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

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ACT-128800
Placebo
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring psoriasis, chronic plaque psoriasis, Moderate to severe chronic plaque psoriasis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Investigative Site 1006
  • Clinical Investigative Site 1002
  • Clinical Investigative Site 1004
  • Clinical Investigative Site 1007
  • Clinical Investigative Site 1001
  • Clinical Investigative Site 1103
  • Clinical Investigative Site 1102
  • Clinical Investigative Site 1101
  • Clinical Investigative Site 1205
  • Clinical Investigative Site 1204
  • Clinical Investigative Site 1202
  • Clinical Investigative Site 1201
  • Clinical Investigative Site 1203
  • Clinical Investigative Site 1206
  • Clinical Investigative Site 1402
  • Clinical Investigative Site 1405
  • Clinical Investigative Site 1406
  • Clinical Investigative Site 1401
  • Clinical Investigative Site 1502
  • Clinical Investigative Site 1504
  • Clinical Investigative Site 1704
  • Clinical Investigative Site 1701
  • Clinical Investigative Site 1707
  • Clinical Investigative Site 1710
  • Clinical Investigative Site 1710
  • Clinical Investigative Site 1705
  • Clinical Investigative Site 1703
  • Clinical Investigative Site 1702
  • Clinical Investigative Site 2002
  • Clinical Investigative Site 2001
  • Clinical Investigative Site 2006
  • Clinical Investigative Site 2005
  • Clinical Investigative Site 2003
  • Clinical Investigative Site 2004
  • Clinical Investigative Site 2315
  • Clinical Investigative Site 2303
  • Clinical Investigative Site 2307
  • Clinical Investigative Site 2317
  • Clinical Investigative Site 2309
  • Clinical Investigative Site 2310
  • Clinical Investigative Site 2304
  • Clinical Investigative Site 2316
  • Clinical Investigative Site 3801
  • Clinical Investigative Site 2608
  • Clinical Investigative Site 2601
  • Clinical Investigative Site 2604
  • Clinical Investigative Site 2603
  • Clinical Investigative Site 2606
  • Clinical Investigative Site 2607
  • Clinical Investigative Site 2602
  • Clinical Investigative Site 2605
  • Clinical Investigative Site 3410
  • Clinical Investigative Site 2704
  • Clinical Investigative Site 2705
  • Clinical Investigative Site 2701
  • Clinical Investigative Site 2708
  • Clinical Investigative Site 2901
  • Clinical Investigative Site 2907
  • Clinical Investigative Site 2902
  • Clinical Investigative Site 2904
  • Clinical Investigative Site 3001
  • Clinical Investigative Site 3006
  • Clinical Investigative Site 3101
  • Clinical Investigative Site 3103
  • Clinical Investigative Site 3512
  • Clinical Investigative Site 3514
  • Clinical Investigative Site 3306
  • Clinical Investigative Site 3304

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Investigational drug - Dose 1

Investigational drug - Dose 2

Matching placebo

Arm Description

Outcomes

Primary Outcome Measures

Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16.

Secondary Outcome Measures

Proportion of patients with "Clear" or "Almost clear" on PGA at Week 16.

