ACT-128800 in Psoriasis

Actelion66 enrolled

Overview

This study will assess the efficacy, safety, and tolerability of ACT-128800 in subjects with moderate to severe plaque psoriasis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Plaque Psoriasis

Interventions

ACT-128800DRUG

ACT-128800 administered orally once daily

PlaceboDRUG

Matching placebo capsules administered orally once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult males and females with moderate to severe plaque psoriasis who require systemic treatment and for whom participation in a placebo-controlled study of an investigational drug is justified. 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 exclusion criteria apply with respect to medical conditions and concomitant treatments which could affect patients' risk from participating in the study.

Locations (14)

Landeskrankenhaus - Universitätsklilnikum Graz, Allgemeine Dermatologie

Graz, Austria

University Klinik of Vienna

Vienna, Austria

Outcomes

Primary Outcomes

Psoriasis Area and Severity Index (PASI) percent change relative to baseline at Week 6 visit.

Time frame: Baseline to week 6

Secondary Outcomes

"Clear - almost clear" Physician Global Assessment (PGA) at Week 6 visit.

Time frame: Week 6

Data from ClinicalTrials.gov

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