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

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ClinicalTrials.gov Identifier: NCT01208090
Recruitment Status : Completed
First Posted : September 23, 2010
Last Update Posted : January 24, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Psoriasis Drug: ACT-128800 Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : October 2010
Primary Completion Date : October 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Proportion of patients with "Clear" or "Almost clear" on PGA at Week 16. [ Time Frame: Baseline to week 16 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01208090


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01208090     History of Changes
Other Study ID Numbers: AC-058A201
First Posted: September 23, 2010    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013

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

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases