Adults 18 to 56, any sex, with Relapsing Remitting Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Total Number of Adverse Events During Evaluation of Long Term Safety and Tolerability of BAF312A in Extension Study.Primary· 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.
Serious adverse events
Group
Value
95% CI
BAF312 10 mg/2 mg
4
BAF312 2 mg/2 mg
7
BAF312 1.25 mg/2 mg
6
BAF312 .5 mg/2 mg
6
BAF312 .25 mg/2 mg
8
Other adverse events
Group
Value
95% CI
BAF312 10 mg/2 mg
30
BAF312 2 mg/2 mg
26
BAF312 1.25 mg/2 mg
42
BAF312 .5 mg/2 mg
29
BAF312 .25 mg/2 mg
42
Number of Participants With Cardiac Conduction Abnormalities During the Titration Phase of the Study (Without Washout)Primary· 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
Conduction-Prolonged QTc
Group
Value
95% CI
BAF312 10 mg/2 mg
5
BAF312 2 mg/2 mg
2
BAF312 1.25 mg/2 mg
5
BAF312 .5 mg/2 mg
2
BAF312 .25 mg/2 mg
4
Conduction - IVCD
Group
Value
95% CI
BAF312 10 mg/2 mg
3
BAF312 2 mg/2 mg
8
BAF312 1.25 mg/2 mg
1
BAF312 .5 mg/2 mg
3
BAF312 .25 mg/2 mg
0
Conduction - AV Mobitz I
Group
Value
95% CI
BAF312 10 mg/2 mg
1
BAF312 2 mg/2 mg
0
BAF312 1.25 mg/2 mg
0
BAF312 .5 mg/2 mg
0
BAF312 .25 mg/2 mg
0
Con:1st degree AV block
Group
Value
95% CI
BAF312 10 mg/2 mg
0
BAF312 2 mg/2 mg
1
BAF312 1.25 mg/2 mg
1
BAF312 .5 mg/2 mg
1
BAF312 .25 mg/2 mg
1
Conduction - WPW
Group
Value
95% CI
BAF312 10 mg/2 mg
0
BAF312 2 mg/2 mg
0
BAF312 1.25 mg/2 mg
0
BAF312 .5 mg/2 mg
1
BAF312 .25 mg/2 mg
0
Number of Participants With Cardiac Conduction-IVCD Abnormality During the Titration Phase of the Study (With Washout)Primary· 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
Group
Value
95% CI
BAF312 .25 mg/2 mg
4
Number of Participants With Changes in Blood Pressure for Overall Extension Study. (Extension Analysis Set)Primary· 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.
SBP Low: ≤ 90
Group
Value
95% CI
BAF312 10 mg/2 mg
1
BAF312 2 mg/2 mg
3
BAF312 1.25 mg/2 mg
2
BAF312 .5 mg/2 mg
1
BAF312 .25 mg/2 mg
1
SBP ≥ 20 decrease from baseline
Group
Value
95% CI
BAF312 10 mg/2 mg
8
BAF312 2 mg/2 mg
10
BAF312 1.25 mg/2 mg
4
BAF312 .5 mg/2 mg
6
BAF312 .25 mg/2 mg
10
SBP High: ≥ 160
Group
Value
95% CI
BAF312 10 mg/2 mg
1
BAF312 2 mg/2 mg
1
BAF312 1.25 mg/2 mg
1
BAF312 .5 mg/2 mg
3
BAF312 .25 mg/2 mg
3
SBP ≥ 20 increase from baseline
Group
Value
95% CI
BAF312 10 mg/2 mg
9
BAF312 2 mg/2 mg
8
BAF312 1.25 mg/2 mg
12
BAF312 .5 mg/2 mg
13
BAF312 .25 mg/2 mg
18
DBP Low: ≤ 50
Group
Value
95% CI
BAF312 10 mg/2 mg
1
BAF312 2 mg/2 mg
0
BAF312 1.25 mg/2 mg
1
BAF312 .5 mg/2 mg
0
BAF312 .25 mg/2 mg
1
DBP ≥ 15 decrease from baseline
Group
Value
95% CI
BAF312 10 mg/2 mg
14
BAF312 2 mg/2 mg
8
BAF312 1.25 mg/2 mg
10
