Managed Access Programs for VAY736, Ianalumab

March 19, 2026 updated by: Novartis Pharmaceuticals
The purpose of this registration is to list Managed Access Programs (MAPs) related to VAY736, ianalumab

Study Overview

Status

Available

Conditions

Intervention / Treatment

Detailed Description

  • CVAY736I12003M - Available - Managed Access Program (MAP) Cohort Treatment Plan CVAY736I12003M to provide access to ianalumab (VAY736) for patients with Primary Immune Thrombocytopenia (ITP)
  • CVAY736A1002M - Available - Managed Access Program (MAP) Cohort Treatment Plan CVAY736A1002M to provide access to ianalumab for adult patients with Sjögren's disease
  • CVAY736A1003I - Available - Managed Access Program (MAP) Individual Patient Request (IPR) Cover Letter CVAY736A1003I to provide access to Ianalumab (VAY736) for Sjögren's Disease
  • CVAY736I12004I - Available - Managed Access Program (MAP) Individual Patient Request (IPR) Cover Letter CVAY736I12004I to provide access to Ianalumab (VAY736) for Primary Immune Thrombocytopenia (ITP) and Evans syndrome

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients
  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 enrol 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVAY736I12003M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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