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

NCT07362017 — Phase 3, Recruiting, 300 participants, Vanda Pharmaceuticals

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

RegistryNCT07362017
StatusRecruiting
PhasePhase 3
Study typeInterventional; na, single group, masking: none, treatment
Enrollment300 (Estimated)
SponsorVanda Pharmaceuticals (Industry)
ConditionsModerate-to-severe Chronic Plaque Psoriasis
InterventionsPonesimod (Drug)
Datesstart 2026-02-17, primary completion 2028-08-01 (estimated), completion 2028-12-01 (estimated), first posted 2026-01-23, last updated 2026-09-22
Locations10 sites in United States

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-Summary

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

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+Arms and interventions

ArmTypeInterventionsDescription
PonesimodExperimentalDrug: PonesimodPonesimod
  • Ponesimod (Drug): Oral Tablet

+Outcome measures

Primary outcomes

  • 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

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (10)

FacilityCityCountryStatus
Vanda Investigational SiteGlendale, ArizonaUnited StatesRecruiting
Vanda Investigational SiteFremont, CaliforniaUnited StatesRecruiting
Vanda Investigational SiteMiami, FloridaUnited StatesRecruiting
Vanda Investigational SiteIndianapolis, IndianaUnited StatesRecruiting
Vanda Investigational SitePortsmouth, New HampshireUnited StatesRecruiting
Vanda Investigational SiteRochester, New YorkUnited StatesRecruiting
Vanda Investigational SiteWilmington, North CarolinaUnited StatesRecruiting
Vanda Investigational SiteSan Antonio, TexasUnited StatesRecruiting
Vanda Investigational SiteWebster, TexasUnited StatesRecruiting
Vanda Investigational SiteSpokane, WashingtonUnited StatesRecruiting

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