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

March 28, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
464

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Actelion

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2009

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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