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

Phase 3RecruitingNCT07362017

Vanda Pharmaceuticals300 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Moderate-to-severe Chronic Plaque Psoriasis

Interventions

PonesimodDRUG

Oral Tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Vanda Investigational Site

Glendale, Arizona, United States

RECRUITING

Vanda Investigational Site

Fremont, California, United States

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: Through study completion, approximately 1 year

Central Contacts

Vanda Pharmaceuticals, Inc.

CONTACT

202-734-3400 clinicaltrials@vandapharma.com

Data from ClinicalTrials.gov

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