Open Label Study to Investigate the Safety and Efficacy of Ponesimod in 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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Moderate-to-severe Chronic Plaque Psoriasis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vanda Investigational Site, Glendale, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ponesimod

Drug

Oral Tablet

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Vanda Pharmaceuticals, Inc.

CONTACT

[email protected]

202-734-3400

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Jan 23, 2026
Registry last updated: Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed