12 completed, 5 terminated, 3 active not recruiting, 3 recruiting. 8 Phase 2, 4 Phase 3, 3 Phase 1, 2 Not applicable, 2 Phase 4.
Follow siponimod: new trials by email Literature Review of siponimod trials Research Report on siponimod
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Repurposing Siponimod for Alzheimer's Disease Siponimod, Placebo - Alzheimer Disease, Mild Alzheimer Disease | Phase 2 | Recruiting | St. Joseph's Hospital and Medical Center, Phoenix | 105 | 2025-08-26 | 2026-03-04 |
| Impact of Mayzent on aSPMS Patients in a Long-term NIS in Italy siponimod - Active Secondary Progressive Multiple Sclerosis | Completed | Novartis Pharmaceuticals | 134 | 2022-06-17 | 2026-05-19 | |
| Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Mayzent Siponimod - Multiple Sclerosis | Recruiting | Novartis Pharmaceuticals | 867 | 2021-12-15 | 2024-05-16 | |
| Swiss Study of the Impact of Mayzent on SPMS Patients in a Long-term Non-interventional Study Siponimod - Secondary Progressive Multiple Sclerosis With Inflammatory Disease Activity | Terminated | Novartis Pharmaceuticals | 8 | 2021-11-19 | 2023-08-29 | |
| Study to Assess the Efficacy of Mayzent on Microglia in Secondary Progressive Multiple Sclerosis Mayzent, Ocrevus - Secondary-progressive Multiple Sclerosis | Phase 2 / Phase 3 | Terminated | State University of New York at Buffalo | 8 | 2021-11-13 | 2025-05-13 |
| Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis Fingolimod, Ofatumumab, Siponimod - Multiple Sclerosis (MS) | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 129 | 2021-10-05 | 2026-05-14 |
| A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies Diroximel Fumarate, Alemtuzumab, Fingolimod - Multiple Sclerosis | Active not recruiting | Biogen | 1178 | 2021-09-24 | 2026-10-15 | |
| Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patients With Secondary Progressive Multiple Sclerosis (AMA-VACC) BAF312, Baseline disease modifying therapies (DMTs), BNT162 - Secondary Progressive Multiple Sclerosis | Phase 4 | Completed | Novartis Pharmaceuticals | 41 | 2021-04-19 | 2024-06-20 |
| Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients Mayzent - Secondary Progressive Multiple Sclerosis (SPMS) | Completed | Novartis Pharmaceuticals | 451 | 2020-10-28 | 2024-02-12 | |
| Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients Siponimod - Multiple Sclerosis, Relapsing Multiple Sclerosis | Phase 3 | Completed | Novartis Pharmaceuticals | 185 | 2019-02-14 | 2024-06-20 |
| Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS Early Highly Effective Therapies Group, Escalation Therapies Group - Multiple Sclerosis, Relapsing-Remitting | Phase 4 | Active not recruiting | The Cleveland Clinic | 800 | 2019-01-03 | 2026-08-31 |
| Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial Natalizumab/natalizumab-sztn, Alemtuzumab, Ocrelizumab, Rituximab/rituximab-arrx/rituximab-abbs/rituximab-pvvr, Cladribine, Ofatumumab, Ublituximab-xiiy, Ocrelizumab and hyaluronidase-ocsq, Glatiramer acetate, Interferons (intramuscular, subcutaneous, pegylated) Teriflunomide, Fumarates (dimethyl, diroximel, monomethyl) Fingolimod, Siponimod, Ozanimod, Ponesimod - Multiple Sclerosis, Relapsing-Remitting | Not applicable | Completed | Johns Hopkins University | 900 | 2018-05-02 | 2026-09-23 |
| Efficacy, Safety and Tolerability of BAF312 Compared to Placebo in Patients With Intracerebral Hemorrhage (ICH). BAF312 solution, Matching Placebo for BAF312 solution, BAF312 tablet - Hemorrhagic Stroke, Intracerebral Hemorrhage (ICH) | Phase 2 | Completed | Novartis Pharmaceuticals | 32 | 2017-12-24 | 2022-08-12 |
| Safety and Efficacy of BAF312 in Dermatomyositis BAF312, Placebo - Active Dermatomyositis | Phase 2 | Terminated | Novartis Pharmaceuticals | 17 | 2013-08-25 | 2021-01-05 |
| A Single-dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of BAF312 in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function BAF312 - Renal Impairment | Phase 1 | Completed | Novartis Pharmaceuticals | 16 | 2013-07-01 | 2020-12-08 |
| Efficacy and Tolerability of BAF312 in Patients With Polymyositis Placebo, BAF312 - Polymyositis | Phase 2 | Terminated | Novartis Pharmaceuticals | 14 | 2013-04-24 | 2021-01-05 |
| Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND) BAF312, Placebo - Secondary Progressive Multiple Sclerosis | Phase 3 | Completed | Novartis Pharmaceuticals | 1651 | 2012-12-20 | 2024-06-05 |
| Pharmacokinetics of BAF312 in Patients With Hepatic Impairment BAF312 - Hepatic Impairment | Phase 1 | Completed | Novartis Pharmaceuticals | 40 | 2012-10-01 | 2020-12-29 |
| Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally in Patients With Relapsing-remitting Multiple Sclerosis BAF312 - Relapsing Remitting Multiple Sclerosis | Phase 2 | Completed | Novartis Pharmaceuticals | 185 | 2010-08-30 | 2018-03-27 |
| Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis BAF312, Placebo - Polymyositis, Dermatomyositis | Phase 2 | Terminated | Novartis Pharmaceuticals | 18 | 2010-06-15 | 2019-04-25 |
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Multiple Sclerosis (7) · Multiple Sclerosis, Chronic Progressive (7) · Multiple Sclerosis, Relapsing-Remitting (4) · Dermatomyositis (2) · Myositis (2) · Myositis, Inclusion Body (2) · Polymyositis (2) · Alzheimer Disease (1) · COVID-19 (1) · Cerebral Hemorrhage (1) · Cognitive Dysfunction (1) · Deglutition Disorders (1) · Demyelinating Diseases (1) · Diffuse Cerebral Sclerosis of Schilder (1) · Exanthema (1)
Novartis Pharmaceuticals (17) · Biogen (1) · Hadassah Medical Organization (1) · Johns Hopkins University (1) · Novartis (1) · St. Joseph's Hospital and Medical Center, Phoenix (1) · State University of New York at Buffalo (1) · The Cleveland Clinic (1)
United States (17) · Hungary (6) · Canada (5) · Germany (5) · Italy (5) · Poland (5) · Czechia (4) · Russia (4) · Spain (4) · Switzerland (4) · Turkey (Türkiye) (4) · Israel (3) · Japan (3) · United Kingdom (3) · Argentina (2)
Boris Decourt, PhD (1) · Daniel Ontaneda, MD, MSc (1) · Ellen M. Mowry, MD, MCR (1) · Kevin N. Sheth, MD (1) · Marwan N Sabbagh, MD (1) · Nikos Evangelou, MD, DPhil (1) · Scott D. Newsome, DO (1) · Yoseph Caraco, MD (1)
PMID 23764350, PMID 26083135, PMID 27380540, PMID 27878474, PMID 29576505, PMID 33328324, PMID 33791945, PMID 35261318, PMID 35379762, PMID 35380078, PMID 35639197, PMID 36381503, PMID 38654416, PMID 40248858, PMID 42218617
2008 (2), 2009 (1), R01AG073212 (1)