ACT-128800 in Psoriasis

NCT ID: NCT00852670

Last Updated: 2009-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-09-30

Brief Summary

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

Detailed Description

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Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Group Type EXPERIMENTAL

ACT-128800

Intervention Type DRUG

ACT-128800 administered orally once daily

B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo capsules administered orally once daily

Interventions

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ACT-128800

ACT-128800 administered orally once daily

Intervention Type DRUG

Placebo

Matching placebo capsules administered orally once daily

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Actelion

INDUSTRY

Sponsor Role lead

Responsible Party

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Actelion

Principal Investigators

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Albrecht Georg Schmidt, MD

Role: STUDY_DIRECTOR

Actelion

Locations

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Landeskrankenhaus - Universitätsklilnikum Graz, Allgemeine Dermatologie

Graz, , Austria

Site Status

University Klinik of Vienna

Vienna, , Austria

Site Status

Departement de Pneumologie/ Unité Immunologie Clinique Allergie- Centre Hospitalier Lyon sud

Lyon, , France

Site Status

CHU de Nice-Hôpital de l'Archet 2 / Service de dermatologie

Nice, , France

Site Status

Dermatologie, Hôpital Purpan Universtité Paul Sabatier

Toulouse, , France

Site Status

Klinik für Dermatologie Venerologie und Allergologie

Berlin, , Germany

Site Status

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Department of Dermatology University Hospital Johannes Gutenberg-University Mainz

Mainz, , Germany

Site Status

University Clinic Münster Clinic and Policlinic for skin diseases

Münster, , Germany

Site Status

Semmelweis Universtity Dept. dermato-venerology and skin oncology

Budapest, , Hungary

Site Status

UNIVERSITY OF DEBRECEN Department of dermatology

Debrecen, , Hungary

Site Status

University of Szeged Department of dermatology and allergology

Szeged, , Hungary

Site Status

Veszprem County Csolnoky Ferenc Hospital Dermatology Department

Veszprém, , Hungary

Site Status

Clinical Centre of Nis Clinic of Dermato-venerology

Niš, , Serbia

Site Status

Countries

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Austria France Germany Hungary Serbia

Other Identifiers

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AC-058A200

Identifier Type: -

Identifier Source: org_study_id

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