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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07362017
- Acronym / sponsor ID
- VP-VSP-128-3102
- Keywords
- psoriasis, Moderate-to-severe chronic plaque psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open label study to investigate the safety and efficacy of ponesimod in participants with moderate-to-severe chronic plaque psoriasis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ponesimod | Experimental | Drug: PonesimodPonesimod |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female subjects aged 18-65 years, inclusive
- BMI >18 and <40
- Minimum affected BSA of 10%
- PASI score ≥ 12
- PGA ≥ 3
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PonesimodOral Tablet | Drug | Ponesimod |
Primary outcome
Safety and tolerability of ponesimod as measured by reporting of adverse events (AEs)
Time frame: Through study completion, approximately 1 year
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Moderate-to-severe Chronic Plaque Psoriasis
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To Check Comparison of Apremilast and Methotrexate Efficacy in Patients With Moderate to Severe Plaque Psoriasis Presented to Tertiary Care Hospital
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanda Pharmaceuticals, Inc. (202-734-3400, clinicaltrials@vandapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of ponesimod as measured by reporting of adverse events (AEs) (time frame: Through study completion, approximately 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.