Full Information

First Posted
September 22, 2010
Last Updated
January 3, 2023
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT01208090
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 31, 2010 (Actual)
Primary Completion Date
October 31, 2012 (Actual)
Study Completion Date
November 30, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
psoriasis, chronic plaque psoriasis, Moderate to severe chronic plaque psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
326 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigational drug - Dose 1
Arm Type
Experimental
Arm Title
Investigational drug - Dose 2
Arm Type
Experimental
Arm Title
Matching placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ACT-128800
Intervention Description
ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily
Primary Outcome Measure Information:
Title
Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16.
Time Frame
Baseline to week 16
Secondary Outcome Measure Information:
Title
Proportion of patients with "Clear" or "Almost clear" on PGA at Week 16.
Time Frame
Baseline to week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Actelion Pharmaceuticals
Organizational Affiliation
Actelion
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Investigative Site 1006
City
Feldkirch
ZIP/Postal Code
6807
Country
Austria
Facility Name
Clinical Investigative Site 1002
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Clinical Investigative Site 1004
City
St. Polten
ZIP/Postal Code
3100
Country
Austria
Facility Name
Clinical Investigative Site 1007
City
Vienna
ZIP/Postal Code
1130
Country
Austria
Facility Name
Clinical Investigative Site 1001
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Clinical Investigative Site 1103
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Clinical Investigative Site 1102
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Clinical Investigative Site 1101
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Clinical Investigative Site 1205
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Clinical Investigative Site 1204
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Clinical Investigative Site 1202
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Clinical Investigative Site 1201
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Clinical Investigative Site 1203
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Clinical Investigative Site 1206
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Clinical Investigative Site 1402
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Clinical Investigative Site 1405
City
Novy Jicin
ZIP/Postal Code
74101
Country
Czechia
Facility Name
Clinical Investigative Site 1406
City
Pardubice
ZIP/Postal Code
53203
Country
Czechia
Facility Name
Clinical Investigative Site 1401
City
Prague
ZIP/Postal Code
10034
Country
Czechia
Facility Name
Clinical Investigative Site 1502
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Clinical Investigative Site 1504
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Clinical Investigative Site 1704
City
Bordeaux Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Clinical Investigative Site 1701
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Clinical Investigative Site 1707
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Clinical Investigative Site 1710
City
Paris Cedex 18
ZIP/Postal Code
75877
Country
France
Facility Name
Clinical Investigative Site 1710
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
Clinical Investigative Site 1705
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
Facility Name
Clinical Investigative Site 1703
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Clinical Investigative Site 1702
City
Saint Etienne Cedex
ZIP/Postal Code
42055
Country
France
Facility Name
Clinical Investigative Site 2002
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Clinical Investigative Site 2001
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Clinical Investigative Site 2006
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Clinical Investigative Site 2005
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Clinical Investigative Site 2003
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Clinical Investigative Site 2004
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Clinical Investigative Site 2315
City
Ancona
ZIP/Postal Code
60020
Country
Italy
Facility Name
Clinical Investigative Site 2303
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
Facility Name
Clinical Investigative Site 2307
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Clinical Investigative Site 2317
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Clinical Investigative Site 2309
City
L'Aquila
ZIP/Postal Code
67100
Country
Italy
Facility Name
Clinical Investigative Site 2310
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Clinical Investigative Site 2304
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Clinical Investigative Site 2316
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Clinical Investigative Site 3801
City
Vilnius
Country
Lithuania
Facility Name
Clinical Investigative Site 2608
City
Bucharest
ZIP/Postal Code
011461
Country
Romania
Facility Name
Clinical Investigative Site 2601
City
Bucharest
ZIP/Postal Code
020125
Country
Romania
Facility Name
Clinical Investigative Site 2604
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Clinical Investigative Site 2603
City
Iasi
ZIP/Postal Code
700368
Country
Romania
Facility Name
Clinical Investigative Site 2606
City
Oradea
ZIP/Postal Code
410167
Country
Romania
Facility Name
Clinical Investigative Site 2607
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Name
Clinical Investigative Site 2602
City
Timisoara
ZIP/Postal Code
300074
Country
Romania
Facility Name
Clinical Investigative Site 2605
City
Tirgu-Mures
ZIP/Postal Code
540342
Country
Romania
Facility Name
Clinical Investigative Site 3410
City
Krasnodar
ZIP/Postal Code
350020
Country
Russian Federation
Facility Name
Clinical Investigative Site 2704
City
Banska Bystrica
ZIP/Postal Code
97517
Country
Slovakia
Facility Name
Clinical Investigative Site 2705
City
Kosice-Saca
ZIP/Postal Code
04015
Country
Slovakia
Facility Name
Clinical Investigative Site 2701
City
Kosice
ZIP/Postal Code
04166
Country
Slovakia
Facility Name
Clinical Investigative Site 2708
City
Trnava
ZIP/Postal Code
91775
Country
Slovakia
Facility Name
Clinical Investigative Site 2901
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Clinical Investigative Site 2907
City
Las Palmas de Gran Canaria
Country
Spain
Facility Name
Clinical Investigative Site 2902
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Clinical Investigative Site 2904
City
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Clinical Investigative Site 3001
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Clinical Investigative Site 3006
City
Umea
ZIP/Postal Code
90185
Country
Sweden
Facility Name
Clinical Investigative Site 3101
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Clinical Investigative Site 3103
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Clinical Investigative Site 3512
City
Poltava
ZIP/Postal Code
36038
Country
Ukraine
Facility Name
Clinical Investigative Site 3514
City
Zaporizhia
ZIP/Postal Code
69063
Country
Ukraine
Facility Name
Clinical Investigative Site 3306
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Clinical Investigative Site 3304
City
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25127208
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.
Results Reference
derived

Learn more about this trial

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

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