Open Label Study to Investigate the Safety and Efficacy of Ponesimod in Moderate-to-Severe Chronic Plaque Psoriasis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVanda Pharmaceuticals
About this trial
An open label study to investigate the safety and efficacy of ponesimod in participants with moderate-to-severe chronic plaque psoriasis
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female subjects aged 18-65 years, inclusive
BMI >18 and <40
Minimum affected BSA of 10%
PASI score ≥ 12
Disqualifiers
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
Design model
Single group
Treatments tested in this trial
Ponesimod
DrugOral Tablet
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: PonesimodExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov