohort Treatment Plan CINC424C2001M to provide access to ruxolitinib for steroid refractory acute and chronic Graft versus Host Disease (SR aGVHD and SR cGHVD).

02

Conditions studied

  • 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
03

In context

Primary Myelofibrosis

625 studies on the registry are indexed under Primary Myelofibrosis; 124 are open to participants now.

Browse Primary Myelofibrosis studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.

Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion criteria

  1. An independent request was received from a licensed physician.
  2. 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.
  3. The patient is not eligible or able to enroll in a clinical trial or continue participation in such trial.
  4. 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.
  5. 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).
  6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
  7. Managed Access provision is allowed per local laws/regulations.
05

Access details

Study type
Expanded access
Access type
Intermediate-size population

Available treatment

  • Patients receive Ruxolitinib

    Also known as: INC424

06

Where to request access

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT04745637
Responsible party
Sponsor
First posted
Feb 9, 2021
Last update
Nov 18, 2025

Study contacts

MAP requests are initiated by a licensed physician.https:// www.novart is.com/healthcare-professionals/managed-access-programs
Contact
novartis.email@novartis.com
1-88-669-6682
Novartis Pharmaceuticals
Contact
+41613241111
View the source record on ClinicalTrials.gov ↗

Requesting access

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