Recruiting
Phase 3

Ponesimod

Sponsor:

Vanda Pharmaceuticals

Code:

NCT07362017

Conditions

Moderate-to-severe Chronic Plaque Psoriasis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Ponesimod

Study Details

Brief summary:

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

Conditions

Moderate-to-severe Chronic Plaque Psoriasis

Study ID

NCT07362017

Start date

Feb 17, 2026

Status verified date

Jun, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ponesimod

Ponesimod

Interventions

Ponesimod

Oral Tablet

Primary outcome measure

  • Safety and tolerability of ponesimod as measured by reporting of adverse events (AEs) [ Time Frame: Through study completion, approximately 1 year ]

Central Contacts and Locations

Central contacts

Vanda Pharmaceuticals, Inc.

202-734-3400clinicaltrials@vandapharma.com

Locations

Vanda Investigational Site

Recruiting

Glendale, Arizona, United States, 85308

Vanda Investigational Site

Recruiting

Fremont, California, United States, 94538

Vanda Investigational Site

Recruiting

Rochester, New York, United States, 14623

Vanda Investigational Site

Recruiting

Spokane, Washington, United States, 99202

More Information

Sponsor

Vanda Pharmaceuticals

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

  • psoriasis
  • Moderate-to-severe chronic plaque psoriasis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanda Pharmaceuticals on 2026-06-11.