Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally in Patients With Relapsing-remitting Multiple Sclerosis

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Dose Blinded Extension Study to the CBAF312A2201 Study to Evaluate Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally Once Daily in Patients With Relapsing-remitting Multiple Sclerosis

ClinicalTrials.gov ID

NCT01185821

Acronym / sponsor ID

CBAF312A2201E1

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

BAF312, siponimod, Multiple Sclerosis, Relapsing remitting Multiple Sclerosis, Demyelinating Autoimmune Diseases, MS, RRMS, inflammatory disease

Phase

Phase 2

Study type

Interventional

Recruitment status

Completed

Enrolment

185 participants (actual)

Lead sponsor

Novartis PharmaceuticalsIndustry (pharma, biotech, devices)

Study start

30 Aug 2010 (actual)

Primary completion

10 Oct 2016 (actual)

Study completion

10 Oct 2016 (actual)

First posted

20 Aug 2010 (estimated)

Results

Posted 12 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

Quadruple blind (participant, care provider, investigator, outcomes assessor)

Number of arms

5

Model description

This extension study was originally set up as a 2 year dose-blinded extension study to maintain blinding of ongoing Core study. Study was later amended to include a subsequent Open-Label treatment phase after Core study was unblinded. During the Dose-Blinded phase of the extension study patients received the same dose from the Core study. Patients who received placebo in Period 1 during the Core Study were equally randomized to 1 of the 3 active doses of siponimod used during Period 1 (0.5, 2.0, or 10 mg) and patients who received placebo in Period 2 were equally randomized to 1 of the 2 active doses of siponimod used during Period 2 (0.25 mg or 1.25 mg).

Who may qualify

Ages

18 to 56 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Total Number of Adverse Events During Evaluation of Long Term Safety and Tolerability of BAF312A in Extension Study.

   Time frame: Baseline up to approximately 5 years

   Refer to adverse events for complete listing of serious adverse events and other adverse events. Adverse events of interest were presented in separate tables. There were no reports of macular edema.

2. Number of Participants With Cardiac Conduction Abnormalities During the Titration Phase of the Study (Without Washout)

   Time frame: Baseline Extension up to day 10

   Number of patients with abnormal ECG conduction findings during dose-blinded titration at any visit post-dose, by type of abnormality and treatment (Extension Set). Number analyzed represent participants who had ECG results. Washout was defined as not being on treatment drug between Core and Extension for >7 days. Abbreviation: Con=conduction, IVCD=intraventricular conduction defect , WPW=Wolff-Parkinson-White syndrome

3. Number of Participants With Cardiac Conduction-IVCD Abnormality During the Titration Phase of the Study (With Washout)

   Time frame: Baseline Extension up to day 10

   Number of patients with abnormal ECG conduction findings during dose-blinded titration at any visit post-dose, by type of abnormality and treatment (Extension Set). Number analyzed represent participants who had ECG results. Washout was defined as not being on treatment drug between Core and Extension for >7 days. Abbreviations: washout = WO, Con=conduction

4. Number of Participants With Changes in Blood Pressure for Overall Extension Study. (Extension Analysis Set)

   Time frame: Baseline Extension up to approximately 5 years

   Sitting blood pressure was measured in triplicate. The categories of notably low and high values and changes are presented for systolic (SBP) and diastolic (DBP). Multiple occurrences for a patient are counted as one occurrence in this table.

5. Number of Participants With Viral Infections of Interest Greater or Equal to 5% in Any Dose Group (Extension Set)

   Time frame: Baseline Extension up to approximately 5 years

   Most infections were clinical diagnoses and were not confirmed by microbiology / virologic investigations. A patient with multiple occurrences of an infection for a preferred term is counted only once in each specific category. Events identified as infections by the Investigator and defined as an AE with onset on or after the first dose of Extension Study drug up to and including 30 days after the date of the last dose

6. Number of Participants With Dermatologic Alterations - Basal Cell Carcinoma (Extension Set)

   Time frame: Baseline Extension up to approximately 5 years

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 27380540Kappos L, Li DK, Stuve O, Hartung HP, Freedman MS, Hemmer B, Rieckmann P, Montalban X, Ziemssen T, Hunter B, Arnould S, Wallstrom E, Selmaj K. Safety and Efficacy of Siponimod (BAF312) in Patients With Relapsing-Remitting Multiple Sclerosis: Dose-Blinded, Randomized Extension of the Phase 2 BOLD Study. JAMA Neurol. 2016 Sep 1;73(9):1089-98. doi: 10.1001/jamaneurol.2016.1451.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

46 sites in 12 countries: see every site and its status.