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Sphingosine-1-phosphate receptor modulator

BAF312 for Multiple Sclerosis

Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to maximum approximately 3 years
Awards & highlights

Summary

This trial tests Siponimod, a medication for patients with secondary progressive multiple sclerosis. It aims to see if Siponimod can slow down disease progression by modulating the immune system. Siponimod is a newer-generation medication that has been recently approved for active secondary progressive multiple sclerosis (SPMS).

Eligible Conditions
  • Secondary Progressive Multiple Sclerosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to maximum approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to maximum approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With 3-month Confirmed Disability Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS)
Secondary study objectives
Annualized Relapse Rate (ARR) for Confirmed Relapses
Change From Baseline in MSWS-12 Converted Score
Change From Baseline in T2 Lesion Volume
+10 more

Side effects data

From 2022 Phase 4 trial • 41 Patients • NCT04792567
24%
COVID-19
18%
Lymphopenia
18%
Injection site pain
12%
Liver function test increased
12%
Pain in extremity
12%
Multiple sclerosis relapse
6%
Escherichia urinary tract infection
6%
Visual impairment
6%
Fatigue
6%
Pyrexia
6%
Injection site pustule
6%
Rhinitis
6%
Urinary tract infection
6%
Upper limb fracture
6%
Back pain
6%
Myalgia
6%
Dizziness
6%
Headache
6%
VIth nerve paralysis
6%
Menstrual disorder
6%
Cough
6%
Flushing
100%
80%
60%
40%
20%
0%
Study treatment Arm
Siponimod Continuous
Siponimod Interrupted
DMT or No MS Treatment

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Siponimod (BAF312)Experimental Treatment1 Intervention
Participants started on Day 1 and were uptitrated from 0.25 mg to 2 mg of BAF312 orally over a period of 6 days. After Day 7, participants continued on the treatment epoch for 3 months. During the Core Part of the study, participants participated in a maximum of 3 epochs. Following the Core Part, eligible patients enter the Extension Part during which all receive open-label BAF312.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo to BAF312 was administered orally during the Core Part of the trial. Following the Core Part, eligible participants enter the Extension Part during which all receive open-label BAF312.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BAF312
2021
Completed Phase 4
~2230

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,893 Previous Clinical Trials
4,199,303 Total Patients Enrolled
105 Trials studying Multiple Sclerosis
50,187 Patients Enrolled for Multiple Sclerosis

Media Library

BAF312 (Sphingosine-1-phosphate receptor modulator) Clinical Trial Eligibility Overview. Trial Name: NCT01665144 — Phase 3
Multiple Sclerosis Research Study Groups: Placebo, Siponimod (BAF312)
Multiple Sclerosis Clinical Trial 2023: BAF312 Highlights & Side Effects. Trial Name: NCT01665144 — Phase 3
BAF312 (Sphingosine-1-phosphate receptor modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01665144 — Phase 3
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