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ACT-128800 in Psoriasis

Primary Purpose

Plaque Psoriasis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

ACT-128800

Placebo

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Landeskrankenhaus - Universitätsklilnikum Graz, Allgemeine Dermatologie
University Klinik of Vienna
Departement de Pneumologie/ Unité Immunologie Clinique Allergie- Centre Hospitalier Lyon sud
CHU de Nice-Hôpital de l'Archet 2 / Service de dermatologie
Dermatologie, Hôpital Purpan Universtité Paul Sabatier
Klinik für Dermatologie Venerologie und Allergologie
Universitätsklinikum Hamburg-Eppendorf
Department of Dermatology University Hospital Johannes Gutenberg-University Mainz
University Clinic Münster Clinic and Policlinic for skin diseases
Semmelweis Universtity Dept. dermato-venerology and skin oncology
UNIVERSITY OF DEBRECEN Department of dermatology
University of Szeged Department of dermatology and allergology
Veszprem County Csolnoky Ferenc Hospital Dermatology Department
Clinical Centre of Nis Clinic of Dermato-venerology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00852670

First Posted

February 26, 2009

Last Updated

November 11, 2009

Sponsor

Actelion

1. Study Identification

Unique Protocol Identification Number

NCT00852670

Brief Title

ACT-128800 in Psoriasis

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Actelion

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plaque Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

ACT-128800

Intervention Description

ACT-128800 administered orally once daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo capsules administered orally once daily

Primary Outcome Measure Information:

Title

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

Time Frame

Baseline to week 6

Secondary Outcome Measure Information:

Title

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

Time Frame

Week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Albrecht Georg Schmidt, MD

Organizational Affiliation

Actelion

Official's Role

Study Director

Facility Information:

Facility Name

Landeskrankenhaus - Universitätsklilnikum Graz, Allgemeine Dermatologie

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

University Klinik of Vienna

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

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

City

Lyon

ZIP/Postal Code

69000

Country

France

Facility Name

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

City

Nice

ZIP/Postal Code

6202

Country

France

Facility Name

Dermatologie, Hôpital Purpan Universtité Paul Sabatier

City

Toulouse

ZIP/Postal Code

31000

Country

France

Facility Name

Klinik für Dermatologie Venerologie und Allergologie

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Universitätsklinikum Hamburg-Eppendorf

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Department of Dermatology University Hospital Johannes Gutenberg-University Mainz

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

University Clinic Münster Clinic and Policlinic for skin diseases

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Semmelweis Universtity Dept. dermato-venerology and skin oncology

City

Budapest

ZIP/Postal Code

1085

Country

Hungary

Facility Name

UNIVERSITY OF DEBRECEN Department of dermatology

City

Debrecen

ZIP/Postal Code

4012

Country

Hungary

Facility Name

University of Szeged Department of dermatology and allergology

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Veszprem County Csolnoky Ferenc Hospital Dermatology Department

City

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Clinical Centre of Nis Clinic of Dermato-venerology

City

Nis

ZIP/Postal Code

18000

Country

Serbia

12. IPD Sharing Statement

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ACT-128800 in Psoriasis

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