Ponesimod in adults with moderate-to-severe chronic plaque psoriasis
Official title: A Multicenter, Open Label Study to Investigate the Safety and Efficacy of Ponesimod in the Treatment of Moderate-to-Severe Chronic Plaque Psoriasis
Run by Vanda Pharmaceuticals · NCT07362017 · Data updated 2026-11-12
This study tests whether ponesimod is safe and helps clear moderate-to-severe plaque psoriasis in adults aged 18–65.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Vanda Pharmaceuticals Industry-sponsored |
| Locations | 10 sites (Glendale, Arizona and 9 other locations) |
| Status | Recruiting |
| Started | February 17, 2026 |
| Main results expected | August 2028 |
| Study ends | December 2028 |
| Registry record updated | September 22, 2026 |
| Trial ID | NCT07362017 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 with moderate-to-severe chronic plaque psoriasis, at least 10% affected BSA, PASI ≥ 12, and PGA ≥ 3.
✕Probably not a fit
Individuals with certain psoriasis forms (erythrodermic, pustular, guttate, or palmoplantar) or known drug sensitivities may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label Phase 3 trial evaluates the safety and potential benefit of ponesimod in adults with moderate-to-severe chronic plaque psoriasis. Eligible participants have a body surface area involvement of at least 10%, a PASI of 12 or higher, and a PGA of 3 or more. The study is conducted at Vanda investigational sites in Glendale, AZ; Fremont, CA; and Miami, FL. Participants will receive ponesimod and will be monitored for safety and treatment response over a defined period.
Why it matters
Potential benefit: Participants may experience improvement in psoriasis symptoms and skin clearance if the treatment is beneficial.
How similar studies have gone: Previous studies of ponesimod have shown safety signals and potential efficacy in similar autoimmune skin conditions, but confirmation in psoriasis requires this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female subjects aged 18-65 years, inclusive * BMI \>18 and \<40 * Minimum affected BSA of 10% * PASI score ≥ 12 * PGA ≥ 3 * Diagnosed with moderate-to-severe plaque psoriasis Exclusion Criteria: * Diagnosis of generalized erythrodermic, generalized pustular (von Zumbusch), guttate, or palmoplantar psoriasis * History of an allergic reaction or known and/or significant sensitivity to study drug
Where it's running
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Vanda Investigational Site
Glendale, Arizona, United States Recruiting -
Vanda Investigational Site
Fremont, California, United States Recruiting -
Vanda Investigational Site
Miami, Florida, United States Recruiting -
Vanda Investigational Site
Indianapolis, Indiana, United States Recruiting -
Vanda Investigational Site
Portsmouth, New Hampshire, United States Recruiting -
Vanda Investigational Site
Rochester, New York, United States Recruiting
Show 4 more locations
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Vanda Investigational Site
Wilmington, North Carolina, United States Recruiting -
Vanda Investigational Site
San Antonio, Texas, United States Recruiting -
Vanda Investigational Site
Webster, Texas, United States Recruiting -
Vanda Investigational Site
Spokane, Washington, United States Recruiting
Study contacts
- Study coordinator: Vanda Pharmaceuticals, Inc.
- Email: clinicaltrials@vandapharma.com
- Phone: 202-734-3400
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.