ACT-128800 in Psoriasis

Phase 2

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: Placebo; Drug: ACT-128800

• Registration Number: NCT00852670
• Lead Sponsor: Actelion

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-02-26
• Study First Submitted QC: 2009-02-26
• Study First Posted: 2009-02-27
• Primary Completion: 2009-07
• Study Completion: 2009-09
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-11
• Last Update Posted: 2009-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Placebo	-
A	ACT-128800	-

Primary Outcome Measures

Name	Time	Method
Psoriasis Area and Severity Index (PASI) percent change relative to baseline at Week 6 visit.	Baseline to week 6

Secondary Outcome Measures

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

Trial Locations

Locations (14)

Landeskrankenhaus - Universitätsklilnikum Graz, Allgemeine Dermatologie; 🇦🇹 Graz, Austria

University Klinik of Vienna; 🇦🇹 Vienna, Austria

Departement de Pneumologie/ Unité Immunologie Clinique Allergie- Centre Hospitalier Lyon sud; 🇫🇷 Lyon, France

CHU de Nice-Hôpital de l'Archet 2 / Service de dermatologie; 🇫🇷 Nice, France

Dermatologie, Hôpital Purpan Universtité Paul Sabatier; 🇫🇷 Toulouse, France

Klinik für Dermatologie Venerologie und Allergologie; 🇩🇪 Berlin, Germany

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Department of Dermatology University Hospital Johannes Gutenberg-University Mainz; 🇩🇪 Mainz, Germany

University Clinic Münster Clinic and Policlinic for skin diseases; 🇩🇪 Muenster, Germany

Semmelweis Universtity Dept. dermato-venerology and skin oncology; 🇭🇺 Budapest, Hungary

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