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

NCT ID: NCT03623243

Last Updated: 2024-06-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-14

Study Completion Date

2022-07-06

Brief Summary

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

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Detailed Description

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This is a 6-month, open-label, multi-center, single arm design, including advancing RMS patients, evaluating the overall safety and tolerability profile of converting from oral, injectable or infusion RMS DMTs to oral siponimod.

Conditions

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Multiple Sclerosis Relapsing Multiple Sclerosis Advancing Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open-label single arm study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Siponimod

Participants will receive titrated doses of siponimod tablets, orally, once daily of 0.25 mg on Day 2, 0.5 mg on Day 3, 0.75 mg on Day 4, 1.25 mg on Day 5, and maintenance dose of siponimod 2.0 mg tablets, orally, once daily from Day 6 up to 6 months.

As of protocol amendment 3, participants entering the trial converting from fingolimod will start directly with 2 mg dose of siponimod.

Group Type EXPERIMENTAL

Siponimod

Intervention Type DRUG

Siponimod 2mg tablets taken once daily

Interventions

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Siponimod

Siponimod 2mg tablets taken once daily

Intervention Type DRUG

Other Intervention Names

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BAF312

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Birmingham, Alabama, United States

Site Status

Novartis Investigative Site

Cullman, Alabama, United States

Site Status

Alabama Neurology Associates

Homewood, Alabama, United States

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Novartis Investigative Site

Tucson, Arizona, United States

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Novartis Investigative Site

Fresno, California, United States

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Novartis Investigative Site

Fullerton, California, United States

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Novartis Investigative Site

Irvine, California, United States

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Novartis Investigative Site

Colorado Springs, Colorado, United States

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Novartis Investigative Site

Denver, Colorado, United States

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Novartis Investigative Site

Fort Collins, Colorado, United States

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Novartis Investigative Site

Boca Raton, Florida, United States

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Novartis Investigative Site

Bradenton, Florida, United States

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MS & Neuromuscular Center of Excellence

Clearwater, Florida, United States

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Novartis Investigative Site

Maitland, Florida, United States

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Novartis Investigative Site

Miami, Florida, United States

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Novartis Investigative Site

Ocala, Florida, United States

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Novartis Investigative Site

Oldsmar, Florida, United States

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Novartis Investigative Site

Orlando, Florida, United States

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Novartis Investigative Site

Ormond Beach, Florida, United States

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Novartis Investigative Site

Sarasota, Florida, United States

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Novartis Investigative Site

Sunrise, Florida, United States

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Novartis Investigative Site

Tampa, Florida, United States

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Novartis Investigative Site

Vero Beach, Florida, United States

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Novartis Investigative Site

Flossmoor, Illinois, United States

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Novartis Investigative Site

Indianapolis, Indiana, United States

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Novartis Investigative Site

Lexington, Kentucky, United States

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Novartis Investigative Site

Lexington, Kentucky, United States

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Novartis Investigative Site

Lexington, Kentucky, United States

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Novartis Investigative Site

Rockville, Maryland, United States

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Novartis Investigative Site

Clinton Township, Michigan, United States

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Novartis Investigative Site

St Louis, Missouri, United States

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Novartis Investigative Site

Las Vegas, Nevada, United States

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Novartis Investigative Site

Hackensack, New Jersey, United States

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Novartis Investigative Site

Asheville, North Carolina, United States

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Novartis Investigative Site

Greensboro, North Carolina, United States

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Novartis Investigative Site

Raleigh, North Carolina, United States

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Novartis Investigative Site

Cincinnati, Ohio, United States

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Novartis Investigative Site

Cleveland, Ohio, United States

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Novartis Investigative Site

Oklahoma City, Oklahoma, United States

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Abington Neurological Associates, Ltd

Abington, Pennsylvania, United States

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Novartis Investigative Site

Philadelphia, Pennsylvania, United States

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Novartis Investigative Site

Willow Grove, Pennsylvania, United States

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Novartis Investigative Site

Greer, South Carolina, United States

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Novartis Investigative Site

Old Point Station, South Carolina, United States

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Novartis Investigative Site

Cordova, Tennessee, United States

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Novartis Investigative Site

Johnson City, Tennessee, United States

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Novartis Investigative Site

Round Rock, Texas, United States

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Novartis Investigative Site

San Antonio, Texas, United States

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Novartis Investigative Site

Falls Church, Virginia, United States

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Novartis Investigative Site

Kirkland, Washington, United States

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Novartis Investigative Site

Seattle, Washington, United States

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Novartis Investigative Site

Spokane, Washington, United States

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Novartis Investigative Site

Tacoma, Washington, United States

Site Status

Novartis Investigative Site

Waukesha, Wisconsin, United States

Site Status

Novartis Investigative Site

Guaynabo, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

References

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Fox RJ, Cohan S, Mao-Draayer Y, Weinstock-Guttman B, Cruz LA, Arnould S, Cox GM, Bar-Or A. Safety and tolerability of conversion to siponimod from other disease-modifying therapies in patients with advancing forms of relapsing MS: Results from the EXCHANGE study. Mult Scler. 2025 May;31(6):706-718. doi: 10.1177/13524585251330085. Epub 2025 Apr 18.

Reference Type DERIVED
PMID: 40248858 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1555

Patient Lay Trial Summary

Other Identifiers

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CBAF312AUS02

Identifier Type: -

Identifier Source: org_study_id

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