Psoriasis
Conditions
Brief summary
To evaluate the safety and tolerability of VX-765 in subjects with chronic plaque psoriasis treated for 28 days.
Interventions
DRUGVX-765
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Inclusion criteria
* Diagnosed with chronic plaque psoriasis for at least 6 months * Prior systemic therapy
Exclusion criteria
* Current or prior history of illness precluding use of immunomodulatory therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | — |
| Abnormal laboratory values | — |
| Abnormal ECGs and vital signs | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects demonstrating ≥ 50% and ≥ 75% decrease from baseline in Psoriasis Area and Severity Index (PASI) to the end of 28 days of treatment | — |
| PK/PD | — |
| Change in PASI from baseline to the end of 28 days of treatment | — |
| Target lesion score after 28 days of treatment | — |
| Proportion of subjects meeting clear or almost clear criteria utilizing a static Physician's Global Assessment (sPGA) | — |
Outcome results
None listed