Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patients With Secondary Progressive Multiple Sclerosis (AMA-VACC)

• Status: Recruiting
• Trial end date: 2022-04-02
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to understand whether participants can mount an immune response to SARS-CoV-2 modRNA vaccines administered either during continuous siponimod treatment or during a treatment break.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Siponimod

Criteria

Inclusion Criteria:

• Secondary Progressive Multiple Sclerosis (SPMS) diagnosis or with Relapsing Remitting Multiple Sclerosis (RRMS) at risk to develop SPMS (at the discretion of the treating physician)

• on stable MS treatment (Siponimod, dimethylfumarate, glatirameracetate, interferon, teriflunomode or no current treatment)

• no recent treatment changes

Exclusion Criteria:

• prior or current COVID-19 disease

• SARS-CoV-2 antibodies at screening Other protocol-defined inclusion/exclusion criteria may apply