ACT-128800 in Psoriasis - Full Text View

Sponsor:	Actelion
Information provided by:	Actelion
ClinicalTrials.gov Identifier:	NCT00852670

Purpose

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

Condition	Intervention	Phase
Plaque Psoriasis	Drug: ACT-128800 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Actelion:

Primary Outcome Measures:

Psoriasis Area and Severity Index (PASI) percent change relative to baseline at Week 6 visit. [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

"Clear - almost clear" Physician Global Assessment (PGA) at Week 6 visit. [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Enrollment:	66
Study Start Date:	October 2008
Study Completion Date:	September 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: ACT-128800 ACT-128800 administered orally once daily
Placebo Comparator: B	Drug: Placebo Matching placebo capsules administered orally once daily

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852670

Locations

Austria
Landeskrankenhaus - Universitätsklilnikum Graz, Allgemeine Dermatologie
Graz, Austria, 8036
University Klinik of Vienna
Vienna, Austria, 1090
France
Departement de Pneumologie/ Unité Immunologie Clinique Allergie- Centre Hospitalier Lyon sud
Lyon, France, 69000
CHU de Nice-Hôpital de l'Archet 2 / Service de dermatologie
Nice, France, 6202
Dermatologie, Hôpital Purpan Universtité Paul Sabatier
Toulouse, France, 31000
Germany
Klinik für Dermatologie Venerologie und Allergologie
Berlin, Germany, 10117
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Department of Dermatology University Hospital Johannes Gutenberg-University Mainz
Mainz, Germany, 55131
University Clinic Münster Clinic and Policlinic for skin diseases
Muenster, Germany, 48149
Hungary
Semmelweis Universtity Dept. dermato-venerology and skin oncology
Budapest, Hungary, 1085
UNIVERSITY OF DEBRECEN Department of dermatology
Debrecen, Hungary, 4012
University of Szeged Department of dermatology and allergology
Szeged, Hungary, 6720
Veszprem County Csolnoky Ferenc Hospital Dermatology Department
Veszprem, Hungary, 8200
Serbia
Clinical Centre of Nis Clinic of Dermato-venerology
Nis, Serbia, 18000

Sponsors and Collaborators

Actelion

Investigators

Study Director:

Albrecht Georg Schmidt, MD

Actelion

More Information

No publications provided

Responsible Party:	Sponsor, Actelion
ClinicalTrials.gov Identifier:	NCT00852670 History of Changes
Other Study ID Numbers:	AC-058A200
Study First Received:	February 26, 2009
Last Updated:	November 11, 2009
Health Authority:	Austria: Agency for Health and Food Safety; Austria: Ethikkommission; France: Afssaps - French Health Products Safety Agency; France: Institutional Ethical Committee; Germany: Federal Institute for Drugs and Medical Devices; Germany: Ethics Commission; Hungary: National Institute of Pharmacy; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Serbia: Ethics Committee

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on February 09, 2012