ACT-128800 in Psoriasis

November 11, 2009 updated by: Actelion

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
Drug: ACT-128800
ACT-128800 administered orally once daily
PLACEBO_COMPARATOR: B
Drug: Placebo
Matching placebo capsules administered orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Psoriasis Area and Severity Index (PASI) percent change relative to baseline at Week 6 visit.
Time Frame: Baseline to week 6
Baseline to week 6

Secondary Outcome Measures

Outcome Measure
Time Frame
"Clear - almost clear" Physician Global Assessment (PGA) at Week 6 visit.
Time Frame: Week 6
Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Actelion

Investigators

  • Study Director: Albrecht Georg Schmidt, MD, Actelion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

July 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

February 26, 2009

First Submitted That Met QC Criteria

February 26, 2009

First Posted (ESTIMATE)

February 27, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 13, 2009

Last Update Submitted That Met QC Criteria

November 11, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-058A200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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