Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Exploring the Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Patients With Advancing Forms of Relapsing Multiple Sclerosis: A 6-month Open Label, Multi- Center Phase IIIb Study

ID
Name
CBAF312AUS02
Description
To assess safety and tolerability of patients converting from approved Relapsing Multiple Sclerosis (RMS) Disease Modifying Therapies (DMTs) to siponimod.
Trial arms
Trial start
2019-02-14
Estimated PCD
2022-07-06
Trial end
2022-07-06
Status
Completed
Phase
Early phase I
Treatment
Siponimod
Siponimod 2mg tablets taken once daily
Arms:
Siponimod
Other names:
BAF312
Size
185
Primary endpoint
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) Related to Study Drug During the Treatment Period
From first dose of study drug up to 30 days after last dose of study drug (up to 7 months)
Eligibility 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. Certain cardiac risk factors defined in the protocol 4. History of hypersensitivity to the study drug or to drugs of similar chemical classes. Other protocol-defined inclusion/exclusion criteria may apply.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-label single arm study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 185, 'type': 'ACTUAL'}}
Updated at
2023-07-20

1 organization

1 product

1 indication

Organization
Novartis Pharmaceuticals
Product
Siponimod
Indication
Multiple Sclerosis