ClinicalTrials.gg
RecruitingNCT07362017Updated Sep 22, 2026

Open Label Study to Investigate the Safety and Efficacy of Ponesimod in Moderate-to-Severe Chronic Plaque Psoriasis

A Phase 3 interventional study of Ponesimod in Moderate-to-severe Chronic Plaque Psoriasis, sponsored by Vanda Pharmaceuticals. Recruiting at 10 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Vanda Pharmaceuticals · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 8 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

An open label study to investigate the safety and efficacy of ponesimod in participants with moderate-to-severe chronic plaque psoriasis

02

Conditions studied

  • Moderate-to-severe Chronic Plaque Psoriasis

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Keywords

  • psoriasis
  • Moderate-to-severe chronic plaque psoriasis
03

In context

Psoriasis

2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.

This study's planned enrollment of 300 is above the median of 75 across 1,565 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Vanda Pharmaceuticals is the lead sponsor of 82 studies on the registry; 17 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 22 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male and female subjects aged 18-65 years, inclusive
  • >18 and \<40
  • Minimum affected BSA of 10%
  • PASI score ≥ 12
  • PGA ≥ 3
  • Diagnosed with moderate-to-severe plaque psoriasis

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Ponesimod

    Ponesimod

    Drug: Ponesimod

Interventions

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Through study completion, approximately 1 year

07

Study locations

10 of 10 sites recruiting
  • Vanda Investigational Site
    Glendale, Arizona 85308, United States
    Recruiting
  • Vanda Investigational Site
    Fremont, California 94538, United States
    Recruiting
  • Vanda Investigational Site
    Miami, Florida 33126, United States
    Recruiting
  • Vanda Investigational Site
    Indianapolis, Indiana 46250, United States
    Recruiting
  • Vanda Investigational Site
    Portsmouth, New Hampshire 03801, United States
    Recruiting
  • Vanda Investigational Site
    Rochester, New York 14623, United States
    Recruiting
  • Vanda Investigational Site
    Wilmington, North Carolina 28405, United States
    Recruiting
  • Vanda Investigational Site
    San Antonio, Texas 78213, United States
    Recruiting
  • Vanda Investigational Site
    Webster, Texas 77598, United States
    Recruiting
  • Vanda Investigational Site
    Spokane, Washington 99202, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Aug 2028, 30 months after the start.

Of 217 industry-sponsored phase 3 interventional studies under Psoriasis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's planned 30 months is above that.

Counting every sponsor, half of 227 studies reached it within 15 months; a quarter within 10 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 20, 2026
First posted
Jan 23, 2026
StartActual
Feb 17, 2026
Primary completionEst.
Aug 2028
CompletionEst.
Dec 2028
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07362017
Responsible party
Sponsor
First posted
Jan 23, 2026
Start date
Feb 17, 2026
Primary completion
Aug 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Sep 22, 2026

Study contacts

Vanda Pharmaceuticals, Inc.
Contact
clinicaltrials@vandapharma.com
202-734-3400

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Ponesimod

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