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

Vanda Pharmaceuticals

Status and phase: Not yet enrolling; Phase 3

Conditions: Moderate-to-severe Chronic Plaque Psoriasis

Treatments: Drug: Ponesimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT07362017

VP-VSP-128-3102

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Ponesimod

Experimental group

Description:

Ponesimod

Treatment:

Drug: Ponesimod