42 completed, 7 active not recruiting, 4 recruiting, 4 terminated. 28 Phase 3, 13 Phase 2, 6 Phase 4, 5 Phase 1, 2 Not applicable.
Follow teriflunomide: new trials by email Literature Review of teriflunomide trials Research Report on teriflunomide
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 |
|---|---|---|---|---|---|---|
| A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple Sclerosis Platform therapies (Dimethyl Fumarate, Teriflunomide, Glatiramer Acetate, Beta-interferons), Anti-CD20 therapies (Ocrelizumab, Rituximab, Ofatumumab) - Relapsing-Remitting Multiple Sclerosis (RRMS), Anti-CD20 Therapy | Phase 3 | Recruiting | University Hospital, Montpellier | 250 | 2026-06-15 | 2026-06-23 |
| The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2) Teriflunomide, Dexamethasone - Immune Thrombocytopenia (ITP) | Phase 2 | Recruiting | Peking University People's Hospital | 132 | 2025-08-19 | 2025-09-08 |
| A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis. Tolebrutinib, Placebo, Teriflunomide - Relapsing Multiple Sclerosis, Secondary Progressive Multiple Sclerosis | Phase 3 | Active not recruiting | Sanofi | 2500 | 2024-04-16 | 2026-08-17 |
| Teriflunomide Plus High-dose Dexamethasone as First-line Treatment in Newly Diagnosed Primary Immune Thrombocytopenia Teriflunomide, Dexamethasone - Immune Thrombocytopenia | Phase 2 | Withdrawn | Peking University People's Hospital | 2023-12-19 | 2025-08-11 | |
| Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis Frexalimab, Teriflunomide, Placebo infusion - Multiple Sclerosis | Phase 3 | Active not recruiting | Sanofi | 1655 | 2023-12-13 | 2026-07-20 |
| The Combination of Teriflunomide and Danazol for Steroid-resistant/Relapse Immune Thrombocytopenia Teriflunomide, Danazol - Immune Thrombocytopenia | Phase 2 | Unknown | Peking University People's Hospital | 124 | 2023-12-05 | 2023-12-20 |
| Teriflunomide for Steroid-resistant/Relapse Immune Thrombocytopenia Teriflunomide - Immune Thrombocytopenia | Phase 2 | Unknown | Peking University People's Hospital | 40 | 2023-12-05 | 2024-01-05 |
| A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis ofatumumab, glatiramer acetate, interferon β1 - Relapsing Multiple Sclerosis | Recruiting | Novartis Pharmaceuticals | 800 | 2022-05-10 | 2026-07-30 | |
| Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-1) Remibrutinib, Teriflunomide - Relapsing Multiple Sclerosis | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 1000 | 2021-12-16 | 2026-08-18 |
| Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-2) Remibrutinib, Teriflunomide - Relapsing Multiple Sclerosis | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 1007 | 2021-12-13 | 2026-08-18 |
| Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis Teriflunomide - HAM/TSP | Phase 1 / Phase 2 | Recruiting | National Institute of Neurological Disorders and Stroke (NINDS) | 24 | 2021-09-24 | 2026-10-05 |
| Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS Ofatumumab, First line DMT - Multiple Sclerosis | Phase 3 | Completed | Novartis Pharmaceuticals | 185 | 2021-07-23 | 2026-03-03 |
| Teriflunomide vs. Placebo During Gluten Challenge in Celiac Disease Teriflunomide Oral Tablet - Celiac Disease | Phase 1 / Phase 2 | Completed | Oslo University Hospital | 15 | 2021-04-16 | 2025-05-16 |
| An International, Multicenter, Randomized, Double-Blind, Double-Masked Study of the Efficacy and Safety of BCD-132 (JSC BIOCAD, Russia) Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple Sclerosis BCD-132, Teriflunomide - Multiple Sclerosis | Phase 3 | Completed | Biocad | 336 | 2021-04-05 | 2024-11-25 |
| Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) Fenebrutinib, Teriflunomide, Placebo - Relapsing Multiple Sclerosis | Phase 3 | Active not recruiting | Hoffmann-La Roche | 751 | 2021-03-24 | 2026-09-17 |
| A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) Fenebrutinib, Teriflunomide, Placebo - Relapsing Multiple Sclerosis | Phase 3 | Active not recruiting | Hoffmann-La Roche | 746 | 2021-03-17 | 2026-09-21 |
| Relationship Between Oral DMT Burden and Adherence in MS Cladribine, Dimethyl fumarate, Fingolimod - Multiple Sclerosis, Adherence, Medication | Unknown | Monash University | 323 | 2020-09-25 | 2022-08-31 | |
| Study of Evobrutinib in Participants With RMS (evolutionRMS 2) Teriflunomide, Evobrutinib - Relapsing Multiple Sclerosis | Phase 3 | Terminated | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | 1166 | 2020-07-02 | 2025-03-21 |
| Discontinuing Disease-modifying Therapies in Stable Relapsing - Onset Multiple Sclerosis (DOT-MS). DMT - Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting | Not applicable | Unknown | Amsterdam UMC, location VUmc | 130 | 2020-07-01 | 2020-10-19 |
| Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1) Tolebrutinib, Teriflunomide, Placebo to match Tolebrutinib - Relapsing Multiple Sclerosis | Phase 3 | Completed | Sanofi | 974 | 2020-06-30 | 2025-07-02 |
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Multiple Sclerosis (34) · Multiple Sclerosis, Relapsing-Remitting (10) · Recurrence (8) · Purpura, Thrombocytopenic, Idiopathic (4) · Charcot-Marie-Tooth disease, Type 1F (2) · Multiple Sclerosis, Chronic Progressive (2) · Carcinoma, Basal Cell (1) · Celiac Disease (1) · Medication Adherence (1) · Melanoma (1) · Motor Activity (1) · Renal Insufficiency (1) · Skin Neoplasms (1)
Sanofi (23) · Novartis Pharmaceuticals (6) · Peking University People's Hospital (4) · Biocad (2) · Centre Hospitalier Universitaire de Nice (2) · Hoffmann-La Roche (2) · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (2) · TG Therapeutics, Inc. (2) · Actelion (1) · Amsterdam UMC, location VUmc (1) · Central Hospital, Nancy, France (1) · Centre hospitalier de l'Université de Montréal (CHUM) (1) · Derrick Scott Robertson (1) · Genzyme, a Sanofi Company (1) · IMPULS Endowment Fund (1)
United States (33) · Canada (28) · Germany (26) · France (24) · Italy (21) · United Kingdom (21) · Spain (20) · Poland (17) · Russia (17) · Turkey (Türkiye) (17) · Austria (16) · Czechia (15) · China (14) · Ukraine (14) · Belgium (13)
Xiao-Hui Zhang, MD (3) · Daniel Ontaneda, MD, MSc (1) · David Haegert, MD (1) · Ellen M. Mowry, MD, MCR (1) · Ernest Butler, PhD; MD (1) · Guillaume Mathey, MSc, MD (1) · J. Killestein, prof. dr. (1)
PMID 33023488, PMID 42546561, PMID 22622860, PMID 28304217, PMID 28607708, PMID 28680917, PMID 32757523, PMID 35266417, PMID 35485424, PMID 36001711, PMID 37606897, PMID 39018512, PMID 39307151, PMID 39512280, PMID 40202623, PMID 41787239, PMID 42292352, PMID 16567708, PMID 21991951, PMID 22307384, PMID 22723573, PMID 23851964, PMID 24126064, PMID 24461574, PMID 28828394, PMID 29055438, PMID 29796289, PMID 30511679, PMID 30729028, PMID 30870983, PMID 31005729, PMID 31198103, PMID 32911306, PMID 33779698, PMID 34800398, PMID 34950502, PMID 36047474, PMID 36550636, PMID 36632983, PMID 37155132, PMID 37603328, PMID 38301149, PMID 38311806, PMID 38619037, PMID 38654416, PMID 39652340, PMID 39855661, PMID 39899371, PMID 42218617
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