Clinical trial NCT01006265: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2009-11-01
Enrollment: 464
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Cumulative Number of New T1 Gadolinium-Enhancing (Gd+) Lesions on Magnetic Resonance Imaging (MRI) Scan From Week 12 to Week 24
timeFrame: From Week 12 to 24
Secondary outcomes:
measure: Annualized Confirmed Relapse Rate
timeFrame: Up to 24 weeks
measure: Number of Participants With First Confirmed Relapse as Assessed by Kaplan-Meier Estimate From Baseline to Week 24
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Clinical Investigative Site 3132
state: Arizona
city: Tucson
country: United States
facility: Clinical Investigative Site 3100
state: Arizona
city: Sacramento
country: United States
facility: Clinical Investigative Site 3115
state: California
city: Stanford
country: United States
facility: Clinical Investigative Site 3117
state: California
city: Sarasota
country: United States
facility: Clinical Invesigative Site 3116
state: Florida
city: Indianapolis
country: United States
facility: Clinical Investigative Site 3101
state: Indiana
city: Kansas City
country: United States
facility: Clinical Investigative Site 3105
state: Kansas
city: Lenexa
country: United States
facility: Clinical Investigative Site 3107
state: Kansas
city: Baltimore
country: United States
facility: Clinical Investigative Site 3118
state: Maryland
city: Worcester
country: United States
facility: Clinical Investigative Site 3133
state: Massachusetts
city: Saint Louis
country: United States
facility: Clinical Investigator 3136
state: Missouri
city: Newark
country: United States
facility: Clinical Investigative Site # 3135
state: New Jersey
city: Latham
country: United States
facility: Clinical Investigative Site 3129
state: New York
city: New York
country: United States
facility: Clinical Investigative Site # 3128
state: New York
city: Schenectady
country: United States
facility: Clinical Investigative Site 3127
state: New York
city: Stony Brook
country: United States
facility: Clinical Investigative Site 3120
state: New York
city: Raleigh
country: United States
facility: Clinical Investigative Site 3119
state: North Carolina
city: Akron
country: United States
facility: Clinical Investigator 3126
state: Ohio
city: Cincinnati
country: United States
facility: Clinical Investigative Site 3113
state: Ohio
city: Columbus
country: United States
facility: Clinical Investigative Site 3130
state: Ohio
city: Portland
country: United States
facility: Clinical Investigator 3104
state: Oregon
city: Philadelphia
country: United States
facility: Clinical Investigative Site 3125
state: Pennsylvania
city: Burlington
country: United States
facility: Clinical Investigative Site 3112
state: Vermont
city: Richmond
country: United States
facility: Clinical Investigative Site 3111
state: Virginia
city: Kirkland
country: United States
facility: Clinical Investigative Site 3102
state: Washington
city: Fitzroy
country: Australia
facility: Clinical Investigative Site # 1001
city: Westmead
country: Australia
facility: Clinical Investigative Site 1000
city: Amstetten
country: Austria
facility: Clinical Investigative Site 1102
city: St Polten
country: Austria
facility: Clinical Investigative Site 1100
city: Vienna
country: Austria
facility: Clinical Investigative Site 1101
city: La Louviere
country: Belgium
facility: Clinical Investigative Site 1201
city: Liege
country: Belgium
facility: Clinical Investigative Site # 1205
city: Ottignies
country: Belgium
facility: Clinical Investigative Site 1204
city: Sijsele-Damme
country: Belgium
facility: Clinical Investigative Site 1203
city: Sofia
country: Bulgaria
facility: Clinical Investigative Site 1302
city: Sofia
country: Bulgaria
facility: Clinical Investigative Site 1301
city: Varna
country: Bulgaria
facility: Clinical Investigative Site 1303
city: Varna
country: Bulgaria
facility: Clinical Investigative Site 1304
city: Burbaby
country: Canada
facility: Clinical Investigative Site 1401
state: British Columbia
city: Burnaby
country: Canada
facility: Clinical Investigative Site # 1401
city: Ottawa
country: Canada
facility: Clinical Investigative Site 1400
city: Brno
country: Czechia
facility: Clinical Investigative Site 1502
city: Jihlava
country: Czechia
facility: Clinical Investigative Site 1506
city: Olomouc
country: Czechia
facility: Clinical Investigative Site 1504
city: Ostrava-Poruba
country: Czechia
facility: Clinical Investigative Site 1501
city: Praha
country: Czechia
facility: Clinical Investigative Site 1500
city: Teplice
country: Czechia
facility: Clinical Investigative Site 1503
city: Helsinki
country: Finland
facility: Clinical Investigative Site 1600
city: Hyvinkaa
country: Finland
facility: Clinical Investigative Site 1601
city: Tampere
country: Finland
facility: Clinical Investigative Site 1603
city: Turku
country: Finland
facility: Clinical Investigative Site 1602
city: Montpellier Cedex
country: France
facility: Clinical Investigative Site 1701
city: Bayreuth
