ACT-128800 in Psoriasis

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00852670
• Other study ID #: AC-058A200
• Status: Completed
• Phase: Phase 2
• First received: February 26, 2009
• Last updated: November 11, 2009
• Start date: October 2008
• Est. completion date: September 2009

Study information

• Verified date: November 2009
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyAustria: EthikkommissionFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical CommitteeGermany: Federal Institute for Drugs and Medical DevicesGermany: Ethics CommissionHungary: National Institute of PharmacySerbia and Montenegro: Agency for Drugs and Medicinal DevicesSerbia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• ACT-128800
ACT-128800 administered orally once daily
• Placebo
Matching placebo capsules administered orally once daily

Locations

Country	Name	City	State
Austria	Landeskrankenhaus - Universitätsklilnikum Graz, Allgemeine Dermatologie	Graz
Austria	University Klinik of Vienna	Vienna
France	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
Germany	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
Hungary	Semmelweis Universtity Dept. dermato-venerology and skin oncology	Budapest
Hungary	UNIVERSITY OF DEBRECEN Department of dermatology	Debrecen
Hungary	University of Szeged Department of dermatology and allergology	Szeged
Hungary	Veszprem County Csolnoky Ferenc Hospital Dermatology Department	Veszprem
Serbia	Clinical Centre of Nis Clinic of Dermato-venerology	Nis

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Countries where clinical trial is conducted

Austria,  France,  Germany,  Hungary,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psoriasis Area and Severity Index (PASI) percent change relative to baseline at Week 6 visit.		Baseline to week 6	No
Secondary	"Clear - almost clear" Physician Global Assessment (PGA) at Week 6 visit.		Week 6	No