Clinical trial NCT00852670: ACT-128800 in Psoriasis
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled, Phase IIa Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800, an S1P1 Receptor Agonist, Administered for 6 Weeks to Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2009-02-27
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Psoriasis Area and Severity Index (PASI) percent change relative to baseline at Week 6 visit.
timeFrame: Baseline to week 6
Secondary outcomes:
measure: "Clear - almost clear" Physician Global Assessment (PGA) at Week 6 visit.
timeFrame: Week 6
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Landeskrankenhaus - Universitätsklilnikum Graz, Allgemeine Dermatologie
city: Vienna
country: Austria
facility: University Klinik of Vienna
city: Lyon
country: France
facility: Departement de Pneumologie/ Unité Immunologie Clinique Allergie- Centre Hospitalier Lyon sud
city: Nice
country: France
facility: CHU de Nice-Hôpital de l'Archet 2 / Service de dermatologie
city: Toulouse
country: France
facility: Dermatologie, Hôpital Purpan Universtité Paul Sabatier
city: Berlin
country: Germany
facility: Klinik für Dermatologie Venerologie und Allergologie
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Mainz
country: Germany
facility: Department of Dermatology University Hospital Johannes Gutenberg-University Mainz
city: Muenster
country: Germany
facility: University Clinic Münster Clinic and Policlinic for skin diseases
city: Budapest
country: Hungary
facility: Semmelweis Universtity Dept. dermato-venerology and skin oncology
city: Debrecen
country: Hungary
facility: UNIVERSITY OF DEBRECEN Department of dermatology
city: Szeged
country: Hungary
facility: University of Szeged Department of dermatology and allergology
city: Veszprem
country: Hungary
facility: Veszprem County Csolnoky Ferenc Hospital Dermatology Department
city: Nis
country: Serbia
facility: Clinical Centre of Nis Clinic of Dermato-venerology
Study officials:
affiliation: Actelion
name: Albrecht Georg Schmidt, MD
role: STUDY_DIRECTOR
References: