Psoriasis
Conditions
Keywords
psoriasis, chronic plaque psoriasis, Moderate to severe chronic plaque psoriasis
Brief summary
This study will assess the efficacy, safety and tolerability of two doses of ACT 128800 in patients with moderate-to-severe chronic plaque psoriasis.
Interventions
DRUGACT-128800
ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily
DRUGPlacebo
ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily
Sponsors
Actelion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Adult males and females aged 18 to 60 years (inclusive) with moderate to severe chronic plaque psoriasis who require systemic treatment.
Exclusion criteria
* Patients with other forms of psoriasis and patients who are currently treated for autoimmune disorders other than psoriasis. * Systemic or topical treatments for psoriasis other than emollients. Ongoing bacterial, viral or fungal infections. History or presence of malignancy. * Additional inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. | Baseline to week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with Clear or Almost clear on PGA at Week 16. | Baseline to week 16 |
Countries
Austria, Belgium, Bulgaria, Czechia, Denmark, France, Hungary, Italy, Lithuania, Romania, Russia, Slovakia, Spain, Sweden, Switzerland, Ukraine, United Kingdom
Outcome results
None listed