Open Label Study to Investigate the Safety and Efficacy of Ponesimod in Moderate-to-Severe Chronic Plaque Psoriasis
Purpose
An open label study to investigate the safety and efficacy of ponesimod in participants with moderate-to-severe chronic plaque psoriasis
Condition
- Moderate-to-severe Chronic Plaque Psoriasis
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Ponesimod |
Ponesimod |
|
Recruiting Locations
Vanda Investigational Site
Glendale, Arizona 85308
Glendale, Arizona 85308
Vanda Investigational Site
Fremont, California 94538
Fremont, California 94538
Vanda Investigational Site
Rochester, New York 14623
Rochester, New York 14623
Vanda Investigational Site
Spokane, Washington 99202
Spokane, Washington 99202
More Details
- Status
- Recruiting
- Sponsor
- Vanda Pharmaceuticals