BAF312 .5 mg/2 mg
10
BAF312 .25 mg/2 mg
10
DBP High: ≥ 100
Group
Value
95% CI
BAF312 10 mg/2 mg
4
BAF312 2 mg/2 mg
7
BAF312 1.25 mg/2 mg
4
BAF312 .5 mg/2 mg
4
BAF312 .25 mg/2 mg
4
DBP ≥ 15 increase from baseline
Group
Value
95% CI
BAF312 10 mg/2 mg
9
BAF312 2 mg/2 mg
13
BAF312 1.25 mg/2 mg
13
BAF312 .5 mg/2 mg
11
BAF312 .25 mg/2 mg
17
Number of Participants With Viral Infections of Interest Greater or Equal to 5% in Any Dose Group (Extension Set)Primary· 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
Oral herpes
Group
Value
95% CI
BAF312 10 mg/2 mg
5
BAF312 2 mg/2 mg
0
BAF312 1.25 mg/2 mg
4
BAF312 .5 mg/2 mg
2
BAF312 .25 mg/2 mg
4
Herpes zoster
Group
Value
95% CI
BAF312 10 mg/2 mg
5
BAF312 2 mg/2 mg
0
BAF312 1.25 mg/2 mg
3
BAF312 .5 mg/2 mg
2
BAF312 .25 mg/2 mg
0
Influenza
Group
Value
95% CI
BAF312 10 mg/2 mg
3
BAF312 2 mg/2 mg
4
BAF312 1.25 mg/2 mg
3
BAF312 .5 mg/2 mg
6
BAF312 .25 mg/2 mg
6
Number of Participants With Dermatologic Alterations - Basal Cell Carcinoma (Extension Set)Primary· Baseline Extension up to approximately 5 years
Group
Value
95% CI
BAF312 10 mg/2 mg
1
BAF312 2 mg/2 mg
0
BAF312 1.25 mg/2 mg
1
BAF312 .5 mg/2 mg
0
BAF312 .25 mg/2 mg
1
Number of Relapses in One Year - Annualized Relapse Rates for Overall Extension Study (ARR) (Extension Set)Secondary· Baseline extension up to approximately 5 years
Group level ARR (raw) is calculated as the total number of relapses for all the patients in the treatment group divided by the total number of days on study for all patients in the group and multiplied by 365.25 to obtain the annual rate.
Model estimates are based on a negative binomial regression model, adjusted for treatment group, age, baseline EDSS, baseline number of Gd-enhanced T1 lesions and number of relapses in previous 2 years as covariates, with log(time on study in years) as the offset variable, using the log link.
Group
Value
95% CI
BAF312 10 mg/2 mg
0.18
0.11 – 0.31
BAF312 2 mg/2 mg
0.15
0.08 – 0.26
BAF312 1.25 mg/2 mg
0.16
0.10 – 0.26
BAF312 .5 mg/2 mg
0.19
0.11 – 0.33
BAF312 .25 mg/2 mg
0.22
0.14 – 0.35
Percentage of Participants Free of Magnetic Resonance Imaging (MRI) Identified Disease Activity at Any Scan During Extension Study (Extension Set)Secondary· Baseline Extension up to approximately 5 years
Free of MRI disease activity is defined as free of Gadolinium enhanced T1 lesions at any scan; free of new or enlarging T2 lesions at any scan: free of both gadolinium enhanced T1 lesions and new or enlarging T2 lesions at any scan. Number of patients analyzed = patients with at least one MRI scan during the specified time period. New lesions at a specific visit are assessed relative to the previous scheduled visit scan.
