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

March 28, 2025 updated by: Actelion

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

326

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Feldkirch, Austria, 6807
        • Clinical Investigative Site 1006
      • Graz, Austria, 8036
        • Clinical Investigative Site 1002
      • St. Polten, Austria, 3100
        • Clinical Investigative Site 1004
      • Vienna, Austria, 1130
        • Clinical Investigative Site 1007
      • Vienna, Austria, A-1090
        • Clinical Investigative Site 1001
  • Belgium
      • Brussels, Belgium, 1200
        • Clinical Investigative Site 1103
      • Edegem, Belgium, 2650
        • Clinical Investigative Site 1102
      • Liege, Belgium, 4000
        • Clinical Investigative Site 1101
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Clinical Investigative Site 1205
      • Plovdiv, Bulgaria, 4002
        • Clinical Investigative Site 1204
      • Sofia, Bulgaria, 1431
        • Clinical Investigative Site 1202
      • Sofia, Bulgaria, 1606
        • Clinical Investigative Site 1201
      • Sofia, Bulgaria, 1606
        • Clinical Investigative Site 1203
      • Stara Zagora, Bulgaria, 6000
        • Clinical Investigative Site 1206
  • Czechia
      • Hradec Kralove, Czechia, 50005
        • Clinical Investigative Site 1402
      • Novy Jicin, Czechia, 74101
        • Clinical Investigative Site 1405
      • Pardubice, Czechia, 53203
        • Clinical Investigative Site 1406
      • Prague, Czechia, 10034
        • Clinical Investigative Site 1401
  • Denmark
      • Copenhagen, Denmark, 2400
        • Clinical Investigative Site 1502
      • Roskilde, Denmark, 4000
        • Clinical Investigative Site 1504
  • France
      • Bordeaux Cedex, France, 86021
        • Clinical Investigative Site 1704
      • Nice, France, 06202
        • Clinical Investigative Site 1701
      • Paris, France, 75877
        • Clinical Investigative Site 1710
      • Paris Cedex 10, France, 75475
        • Clinical Investigative Site 1707
      • Paris Cedex 18, France, 75877
        • Clinical Investigative Site 1710
      • Pierre Benite, France, 69310
        • Clinical Investigative Site 1705
      • Poitiers Cedex, France, 86021
        • Clinical Investigative Site 1703
      • Saint Etienne Cedex, France, 42055
        • Clinical Investigative Site 1702
  • Hungary
      • Budapest, Hungary, 1085
        • Clinical Investigative Site 2002
      • Debrecen, Hungary, 4012
        • Clinical Investigative Site 2001
      • Miskolc, Hungary, 3529
        • Clinical Investigative Site 2006
      • Pecs, Hungary, 7624
        • Clinical Investigative Site 2005
      • Szeged, Hungary, 6720
        • Clinical Investigative Site 2003
      • Veszprem, Hungary, 8200
        • Clinical Investigative Site 2004
  • Italy
      • Ancona, Italy, 60020
        • Clinical Investigative Site 2315
      • Bergamo, Italy, 24128
        • Clinical Investigative Site 2303
      • Bologna, Italy, 40138
        • Clinical Investigative Site 2307
      • Genova, Italy, 16132
        • Clinical Investigative Site 2317
      • L'Aquila, Italy, 67100
        • Clinical Investigative Site 2309
      • Pisa, Italy, 56126
        • Clinical Investigative Site 2310
      • Roma, Italy, 00133
        • Clinical Investigative Site 2304
      • Rome, Italy, 00168
        • Clinical Investigative Site 2316
  • Lithuania
      • Vilnius, Lithuania
        • Clinical Investigative Site 3801
  • Romania
      • Bucharest, Romania, 011461
        • Clinical Investigative Site 2608
      • Bucharest, Romania, 020125
        • Clinical Investigative Site 2601
      • Cluj-Napoca, Romania, 400006
        • Clinical Investigative Site 2604
      • Iasi, Romania, 700368
        • Clinical Investigative Site 2603
      • Oradea, Romania, 410167
        • Clinical Investigative Site 2606
      • Sibiu, Romania, 550245
        • Clinical Investigative Site 2607
      • Timisoara, Romania, 300074
        • Clinical Investigative Site 2602
      • Tirgu-Mures, Romania, 540342
        • Clinical Investigative Site 2605
  • Russian Federation
      • Krasnodar, Russian Federation, 350020
        • Clinical Investigative Site 3410
  • Slovakia
      • Banska Bystrica, Slovakia, 97517
        • Clinical Investigative Site 2704
      • Kosice, Slovakia, 04166
        • Clinical Investigative Site 2701
      • Kosice-Saca, Slovakia, 04015
        • Clinical Investigative Site 2705
      • Trnava, Slovakia, 91775
        • Clinical Investigative Site 2708
  • Spain
      • Barcelona, Spain, 08025
        • Clinical Investigative Site 2901
      • Las Palmas de Gran Canaria, Spain
        • Clinical Investigative Site 2907
      • Madrid, Spain, 28041
        • Clinical Investigative Site 2902
      • Madrid, Spain, 28922
        • Clinical Investigative Site 2904
  • Sweden
      • Stockholm, Sweden, 17176
        • Clinical Investigative Site 3001
      • Umea, Sweden, 90185
        • Clinical Investigative Site 3006
  • Switzerland
      • Lausanne, Switzerland, 1011
        • Clinical Investigative Site 3101
      • Zurich, Switzerland, 8091
        • Clinical Investigative Site 3103
  • Ukraine
      • Poltava, Ukraine, 36038
        • Clinical Investigative Site 3512
      • Zaporizhia, Ukraine, 69063
        • Clinical Investigative Site 3514
  • United Kingdom
      • Dundee, United Kingdom, DD1 9SY
        • Clinical Investigative Site 3306
      • London, United Kingdom, E11 1NR
        • Clinical Investigative Site 3304

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Matching placebo
Drug: Placebo
ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16.
Time Frame: Baseline to week 16
Baseline to week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with "Clear" or "Almost clear" on PGA at Week 16.
Time Frame: Baseline to week 16
Baseline to week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Actelion

Investigators

  • Study Director: Actelion Pharmaceuticals, Actelion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2010

Primary Completion (Actual)

October 31, 2012

Study Completion (Actual)

November 30, 2012

Study Registration Dates

First Submitted

September 22, 2010

First Submitted That Met QC Criteria

September 22, 2010

First Posted (Estimated)

September 23, 2010

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-058A201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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