ACT-128800 in Patients With Moderate to Severe Chronic Plaque Psoriasis - Full Text View

Purpose

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

Condition	Intervention	Phase
Psoriasis	Drug: ACT-128800 Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety & Tolerability of Two Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered up to Twenty-eight Weeks in Patients With Moderate to Severe Chronic Plaque Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Actelion:

Primary Outcome Measures:

Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. [ Time Frame: Baseline to week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients with "Clear" or "Almost clear" on PGA at Week 16. [ Time Frame: Baseline to week 16 ] [ Designated as safety issue: No ]

Enrollment:	326
Study Start Date:	October 2010
Study Completion Date:	November 2012
Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Investigational drug - Dose 1	Drug: ACT-128800 ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily
Experimental: Investigational drug - Dose 2	Drug: ACT-128800 ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily
Placebo Comparator: Matching placebo	Drug: Placebo ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult males and females aged 18 to 60 years (inclusive) with moderate to severe chronic plaque psoriasis who require systemic treatment.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208090

Show 68 Study Locations

Sponsors and Collaborators

Actelion

Investigators

Study Director:

Actelion Pharmaceuticals

Actelion

More Information

No publications provided

Responsible Party:	Actelion
ClinicalTrials.gov Identifier:	NCT01208090 History of Changes
Other Study ID Numbers:	AC-058A201
Study First Received:	September 22, 2010
Last Updated:	January 23, 2013
Health Authority:	Austria: Agency for Health and Food Safety Austria: Ethikkommission Belgium: Ethics Committee Belgium: Federal Agency for Medicinal Products and Health Products Bulgaria: Bulgarian Drug Agency Bulgaria: Ethics committee Czech Republic: Ethics Committee Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency Denmark: Ethics Committee Estonia: The State Agency of Medicine France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Conseil National de l'Ordre des Médecins France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé France: Institutional Ethical Committee Hungary: National Institute of Pharmacy Hungary: Research Ethics Medical Committee Italy: Ethics Committee Italy: The Italian Medicines Agency Latvia: Institutional Review Board Latvia: State Agency of Medicines Lithuania: State Medicine Control Agency - Ministry of Health Romania: Ethics Committee Romania: National Medicines Agency Russia: Ethics Committee Russia: Ministry of Health of the Russian Federation Slovak Republic: Ethics Committee Slovakia: State Institute for Drug Control Sweden: Medical Products Agency Switzerland: Ethikkommission Switzerland: Swissmedic Ukraine: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee

Keywords provided by Actelion:

psoriasis
chronic plaque psoriasis
Moderate to severe chronic plaque psoriasis

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013