NCT07362017

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
28mo left

Started Feb 2026

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Feb 2026Dec 2028

First Submitted

Initial submission to the registry

January 20, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

February 17, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

2.5 years

First QC Date

January 20, 2026

Last Update Submit

June 10, 2026

Conditions

Moderate-to-severe Chronic Plaque Psoriasis

Keywords

psoriasisModerate-to-severe chronic plaque psoriasis

Outcome Measures

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

    Through study completion, approximately 1 year

Study Arms (1)

Ponesimod

EXPERIMENTAL

Ponesimod

Drug: Ponesimod

Interventions

PonesimodDRUG

Oral Tablet

Ponesimod

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Vanda Investigational Site

Glendale, Arizona, 85308, United States

RECRUITING

Vanda Investigational Site

Fremont, California, 94538, United States

RECRUITING

Vanda Investigational Site

Rochester, New York, 14623, United States

RECRUITING

Vanda Investigational Site

Spokane, Washington, 99202, United States

RECRUITING

MeSH Terms

Conditions

Psoriasis

Interventions

ponesimod

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Vanda Pharmaceuticals, Inc.

CONTACT

202-734-3400clinicaltrials@vandapharma.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2026

First Posted

January 23, 2026

Study Start

February 17, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(4)