Recruiting NCT07362017
Open Label Study to Investigate the Safety and Efficacy of Ponesimod in Moderate-to-Severe Chronic Plaque Psoriasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ponesimod.
- Who it may be relevant to
- Registry conditions: Moderate-to-severe Chronic Plaque Psoriasis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Open Label Study to Investigate the Safety and Efficacy of Ponesimod in the Treatment of Moderate-to-Severe Chronic Plaque Psoriasis
Overview
An open label study to investigate the safety and efficacy of ponesimod in participants with moderate-to-severe chronic plaque psoriasis
Interventions
- Drug Ponesimod
Oral Tablet
Primary outcome measures
- Safety and tolerability of ponesimod as measured by reporting of adverse events (AEs) [Time frame: Through study completion, approximately 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- Vanda Investigational Site — Glendale
- Vanda Investigational Site — Fremont
- Vanda Investigational Site — Rochester
- Vanda Investigational Site — Spokane
Identifiers
NCT: NCT07362017 · VP-VSP-128-3102