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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 baseline, every year up to the maximum of approximately 3 years

Awards & highlights

Study Summary

This trial is testing a new drug, Siponimod, to see if it is safe and effective in treating people with secondary progressive multiple sclerosis. The trial will have two parts: first, a variable treatment duration with Siponimod or placebo, followed by an extension part where everyone will receive Siponimod to see how it works in the long term.

Eligible Conditions

Secondary Progressive Multiple Sclerosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, every year up to the maximum of approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, every year up to the maximum of approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, every year up to the maximum of approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants With 3-month Confirmed Disibility Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS)

Secondary outcome measures

Effect on 3-month Confirmed Disability Progression as Defined by EDSS in Predefined Sub-groups

Effect on Inflammatory Disease Activity and Burden of Disease as Measured by MRI

Efficacy of BAF Relative to Placebo in Annualized Relapses Rate and Time to the First Relapse

+4 more

Side effects data

From 2023 Phase 3 trial • 1653 Patients • NCT01665144

14%

HEADACHE

14%

NASOPHARYNGITIS

12%

URINARY TRACT INFECTION

11%

FALL

10%

HYPERTENSION

FATIGUE

UPPER RESPIRATORY TRACT INFECTION

DIZZINESS

NAUSEA

INFLUENZA

BACK PAIN

DIARRHOEA

ALANINE AMINOTRANSFERASE INCREASED

PAIN IN EXTREMITY

ARTHRALGIA

DEPRESSION

BASAL CELL CARCINOMA

100%

80%

60%

40%

20%

Study treatment Arm

Siponimod (BAF312)

Placebo

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

~2240

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,195,734 Total Patients Enrolled

100 Trials studying Multiple Sclerosis

50,474 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does age play a role in a patient's ability to participate in this research?

"This study only includes patients that are between 18-60 years old."

Answered by AI

Does this study have a presence in North America?

"There are a total of 57 locations where this trial is taking place, with sites in San Antonio, Las Vegas, Greenfield Park, and 54 other locations. It is important to choose the location that is closest to you to minimize travel requirements if you enroll."

Answered by AI

Are there any other investigations that have looked at BAF312's effects?

"The first clinical trial for BAF312 was completed in 2012 at Novartis Investigative Site. To date, a total of 18272 trials have been completed. Currently, there are 4 trials in progress, with a bulk of these taking place in San Antonio, Texas."

Answered by AI

Is this an innovative or original study?

"There have been 4 studies conducted on the efficacy of BAF312 spanning 38 countries and 147 cities. The first study was sponsored by Novartis Pharmaceuticals and completed Phase 3 in 2012. A total of 1652 patients were involved. Since 2012, there have been a total of 18272 studies."

Answered by AI

What is the total number of patients that can be enrolled in this clinical trial?

"Presently, this clinical trial is not searching for patients that meet the necessary requirements. The study was originally posted on December 20th, 2012 but was updated as recently as October 17th, 2022. There are presently 1213 trials for multiple sclerosis, chronic progressive and 4 trials for BAF312 that are actively recruiting participants."

Answered by AI