At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 451 enrolled
Drug / intervention
voclosporin +1 moredrug
Likely dose
Voclosporin 0.2, 0.3, or 0.4 mg/kg orally twice dailyAI-extracted
Key inclusion· 4
- ✓Plaque psoriasis diagnosis for ≥6 months prior to screening
- ✓Stable plaque psoriasis (not improving or worsening in the 4 weeks before screening)
- ✓Plaque psoriasis involving ≥10% body surface area at screening and day 0
- ✓PASI score ≥10 at screening and day 0
Key exclusion· 10
- ✕Erythrodermic, guttate, or pustular psoriasis (only plaque psoriasis allowed)
- ✕Malignancy within 5 years (except surgically excised squamous or basal cell carcinoma) or any history of lymphoma
- ✕Current uncontrolled bacterial, viral, or fungal infections requiring IV antibiotics/antifungals, or such infections within 60 days
- ✕Streptococcal infection requiring oral antibiotics within 30 days
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Multicentre, Double-Blind, Placebo-Controlled Study of ISA247 in Plaque Psoriasis Patients
In Brief
A Phase 3 clinical trial evaluating voclosporin and Placebo for Psoriasis. Completed, enrolled 451 participants across 31 sites.
Detailed Summary
The purpose of this study is to determine which dose of voclosporin is effective in the treatment of plaque psoriasis compared to placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
CountriesCanada
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2004
Primary CompletionOct 2005
First PostedOct 2005
TodayJul 2026
First PostedOct 27, 2005
Enrollment StartDec 1, 2004
Primary CompletionOct 1, 2005
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 20.7 years ago
Interventions
voclosporindrug
voclosporin 0.2, 0.3, or 0.4 mg/kg po BID
Placebodrug
Placebo