country: Germany
facility: Clinical Investigative Site # 1806
city: Berlin
country: Germany
facility: Clinical Investigative 1807
city: Berlin
country: Germany
facility: Clinical Investigative Site 1803
city: Dusseldorf
country: Germany
facility: Clinical Investigative site 1800
city: Essen
country: Germany
facility: Clinical Investigative Site 1802
city: Homburg/Saar
country: Germany
facility: Clinical Investigative Site 1805
city: Ulm
country: Germany
facility: Clinical Investigative Site 1804
city: Budapest
country: Hungary
facility: Clinical Investigative Site 1905
city: Budapest
country: Hungary
facility: Clinical Investigative Site # 1904
city: Budapest
country: Hungary
facility: Clinical Investigative Site 1908
city: Gyor
country: Hungary
facility: Clinical Investigative Site 1902
city: Petofi
country: Hungary
facility: Clinical Investigative Site 1900
city: Szentpeteri-Kapu
country: Hungary
facility: Clinical Investigative Site 1901
city: Ashkelon
country: Israel
facility: Clinical Investigative Site 2000
city: Tel-Aviv
country: Israel
facility: Clinical Investigative Site 2003
city: Tel-Hashomer
country: Israel
facility: Clinical Investigative Site 2001
city: Zerifin
country: Israel
facility: Clinical Investigative Site 2002
city: Gallarte
country: Italy
facility: Clinical Investigative Site 2101
city: Genova
country: Italy
facility: Clinical Investigative Site 2104
city: Milan
country: Italy
facility: Clinical Investigative Site # 2106
city: Padova
country: Italy
facility: Clinical Investigative Site 2102
city: Roma
country: Italy
facility: Clinical Investigative Site 2103
city: Siena
country: Italy
facility: Clinical Investigative Site 2105
city: Breda
country: Netherlands
facility: Clinical Investigative Site 2203
city: Nijmegen
country: Netherlands
facility: Clinical Investigative Site 2202
city: Sittard-Geleen
country: Netherlands
facility: Clinical Investigative Site 2201
city: Katowice
country: Poland
facility: Clinical Investigative Site 2305
city: Poznan
country: Poland
facility: Clinical Investigative Site 2303
city: Warsaw
country: Poland
facility: Clinical Investigative Site 2304
city: Wroclaw
country: Poland
facility: Clinical Investigative Site 2302
city: Bucuresti
country: Romania
facility: Clinical Investigative Site 2400
city: Cluj-Napoca
country: Romania
facility: Clinical Investigative Site 2401
city: Timisoara
country: Romania
facility: Clinical Investigative Site 2402
city: Moscow
country: Russian Federation
facility: Clinical Investigative Site # 3202
city: Nizhniy Novgorod
country: Russian Federation
facility: Clinical Investigative Site # 3203
city: Pyatigorsk
country: Russian Federation
facility: Clinical Investigative Site # 3206
city: Samara
country: Russian Federation
facility: Clinical Investigative Site # 3201
city: Saratov
country: Russian Federation
facility: Clinical Investigative Site 3209
city: St. Petersburg
country: Russian Federation
facility: Clinical Investigative Site # 3204
city: St. Petersburg
country: Russian Federation
facility: Clinical Investigative Site 3201
city: St. Petersburg
country: Russian Federation
facility: Clinical Investigative Site 3200
city: Ufa
country: Russian Federation
facility: Clinical Investigative Site 3208
city: Belgrade
country: Serbia
facility: Clinical Investigative Site 2501
city: Kragujevac
country: Serbia
facility: Clinical Investigative Site 2503
city: Nis
country: Serbia
facility: Clinical Investigative Site 2502
city: Barcelona
country: Spain
facility: Clinical Investigative Site 2706
city: Madrid
country: Spain
facility: Clinical Investigative Site 2702
city: Madrid
country: Spain
facility: Clinical Investigative Site 2705
city: Malaga
country: Spain
facility: Clinical Investigative Site 2701
city: Sevilla
country: Spain
facility: Clinical Investigative Site 2700
city: Valencia
country: Spain
facility: Clinical Investigative Site 2704
city: Goteburg
country: Sweden
facility: Clinical Investigative Site 2802
city: Stockholm
country: Sweden
facility: Clinical Investigative Site 2800
city: Umed
country: Sweden
facility: Clinical Investigative Site 2801
city: Lugano
country: Switzerland
facility: Clinical Investigative Site 2901
city: St Gallen
country: Switzerland
facility: Clinical Investigative Site 2900
city: Chernihiv
country: Ukraine
facility: Clinical Investigative Site 3302
city: Dnipropetrovsk
country: Ukraine
facility: Clinical Investigative Site 3303
city: Kyiv
country: Ukraine
facility: Clinical Investigative Site 3300
city: Odesa
country: Ukraine
facility: Clinical Investigative Site 3304
city: Bristol
country: United Kingdom
facility: Clinical Investigative Site 3003
city: Devon
country: United Kingdom
facility: Clinical Investigative Site 3004
city: London
country: United Kingdom
facility: Clinical Investigative Site 3002
Study officials:
affiliation: Actelion
name: Actelion Pharmaceuticals
role: STUDY_DIRECTOR
References:
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.
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.