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CompletedNCT00852670Updated Nov 13, 2009

ACT-128800 in Psoriasis

A Phase 2 interventional study of ACT-128800 and Placebo in Plaque Psoriasis, sponsored by Actelion. Completed at 14 sites in 5 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2009-11-13.

Sponsored by Actelion · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Plaque Psoriasis

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 66 is close to the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Actelion is the lead sponsor of 140 studies on the registry; 1 is open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 24 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    A

    Drug: ACT-128800

  • Placebo comparator
    B

    Drug: Placebo

Interventions

  • DrugACT-128800

    ACT-128800 administered orally once daily

  • DrugPlacebo

    Matching placebo capsules administered orally once daily

06

What researchers measure

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

07

Study locations

14 sites
  • Landeskrankenhaus - Universitätsklilnikum Graz, Allgemeine Dermatologie
    Graz, 8036, Austria
  • University Klinik of Vienna
    Vienna, 1090, Austria
  • Departement de Pneumologie/ Unité Immunologie Clinique Allergie- Centre Hospitalier Lyon sud
    Lyon, 69000, France
  • CHU de Nice-Hôpital de l'Archet 2 / Service de dermatologie
    Nice, 6202, France
  • Dermatologie, Hôpital Purpan Universtité Paul Sabatier
    Toulouse, 31000, France
  • Klinik für Dermatologie Venerologie und Allergologie
    Berlin, 10117, Germany
  • Universitätsklinikum Hamburg-Eppendorf
    Hamburg, 20246, Germany
  • Department of Dermatology University Hospital Johannes Gutenberg-University Mainz
    Mainz, 55131, Germany
  • University Clinic Münster Clinic and Policlinic for skin diseases
    Muenster, 48149, Germany
  • Semmelweis Universtity Dept. dermato-venerology and skin oncology
    Budapest, 1085, Hungary
  • UNIVERSITY OF DEBRECEN Department of dermatology
    Debrecen, 4012, Hungary
  • University of Szeged Department of dermatology and allergology
    Szeged, 6720, Hungary
  • Veszprem County Csolnoky Ferenc Hospital Dermatology Department
    Veszprem, 8200, Hungary
  • Clinical Centre of Nis Clinic of Dermato-venerology
    Nis, 18000, Serbia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00852670
Lead sponsor
Actelion
First posted
Feb 27, 2009
Start date
Oct 2008
Primary completion
Jul 2009
Completion
Sep 2009
Last update
Nov 13, 2009

Study contacts

Albrecht Georg Schmidt, MD
study director · Actelion

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

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