ACT-128800 in Psoriasis

NCT00852670 | Completed Phase 2 DMC

• 1 other identifier: AC-058A200
• Study Type: interventional
• Target: 66
• Locations: 5 countries
• Sites: 14

Brief Summary

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

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Psoriasis Area and Severity Index (PASI) percent change relative to baseline at Week 6 visit.

  Baseline to week 6

Secondary Outcomes (1)

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

  Week 6

Study Arms (2)

A

EXPERIMENTAL

Drug: ACT-128800

B

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ACT-128800 DRUG

ACT-128800 administered orally once daily

A

Placebo DRUG

Matching placebo capsules administered orally once daily

B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Actelion: lead

Study Sites (14)

Landeskrankenhaus - Universitätsklilnikum Graz, Allgemeine Dermatologie

Graz, 8036, Austria

Location

University Klinik of Vienna

Vienna, 1090, Austria

Location

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

Lyon, 69000, France

Location

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

Nice, 6202, France

Location

Dermatologie, Hôpital Purpan Universtité Paul Sabatier

Toulouse, 31000, France

Location

Klinik für Dermatologie Venerologie und Allergologie

Berlin, 10117, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Department of Dermatology University Hospital Johannes Gutenberg-University Mainz

Mainz, 55131, Germany

Location

University Clinic Münster Clinic and Policlinic for skin diseases

Münster, 48149, Germany

Location

Semmelweis Universtity Dept. dermato-venerology and skin oncology

Budapest, 1085, Hungary

Location

UNIVERSITY OF DEBRECEN Department of dermatology

Debrecen, 4012, Hungary

Location

University of Szeged Department of dermatology and allergology

Szeged, 6720, Hungary

Location

Veszprem County Csolnoky Ferenc Hospital Dermatology Department

Veszprém, 8200, Hungary

Location

Clinical Centre of Nis Clinic of Dermato-venerology

Niš, 18000, Serbia

Location

MeSH Terms

Interventions

ponesimod

Study Officials

• Albrecht Georg Schmidt, MD

  Actelion

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: February 27, 2009
• Study Start: October 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: September 1, 2009
• Last Updated: November 13, 2009

Record last verified: 2009-11

Locations

FR (3); DE (4); AU (2); HU (4); SE (1)