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

NCT01006265 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: AC-058B201
• Study Type: interventional
• Target: 464
• Locations: 21 countries
• Sites: 110

Brief Summary

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

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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.

  From Week 12 to 24

Secondary Outcomes (2)

• Annualized Confirmed Relapse Rate

  Up to 24 weeks

• Number of Participants With First Confirmed Relapse as Assessed by Kaplan-Meier Estimate From Baseline to Week 24

  Baseline to Week 24

Study Arms (4)

ACT-128800 Dose 1

EXPERIMENTAL

ACT-128800 Dose 1

Drug: ACT-128800 Dose 1

ACT-128800 Dose 2

EXPERIMENTAL

ACT-128800 Dose 2

Drug: ACT-128800 Dose 2

ACT-128800 Dose 3

EXPERIMENTAL

ACT-128800 Dose 3

Drug: ACT-128800 Dose 3

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

ACT-128800 Dose 1 DRUG

ACT-128800 (Dose 1) administered orally once daily

ACT-128800 Dose 1

Placebo DRUG

Matching placebo administered orally once daily

Placebo

ACT-128800 Dose 2 DRUG

ACT-128800 (Dose 2) administered orally once daily

ACT-128800 Dose 2

ACT-128800 Dose 3 DRUG

ACT-128800 (Dose 3) administered orally once daily

ACT-128800 Dose 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Actelion: lead

Study Sites (115)

