13 completed, 2 active not recruiting, 2 recruiting, 2 terminated. 6 Phase 1, 5 Phase 3, 4 Phase 2, 1 Not applicable, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 6 | Completed 6 |
| Phase 3 | 5 | Completed 2, Recruiting 2, Terminated 1 |
| Phase 2 | 4 | Completed 3, Terminated 1 |
| Not applicable | 1 | Completed 1 |
| Phase 4 | 1 | Active not recruiting 1 |
Follow ponesimod: new trials by email Literature Review of ponesimod trials Research Report on ponesimod
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 |
|---|---|---|---|---|---|---|
| Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative Colitis Ponesimod, Placebo - Ulcerative Colitis (UC) | Phase 3 | Recruiting | Vanda Pharmaceuticals | 150 | 2026-09-01 | 2026-08-18 |
| Open Label Study to Investigate the Safety and Efficacy of Ponesimod in Moderate-to-Severe Chronic Plaque Psoriasis Ponesimod - Moderate-to-severe Chronic Plaque Psoriasis | Phase 3 | Recruiting | Vanda Pharmaceuticals | 300 | 2026-02-17 | 2026-09-22 |
| A Study of Ponesimod in Healthy Adult Participants Ponesimod, Carbamazepine - Healthy | Phase 1 | Completed | Janssen Pharmaceutica N.V., Belgium | 28 | 2022-10-18 | 2025-04-27 |
| 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 | |
| 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 |
| Czech Pharmaco-epidemiological Study on Disease Modifying Drugs interferons, glatiramer acetate, teriflunomide, dimethyl fumarate, alemtuzumab, cladribine, fingolimod, ponesimod, rituximab, ocrelizumab, ofatumumab, natalizumab - Multiple Sclerosis | Completed | IMPULS Endowment Fund | 17478 | 2019-01-01 | 2023-03-09 | |
| 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 |
| Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis Ponesimod - Multiple Sclerosis | Phase 3 | Completed | Actelion | 877 | 2017-07-05 | 2025-06-22 |
| Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®) Ponesimod, Placebo - Multiple Sclerosis | Phase 3 | Terminated | Actelion | 136 | 2017-03-30 | 2021-05-18 |
| Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of Ponesimod in Subjects With Symptomatic Chronic GVHD Ponesimod - Chronic Graft Versus Host Disease | Phase 2 | Terminated | Actelion | 1 | 2016-09-29 | 2025-02-04 |
| Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis ponesimod, teriflunomide - Multiple Sclerosis | Phase 3 | Completed | Actelion | 1133 | 2015-06-04 | 2025-03-30 |
| Study to Investigate the Absolute Bioavailability of a Single Oral Dose of Ponesimod in Healthy Male Subjects Ponesimod 5mg i.v., Ponesimod i.v., Ponesimod 10 mg tablet - Healthy | Phase 1 | Completed | Actelion | 17 | 2014-08-01 | 2015-05-21 |
| Study of the Electrocardiographic Effects of Ponesimod in Healthy Male and Female Subjects Ponesimod Placebo, Moxifloxacin Placebo, Ponesimod 10 mg - Healthy | Phase 1 | Completed | Actelion | 116 | 2011-08-01 | 2014-05-13 |
| ACT-128800 in Patients With Moderate to Severe Chronic Plaque Psoriasis ACT-128800, Placebo - Psoriasis | Phase 2 | Completed | Actelion | 326 | 2010-10-31 | 2025-03-30 |
| Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis Ponesimod 10 mg, Ponesimod 20 mg, Ponesimod 40 mg - Multiple Sclerosis | Phase 2 | Completed | Actelion | 353 | 2010-05-12 | 2025-03-30 |
| Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-128800 in Healthy Subjects ACT-128800, Placebo - Safety and Tolerability | Phase 1 | Completed | Actelion | 16 | 2010-04-01 | 2014-01-08 |
| Mass Balance, Pharmacokinetics, and Metabolism of 14C-labeled ACT-128800 Administered to Healthy Male Subjects ACT-128800 - Pharmacokinetics | Phase 1 | Completed | Actelion | 6 | 2009-03-01 | 2014-04-30 |
| Study to Evaluate the Pharmacokinetics, Tolerability, and Safety of ACT-128800 in Japanese and Caucasian Healthy Male and Female Subjects ACT-128800 - Healthy | Phase 1 | Completed | Actelion | 20 | 2009-02-01 | 2014-08-22 |
| ACT-128800 in Psoriasis ACT-128800, Placebo - Plaque Psoriasis | Phase 2 | Completed | Actelion | 66 | 2008-10-01 | 2009-11-13 |
Multiple Sclerosis (6) · Multiple Sclerosis, Relapsing-Remitting (2) · Psoriasis (2) · Bronchiolitis Obliterans Syndrome (1) · Colitis, Ulcerative (1)
Actelion (12) · Vanda Pharmaceuticals (2) · Biogen (1) · IMPULS Endowment Fund (1) · Janssen Pharmaceutica N.V., Belgium (1) · Johns Hopkins University (1) · The Cleveland Clinic (1)
United States (11) · United Kingdom (8) · Czechia (6) · France (6) · Hungary (6) · Bulgaria (5) · Germany (5) · Russia (5) · Spain (5) · Austria (4) · Canada (4) · Italy (4) · Poland (4) · Romania (4) · Serbia (4)
Patrick Brossard, PhD (3) · Tatiana Scherz, MD, PhD (2) · Albrecht Georg Schmidt, MD (1) · Daniel Ontaneda, MD, MSc (1) · Daniela Baldoni, PharmD, PhD (1) · Daniele D'Ambrosio, MD, PhD (1) · Darren Wilbraham, MBBS, DCPSA (1) · Ellen M. Mowry, MD, MCR (1) · Nikos Evangelou, MD, DPhil (1) · Scott D. Newsome, DO (1) · Tatiana Sidorenko, MD, PhD (1)
PMID 25127208, PMID 25287214, PMID 33779698, PMID 36047474, PMID 36550636, PMID 37155132, PMID 38301149, PMID 38654416, PMID 40700861, PMID 42218617
2009 (1), 2016 (1)