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Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ACT-128800 Dose 1
Placebo
ACT-128800 Dose 2
ACT-128800 Dose 3
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult males and females
  • Diagnosis of RRMS as defined by the revised (2005) McDonald Diagnostic Criteria for Multiple Sclerosis (MS).
  • Signed inform consent prior to initiation of any study-mandated procedure.

Exclusion Criteria:

  • A diagnosis of MS categorized as primary progressive or secondary progressive or progressive relapsing.
  • Patients currently treated for an autoimmune disorder other than MS.
  • Contraindications for MRI.
  • Ongoing bacterial, viral, or fungal infection.
  • 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 3132
  • Clinical Investigative Site 3100
  • Clinical Investigative Site 3115
  • Clinical Investigative Site 3117
  • Clinical Invesigative Site 3116
  • Clinical Investigative Site 3101
  • Clinical Investigative Site 3105
  • Clinical Investigative Site 3107
  • Clinical Investigative Site 3118
  • Clinical Investigative Site 3133
  • Clinical Investigator 3136
  • Clinical Investigative Site # 3135
  • Clinical Investigative Site 3129
  • Clinical Investigative Site # 3128
  • Clinical Investigative Site 3127
  • Clinical Investigative Site 3120
  • Clinical Investigative Site 3119
  • Clinical Investigator 3126
  • Clinical Investigative Site 3113
  • Clinical Investigative Site 3130
  • Clinical Investigator 3104
  • Clinical Investigative Site 3125
  • Clinical Investigative Site 3112
  • Clinical Investigative Site 3111
  • Clinical Investigative Site 3102
  • Clinical Investigative Site # 1001
  • Clinical Investigative Site 1000
  • Clinical Investigative Site 1102
  • Clinical Investigative Site 1100
  • Clinical Investigative Site 1101
  • Clinical Investigative Site 1201
  • Clinical Investigative Site # 1205
  • Clinical Investigative Site 1204
  • Clinical Investigative Site 1203
  • Clinical Investigative Site 1302
  • Clinical Investigative Site 1301
  • Clinical Investigative Site 1303
  • Clinical Investigative Site 1304
  • Clinical Investigative Site 1401
  • Clinical Investigative Site # 1401
  • Clinical Investigative Site 1400
  • Clinical Investigative Site 1502
  • Clinical Investigative Site 1506
  • Clinical Investigative Site 1504
  • Clinical Investigative Site 1501
  • Clinical Investigative Site 1500
  • Clinical Investigative Site 1503
  • Clinical Investigative Site 1600
  • Clinical Investigative Site 1601
  • Clinical Investigative Site 1603
  • Clinical Investigative Site 1602
  • Clinical Investigative Site 1701
  • Clinical Investigative Site # 1806
  • Clinical Investigative 1807
  • Clinical Investigative Site 1803
  • Clinical Investigative site 1800
  • Clinical Investigative Site 1802
  • Clinical Investigative Site 1805
  • Clinical Investigative Site 1804
  • Clinical Investigative Site 1905
  • Clinical Investigative Site # 1904
  • Clinical Investigative Site 1908
  • Clinical Investigative Site 1902
  • Clinical Investigative Site 1900
  • Clinical Investigative Site 1901
  • Clinical Investigative Site 2000
  • Clinical Investigative Site 2003
  • Clinical Investigative Site 2001
  • Clinical Investigative Site 2002
  • Clinical Investigative Site 2101
  • Clinical Investigative Site 2104
  • Clinical Investigative Site # 2106
  • Clinical Investigative Site 2102
  • Clinical Investigative Site 2103
  • Clinical Investigative Site 2105
  • Clinical Investigative Site 2203
  • Clinical Investigative Site 2202
  • Clinical Investigative Site 2201
  • Clinical Investigative Site 2305
  • Clinical Investigative Site 2303
  • Clinical Investigative Site 2304
  • Clinical Investigative Site 2302
  • Clinical Investigative Site 2400
  • Clinical Investigative Site 2401
  • Clinical Investigative Site 2402
  • Clinical Investigative Site # 3202
  • Clinical Investigative Site # 3203
  • Clinical Investigative Site # 3206
  • Clinical Investigative Site # 3201
  • Clinical Investigative Site 3209
  • Clinical Investigative Site # 3204
  • Clinical Investigative Site 3201
  • Clinical Investigative Site 3200
  • Clinical Investigative Site 3208
  • Clinical Investigative Site 2501
  • Clinical Investigative Site 2503
  • Clinical Investigative Site 2502
  • Clinical Investigative Site 2706
  • Clinical Investigative Site 2702
  • Clinical Investigative Site 2705
  • Clinical Investigative Site 2701
  • Clinical Investigative Site 2700
  • Clinical Investigative Site 2704
  • Clinical Investigative Site 2802
  • Clinical Investigative Site 2800
  • Clinical Investigative Site 2801
  • Clinical Investigative Site 2901
  • Clinical Investigative Site 2900
  • Clinical Investigative Site 3302
  • Clinical Investigative Site 3303
  • Clinical Investigative Site 3300
  • Clinical Investigative Site 3304
  • Clinical Investigative Site 3003
  • Clinical Investigative Site 3004
  • Clinical Investigative Site 3002

