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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01208090
First received: September 22, 2010
Last updated: January 23, 2013
Last verified: January 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014