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

NCT01208090 | Completed Phase 2

• 1 other identifier: AC-058A201
• Study Type: interventional
• Target: 326
• Locations: 17 countries
• Sites: 67

Brief Summary

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

Conditions

Psoriasis

Keywords

psoriasis; chronic plaque psoriasis; Moderate to severe chronic plaque psoriasis

Outcome Measures

Primary Outcomes (1)

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

  Baseline to week 16

Secondary Outcomes (1)

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

  Baseline to week 16

Study Arms (3)

Investigational drug - Dose 1

EXPERIMENTAL

Drug: ACT-128800

Investigational drug - Dose 2

EXPERIMENTAL

Drug: ACT-128800

Matching placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ACT-128800 DRUG

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

Investigational drug - Dose 1; Investigational drug - Dose 2

Placebo DRUG

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

Matching placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult males and females aged 18 to 60 years (inclusive) with moderate to severe chronic plaque psoriasis who require systemic treatment.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Actelion: lead

Study Sites (67)

Clinical Investigative Site 1006

Feldkirch, 6807, Austria

Location

Clinical Investigative Site 1002

Graz, 8036, Austria

Location

Clinical Investigative Site 1004

Sankt Pölten, 3100, Austria

Location

Clinical Investigative Site 1007

Vienna, 1130, Austria

Location

Clinical Investigative Site 1001

Vienna, A-1090, Austria

Location

Clinical Investigative Site 1103

Brussels, 1200, Belgium

Location

Clinical Investigative Site 1102

Edegem, 2650, Belgium

Location

Clinical Investigative Site 1101

Liège, 4000, Belgium

Location

Clinical Investigative Site 1205

Pleven, 5800, Bulgaria

Location

Clinical Investigative Site 1204

Plovdiv, 4002, Bulgaria

Location

Clinical Investigative Site 1202

Sofia, 1431, Bulgaria

Location

Clinical Investigative Site 1201

Sofia, 1606, Bulgaria

Location

Clinical Investigative Site 1203

Sofia, 1606, Bulgaria

Location

Clinical Investigative Site 1206

Stara Zagora, 6000, Bulgaria

Location

Clinical Investigative Site 1402

Hradec Králové, 50005, Czechia

Location

Clinical Investigative Site 1405

Nový Jičín, 74101, Czechia

Location

Clinical Investigative Site 1406

Pardubice, 53203, Czechia

Location

Clinical Investigative Site 1401

Prague, 10034, Czechia

Location

Clinical Investigative Site 1502

Copenhagen, 2400, Denmark

Location

Clinical Investigative Site 1504

Roskilde, 4000, Denmark

Location

Clinical Investigative Site 1704

Bordeaux, 86021, France

Location

Clinical Investigative Site 1701

Nice, 06202, France

Location

Clinical Investigative Site 1707

Paris, 75475, France

Location

Clinical Investigative Site 1710

Paris, 75877, France

Location

Clinical Investigative Site 1705

Pierre-Bénite, 69310, France

Location

Clinical Investigative Site 1703

Poitiers, 86021, France

Location

Clinical Investigative Site 1702

Saint-Etienne, 42055, France

Location

Clinical Investigative Site 2002

Budapest, 1085, Hungary

Location

Clinical Investigative Site 2001

Debrecen, 4012, Hungary

Location

Clinical Investigative Site 2006

Miskolc, 3529, Hungary

Location

Clinical Investigative Site 2005

Pécs, 7624, Hungary

Location

Clinical Investigative Site 2003

Szeged, 6720, Hungary

Location

Clinical Investigative Site 2004

Veszprém, 8200, Hungary

Location

Clinical Investigative Site 2315

Ancona, 60020, Italy

Location

Clinical Investigative Site 2303

Bergamo, 24128, Italy

Location

Clinical Investigative Site 2307

Bologna, 40138, Italy

Location

Clinical Investigative Site 2317

Genova, 16132, Italy

Location

Clinical Investigative Site 2309

L’Aquila, 67100, Italy

Location

Clinical Investigative Site 2310

Pisa, 56126, Italy

Location

Clinical Investigative Site 2304

Roma, 00133, Italy

Location

Clinical Investigative Site 2316

Rome, 00168, Italy

Location

Clinical Investigative Site 3801

Vilnius, Lithuania

Location

Clinical Investigative Site 2608

Bucharest, 011461, Romania

Location

Clinical Investigative Site 2601

Bucharest, 020125, Romania

Location

Clinical Investigative Site 2604

Cluj-Napoca, 400006, Romania

Location

Clinical Investigative Site 2603

Iași, 700368, Romania

Location

Clinical Investigative Site 2606

Oradea, 410167, Romania

Location

Clinical Investigative Site 2607

Sibiu, 550245, Romania

Location

Clinical Investigative Site 2605

Târgu Mureş, 540342, Romania

Location

Clinical Investigative Site 2602

Timișoara, 300074, Romania

Location

Clinical Investigative Site 3410

Krasnodar, 350020, Russia

Location

Clinical Investigative Site 2704

Banská Bystrica, 97517, Slovakia

Location

Clinical Investigative Site 2705

Kosice-Saca, 04015, Slovakia

Location

Clinical Investigative Site 2701

Košice, 04166, Slovakia

Location

Clinical Investigative Site 2708

Trnava, 91775, Slovakia

Location

Clinical Investigative Site 2901

Barcelona, 08025, Spain

Location

Clinical Investigative Site 2907

Las Palmas de Gran Canaria, Spain

Location

Clinical Investigative Site 2902

Madrid, 28041, Spain

Location

Clinical Investigative Site 2904

Madrid, 28922, Spain

Location

Clinical Investigative Site 3001

Stockholm, 17176, Sweden

Location

Clinical Investigative Site 3006

Umeå, 90185, Sweden

Location

Clinical Investigative Site 3101

Lausanne, 1011, Switzerland

Location

Clinical Investigative Site 3103

Zurich, 8091, Switzerland

Location

Clinical Investigative Site 3512

Poltava, 36038, Ukraine

Location

Clinical Investigative Site 3514

Zaporizhia, 69063, Ukraine

Location

Clinical Investigative Site 3306

Dundee, DD1 9SY, United Kingdom

Location

Clinical Investigative Site 3304

London, E11 1NR, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 25127208 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

ponesimod

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Actelion Pharmaceuticals

  Actelion

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2010
• First Posted: September 23, 2010
• Study Start: October 31, 2010
• Primary Completion: October 31, 2012
• Study Completion: November 30, 2012
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

HU (6); CH (2); UA (2); LI (1); IT (8); BU (6); SL (4); AU (5); SE (2); GB (2); CZ (4); BE (3); FR (7); RU (1); ES (4); RO (8); DK (2)