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

ACT-128800 Dose 1

ACT-128800 Dose 2

ACT-128800 Dose 3

Placebo

Arm Description

ACT-128800 Dose 1

ACT-128800 Dose 2

ACT-128800 Dose 3

Matching placebo

Outcomes

Primary Outcome Measures

Cumulative Number of New T1 Gadolinium-Enhancing (Gd+) Lesions on Magnetic Resonance Imaging (MRI) Scan From Week 12 to Week 24
Cumulative Number of new T1 gadolinium-enhancing (Gd+) lesions per year on magnetic resonance imaging (MRI) scan from Week 12 to Week 24 were reported. Negative binomial (NB) regression analysis on Per protocol analysis set and imputation was applied for the missing data. Here, MS signifies multiple sclerosis.

Secondary Outcome Measures

Annualized Confirmed Relapse Rate
Relapse: occurrence of acute episode of one or more new symptoms or worsened symptoms of Multiple Sclerosis (MS), not associated with fever/infection and lasting 24 hours after stable 30 days period. Confirmed relapse: increase from baseline at least 0.5 point Expanded Disability Status Scale (EDSS) score or increase of one point in one, two or three Functional Systems (FS), excluding bowel/bladder and cerebral/mental FS. EDSS and FS scores are based on neurological examination for assessing its impairment in MS. Among eight FS, seven are ordinal clinical rating scales ranging from 0-5 or 6 with higher scale indicating overall functional impairment assessing Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel/Bladder and Cerebral functions. Rating individual FS scores is used to rate EDSS with information concerning gait and use of assistance. EDSS is ordinal clinical scale ranges 0 (normal neurological examination) to 10(death due to MS)
Number of Participants With First Confirmed Relapse as Assessed by Kaplan-Meier Estimate From Baseline to Week 24
Relapse: occurrence of acute episode of one or more new symptoms or worsened symptoms of MS, not associated with fever/infection and lasting 24 hours after stable 30 days period. Confirmed relapse: increase from baseline at least 0.5 point Expanded Disability Status Scale (EDSS) score or increase of one point in one, two or three Functional Systems (FS), excluding bowel/bladder and cerebral/mental FS. EDSS and FS scores are based on neurological examination for assessing its impairment in MS. Among eight FS, seven are ordinal clinical rating scales ranging from 0-5 or 6 with higher scale indicating overall functional impairment assessing Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel/Bladder and Cerebral functions. Rating individual FS scores is used to rate EDSS with information concerning gait and use of assistance. EDSS is ordinal clinical scale ranges 0 (normal neurological examination) to 10(death due to MS). Kaplan-Meier estimate used for Outcome Measure analysis.

