ACT-128800 in Psoriasis
This study has been completed.
Sponsor:
Actelion
Information provided by:
Actelion
ClinicalTrials.gov Identifier:
NCT00852670
First received: February 26, 2009
Last updated: November 11, 2009
Last verified: November 2009
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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
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 May 21, 2013