No imputation of missing scans is performed. As a result missing scans can lead to an overestimation of the proportion of patients free of a specific MRI activity.
Free of Gd-enhanced T1 lesions at any scan
Group
Value
95% CI
BAF312 10 mg/2 mg
58.1
BAF312 2 mg/2 mg
57.7
BAF312 1.25 mg/2 mg
58.1
BAF312 .5 mg/2 mg
44.8
BAF312 .25 mg/2 mg
66.0
Free of new/enlarging T2 lesions at any scan
Group
Value
95% CI
BAF312 10 mg/2 mg
32.3
BAF312 2 mg/2 mg
42.3
BAF312 1.25 mg/2 mg
46.5
BAF312 .5 mg/2 mg
20.7
BAF312 .25 mg/2 mg
40.4
Free of Gd-enhanced T1 and new enlarged T2 lesions
Group
Value
95% CI
BAF312 10 mg/2 mg
32.3
BAF312 2 mg/2 mg
42.3
BAF312 1.25 mg/2 mg
44.2
BAF312 .5 mg/2 mg
20.7
BAF312 .25 mg/2 mg
40.4
Percentage of Participants Free of Confirmed Disability Progression in Extension Study (Extension Set)Secondary· Baseline Extension up to approximately 5 years
Six-month disability progression was defined relative to extension baseline EDSS score: 1.5 point increase in patients with baseline EDSS score of 0, 1.0 increase in patients with baseline EDSS score of between 0.5 to 5.0, inclusive and 0.5 increase in patients with baseline EDSS score of ≥ 5.5. The criteria for 6-month disability progression included detection of onset of progression and confirmation of progression for a period of at least 6 months.
Group
Value
95% CI
BAF312 10 mg/2 mg
72.3
56.0 – 88.7
BAF312 2 mg/2 mg
82.4
66.6 – 98.3
BAF312 1.25 mg/2 mg
84.8
73.5 – 96.0
BAF312 .5 mg/2 mg
81.4
66.6 – 96.1
BAF312 .25 mg/2 mg
78.6
65.4 – 91.9
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events (AEs) are collected from First Patient First Visit (FPFV)until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit..
Reporting threshold: 3.999%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
BAF312 10/2 mg
Serious: 4/33 (12%)
Deaths: —
BAF312 2/2 mg
Serious: 7/29 (24%)
Deaths: —
BAF312 1.25/2 mg
Serious: 6/43 (14%)
Deaths: —
BAF312 0.5/2 mg
Serious: 6/29 (21%)
Deaths: —
BAF312 0.25/2 mg
Serious: 8/50 (16%)
Deaths: —
All Patients
Serious: 31/184 (17%)
Deaths: —
Serious adverse events (40 terms)
Reaction
System
BAF312 10/2 mg
BAF312 2/2 mg
BAF312 1.25/2 mg
BAF312 0.5/2 mg
BAF312 0.25/2 mg
All Patients
Multiple sclerosis relapse
Nervous system disorders
—
—
—
—
—
—
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
—
—
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
—
—
Splenic cyst
Blood and lymphatic system disorders
—
—
—
—
—
—
Otosclerosis
Ear and labyrinth disorders
—
—
—
—
—
—
Glaucoma
Eye disorders
—
—
—
—
—
—
Abdominal discomfort
Gastrointestinal disorders
—
—
—
—
—
—
Gastritis
Gastrointestinal disorders
—
—
—
—
—
—
Nausea
Gastrointestinal disorders
—
—
—
—
—
—
Pancreatitis acute
Gastrointestinal disorders
—
—
—
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
—
—
—
Submandibular mass
General disorders
—
—
—
—
—
—
Biliary dyskinesia
Hepatobiliary disorders
—
—
—
—
—
—
Anaphylactic reaction
Immune system disorders
—
—
—
—
—
—
Oral herpes
Infections and infestations
—
—
—
—
—
—
Pyelonephritis
Infections and infestations
—
—
—
—
—
—
Pyelonephritis acute
Infections and infestations
—
—
—
—
—
—
Respiratory tract infection
Infections and infestations
—
—
—
—
—
—
Upper respiratory tract infection
Infections and infestations
—
—
—
—
—
—
Urinary tract infection
Infections and infestations
—
—
—
—
—
—