Full Information

First Posted
October 30, 2009
Last Updated
February 4, 2022
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT01006265
Brief Title
Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis
Official Title
Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy, Safety, and Tolerability of Three Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered for Twenty-four Weeks in Patients With Relapsing-remitting Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2009 (Actual)
Primary Completion Date
June 1, 2011 (Actual)
Study Completion Date
July 1, 2011 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
ACT-128800 Dose 1
Arm Type
Experimental
Arm Description
ACT-128800 Dose 1
Arm Title
ACT-128800 Dose 2
Arm Type
Experimental
Arm Description
ACT-128800 Dose 2
Arm Title
ACT-128800 Dose 3
Arm Type
Experimental
Arm Description
ACT-128800 Dose 3
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
ACT-128800 Dose 1
Intervention Description
ACT-128800 (Dose 1) administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo administered orally once daily
Intervention Type
Drug
Intervention Name(s)
ACT-128800 Dose 2
Intervention Description
ACT-128800 (Dose 2) administered orally once daily
Intervention Type
Drug
Intervention Name(s)
ACT-128800 Dose 3
Intervention Description
ACT-128800 (Dose 3) administered orally once daily
Primary Outcome Measure Information:
Title
Cumulative Number of New T1 Gadolinium-Enhancing (Gd+) Lesions on Magnetic Resonance Imaging (MRI) Scan From Week 12 to Week 24
Description
Cumulative Number of new T1 gadolinium-enhancing (Gd+) lesions per year on magnetic resonance imaging (MRI) scan from Week 12 to Week 24 were reported. Negative binomial (NB) regression analysis on Per protocol analysis set and imputation was applied for the missing data. Here, MS signifies multiple sclerosis.
Time Frame
From Week 12 to 24
Secondary Outcome Measure Information:
Title
Annualized Confirmed Relapse Rate
Description
Relapse: occurrence of acute episode of one or more new symptoms or worsened symptoms of Multiple Sclerosis (MS), not associated with fever/infection and lasting 24 hours after stable 30 days period. Confirmed relapse: increase from baseline at least 0.5 point Expanded Disability Status Scale (EDSS) score or increase of one point in one, two or three Functional Systems (FS), excluding bowel/bladder and cerebral/mental FS. EDSS and FS scores are based on neurological examination for assessing its impairment in MS. Among eight FS, seven are ordinal clinical rating scales ranging from 0-5 or 6 with higher scale indicating overall functional impairment assessing Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel/Bladder and Cerebral functions. Rating individual FS scores is used to rate EDSS with information concerning gait and use of assistance. EDSS is ordinal clinical scale ranges 0 (normal neurological examination) to 10(death due to MS)
Time Frame
Up to 24 weeks
Title
Number of Participants With First Confirmed Relapse as Assessed by Kaplan-Meier Estimate From Baseline to Week 24
Description
Relapse: occurrence of acute episode of one or more new symptoms or worsened symptoms of MS, not associated with fever/infection and lasting 24 hours after stable 30 days period. Confirmed relapse: increase from baseline at least 0.5 point Expanded Disability Status Scale (EDSS) score or increase of one point in one, two or three Functional Systems (FS), excluding bowel/bladder and cerebral/mental FS. EDSS and FS scores are based on neurological examination for assessing its impairment in MS. Among eight FS, seven are ordinal clinical rating scales ranging from 0-5 or 6 with higher scale indicating overall functional impairment assessing Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel/Bladder and Cerebral functions. Rating individual FS scores is used to rate EDSS with information concerning gait and use of assistance. EDSS is ordinal clinical scale ranges 0 (normal neurological examination) to 10(death due to MS). Kaplan-Meier estimate used for Outcome Measure analysis.
Time Frame
Baseline to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult males and females Diagnosis of RRMS as defined by the revised (2005) McDonald Diagnostic Criteria for Multiple Sclerosis (MS). Signed inform consent prior to initiation of any study-mandated procedure. Exclusion Criteria: A diagnosis of MS categorized as primary progressive or secondary progressive or progressive relapsing. Patients currently treated for an autoimmune disorder other than MS. Contraindications for MRI. Ongoing bacterial, viral, or fungal infection. 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 3132
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Clinical Investigative Site 3100
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Clinical Investigative Site 3115
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Clinical Investigative Site 3117
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Clinical Invesigative Site 3116
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
Clinical Investigative Site 3101
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Clinical Investigative Site 3105
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Clinical Investigative Site 3107
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
Clinical Investigative Site 3118
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Clinical Investigative Site 3133
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Clinical Investigator 3136
