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

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07362017

Enrollment

300

Registered

2026-01-23

Start date

2026-01-01

Completion date

2028-12-01

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate-to-severe Chronic Plaque Psoriasis

Keywords

psoriasis, Moderate-to-severe chronic plaque psoriasis

Brief summary

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

Interventions

DRUGPonesimod

Oral Tablet

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability of ponesimod as measured by reporting of adverse events (AEs)	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

Contacts

CONTACTVanda Pharmaceuticals, Inc.

clinicaltrials@vandapharma.com202-734-3400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026