Overview

This trial is active, not recruiting.

Condition secondary progressive multiple sclerosis
Treatments baf312, placebo
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date December 2012
End date August 2017
Trial size 1652 participants
Trial identifier NCT01665144, CBAF312A2304

Summary

Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment duration in patients with secondary progressive multiple sclerosis (Core Part) followed by extended treatment with open-label BAF312 to obtain data on long-term safety, tolerabiilty and efficacy (Extension Part).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
1090 patients will be randomized to receive BAF312 during the trial for a maximum of approximately 3 years (Core Part). Patients who meet all inclusion and none of the exclusion criteria will be treated with BAF312 daily. Following the Core Part, eligible patients enter the Extension Part during which all receive open-label BAF312 for a maximum of 84 additional months.
baf312
Patients will be randomized to receive BAF312. BAF312 will be provided in a dose titration from 0.25 mg to a 2 mg dose.
(Placebo Comparator)
Matching Placebo administered orally during the Core Part of the trial. Following the Core Part, eligible patients enter the Extension Part during which all receive open-label BAF312 for a maximum of 84 additional months.
placebo
Placebo

Primary Outcomes

Measure
The delay in time to confirmed disability progression as measured by EDSS.
time frame: Baseline, every 3 month up to the maximum of approximately 3 years

Secondary Outcomes

Measure
Efficacy of BAF312 relative to placebo in confirmed worsening of 25 foot walk test
time frame: Baseline , every 3 months up to the maximum of approximately 3 years
Efficacy of BAF312 relative to placebo in reducing the increase in T2 lesion volume
time frame: Baseline, every year up to the maximum of approximately 3 years
The delay in time to confirmed disability progression as measured by EDSS.
time frame: Baseline, every 6 months up to the maximum of approximately 3 years
Efficacy of BAF relative to placebo in annualized relapses rate and time to the first relapse
time frame: Baseline every 3 months up to the maximum of approximately 3 years
Overall response rate on the MSWS-12.
time frame: Baseline, every 6 months up to the maximum of approximately 3 years
Effect on inflammatory disease activity and burden of disease as measured by MRI
time frame: Baseline, every 12 month up to the maximum of approximately 3 years
effect on 3-month confirmed disability progression as defined by EDSS in predefined sub-groups
time frame: Baseline, every 3 months up to the maximum of approximately 3 years
Number of patients with adverse events during the Core Part
time frame: Baseline, every 3 months up to the maximum of approximately 3 years
Number of patients with abnormal lab tests during the Core Part
time frame: Baseline, every 3 months up to the maximum of approximately 3 years
Number of patients with adverse events during the Extension Part
time frame: Following the Core Part of the study, every 3 months for one year and then every 6 months up to the maximum of 84 months
Number of patients with abnormal lab tests during the Extension Part
time frame: Following the Core Part of the study, every 3 months for the first year and then every 6 months up to the maximum of 84 months

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: - Prior history of relapsing remitting MS - SPMS defined as progressive increase of disability over at least 6 months - EDSS score of 3.0 to 6.5 - No relapse of corticosteroid treatment within 3 months Exclusion Criteria: - Women of child bearing potential must use reliable forms of contraception. - Diagnosis of Macular edema during screening period - Any medically unstable condition determined by investigator. - Unable to undergo MRI scans - Hypersensitivity to any study drugs or drugs of similar class Other protocol defined inclusion/exclusion may apply.

Additional Information

Official title A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients With Secondary Progressive Multiple Sclerosis Followed by Extended Treatment With Open-label BAF312.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Novartis.