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63100
Country
United States
Facility Name
Clinical Investigative Site # 3135
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Clinical Investigative Site 3129
City
Latham
State/Province
New York
ZIP/Postal Code
12110
Country
United States
Facility Name
Clinical Investigative Site # 3128
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Clinical Investigative Site 3127
City
Schenectady
State/Province
New York
ZIP/Postal Code
12308
Country
United States
Facility Name
Clinical Investigative Site 3120
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Clinical Investigative Site 3119
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Clinical Investigator 3126
City
Akron
State/Province
Ohio
ZIP/Postal Code
44320
Country
United States
Facility Name
Clinical Investigative Site 3113
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Clinical Investigative Site 3130
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Clinical Investigator 3104
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Clinical Investigative Site 3125
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Clinical Investigative Site 3112
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Clinical Investigative Site 3111
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Clinical Investigative Site 3102
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Clinical Investigative Site # 1001
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Facility Name
Clinical Investigative Site 1000
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Facility Name
Clinical Investigative Site 1102
City
Amstetten
ZIP/Postal Code
3300
Country
Austria
Facility Name
Clinical Investigative Site 1100
City
St Polten
ZIP/Postal Code
3100
Country
Austria
Facility Name
Clinical Investigative Site 1101
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Clinical Investigative Site 1201
City
La Louviere
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Clinical Investigative Site # 1205
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Clinical Investigative Site 1204
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
Facility Name
Clinical Investigative Site 1203
City
Sijsele-Damme
ZIP/Postal Code
8340
Country
Belgium
Facility Name
Clinical Investigative Site 1302
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
Clinical Investigative Site 1301
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Clinical Investigative Site 1303
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Clinical Investigative Site 1304
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Clinical Investigative Site 1401
City
Burbaby
State/Province
British Columbia
ZIP/Postal Code
V5G 2X6
Country
Canada
Facility Name
Clinical Investigative Site # 1401
City
Burnaby
ZIP/Postal Code
V5G 2X6
Country
Canada
Facility Name
Clinical Investigative Site 1400
City
Ottawa
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Clinical Investigative Site 1502
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Clinical Investigative Site 1506
City
Jihlava
ZIP/Postal Code
586 33
Country
Czechia
Facility Name
Clinical Investigative Site 1504
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Clinical Investigative Site 1501
City
Ostrava-Poruba
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Clinical Investigative Site 1500
City
Praha
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Clinical Investigative Site 1503
City
Teplice
Country
Czechia
Facility Name
Clinical Investigative Site 1600
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Name
Clinical Investigative Site 1601
City
Hyvinkaa
ZIP/Postal Code
05800
Country
Finland
Facility Name
Clinical Investigative Site 1603
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Clinical Investigative Site 1602
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
Clinical Investigative Site 1701
City
Montpellier Cedex
ZIP/Postal Code
34295
Country
France
Facility Name
Clinical Investigative Site # 1806
City
Bayreuth
ZIP/Postal Code
95445
Country
Germany
Facility Name
Clinical Investigative 1807
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Clinical Investigative Site 1803
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
Clinical Investigative site 1800
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Clinical Investigative Site 1802
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Clinical Investigative Site 1805
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
Clinical Investigative Site 1804
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Clinical Investigative Site 1905
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Clinical Investigative Site # 1904
City
Budapest
ZIP/Postal Code
H-1115
Country
Hungary
Facility Name
Clinical Investigative Site 1908
City
Budapest
ZIP/Postal Code
H-1145
Country
Hungary
Facility Name
Clinical Investigative Site 1902
City
Gyor
ZIP/Postal Code
11-9024
Country
Hungary
Facility Name
Clinical Investigative Site 1900
City
Petofi
ZIP/Postal Code
2500
Country
Hungary
Facility Name
Clinical Investigative Site 1901
City
Szentpeteri-Kapu
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Clinical Investigative Site 2000
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Clinical Investigative Site 2003
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Clinical Investigative Site 2001
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Clinical Investigative Site 2002
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Clinical Investigative Site 2101
