ACT-128800 in Psoriasis

This study has been completed.
Sponsor:
Information provided by:
Actelion
ClinicalTrials.gov Identifier:
NCT00852670
First received: February 26, 2009
Last updated: November 11, 2009
Last verified: November 2009
  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 2

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:


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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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 October 19, 2014