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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
Pivotal Trial
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to maximum approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to maximum approximately 3 years
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 moreSide effects data
From 2022 Phase 4 trial • 41 Patients • NCT0479256724%
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
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
2,911 Previous Clinical Trials
4,249,026 Total Patients Enrolled
107 Trials studying Multiple Sclerosis
50,137 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been experiencing a gradual increase in disability for at least 6 months, which is known as secondary progressive multiple sclerosis (SPMS).There may be other criteria determined by the study that will be used to determine if you are eligible to participate.You are allergic to the study drug or any similar medications.You have had multiple sclerosis that has come and gone in the past.You have a disability level between moderate and severe as measured by the EDSS score.You cannot have an MRI scan.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Siponimod (BAF312)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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