City
Gallarte
ZIP/Postal Code
21013
Country
Italy
Facility Name
Clinical Investigative Site 2104
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Clinical Investigative Site # 2106
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Clinical Investigative Site 2102
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Clinical Investigative Site 2103
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Clinical Investigative Site 2105
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Clinical Investigative Site 2203
City
Breda
ZIP/Postal Code
4818
Country
Netherlands
Facility Name
Clinical Investigative Site 2202
City
Nijmegen
ZIP/Postal Code
6533
Country
Netherlands
Facility Name
Clinical Investigative Site 2201
City
Sittard-Geleen
ZIP/Postal Code
6162
Country
Netherlands
Facility Name
Clinical Investigative Site 2305
City
Katowice
ZIP/Postal Code
47-752
Country
Poland
Facility Name
Clinical Investigative Site 2303
City
Poznan
ZIP/Postal Code
60-355
Country
Poland
Facility Name
Clinical Investigative Site 2304
City
Warsaw
ZIP/Postal Code
02-957
Country
Poland
Facility Name
Clinical Investigative Site 2302
City
Wroclaw
ZIP/Postal Code
50-044
Country
Poland
Facility Name
Clinical Investigative Site 2400
City
Bucuresti
ZIP/Postal Code
022903
Country
Romania
Facility Name
Clinical Investigative Site 2401
City
Cluj-Napoca
ZIP/Postal Code
428063
Country
Romania
Facility Name
Clinical Investigative Site 2402
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Clinical Investigative Site # 3202
City
Moscow
ZIP/Postal Code
127018
Country
Russian Federation
Facility Name
Clinical Investigative Site # 3203
City
Nizhniy Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Facility Name
Clinical Investigative Site # 3206
City
Pyatigorsk
ZIP/Postal Code
357538
Country
Russian Federation
Facility Name
Clinical Investigative Site # 3201
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
Clinical Investigative Site 3209
City
Saratov
ZIP/Postal Code
410030
Country
Russian Federation
Facility Name
Clinical Investigative Site # 3204
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Clinical Investigative Site 3201
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Clinical Investigative Site 3200
City
St. Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
Facility Name
Clinical Investigative Site 3208
City
Ufa
ZIP/Postal Code
450005
Country
Russian Federation
Facility Name
Clinical Investigative Site 2501
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Investigative Site 2503
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinical Investigative Site 2502
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Clinical Investigative Site 2706
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Clinical Investigative Site 2702
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Clinical Investigative Site 2705
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Clinical Investigative Site 2701
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Clinical Investigative Site 2700
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Clinical Investigative Site 2704
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Clinical Investigative Site 2802
City
Goteburg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Clinical Investigative Site 2800
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Clinical Investigative Site 2801
City
Umed
ZIP/Postal Code
90185
Country
Sweden
Facility Name
Clinical Investigative Site 2901
City
Lugano
ZIP/Postal Code
CH-6900
Country
Switzerland
Facility Name
Clinical Investigative Site 2900
City
St Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland
Facility Name
Clinical Investigative Site 3302
City
Chernihiv
ZIP/Postal Code
14029
Country
Ukraine
Facility Name
Clinical Investigative Site 3303
City
Dnipropetrovsk
ZIP/Postal Code
49044
Country
Ukraine
Facility Name
Clinical Investigative Site 3300
City
Kyiv
ZIP/Postal Code
03110
Country
Ukraine
Facility Name
Clinical Investigative Site 3304
City
Odesa
ZIP/Postal Code
65000
Country
Ukraine
Facility Name
Clinical Investigative Site 3003
City
Bristol
ZIP/Postal Code
BS16 1LE
Country
United Kingdom
Facility Name
Clinical Investigative Site 3004
City
Devon
ZIP/Postal Code
PL6 SBX
Country
United Kingdom
Facility Name
Clinical Investigative Site 3002
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24659797
Citation
Olsson T, Boster A, Fernandez O, Freedman MS, Pozzilli C, Bach D, Berkani O, Mueller MS, Sidorenko T, Radue EW, Melanson M. Oral ponesimod in relapsing-remitting multiple sclerosis: a randomised phase II trial. J Neurol Neurosurg Psychiatry. 2014 Nov;85(11):1198-208. doi: 10.1136/jnnp-2013-307282. Epub 2014 Mar 21.
Results Reference
result
PubMed Identifier
33914286
Citation
Gisleskog PO, Valenzuela B, Scherz T, Burcklen M, Perez-Ruixo JJ, Poggesi I. An Exposure-Response Analysis of the Clinical Efficacy of Ponesimod in a Randomized Phase II Study in Patients with Multiple Sclerosis. Clin Pharmacokinet. 2021 Sep;60(9):1227-1237. doi: 10.1007/s40262-021-01020-2. Epub 2021 Apr 29.
Results Reference
derived
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&parentIdentifier=AC-058B201&attachmentIdentifier=e1d8c0a4-1949-4873-b703-5a8f2bbc4094&fileName=AC-058B201_Additional_result_data_CH.pdf&versionIdentifier=
Description
A dose-finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis

Learn more about this trial

Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis

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