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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational drug - Dose 1 | Experimental |
| |
| Investigational drug - Dose 2 | Experimental |
| |
| Matching placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT-128800 | Drug | ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. | Baseline to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with "Clear" or "Almost clear" on PGA at Week 16. | Baseline to week 16 |
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Inclusion Criteria:
Exclusion Criteria:
History or presence of malignancy.
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| Name | Affiliation | Role |
|---|---|---|
| Actelion Pharmaceuticals | Actelion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Investigative Site 1006 | Feldkirch | 6807 | Austria | |||
| Clinical Investigative Site 1002 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25127208 | Derived | 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. |
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| Placebo | Drug | ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily |
|
| Graz |
| 8036 |
| Austria |
| Clinical Investigative Site 1004 | Sankt Pölten | 3100 | Austria |
| Clinical Investigative Site 1007 | Vienna | 1130 | Austria |
| Clinical Investigative Site 1001 | Vienna | A-1090 | Austria |
| Clinical Investigative Site 1103 | Brussels | 1200 | Belgium |
| Clinical Investigative Site 1102 | Edegem | 2650 | Belgium |
| Clinical Investigative Site 1101 | Liège | 4000 | Belgium |
| Clinical Investigative Site 1205 | Pleven | 5800 | Bulgaria |
| Clinical Investigative Site 1204 | Plovdiv | 4002 | Bulgaria |
| Clinical Investigative Site 1202 | Sofia | 1431 | Bulgaria |
| Clinical Investigative Site 1201 | Sofia | 1606 | Bulgaria |
| Clinical Investigative Site 1203 | Sofia | 1606 | Bulgaria |
| Clinical Investigative Site 1206 | Stara Zagora | 6000 | Bulgaria |
| Clinical Investigative Site 1402 | Hradec Králové | 50005 | Czechia |
| Clinical Investigative Site 1405 | Nový Jičín | 74101 | Czechia |
| Clinical Investigative Site 1406 | Pardubice | 53203 | Czechia |
| Clinical Investigative Site 1401 | Prague | 10034 | Czechia |
| Clinical Investigative Site 1502 | Copenhagen | 2400 | Denmark |
| Clinical Investigative Site 1504 | Roskilde | 4000 | Denmark |
| Clinical Investigative Site 1704 | Bordeaux | 86021 | France |
| Clinical Investigative Site 1701 | Nice | 06202 | France |
| Clinical Investigative Site 1707 | Paris | 75475 | France |
| Clinical Investigative Site 1710 | Paris | 75877 | France |
| Clinical Investigative Site 1705 | Pierre-Bénite | 69310 | France |
| Clinical Investigative Site 1703 | Poitiers | 86021 | France |
| Clinical Investigative Site 1702 | Saint-Etienne | 42055 | France |
| Clinical Investigative Site 2002 | Budapest | 1085 | Hungary |
| Clinical Investigative Site 2001 | Debrecen | 4012 | Hungary |
| Clinical Investigative Site 2006 | Miskolc | 3529 | Hungary |
| Clinical Investigative Site 2005 | Pécs | 7624 | Hungary |
| Clinical Investigative Site 2003 | Szeged | 6720 | Hungary |
| Clinical Investigative Site 2004 | Veszprém | 8200 | Hungary |
| Clinical Investigative Site 2315 | Ancona | 60020 | Italy |
| Clinical Investigative Site 2303 | Bergamo | 24128 | Italy |
| Clinical Investigative Site 2307 | Bologna | 40138 | Italy |
| Clinical Investigative Site 2317 | Genova | 16132 | Italy |
| Clinical Investigative Site 2309 | L’Aquila | 67100 | Italy |
| Clinical Investigative Site 2310 | Pisa | 56126 | Italy |
| Clinical Investigative Site 2304 | Roma | 00133 | Italy |
| Clinical Investigative Site 2316 | Rome | 00168 | Italy |
| Clinical Investigative Site 3801 | Vilnius | Lithuania |
| Clinical Investigative Site 2608 | Bucharest | 011461 | Romania |
| Clinical Investigative Site 2601 | Bucharest | 020125 | Romania |
| Clinical Investigative Site 2604 | Cluj-Napoca | 400006 | Romania |
| Clinical Investigative Site 2603 | Iași | 700368 | Romania |
| Clinical Investigative Site 2606 | Oradea | 410167 | Romania |
| Clinical Investigative Site 2607 | Sibiu | 550245 | Romania |
| Clinical Investigative Site 2605 | Târgu Mureş | 540342 | Romania |
| Clinical Investigative Site 2602 | Timișoara | 300074 | Romania |
| Clinical Investigative Site 3410 | Krasnodar | 350020 | Russia |
| Clinical Investigative Site 2704 | Banská Bystrica | 97517 | Slovakia |
| Clinical Investigative Site 2705 | Kosice-Saca | 04015 | Slovakia |
| Clinical Investigative Site 2701 | Košice | 04166 | Slovakia |
| Clinical Investigative Site 2708 | Trnava | 91775 | Slovakia |
| Clinical Investigative Site 2901 | Barcelona | 08025 | Spain |
| Clinical Investigative Site 2907 | Las Palmas de Gran Canaria | Spain |
| Clinical Investigative Site 2902 | Madrid | 28041 | Spain |
| Clinical Investigative Site 2904 | Madrid | 28922 | Spain |
| Clinical Investigative Site 3001 | Stockholm | 17176 | Sweden |
| Clinical Investigative Site 3006 | Umeå | 90185 | Sweden |
| Clinical Investigative Site 3101 | Lausanne | 1011 | Switzerland |
| Clinical Investigative Site 3103 | Zurich | 8091 | Switzerland |
| Clinical Investigative Site 3512 | Poltava | 36038 | Ukraine |
| Clinical Investigative Site 3514 | Zaporizhia | 69063 | Ukraine |
| Clinical Investigative Site 3306 | Dundee | DD1 9SY | United Kingdom |
| Clinical Investigative Site 3304 | London | E11 1NR | United Kingdom |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C550169 | ponesimod |
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