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

February 4, 2022 updated by: Actelion

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

464

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Fitzroy, Australia, 3065
        • Clinical Investigative Site # 1001
      • Westmead, Australia, 2145
        • Clinical Investigative Site 1000
  • Austria
      • Amstetten, Austria, 3300
        • Clinical Investigative Site 1102
      • St Polten, Austria, 3100
        • Clinical Investigative Site 1100
      • Vienna, Austria, 1090
        • Clinical Investigative Site 1101
  • Belgium
      • La Louviere, Belgium, 7100
        • Clinical Investigative Site 1201
      • Liege, Belgium, 4000
        • Clinical Investigative Site # 1205
      • Ottignies, Belgium, 1340
        • Clinical Investigative Site 1204
      • Sijsele-Damme, Belgium, 8340
        • Clinical Investigative Site 1203
  • Bulgaria
      • Sofia, Bulgaria, 1309
        • Clinical Investigative Site 1302
      • Sofia, Bulgaria, 1431
        • Clinical Investigative Site 1301
      • Varna, Bulgaria, 9010
        • Clinical Investigative Site 1303
      • Varna, Bulgaria, 9010
        • Clinical Investigative Site 1304
  • Canada
      • Burnaby, Canada, V5G 2X6
        • Clinical Investigative Site # 1401
      • Ottawa, Canada, K1H 8L6
        • Clinical Investigative Site 1400
    • British Columbia
      • Burbaby, British Columbia, Canada, V5G 2X6
        • Clinical Investigative Site 1401
  • Czechia
      • Brno, Czechia, 656 91
        • Clinical Investigative Site 1502
      • Jihlava, Czechia, 586 33
        • Clinical Investigative Site 1506
      • Olomouc, Czechia, 775 20
        • Clinical Investigative Site 1504
      • Ostrava-Poruba, Czechia, 70852
        • Clinical Investigative Site 1501
      • Praha, Czechia, 128 08
        • Clinical Investigative Site 1500
      • Teplice, Czechia
        • Clinical Investigative Site 1503
  • Finland
      • Helsinki, Finland, 00100
        • Clinical Investigative Site 1600
      • Hyvinkaa, Finland, 05800
        • Clinical Investigative Site 1601
      • Tampere, Finland, 33520
        • Clinical Investigative Site 1603
      • Turku, Finland, 20100
        • Clinical Investigative Site 1602
  • France
      • Montpellier Cedex, France, 34295
        • Clinical Investigative Site 1701
  • Germany
      • Bayreuth, Germany, 95445
        • Clinical Investigative Site # 1806
      • Berlin, Germany, 10117
        • Clinical Investigative 1807
      • Berlin, Germany, 13347
        • Clinical Investigative Site 1803
      • Dusseldorf, Germany, 40225
        • Clinical Investigative site 1800
      • Essen, Germany, 45147
        • Clinical Investigative Site 1802
      • Homburg/Saar, Germany, 66421
        • Clinical Investigative Site 1805
      • Ulm, Germany, 89081
        • Clinical Investigative Site 1804
  • Hungary
      • Budapest, Hungary, 1134
        • Clinical Investigative Site 1905
      • Budapest, Hungary, H-1115
        • Clinical Investigative Site # 1904
      • Budapest, Hungary, H-1145
        • Clinical Investigative Site 1908
      • Gyor, Hungary, 11-9024
        • Clinical Investigative Site 1902
      • Petofi, Hungary, 2500
        • Clinical Investigative Site 1900
      • Szentpeteri-Kapu, Hungary, 3526
        • Clinical Investigative Site 1901
  • Israel
      • Ashkelon, Israel, 78278
        • Clinical Investigative Site 2000
      • Tel-Aviv, Israel, 64239
        • Clinical Investigative Site 2003
      • Tel-Hashomer, Israel, 52621
        • Clinical Investigative Site 2001
      • Zerifin, Israel, 70300
        • Clinical Investigative Site 2002
  • Italy
      • Gallarte, Italy, 21013
        • Clinical Investigative Site 2101
      • Genova, Italy, 16132
        • Clinical Investigative Site 2104
      • Milan, Italy, 20132
        • Clinical Investigative Site # 2106
      • Padova, Italy, 35128
        • Clinical Investigative Site 2102
      • Roma, Italy, 00189
        • Clinical Investigative Site 2103
      • Siena, Italy, 53100
        • Clinical Investigative Site 2105
  • Netherlands
      • Breda, Netherlands, 4818
        • Clinical Investigative Site 2203
      • Nijmegen, Netherlands, 6533
        • Clinical Investigative Site 2202
      • Sittard-Geleen, Netherlands, 6162
        • Clinical Investigative Site 2201
  • Poland
      • Katowice, Poland, 47-752
        • Clinical Investigative Site 2305
      • Poznan, Poland, 60-355
        • Clinical Investigative Site 2303
      • Warsaw, Poland, 02-957
        • Clinical Investigative Site 2304
      • Wroclaw, Poland, 50-044
        • Clinical Investigative Site 2302
  • Romania
      • Bucuresti, Romania, 022903
        • Clinical Investigative Site 2400
      • Cluj-Napoca, Romania, 428063
        • Clinical Investigative Site 2401
      • Timisoara, Romania, 300736
        • Clinical Investigative Site 2402
  • Russian Federation
      • Moscow, Russian Federation, 127018
        • Clinical Investigative Site # 3202
      • Nizhniy Novgorod, Russian Federation, 603155
        • Clinical Investigative Site # 3203
      • Pyatigorsk, Russian Federation, 357538
        • Clinical Investigative Site # 3206
      • Samara, Russian Federation, 443095
        • Clinical Investigative Site # 3201
      • Saratov, Russian Federation, 410030
        • Clinical Investigative Site 3209
      • St. Petersburg, Russian Federation, 194354
        • Clinical Investigative Site # 3204
      • St. Petersburg, Russian Federation, 197022
        • Clinical Investigative Site 3201
      • St. Petersburg, Russian Federation, 197376
        • Clinical Investigative Site 3200
