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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
326

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Actelion

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2010

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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