Managed Access Programs for VAY736, Ianalumab

NCT ID: NCT07244289

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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The purpose of this registration is to list Managed Access Programs (MAPs) related to VAY736, ianalumab

Detailed Description

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* CVAY736I12003M - Available - Managed Access Program (MAP) Cohort Treatment Plan CVAY736I12003M to provide access to ianalumab (VAY736) for patients with Primary Immune Thrombocytopenia (ITP)
* CVAY736A1002M - Not yet available - Managed Access Program (MAP) Cohort Treatment Plan CVAY736A1002M to provide access to ianalumab for adult patients with Sjögren's disease

Conditions

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Primary Immune Thrombocytopenia Sjögren's Syndrome

Interventions

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ianalumab

Patients receive ianalumab

Intervention Type DRUG

Other Intervention Names

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VAY736

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

+41613241111

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

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CVAY736I12003M

Identifier Type: -

Identifier Source: org_study_id

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