      • Ufa, Russian Federation, 450005
        • Clinical Investigative Site 3208
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Investigative Site 2501
      • Kragujevac, Serbia, 34000
        • Clinical Investigative Site 2503
      • Nis, Serbia, 18000
        • Clinical Investigative Site 2502
  • Spain
      • Barcelona, Spain, 08035
        • Clinical Investigative Site 2706
      • Madrid, Spain, 28040
        • Clinical Investigative Site 2702
      • Madrid, Spain, 28222
        • Clinical Investigative Site 2705
      • Malaga, Spain, 29010
        • Clinical Investigative Site 2701
      • Sevilla, Spain, 41009
        • Clinical Investigative Site 2700
      • Valencia, Spain, 46009
        • Clinical Investigative Site 2704
  • Sweden
      • Goteburg, Sweden, 41345
        • Clinical Investigative Site 2802
      • Stockholm, Sweden, 17176
        • Clinical Investigative Site 2800
      • Umed, Sweden, 90185
        • Clinical Investigative Site 2801
  • Switzerland
      • Lugano, Switzerland, CH-6900
        • Clinical Investigative Site 2901
      • St Gallen, Switzerland, CH-9007
        • Clinical Investigative Site 2900
  • Ukraine
      • Chernihiv, Ukraine, 14029
        • Clinical Investigative Site 3302
      • Dnipropetrovsk, Ukraine, 49044
        • Clinical Investigative Site 3303
      • Kyiv, Ukraine, 03110
        • Clinical Investigative Site 3300
      • Odesa, Ukraine, 65000
        • Clinical Investigative Site 3304
  • United Kingdom
      • Bristol, United Kingdom, BS16 1LE
        • Clinical Investigative Site 3003
      • Devon, United Kingdom, PL6 SBX
        • Clinical Investigative Site 3004
      • London, United Kingdom, SE5 9RS
        • Clinical Investigative Site 3002
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Clinical Investigative Site 3132
      • Tucson, Arizona, United States, 85741
        • Clinical Investigative Site 3100
    • California
      • Sacramento, California, United States, 95817
        • Clinical Investigative Site 3115
      • Stanford, California, United States, 94305
        • Clinical Investigative Site 3117
    • Florida
      • Sarasota, Florida, United States, 34233
        • Clinical Invesigative Site 3116
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Clinical Investigative Site 3101
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Clinical Investigative Site 3105
      • Lenexa, Kansas, United States, 66214
        • Clinical Investigative Site 3107
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Clinical Investigative Site 3118
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Clinical Investigative Site 3133
    • Missouri
      • Saint Louis, Missouri, United States, 63100
        • Clinical Investigator 3136
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Clinical Investigative Site # 3135
    • New York
      • Latham, New York, United States, 12110
        • Clinical Investigative Site 3129
      • New York, New York, United States, 10032
        • Clinical Investigative Site # 3128
      • Schenectady, New York, United States, 12308
        • Clinical Investigative Site 3127
      • Stony Brook, New York, United States, 11794
        • Clinical Investigative Site 3120
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Clinical Investigative Site 3119
    • Ohio
      • Akron, Ohio, United States, 44320
        • Clinical Investigator 3126
      • Cincinnati, Ohio, United States, 45219
        • Clinical Investigative Site 3113
      • Columbus, Ohio, United States, 43221
        • Clinical Investigative Site 3130
    • Oregon
      • Portland, Oregon, United States, 97225
        • Clinical Investigator 3104
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Clinical Investigative Site 3125
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Clinical Investigative Site 3112
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Clinical Investigative Site 3111
    • Washington
      • Kirkland, Washington, United States, 98034
        • Clinical Investigative Site 3102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
Matching placebo administered orally once daily
Experimental: ACT-128800 Dose 1
Drug: ACT-128800 Dose 1
ACT-128800 (Dose 1) administered orally once daily
Experimental: ACT-128800 Dose 2
Drug: ACT-128800 Dose 2
ACT-128800 (Dose 2) administered orally once daily
Experimental: ACT-128800 Dose 3
Drug: ACT-128800 Dose 3
ACT-128800 (Dose 3) administered orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Number of New T1 Gadolinium-Enhancing (Gd+) Lesions on Magnetic Resonance Imaging (MRI) Scan From Week 12 to Week 24
Time Frame: From Week 12 to 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.
From Week 12 to 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized Confirmed Relapse Rate
Time Frame: Up to 24 weeks
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)
Up to 24 weeks
Number of Participants With First Confirmed Relapse as Assessed by Kaplan-Meier Estimate From Baseline to Week 24
Time Frame: 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.
Baseline to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Actelion

Investigators

  • Study Director: Actelion Pharmaceuticals, Actelion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

October 30, 2009

First Submitted That Met QC Criteria

October 30, 2009

First Posted (Estimate)

November 1, 2009

Study Record Updates

Last Update Posted (Actual)

February 7, 2022

Last Update Submitted That Met QC Criteria

February 4, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-058B201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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