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Completed

NCT Number: NCT00852670

ACT-128800 in Psoriasis

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

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Key information

Conditions

Plaque Psoriasis

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Landeskrankenhaus - Universitätsklilnikum Graz, Allgemeine Dermatologie, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACT-128800

Drug

ACT-128800 administered orally once daily

Placebo

Drug

Matching placebo capsules administered orally once daily

Primary outcomes

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

    Time frame: Baseline to week 6

Secondary outcomes

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

    Time frame: Week 6

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 27, 2009
Registry last updated
Nov 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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