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

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ClinicalTrials.gov Identifier: NCT01208090
Recruitment Status : Completed
First Posted : September 23, 2010
Last Update Posted : January 24, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: ACT-128800 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Investigational drug - Dose 1 Drug: ACT-128800
ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily

Experimental: Investigational drug - Dose 2 Drug: ACT-128800
ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily

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




Primary Outcome Measures :
  1. Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. [ Time Frame: Baseline to week 16 ]

Secondary Outcome Measures :
  1. Proportion of patients with "Clear" or "Almost clear" on PGA at Week 16. [ Time Frame: Baseline to week 16 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01208090


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Locations
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Austria
Clinical Investigative Site 1006
Feldkirch, Austria, 6807
Clinical Investigative Site 1002
Graz, Austria, 8036
Clinical Investigative Site 1004
St. Polten, Austria, 3100
Clinical Investigative Site 1007
Vienna, Austria, 1130
Clinical Investigative Site 1001
Vienna, Austria, A-1090
Belgium
Clinical Investigative Site 1103
Brussels, Belgium, 1200
Clinical Investigative Site 1102
Edegem, Belgium, 2650
Clinical Investigative Site 1101
Liege, Belgium, 4000
Bulgaria
Clinical Investigative Site 1205
Pleven, Bulgaria, 5800
Clinical Investigative Site 1204
Plovdiv, Bulgaria, 4002
Clinical Investigative Site 1202
Sofia, Bulgaria, 1431
Clinical Investigative Site 1201
Sofia, Bulgaria, 1606
Clinical Investigative Site 1203
Sofia, Bulgaria, 1606
Clinical Investigative Site 1206
Stara Zagora, Bulgaria, 6000
Czech Republic
Clinical Investigative Site 1402
Hradec Kralove, Czech Republic, 50005
Clinical Investigative Site 1405
Novy Jicin, Czech Republic, 74101
Clinical Investigative Site 1406
Pardubice, Czech Republic, 53203
Clinical Investigative Site 1401
Prague, Czech Republic, 10034
Denmark
Clinical Investigative Site 1502
Copenhagen, Denmark, 2400
Clinical Investigative Site 1504
Roskilde, Denmark, 4000
France
Clinical Investigative Site 1704
Bordeaux Cedex, France, 86021
Clinical Investigative Site 1701
Nice, France, 06202
Clinical Investigative Site 1707
Paris Cedex 10, France, 75475
Clinical Investigative Site 1710
Paris Cedex 18, France, 75877
Clinical Investigative Site 1710
Paris, France, 75877
Clinical Investigative Site 1705
Pierre Benite, France, 69310
Clinical Investigative Site 1703
Poitiers Cedex, France, 86021
Clinical Investigative Site 1702
Saint Etienne Cedex, France, 42055
Hungary
Clinical Investigative Site 2002
Budapest, Hungary, 1085
Clinical Investigative Site 2001
Debrecen, Hungary, 4012
Clinical Investigative Site 2006
Miskolc, Hungary, 3529
Clinical Investigative Site 2005
Pecs, Hungary, 7624
Clinical Investigative Site 2003
Szeged, Hungary, 6720
Clinical Investigative Site 2004
Veszprem, Hungary, 8200
Italy
Clinical Investigative Site 2315
Ancona, Italy, 60020
Clinical Investigative Site 2303
Bergamo, Italy, 24128
Clinical Investigative Site 2307
Bologna, Italy, 40138
Clinical Investigative Site 2317
Genova, Italy, 16132
Clinical Investigative Site 2309
L'Aquila, Italy, 67100
Clinical Investigative Site 2310
Pisa, Italy, 56126
Clinical Investigative Site 2304
Roma, Italy, 00133
Clinical Investigative Site 2316
Rome, Italy, 00168
Lithuania
Clinical Investigative Site 3801
Vilnius, Lithuania
Romania
Clinical Investigative Site 2608
Bucharest, Romania, 011461
Clinical Investigative Site 2601
Bucharest, Romania, 020125
Clinical Investigative Site 2604
Cluj-Napoca, Romania, 400006
Clinical Investigative Site 2603
Iasi, Romania, 700368
Clinical Investigative Site 2606
Oradea, Romania, 410167
Clinical Investigative Site 2607
Sibiu, Romania, 550245
Clinical Investigative Site 2602
Timisoara, Romania, 300074
Clinical Investigative Site 2605
Tirgu-Mures, Romania, 540342
Russian Federation
Clinical Investigative Site 3410
Krasnodar, Russian Federation, 350020
Slovakia
Clinical Investigative Site 2704
Banska Bystrica, Slovakia, 97517
Clinical Investigative Site 2705
Kosice-Saca, Slovakia, 04015
Clinical Investigative Site 2701
Kosice, Slovakia, 04166
Clinical Investigative Site 2708
Trnava, Slovakia, 91775
Spain
Clinical Investigative Site 2901
Barcelona, Spain, 08025
Clinical Investigative Site 2907
Las Palmas de Gran Canaria, Spain
Clinical Investigative Site 2902
Madrid, Spain, 28041
Clinical Investigative Site 2904
Madrid, Spain, 28922
Sweden
Clinical Investigative Site 3001
Stockholm, Sweden, 17176
Clinical Investigative Site 3006
Umea, Sweden, 90185
Switzerland
Clinical Investigative Site 3101
Lausanne, Switzerland, 1011
Clinical Investigative Site 3103
Zurich, Switzerland, 8091
Ukraine
Clinical Investigative Site 3512
Poltava, Ukraine, 36038
Clinical Investigative Site 3514
Zaporizhia, Ukraine, 69063
United Kingdom
Clinical Investigative Site 3306
Dundee, United Kingdom, DD1 9SY
Clinical Investigative Site 3304
London, United Kingdom, E11 1NR
Sponsors and Collaborators
Actelion
Investigators
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Study Director: Actelion Pharmaceuticals Actelion

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01208090     History of Changes
Other Study ID Numbers: AC-058A201
First Posted: September 23, 2010    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013

Keywords provided by Actelion:
psoriasis
chronic plaque psoriasis
Moderate to severe chronic plaque psoriasis

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases