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Completed

NCT Number: NCT01208090

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

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

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Investigative Site 1006, Feldkirch, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

ACT-128800

Drug

ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily

Placebo

Drug

ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily

Primary outcomes

  1. Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16.

    Time frame: Baseline to week 16

Secondary outcomes

  1. Proportion of patients with "Clear" or "Almost clear" on PGA at Week 16.

    Time frame: Baseline to week 16

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 23, 2010
Registry last updated
Mar 30, 2025

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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