Moderate-to-severe Chronic Plaque PsoriasisPhase 3NCT07362017
Open Label Study to Investigate the Safety and Efficacy of Ponesimod in Moderate-to-Severe Chronic Plaque Psoriasis
A Phase 3 study testing Ponesimod in people with Moderate-to-severe Chronic Plaque Psoriasis, run by Vanda Pharmaceuticals at 10 sites in United States.
Trial summary
An open label study to investigate the safety and efficacy of ponesimod in participants with moderate-to-severe chronic plaque psoriasis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Moderate-to-severe Chronic Plaque Psoriasis
- What is being tested?
- Ponesimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 10 sitesUnited States
- Study dates
- 17 Feb 2026to Dec 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Vanda Investigational Site
Fremont, California, 94538
- Recruiting
Vanda Investigational Site
Glendale, Arizona, 85308
- Recruiting
Vanda Investigational Site
Indianapolis, Indiana, 46250
- Recruiting
Vanda Investigational Site
Miami, Florida, 33126
- Recruiting
Vanda Investigational Site
Portsmouth, New Hampshire, 03801
- Recruiting
Vanda Investigational Site
Rochester, New York, 14623
- Recruiting
Vanda Investigational Site
San Antonio, Texas, 78213
- Recruiting
Vanda Investigational Site
Spokane, Washington, 99202
- Recruiting
Vanda Investigational Site
Webster, Texas, 77598
- Recruiting
Vanda Investigational Site
Wilmington, North Carolina, 28405
About this study
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
An open label study to investigate the safety and efficacy of ponesimod in participants with moderate-to-severe chronic plaque psoriasis
- Being tested
- Ponesimod
- Keywords
- psoriasis, Moderate-to-severe chronic plaque psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PonesimodDrug
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Ponesimod | Experimental | Ponesimod Receives: Drug: Ponesimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of ponesimod as measured by reporting of adverse events (AEs)
Safety will be assessed based on frequency of treatment-emergent adverse events and serious adverse events, and frequency of clinically notable abnormal vital signs, blood chemistry, hematology, urology, and ECGs
Measured: Through study completion, approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start17 Feb 2026
- Primary completionAug 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate-to-severe Chronic Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362017
- Sponsor's protocol ID
- VP-VSP-128-3102
- Status last verified
- Sep 2026
- First submitted
- 20 Jan 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No