ACT-128800 in Patients With Moderate to Severe Chronic Plaque Psoriasis
- Registration Number
- NCT01208090
- Lead Sponsor
- Actelion
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 326
- Adult males and females aged 18 to 60 years (inclusive) with moderate to severe chronic plaque psoriasis who require systemic treatment.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Matching placebo Placebo - Investigational drug - Dose 1 ACT-128800 - Investigational drug - Dose 2 ACT-128800 -
- Primary Outcome Measures
Name Time Method Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. Baseline to week 16
- Secondary Outcome Measures
Name Time Method Proportion of patients with "Clear" or "Almost clear" on PGA at Week 16. Baseline to week 16
Trial Locations
- Locations (134)
Clinical Investigative Site 1103
🇧🇪Brussels, Belgium
Clinical Investigative Site 2601
🇷🇴Bucharest, Romania
Clinical Investigative Site 1006
🇦🇹Feldkirch, Austria
Clinical Investigative Site 1004
🇦🇹St. Polten, Austria
Clinical Investigative Site 1007
🇦🇹Vienna, Austria
Clinical Investigative Site 1001
🇦🇹Vienna, Austria
Clinical Investigative Site 1002
🇦🇹Graz, Austria
Clinical Investigative Site 1102
🇧🇪Edegem, Belgium
Clinical Investigative Site 1204
🇧🇬Plovdiv, Bulgaria
Clinical Investigative Site 1202
🇧🇬Sofia, Bulgaria
Clinical Investigative Site 1206
🇧🇬Stara Zagora, Bulgaria
Clinical Investigative Site 1401
🇨🇿Prague, Czechia
Clinical Investigative Site 1703
🇫🇷Poitiers Cedex, France
Clinical Investigative Site 1203
🇧🇬Sofia, Bulgaria
Clinical Investigative Site 1405
🇨🇿Novy Jicin, Czechia
Clinical Investigative Site 2307
🇮🇹Bologna, Italy
Clinical Investigative Site 2003
ðŸ‡ðŸ‡ºSzeged, Hungary
Clinical Investigative Site 1402
🇨🇿Hradec Kralove, Czechia
Clinical Investigative Site 1201
🇧🇬Sofia, Bulgaria
Clinical Investigative Site 2004
ðŸ‡ðŸ‡ºVeszprem, Hungary
Clinical Investigative Site 2002
ðŸ‡ðŸ‡ºBudapest, Hungary
Clinical Investigative Site 2006
ðŸ‡ðŸ‡ºMiskolc, Hungary
Clinical Investigative Site 1705
🇫🇷Pierre Benite, France
Clinical Investigative Site 1406
🇨🇿Pardubice, Czechia
Clinical Investigative Site 1701
🇫🇷Nice, France
Clinical Investigative Site 2304
🇮🇹Roma, Italy
Clinical Investigative Site 1504
🇩🇰Roskilde, Denmark
Clinical Investigative Site 1502
🇩🇰Copenhagen, Denmark
Clinical Investigative Site 1101
🇧🇪Liege, Belgium
Clinical Investigative Site 1707
🇫🇷Paris Cedex 10, France
Clinical Investigative Site 1702
🇫🇷Saint Etienne Cedex, France
Clinical Investigative Site 1704
🇫🇷Bordeaux Cedex, France
Clinical Investigative Site 2001
ðŸ‡ðŸ‡ºDebrecen, Hungary
Clinical Investigative Site 1710
🇫🇷Paris, France
Clinical Investigative Site 2005
ðŸ‡ðŸ‡ºPecs, Hungary
Clinical Investigative Site 2303
🇮🇹Bergamo, Italy
Clinical Investigative Site 2315
🇮🇹Ancona, Italy
Clinical Investigative Site 2317
🇮🇹Genova, Italy
Clinical Investigative Site 2309
🇮🇹L'Aquila, Italy
Clinical Investigative Site 2310
🇮🇹Pisa, Italy
Clinical Investigative Site 3801
🇱🇹Vilnius, Lithuania
Clinical Investigative Site 2316
🇮🇹Rome, Italy
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, Romania
Clinical Investigative Site 2704
🇸🇰Banska Bystrica, Slovakia
Clinical Investigative Site 3410
🇷🇺Krasnodar, Russian Federation
Clinical Investigative Site 2705
🇸🇰Kosice-Saca, Slovakia
Clinical Investigative Site 2701
🇸🇰Kosice, Slovakia
Clinical Investigative Site 2708
🇸🇰Trnava, Slovakia
Clinical Investigative Site 2901
🇪🇸Barcelona, Spain
Clinical Investigative Site 3101
🇨ðŸ‡Lausanne, Switzerland
Clinical Investigative Site 2907
🇪🇸Las Palmas de Gran Canaria, Spain
Clinical Investigative Site 2902
🇪🇸Madrid, Spain
Clinical Investigative Site 2904
🇪🇸Madrid, Spain
Clinical Investigative Site 3001
🇸🇪Stockholm, Sweden
Clinical Investigative Site 3006
🇸🇪Umea, Sweden
Clinical Investigative Site 3103
🇨ðŸ‡Zurich, Switzerland
Clinical Investigative Site 3512
🇺🇦Poltava, Ukraine
Clinical Investigative Site 3306
🇬🇧Dundee, United Kingdom
Clinical Investigative Site 3304
🇬🇧London, United Kingdom
Clinical Investigative Site 3514
🇺🇦Zaporizhia, Ukraine
Clinical Investigative Site 2608
🇷🇴Bucharest, Romania
Clinical Investigative Site 1205
🇧🇬Pleven, Bulgaria
Clinical Investigative Site 1006
🇦🇹Feldkirch, Austria
Clinical Investigative Site 1002
🇦🇹Graz, Austria
Clinical Investigative Site 1004
🇦🇹St. Polten, Austria
Clinical Investigative Site 1007
🇦🇹Vienna, Austria
Clinical Investigative Site 1001
🇦🇹Vienna, Austria
Clinical Investigative Site 1103
🇧🇪Brussels, Belgium
Clinical Investigative Site 1102
🇧🇪Edegem, Belgium
Clinical Investigative Site 1101
🇧🇪Liege, Belgium
Clinical Investigative Site 1205
🇧🇬Pleven, Bulgaria
Clinical Investigative Site 1204
🇧🇬Plovdiv, Bulgaria
Clinical Investigative Site 1202
🇧🇬Sofia, Bulgaria
Clinical Investigative Site 1201
🇧🇬Sofia, Bulgaria
Clinical Investigative Site 1203
🇧🇬Sofia, Bulgaria
Clinical Investigative Site 1206
🇧🇬Stara Zagora, Bulgaria
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, Czechia
Clinical Investigative Site 1502
🇩🇰Copenhagen, Denmark
Clinical Investigative Site 1504
🇩🇰Roskilde, Denmark
Clinical Investigative Site 1704
🇫🇷Bordeaux Cedex, France
Clinical Investigative Site 1701
🇫🇷Nice, France
Clinical Investigative Site 1707
🇫🇷Paris Cedex 10, France
Clinical Investigative Site 1710
🇫🇷Paris, France
Clinical Investigative Site 1705
🇫🇷Pierre Benite, France
Clinical Investigative Site 1703
🇫🇷Poitiers Cedex, France
Clinical Investigative Site 1702
🇫🇷Saint Etienne Cedex, France
Clinical Investigative Site 2002
ðŸ‡ðŸ‡ºBudapest, Hungary
Clinical Investigative Site 2001
ðŸ‡ðŸ‡ºDebrecen, Hungary
Clinical Investigative Site 2006
ðŸ‡ðŸ‡ºMiskolc, Hungary
Clinical Investigative Site 2005
ðŸ‡ðŸ‡ºPecs, Hungary
Clinical Investigative Site 2003
ðŸ‡ðŸ‡ºSzeged, Hungary
Clinical Investigative Site 2004
ðŸ‡ðŸ‡ºVeszprem, Hungary
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 2604
🇷🇴Cluj-Napoca, Romania
Clinical Investigative Site 2607
🇷🇴Sibiu, Romania
Clinical Investigative Site 3006
🇸🇪Umea, Sweden
Clinical Investigative Site 3101
🇨ðŸ‡Lausanne, Switzerland
Clinical Investigative Site 2310
🇮🇹Pisa, Italy
Clinical Investigative Site 2304
🇮🇹Roma, Italy
Clinical Investigative Site 2316
🇮🇹Rome, Italy
Clinical Investigative Site 2606
🇷🇴Oradea, Romania
Clinical Investigative Site 2602
🇷🇴Timisoara, Romania
Clinical Investigative Site 2605
🇷🇴Tirgu-Mures, Romania
Clinical Investigative Site 3801
🇱🇹Vilnius, Lithuania
Clinical Investigative Site 2603
🇷🇴Iasi, Romania
Clinical Investigative Site 2705
🇸🇰Kosice-Saca, Slovakia
Clinical Investigative Site 2701
🇸🇰Kosice, Slovakia
Clinical Investigative Site 2708
🇸🇰Trnava, Slovakia
Clinical Investigative Site 2904
🇪🇸Madrid, Spain
Clinical Investigative Site 2608
🇷🇴Bucharest, Romania
Clinical Investigative Site 2601
🇷🇴Bucharest, Romania
Clinical Investigative Site 2704
🇸🇰Banska Bystrica, Slovakia
Clinical Investigative Site 3410
🇷🇺Krasnodar, Russian Federation
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 3001
🇸🇪Stockholm, Sweden
Clinical Investigative Site 3103
🇨ðŸ‡Zurich, Switzerland
Clinical Investigative Site 3512
🇺🇦Poltava, Ukraine
Clinical Investigative Site 3514
🇺🇦Zaporizhia, Ukraine
Clinical Investigative Site 3306
🇬🇧Dundee, United Kingdom
Clinical Investigative Site 3304
🇬🇧London, United Kingdom