Clinical trial NCT01208090: ACT-128800 in Patients With Moderate to Severe Chronic Plaque Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: psoriasis
chronic plaque psoriasis
Moderate to severe chronic plaque psoriasis
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2010-09-23
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16.
timeFrame: Baseline to week 16
Secondary outcomes:
measure: Proportion of patients with "Clear" or "Almost clear" on PGA at Week 16.
timeFrame: Baseline to week 16
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: Clinical Investigative Site 1006
city: Graz
country: Austria
facility: Clinical Investigative Site 1002
city: St. Polten
country: Austria
facility: Clinical Investigative Site 1004
city: Vienna
country: Austria
facility: Clinical Investigative Site 1007
city: Vienna
country: Austria
facility: Clinical Investigative Site 1001
city: Brussels
country: Belgium
facility: Clinical Investigative Site 1103
city: Edegem
country: Belgium
facility: Clinical Investigative Site 1102
city: Liege
country: Belgium
facility: Clinical Investigative Site 1101
city: Pleven
country: Bulgaria
facility: Clinical Investigative Site 1205
city: Plovdiv
country: Bulgaria
facility: Clinical Investigative Site 1204
city: Sofia
country: Bulgaria
facility: Clinical Investigative Site 1202
city: Sofia
country: Bulgaria
facility: Clinical Investigative Site 1201
city: Sofia
country: Bulgaria
facility: Clinical Investigative Site 1203
city: Stara Zagora
country: Bulgaria
facility: Clinical Investigative Site 1206
city: Hradec Kralove
country: Czechia
facility: Clinical Investigative Site 1402
city: Novy Jicin
country: Czechia
facility: Clinical Investigative Site 1405
city: Pardubice
country: Czechia
facility: Clinical Investigative Site 1406
city: Prague
country: Czechia
facility: Clinical Investigative Site 1401
city: Copenhagen
country: Denmark
facility: Clinical Investigative Site 1502
city: Roskilde
country: Denmark
facility: Clinical Investigative Site 1504
city: Bordeaux Cedex
country: France
facility: Clinical Investigative Site 1704
city: Nice
country: France
facility: Clinical Investigative Site 1701
city: Paris Cedex 10
country: France
facility: Clinical Investigative Site 1707
city: Paris Cedex 18
country: France
facility: Clinical Investigative Site 1710
city: Paris
country: France
facility: Clinical Investigative Site 1710
city: Pierre Benite
country: France
facility: Clinical Investigative Site 1705
city: Poitiers Cedex
country: France
facility: Clinical Investigative Site 1703
city: Saint Etienne Cedex
country: France
facility: Clinical Investigative Site 1702
city: Budapest
country: Hungary
facility: Clinical Investigative Site 2002
city: Debrecen
country: Hungary
facility: Clinical Investigative Site 2001
city: Miskolc
country: Hungary
facility: Clinical Investigative Site 2006
city: Pecs
country: Hungary
facility: Clinical Investigative Site 2005
city: Szeged
country: Hungary
facility: Clinical Investigative Site 2003
city: Veszprem
country: Hungary
facility: Clinical Investigative Site 2004
city: Ancona
country: Italy
facility: Clinical Investigative Site 2315
city: Bergamo
country: Italy
facility: Clinical Investigative Site 2303
city: Bologna
country: Italy
facility: Clinical Investigative Site 2307
city: Genova
country: Italy
facility: Clinical Investigative Site 2317
city: L'Aquila
country: Italy
facility: Clinical Investigative Site 2309
city: Pisa
country: Italy
facility: Clinical Investigative Site 2310
city: Roma
country: Italy
facility: Clinical Investigative Site 2304
city: Rome
country: Italy
facility: Clinical Investigative Site 2316
city: Vilnius
country: Lithuania
facility: Clinical Investigative Site 3801
city: Bucharest
country: Romania
facility: Clinical Investigative Site 2608
city: Bucharest
country: Romania
facility: Clinical Investigative Site 2601
city: Cluj-Napoca
country: Romania
facility: Clinical Investigative Site 2604
city: Iasi
country: Romania
facility: Clinical Investigative Site 2603
city: Oradea
country: Romania
facility: Clinical Investigative Site 2606
city: Sibiu
country: Romania
facility: Clinical Investigative Site 2607
city: Timisoara
country: Romania
facility: Clinical Investigative Site 2602
city: Tirgu-Mures
country: Romania
facility: Clinical Investigative Site 2605
city: Krasnodar
country: Russian Federation
facility: Clinical Investigative Site 3410
city: Banska Bystrica
country: Slovakia
facility: Clinical Investigative Site 2704
city: Kosice-Saca
country: Slovakia
facility: Clinical Investigative Site 2705
city: Kosice
country: Slovakia
facility: Clinical Investigative Site 2701
city: Trnava
country: Slovakia
facility: Clinical Investigative Site 2708
city: Barcelona
country: Spain
facility: Clinical Investigative Site 2901
city: Las Palmas de Gran Canaria
country: Spain
facility: Clinical Investigative Site 2907
city: Madrid
country: Spain
facility: Clinical Investigative Site 2902
city: Madrid
country: Spain
facility: Clinical Investigative Site 2904
city: Stockholm
country: Sweden
facility: Clinical Investigative Site 3001
city: Umea
country: Sweden
facility: Clinical Investigative Site 3006
city: Lausanne
country: Switzerland
facility: Clinical Investigative Site 3101
city: Zurich
country: Switzerland
facility: Clinical Investigative Site 3103
city: Poltava
country: Ukraine
facility: Clinical Investigative Site 3512
city: Zaporizhia
country: Ukraine
facility: Clinical Investigative Site 3514
city: Dundee
country: United Kingdom
facility: Clinical Investigative Site 3306
city: London
country: United Kingdom
facility: Clinical Investigative Site 3304
Study officials:
affiliation: Actelion
name: Actelion Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.