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

This study has been completed.
Information provided by (Responsible Party):
Actelion Identifier:
First received: September 22, 2010
Last updated: January 23, 2013
Last verified: January 2013
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
Drug: ACT-128800
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Proportion of patients with "Clear" or "Almost clear" on PGA at Week 16. [ Time Frame: Baseline to week 16 ]

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


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01208090

  Show 68 Study Locations
Sponsors and Collaborators
Study Director: Actelion Pharmaceuticals Actelion
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Actelion Identifier: NCT01208090     History of Changes
Other Study ID Numbers: AC-058A201
Study First Received: September 22, 2010
Last Updated: January 23, 2013

Keywords provided by Actelion:
chronic plaque psoriasis
Moderate to severe chronic plaque psoriasis

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases processed this record on May 22, 2017