Managed Access Programs for AIN457, Secukinumab

Novartis

Status

Conditions: Hidradenitis Suppurativa (HS)

Treatments: Drug: secukinumab

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT05583604

CAIN457M2002M

Details and patient eligibility

About

The purpose of this registration is to list Managed Access Programs (MAPs) related to AIN457, secukinumab

Full description

CAIN457M2002M - Available - Managed Access Program (MAP) Cohort Treatment Plan CAIN457M2002M to provide access to Secukinumab for adult and adolescent patients with Hidradenitis Suppurativa (HS)

Sex: All

Ages: 12 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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.