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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01006265




Registration number
NCT01006265
Ethics application status
Date submitted
30/10/2009
Date registered
1/11/2009
Date last updated
7/02/2022

Titles & IDs
Public title
Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis
Scientific 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
Secondary ID [1] 0 0
AC-058B201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ACT-128800 Dose 1
Treatment: Drugs - Placebo
Treatment: Drugs - ACT-128800 Dose 2
Treatment: Drugs - ACT-128800 Dose 3

Experimental: ACT-128800 Dose 1 - ACT-128800 Dose 1

Experimental: ACT-128800 Dose 2 - ACT-128800 Dose 2

Experimental: ACT-128800 Dose 3 - ACT-128800 Dose 3

Placebo comparator: Placebo - Matching placebo


Treatment: Drugs: ACT-128800 Dose 1
ACT-128800 (Dose 1) administered orally once daily

Treatment: Drugs: Placebo
Matching placebo administered orally once daily

Treatment: Drugs: ACT-128800 Dose 2
ACT-128800 (Dose 2) administered orally once daily

Treatment: Drugs: ACT-128800 Dose 3
ACT-128800 (Dose 3) administered orally once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cumulative Number of New T1 Gadolinium-Enhancing (Gd+) Lesions on Magnetic Resonance Imaging (MRI) Scan From Week 12 to Week 24
Timepoint [1] 0 0
From Week 12 to 24
Secondary outcome [1] 0 0
Annualized Confirmed Relapse Rate
Timepoint [1] 0 0
Up to 24 weeks
Secondary outcome [2] 0 0
Number of Participants With First Confirmed Relapse as Assessed by Kaplan-Meier Estimate From Baseline to Week 24
Timepoint [2] 0 0
Baseline to Week 24

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2011
Sample size
Target
Accrual to date
Final
464
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Clinical Investigative Site # 1001 - Fitzroy
Recruitment hospital [2] 0 0
Clinical Investigative Site 1000 - Westmead
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment outside Australia
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United States of America
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Arizona
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California
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Vermont
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Virginia
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Washington
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Austria
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Amstetten
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St Polten
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Vienna
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Belgium
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La Louviere
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Belgium
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Liege
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Belgium
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Ottignies
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Sofia
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Varna
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Ottawa
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Brno
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Ulm
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Gyor
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Bucuresti
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Timisoara
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Belgrade
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Serbia
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Nis
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Barcelona
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Sevilla
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Valencia
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Sweden
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Goteburg
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Stockholm
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Umed
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Switzerland
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Lugano
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Ukraine
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Chernihiv
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Dnipropetrovsk
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Ukraine
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Kyiv
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Ukraine
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Odesa
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United Kingdom
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Bristol
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Devon
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Actelion
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.
Trial website
https://clinicaltrials.gov/study/NCT01006265
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Actelion Pharmaceuticals
Address 0 0
Actelion
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01006265