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

NCT ID: NCT01208090

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-11-30

Brief Summary

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

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Investigational drug - Dose 1

Group Type EXPERIMENTAL

ACT-128800

Intervention Type DRUG

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

Investigational drug - Dose 2

Group Type EXPERIMENTAL

ACT-128800

Intervention Type DRUG

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

Matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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ACT-128800

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Actelion

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Actelion Pharmaceuticals

Role: STUDY_DIRECTOR

Actelion

Locations

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Clinical Investigative Site 1006

Feldkirch, , Austria

Site Status

Clinical Investigative Site 1002

Graz, , Austria

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Clinical Investigative Site 1004

Sankt Pölten, , Austria

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Clinical Investigative Site 1007

Vienna, , Austria

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Clinical Investigative Site 1001

Vienna, , Austria

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Clinical Investigative Site 1103

Brussels, , Belgium

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Clinical Investigative Site 1102

Edegem, , Belgium

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Clinical Investigative Site 1101

Liège, , Belgium

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Clinical Investigative Site 1205

Pleven, , Bulgaria

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Clinical Investigative Site 1204

Plovdiv, , Bulgaria

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Clinical Investigative Site 1202

Sofia, , Bulgaria

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Clinical Investigative Site 1201

Sofia, , Bulgaria

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Clinical Investigative Site 1203

Sofia, , Bulgaria

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Clinical Investigative Site 1206

Stara Zagora, , Bulgaria

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Clinical Investigative Site 1402

Hradec Králové, , Czechia

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Clinical Investigative Site 1405

Nový Jičín, , Czechia

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Clinical Investigative Site 1406

Pardubice, , Czechia

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Clinical Investigative Site 1401

Prague, , Czechia

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Clinical Investigative Site 1502

Copenhagen, , Denmark

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Clinical Investigative Site 1504

Roskilde, , Denmark

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Clinical Investigative Site 1704

Bordeaux, , France

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Clinical Investigative Site 1701

Nice, , France

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Clinical Investigative Site 1707

Paris, , France

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Clinical Investigative Site 1710

Paris, , France

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Clinical Investigative Site 1705

Pierre-Bénite, , France

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Clinical Investigative Site 1703

Poitiers, , France

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Clinical Investigative Site 1702

Saint-Etienne, , France

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Clinical Investigative Site 2002

Budapest, , Hungary

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Clinical Investigative Site 2001

Debrecen, , Hungary

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Clinical Investigative Site 2006

Miskolc, , Hungary

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Clinical Investigative Site 2005

Pécs, , Hungary

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Clinical Investigative Site 2003

Szeged, , Hungary

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Clinical Investigative Site 2004

Veszprém, , Hungary

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Clinical Investigative Site 2315

Ancona, , Italy

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Clinical Investigative Site 2303

Bergamo, , Italy

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Clinical Investigative Site 2307

Bologna, , Italy

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Clinical Investigative Site 2317

Genova, , Italy

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Clinical Investigative Site 2309

L’Aquila, , Italy

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Clinical Investigative Site 2310

Pisa, , Italy

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Clinical Investigative Site 2304

Roma, , Italy

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Clinical Investigative Site 2316

Rome, , Italy

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Clinical Investigative Site 3801

Vilnius, , Lithuania

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Clinical Investigative Site 2608

Bucharest, , Romania

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Clinical Investigative Site 2601

Bucharest, , Romania

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Clinical Investigative Site 2604

Cluj-Napoca, , Romania

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Clinical Investigative Site 2603

Iași, , Romania

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Clinical Investigative Site 2606

Oradea, , Romania

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Clinical Investigative Site 2607

Sibiu, , Romania

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Clinical Investigative Site 2605

Târgu Mureş, , Romania

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Clinical Investigative Site 2602

Timișoara, , Romania

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Clinical Investigative Site 3410

Krasnodar, , Russia

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Clinical Investigative Site 2704

Banská Bystrica, , Slovakia

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Clinical Investigative Site 2705

Kosice-Saca, , Slovakia

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Clinical Investigative Site 2701

Košice, , Slovakia

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Clinical Investigative Site 2708

Trnava, , Slovakia

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Clinical Investigative Site 2901

Barcelona, , Spain

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Clinical Investigative Site 2907

Las Palmas de Gran Canaria, , Spain

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Clinical Investigative Site 2902

Madrid, , Spain

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Clinical Investigative Site 2904

Madrid, , Spain

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Clinical Investigative Site 3001

Stockholm, , Sweden

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Clinical Investigative Site 3006

Umeå, , Sweden

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Clinical Investigative Site 3101

Lausanne, , Switzerland

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Clinical Investigative Site 3103

Zurich, , Switzerland

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Clinical Investigative Site 3512

Poltava, , Ukraine

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Clinical Investigative Site 3514

Zaporizhia, , Ukraine

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Clinical Investigative Site 3306

Dundee, , United Kingdom

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Clinical Investigative Site 3304

London, , United Kingdom

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Countries

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Austria Belgium Bulgaria Czechia Denmark France Hungary Italy Lithuania Romania Russia Slovakia Spain Sweden Switzerland Ukraine United Kingdom

References

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Vaclavkova A, Chimenti S, Arenberger P, Hollo P, Sator PG, Burcklen M, Stefani M, D'Ambrosio D. Oral ponesimod in patients with chronic plaque psoriasis: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet. 2014 Dec 6;384(9959):2036-45. doi: 10.1016/S0140-6736(14)60803-5. Epub 2014 Aug 10.

Reference Type DERIVED
PMID: 25127208 (View on PubMed)

Other Identifiers

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AC-058A201

Identifier Type: -

Identifier Source: org_study_id

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