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

• ClinicalTrials.gov Identifier: NCT03623243
• Recruitment Status: Completed
• First Posted: August 9, 2018
• Last Update Posted: December 14, 2022
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Tracking Information

• First Submitted Date: August 7, 2018
• First Posted Date: August 9, 2018
• Last Update Posted Date: December 14, 2022
• Actual Study Start Date: February 14, 2019
• Actual Primary Completion Date: July 6, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 5, 2020)

Number of patients with treatment emergent adverse events [ Time Frame: Baseline up to 6 months ]

Adverse events considered to be drug related will be collected to assess safety and tolerability at scheduled visits after converting from disease modifying therapies

Original Primary Outcome Measures (submitted: August 8, 2018)

Number of patients with adverse events [ Time Frame: 6 months ]

safety and tolerability after converting from DMTs.

Current Secondary Outcome Measures (submitted: January 7, 2022)

• Number of patients satisfied with treatment as measured by Treatment Satisfaction Questionnaire for Medication [ Time Frame: Baseline up to 6 months ]
  TSQM9 - Treatment Satisfaction Questionnaire for Medication: measures patient satisfaction with the medication in 3 domains: effectiveness, convenience, and global satisfaction. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain.
• Change in Heart Rate from baseline [ Time Frame: Baseline to 6 hours post initial treatment ]
  Heart rate will be evaluated from the time of initial dose intake until 6 hours post dose intake via heart monitor
• Treatment persistence with Siponimod [ Time Frame: Baseline up to 6 months ]
  Patient retention will be assessed over the study period. Treatment compliance is defined as being 80% adherent and will be assessed via drug accountability performed at the site.

Original Secondary Outcome Measures (submitted: August 8, 2018)

• Number of patients satisfied with treatment [ Time Frame: 6 months ]
  patient satisfaction
• Adherence [ Time Frame: 6 months ]
  percent of patients who adhere to therapy

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients.
• Official Title: 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
• Brief Summary: To assess safety and tolerability of patients converting from approved Relapsing Multiple Sclerosis (RMS) Disease Modifying Therapies (DMTs) to siponimod.
• Detailed Description: 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.
• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Open-label single arm study

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Multiple Sclerosis
• Relapsing Multiple Sclerosis
• Advancing Multiple Sclerosis

Intervention

Drug: Siponimod

Siponimod 2mg tablets taken once daily

Other Name: BAF312

Study Arms

Experimental: Siponimod 2 mg

Siponimod 2mg tablets taken once daily after a 5 day titration

Intervention: Drug: Siponimod

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 21, 2022): 187
• Original Estimated Enrollment (submitted: August 8, 2018): 300
• Actual Study Completion Date: July 6, 2022
• Actual Primary Completion Date: July 6, 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Puerto Rico, United States

Administrative Information

• NCT Number: NCT03623243
• Other Study ID Numbers: CBAF312AUS02
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes

Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

• Current Responsible Party: Novartis ( Novartis Pharmaceuticals )
• Original Responsible Party: Same as current
• Current Study Sponsor: Novartis Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

• PRS Account: Novartis
• Verification Date: December 2022