Ankle fracture
Injury, poisoning and procedural complications
—
—
—
—
—
—
Craniocerebral injury
Injury, poisoning and procedural complications
—
—
—
—
—
—
Femur fracture
Injury, poisoning and procedural complications
—
—
—
—
—
—
Tendon rupture
Injury, poisoning and procedural complications
—
—
—
—
—
—
Smear cervix abnormal
Investigations
—
—
—
—
—
—
Other adverse events (125 terms — click to expand)
Reaction
System
BAF312 10/2 mg
BAF312 2/2 mg
BAF312 1.25/2 mg
BAF312 0.5/2 mg
BAF312 0.25/2 mg
All Patients
Nasopharyngitis
Infections and infestations
—
—
—
—
—
—
Headache
Nervous system disorders
—
—
—
—
—
—
Upper respiratory tract infection
Infections and infestations
—
—
—
—
—
—
Influenza
Infections and infestations
—
—
—
—
—
—
Lymphopenia
Blood and lymphatic system disorders
—
—
—
—
—
—
Urinary tract infection
Infections and infestations
—
—
—
—
—
—
Insomnia
Psychiatric disorders
—
—
—
—
—
—
Diarrhoea
Gastrointestinal disorders
—
—
—
—
—
—
Back pain
Musculoskeletal and connective tissue disorders
—
—
—
—
—
—
Fatigue
General disorders
—
—
—
—
—
—
Sinusitis
Infections and infestations
—
—
—
—
—
—
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
—
—
Depression
Psychiatric disorders
—
—
—
—
—
—
Pharyngitis
Infections and infestations
—
—
—
—
—
—
Vertigo
Ear and labyrinth disorders
—
—
—
—
—
—
Bronchitis
Infections and infestations
—
—
—
—
—
—
Hypertension
Vascular disorders
—
—
—
—
—
—
Pyrexia
General disorders
—
—
—
—
—
—
Oral herpes
Infections and infestations
—
—
—
—
—
—
Alanine aminotransferase increased
Investigations
—
—
—
—
—
—
Lymphocyte count decreased
Investigations
—
—
—
—
—
—
Cough
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
Arthralgia
Musculoskeletal and connective tissue disorders
—
—
—
—
—
—
Gamma-glutamyltransferase increased
Investigations
—
—
—
—
—
—
Abdominal pain upper
Gastrointestinal disorders
—
—
—
—
—
—
Hypercholesterolaemia
Metabolism and nutrition disorders
—
—
—
—
—
—
Pain in extremity
Musculoskeletal and connective tissue disorders
—
—
—
—
—
—
Toothache
Gastrointestinal disorders
—
—
—
—
—
—
Gastroenteritis
Infections and infestations
—
—
—
—
—
—
Herpes zoster
Infections and infestations
—
—
—
—
—
—
Tonsillitis
Infections and infestations
—
—
—
—
—
—
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This study consisted of a two year dose blinded phase during which patients received one of five doses of siponimod (10, 2, 1.25, 0.5 or 0.25mg) following which patients were switched to open label treatment with siponimod 2mg for approximately a further 3 years. It will provide data on long term safety, tolerability and efficacy of siponimod in the RRMS patient population
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04792567 — Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patients With Secondary Progressive Multiple Sclerosis (A
· Phase 4
· completed
NCT02029274 — Safety and Efficacy of BAF312 in Dermatomyositis
· Phase 2
· terminated
NCT01801917 — Efficacy and Tolerability of BAF312 in Patients With Polymyositis
· Phase 2
· terminated
NCT01665144 — Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)
· Phase 3
· completed
NCT01148810 — Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis
· Phase 2
· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 27 March 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01185821.