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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

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

Browse trials for

Keywords

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

Who can participate

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

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

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
04

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

  • DrugPonesimod

    Oral Tablet

05

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

06

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
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07362017
Lead sponsor
Vanda Pharmaceuticals
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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