Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients.

• Status: Recruiting
• Trial end date: 2022-01-12
• Target enrollment: 0
• Participant gender: All

Summary

To assess safety and tolerability of patients converting from approved Relapsing Multiple Sclerosis (RMS) Disease Modifying Therapies (DMTs) to siponimod.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Siponimod

Criteria

Key Inclusion Criteria:

1. Signed informed consent.

2. Male or female aged 18 to 65 years (inclusive).

3. Patients with advancing RMS as defined by the principal investigator.

4. Prior history of relapsing MS (RMS), with or without progressive features, according to the 2010 Revised McDonald or Lublin criteria (Lublin et al, 2013).

5. EDSS score of >/= 2.0 to 6.5 (inclusive).

6. Having been continuously treated with RMS Disease Modifying Therapies.

Key Exclusion criteria:

1. Pregnant or nursing (lactating) women.

2. Patients with any medically unstable condition as determined by the investigator.

3. History of hypersensitivity to the study drug or to drugs of similar chemical classes.

Other protocol-defined inclusion/exclusion criteria may apply.