Clinical Investigative Site 3132

Scottsdale, Arizona, 85259, United States

Location

Clinical Investigative Site 3100

Tucson, Arizona, 85741, United States

Location

Clinical Investigative Site 3115

Sacramento, California, 95817, United States

Location

Clinical Investigative Site 3117

Stanford, California, 94305, United States

Location

Clinical Invesigative Site 3116

Sarasota, Florida, 34233, United States

Location

Clinical Investigative Site 3101

Indianapolis, Indiana, 46202, United States

Location

Clinical Investigative Site 3105

Kansas City, Kansas, 66160, United States

Location

Clinical Investigative Site 3107

Lenexa, Kansas, 66214, United States

Location

Clinical Investigative Site 3118

Baltimore, Maryland, 21201, United States

Location

Clinical Investigative Site 3133

Worcester, Massachusetts, 01605, United States

Location

Clinical Investigator 3136

St Louis, Missouri, 63100, United States

Location

Clinical Investigative Site # 3135

Newark, New Jersey, 07103, United States

Location

Clinical Investigative Site 3129

Latham, New York, 12110, United States

Location

Clinical Investigative Site # 3128

New York, New York, 10032, United States

Location

Clinical Investigative Site 3127

Schenectady, New York, 12308, United States

Location

Clinical Investigative Site 3120

Stony Brook, New York, 11794, United States

Location

Clinical Investigative Site 3119

Raleigh, North Carolina, 27607, United States

Location

Clinical Investigator 3126

Akron, Ohio, 44320, United States

Location

Clinical Investigative Site 3113

Cincinnati, Ohio, 45219, United States

Location

Clinical Investigative Site 3130

Columbus, Ohio, 43221, United States

Location

Clinical Investigator 3104

Portland, Oregon, 97225, United States

Location

Clinical Investigative Site 3125

Philadelphia, Pennsylvania, 19107, United States

Location

Clinical Investigative Site 3112

Burlington, Vermont, 05401, United States

Location

Clinical Investigative Site 3111

Richmond, Virginia, 23298, United States

Location

Clinical Investigative Site 3102

Kirkland, Washington, 98034, United States

Location

Clinical Investigative Site # 1001

Fitzroy, 3065, Australia

Location

Clinical Investigative Site 1000

Westmead, 2145, Australia

Location

Clinical Investigative Site 1102

Amstetten, 3300, Austria

Location

Clinical Investigative Site 1100

Sankt Pölten, 3100, Austria

Location

Clinical Investigative Site 1101

Vienna, 1090, Austria

Location

Clinical Investigative Site 1201

La Louvière, 7100, Belgium

Location

Clinical Investigative Site # 1205

Liège, 4000, Belgium

Location

Clinical Investigative Site 1204

Ottignies, 1340, Belgium

Location

Clinical Investigative Site 1203

Sijsele-Damme, 8340, Belgium

Location

Clinical Investigative Site 1302

Sofia, 1309, Bulgaria

Location

Clinical Investigative Site 1301

Sofia, 1431, Bulgaria

Location

Clinical Investigative Site 1303

Varna, 9010, Bulgaria

Location

Clinical Investigative Site 1304

Varna, 9010, Bulgaria

Location

Clinical Investigative Site 1401

Burbaby, British Columbia, V5G 2X6, Canada

Location

Clinical Investigative Site # 1401

Burnaby, V5G 2X6, Canada

Location

Clinical Investigative Site 1400

Ottawa, K1H 8L6, Canada

Location

Clinical Investigative Site 1502

Brno, 656 91, Czechia

Location

Clinical Investigative Site 1506

Jihlava, 586 33, Czechia

Location

Clinical Investigative Site 1504

Olomouc, 775 20, Czechia

Location

Clinical Investigative Site 1501

Ostrava-Poruba, 70852, Czechia

Location

Clinical Investigative Site 1500

Prague, 128 08, Czechia

Location

Clinical Investigative Site 1503

Teplice, Czechia

Location

Clinical Investigative Site 1600

Helsinki, 00100, Finland

Location

Clinical Investigative Site 1601

Hyvinkää, 05800, Finland

Location

Clinical Investigative Site 1603

Tampere, 33520, Finland

Location

Clinical Investigative Site 1602

Turku, 20100, Finland

Location

Clinical Investigative Site 1701

Montpellier, 34295, France

Location

Clinical Investigative Site # 1806

Bayreuth, 95445, Germany

Location

Clinical Investigative 1807

Berlin, 10117, Germany

Location

Clinical Investigative Site 1803

Berlin, 13347, Germany

Location

Clinical Investigative site 1800

Düsseldorf, 40225, Germany

Location

Clinical Investigative Site 1802

Essen, 45147, Germany

Location

Clinical Investigative Site 1805

Homburg/Saar, 66421, Germany

Location

Clinical Investigative Site 1804

Ulm, 89081, Germany

Location

Clinical Investigative Site 1905

Budapest, 1134, Hungary

Location

Clinical Investigative Site # 1904

Budapest, H-1115, Hungary

Location

Clinical Investigative Site 1908

Budapest, H-1145, Hungary

Location

Clinical Investigative Site 1902

Győr, 11-9024, Hungary

Location

Clinical Investigative Site 1900

Petofi, 2500, Hungary

Location

Clinical Investigative Site 1901

Szentpeteri-Kapu, 3526, Hungary

Location

Clinical Investigative Site 2000

Ashkelon, 78278, Israel

Location

Clinical Investigative Site 2003

Tel Aviv, 64239, Israel

Location

Clinical Investigative Site 2001

Tel Litwinsky, 52621, Israel

Location

Clinical Investigative Site 2002

Ẕerifin, 70300, Israel

Location

Clinical Investigative Site 2101

Gallarte, 21013, Italy

Location

Clinical Investigative Site 2104

Genova, 16132, Italy

Location

Clinical Investigative Site # 2106

Milan, 20132, Italy

Location

Clinical Investigative Site 2102

Padua, 35128, Italy

Location

Clinical Investigative Site 2103

Roma, 00189, Italy

Location

Clinical Investigative Site 2105

Siena, 53100, Italy

Location

Clinical Investigative Site 2203

Breda, 4818, Netherlands

Location

Clinical Investigative Site 2202

Nijmegen, 6533, Netherlands

Location

Clinical Investigative Site 2201

Sittard-Geleen, 6162, Netherlands

Location

Clinical Investigative Site 2305

Katowice, 47-752, Poland

Location

Clinical Investigative Site 2303

Poznan, 60-355, Poland

Location

Clinical Investigative Site 2304

Warsaw, 02-957, Poland

Location

Clinical Investigative Site 2302

Wroclaw, 50-044, Poland

Location

Clinical Investigative Site 2400

Bucharest, 022903, Romania

Location

Clinical Investigative Site 2401

Cluj-Napoca, 428063, Romania

Location

Clinical Investigative Site 2402

Timișoara, 300736, Romania

Location

Clinical Investigative Site # 3202

Moscow, 127018, Russia

Location

Clinical Investigative Site # 3203

Nizhny Novgorod, 603155, Russia

Location

Clinical Investigative Site # 3206

Pyatigorsk, 357538, Russia

Location

Clinical Investigative Site # 3204

Saint Petersburg, 194354, Russia

Location

Clinical Investigative Site 3201

Saint Petersburg, 197022, Russia

Location

Clinical Investigative Site 3200

Saint Petersburg, 197376, Russia

Location

Clinical Investigative Site # 3201

Samara, 443095, Russia

Location

Clinical Investigative Site 3209

Saratov, 410030, Russia

Location

Clinical Investigative Site 3208

Ufa, 450005, Russia

Location

Clinical Investigative Site 2501

Belgrade, 11000, Serbia

Location

Clinical Investigative Site 2503

Kragujevac, 34000, Serbia

Location

Clinical Investigative Site 2502

Niš, 18000, Serbia

Location

Clinical Investigative Site 2706

Barcelona, 08035, Spain

Location

Clinical Investigative Site 2702

Madrid, 28040, Spain

Location

Clinical Investigative Site 2705

Madrid, 28222, Spain

Location

Clinical Investigative Site 2701

Málaga, 29010, Spain

Location

Clinical Investigative Site 2700

Seville, 41009, Spain

Location

Clinical Investigative Site 2704

Valencia, 46009, Spain

Location

Clinical Investigative Site 2802

Gothenburg, 41345, Sweden

Location

Clinical Investigative Site 2800

Stockholm, 17176, Sweden

Location

Clinical Investigative Site 2801

Umed, 90185, Sweden

Location

Clinical Investigative Site 2901

Lugano, CH-6900, Switzerland

Location

Clinical Investigative Site 2900

Sankt Gallen, CH-9007, Switzerland

Location

Clinical Investigative Site 3302

Chernihiv, 14029, Ukraine

Location

Clinical Investigative Site 3303

Dnipropetrovsk, 49044, Ukraine

Location

Clinical Investigative Site 3300

Kyiv, 03110, Ukraine

Location

Clinical Investigative Site 3304

Odesa, 65000, Ukraine

Location

Clinical Investigative Site 3003

Bristol, BS16 1LE, United Kingdom

Location

Clinical Investigative Site 3004

Devon, PL6 SBX, United Kingdom

Location

Clinical Investigative Site 3002

London, SE5 9RS, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 24659797 RESULT

• 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.

  PMID: 33914286 DERIVED

Related Links

• 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

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

No limitation was identified for this study.

Results Point of Contact

• Title: Clinical Leader
• Organization: Actelion Pharmaceuticals Ltd.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Actelion Pharmaceuticals

  Actelion

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2009
• First Posted: November 2, 2009
• Study Start: October 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: March 30, 2025
• Results First Posted: June 11, 2021

Record last verified: 2025-03

Locations

CZ (6); IT (6); PL (4); RU (9); BU (4); SE (3); AU (3); DE (7); CA (3); CH (2); NL (3); FR (1); BE (4); GB (3); US (25); FI (4); RO (3); IL (4); ES (6); HU (6); UA (4)