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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01208090
• Other study ID #: AC-058A201
• Status: Completed
• Phase: Phase 2
• Start date: October 31, 2010
• Est. completion date: November 30, 2012

Study information

• Verified date: January 2023
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: November 30, 2012
• Est. primary completion date: October 31, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• ACT-128800
ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily
• Placebo
ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily

Locations

Country	Name	City	State
Austria	Clinical Investigative Site 1006	Feldkirch
Austria	Clinical Investigative Site 1002	Graz
Austria	Clinical Investigative Site 1004	St. Polten
Austria	Clinical Investigative Site 1001	Vienna
Austria	Clinical Investigative Site 1007	Vienna
Belgium	Clinical Investigative Site 1103	Brussels
Belgium	Clinical Investigative Site 1102	Edegem
Belgium	Clinical Investigative Site 1101	Liege
Bulgaria	Clinical Investigative Site 1205	Pleven
Bulgaria	Clinical Investigative Site 1204	Plovdiv
Bulgaria	Clinical Investigative Site 1201	Sofia
Bulgaria	Clinical Investigative Site 1202	Sofia
Bulgaria	Clinical Investigative Site 1203	Sofia
Bulgaria	Clinical Investigative Site 1206	Stara Zagora
Czechia	Clinical Investigative Site 1402	Hradec Kralove
Czechia	Clinical Investigative Site 1405	Novy Jicin
Czechia	Clinical Investigative Site 1406	Pardubice
Czechia	Clinical Investigative Site 1401	Prague
Denmark	Clinical Investigative Site 1502	Copenhagen
Denmark	Clinical Investigative Site 1504	Roskilde
France	Clinical Investigative Site 1704	Bordeaux Cedex
France	Clinical Investigative Site 1701	Nice
France	Clinical Investigative Site 1710	Paris
France	Clinical Investigative Site 1707	Paris Cedex 10
France	Clinical Investigative Site 1710	Paris Cedex 18
France	Clinical Investigative Site 1705	Pierre Benite
France	Clinical Investigative Site 1703	Poitiers Cedex
France	Clinical Investigative Site 1702	Saint Etienne Cedex
Hungary	Clinical Investigative Site 2002	Budapest
Hungary	Clinical Investigative Site 2001	Debrecen
Hungary	Clinical Investigative Site 2006	Miskolc
Hungary	Clinical Investigative Site 2005	Pecs
Hungary	Clinical Investigative Site 2003	Szeged
Hungary	Clinical Investigative Site 2004	Veszprem
Italy	Clinical Investigative Site 2315	Ancona
Italy	Clinical Investigative Site 2303	Bergamo
Italy	Clinical Investigative Site 2307	Bologna
Italy	Clinical Investigative Site 2317	Genova
Italy	Clinical Investigative Site 2309	L'Aquila
Italy	Clinical Investigative Site 2310	Pisa
Italy	Clinical Investigative Site 2304	Roma
Italy	Clinical Investigative Site 2316	Rome
Lithuania	Clinical Investigative Site 3801	Vilnius
Romania	Clinical Investigative Site 2601	Bucharest
Romania	Clinical Investigative Site 2608	Bucharest
Romania	Clinical Investigative Site 2604	Cluj-Napoca
Romania	Clinical Investigative Site 2603	Iasi
Romania	Clinical Investigative Site 2606	Oradea
Romania	Clinical Investigative Site 2607	Sibiu
Romania	Clinical Investigative Site 2602	Timisoara
Romania	Clinical Investigative Site 2605	Tirgu-Mures
Russian Federation	Clinical Investigative Site 3410	Krasnodar
Slovakia	Clinical Investigative Site 2704	Banska Bystrica
Slovakia	Clinical Investigative Site 2701	Kosice
Slovakia	Clinical Investigative Site 2705	Kosice-Saca
Slovakia	Clinical Investigative Site 2708	Trnava
Spain	Clinical Investigative Site 2901	Barcelona
Spain	Clinical Investigative Site 2907	Las Palmas de Gran Canaria
Spain	Clinical Investigative Site 2902	Madrid
Spain	Clinical Investigative Site 2904	Madrid
Sweden	Clinical Investigative Site 3001	Stockholm
Sweden	Clinical Investigative Site 3006	Umea
Switzerland	Clinical Investigative Site 3101	Lausanne
Switzerland	Clinical Investigative Site 3103	Zurich
Ukraine	Clinical Investigative Site 3512	Poltava
Ukraine	Clinical Investigative Site 3514	Zaporizhia
United Kingdom	Clinical Investigative Site 3306	Dundee
United Kingdom	Clinical Investigative Site 3304	London

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16.		Baseline to week 16
Secondary	Proportion of patients with "Clear" or "Almost clear" on PGA at Week 16.		Baseline to week 16