Clinical trial NCT01226745: Phase 2 Extension Trial in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)
Official title: A Safety and Efficacy Extension Study of ONO-4641 (MSC2430913A) in Patients With Relapsing-Remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
ONO-4641
MSC2430913A
Efficacy
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
name: Ono Pharmaceutical Co. Ltd
First posted: 2010-10-22
Enrollment: 340
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: The objective of this active-drug Extension Study is to evaluate the continuing safety and efficacy of ONO-4641 (MSC2430913A) in subjects with relapsing-remitting multiple sclerosis (RRMS) who have completed an initial 26-week Core Study (ONO-4641POU006 \[NCT01081782\]).


Eligibility criteria: Inclusion Criteria:

* Completed 26 weeks of double-blind phase of Study ONO-4641POU006

Exclusion Criteria:

* Presence of any dermatological abnormalities during Study ONO-4641POU006 that could increase the risk of the patient developing a skin cancer

Primary outcomes:
measure: Number of Subjects With Clinically Significant Abnormal Vital Signs
timeFrame: Baseline up to Week 255
measure: Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent (%) Predicted Value)
timeFrame: Baseline, Week 40, 52, 76, 100, 124, 148, early termination, Week 152, 200, early termination 2, Week 255
measure: Change From Baseline in Forced Vital Capacity (FVC)
timeFrame: Baseline, Week 40, 52, 76, 100, 124, 148, early termination, Week 152, 200, early termination 2, Week 255
measure: Change From Baseline in Diffusing Capacity of Lung for Carbon Monoxide (DLCO)
timeFrame: Baseline, Week 40, 52, early termination, Week 152, 200, 255
measure: Number of Subjects With Clinically Significant Abnormal Electrocardiogram (ECG) Measures
timeFrame: Baseline up to Week 255
measure: Number of Subjects With Clinically Significant Abnormal Ophthalmologic Examination
timeFrame: Baseline up to Week 255
measure: Number of Subjects With Clinically Significant Abnormalities in Dermatological Examination
timeFrame: Baseline up to end of the treatment, assessed up to Week 255
measure: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Discontinuation
timeFrame: From the first dose of study drug administration up to 35 days after the last dose of study drug administration, assessed up to 5 years
Secondary outcomes:
measure: Number of Gadolinium (Gd)-Enhanced Lesions
timeFrame: Baseline, Week 40, 52, 100, 148, early termination, Week 152, 200, early termination 2, Week 255 and end of treatment (5 years)
measure: Change From Baseline in Lesion Volume at the End of the Treatment (EoT)
timeFrame: Baseline, End of treatment (5 years)
measure: Percent Brain Volume Change (PBVC) From Baseline at the End of Treatment
timeFrame: Baseline and at end of treatment (Week 255)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tucson Clinical Site 133
state: Arizona
city: Aurora
country: United States
facility: Aurora Clinical Site 132
state: Colorado
city: Fort Collins
country: United States
facility: Fort Collins Clinical Site 123
state: Colorado
city: Fairfield
country: United States
facility: Fairfield Clinical Site 110
state: Connecticut
city: Ormond Beach
country: United States
facility: Ormond Beach Clinical Site 129
state: Florida
city: Sarasota
country: United States
facility: Sarasota Clinical Site 116
state: Florida
city: Northbrook
country: United States
facility: Northbrook Clinical Site 135
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Clinical Site 111
state: Indiana
city: Indianapolis
country: United States
facility: Indianapolis Clinical Site 121
state: Indiana
city: Detroit
country: United States
facility: Detroit Clinical Site 104
state: Michigan
city: Farmington Hills
country: United States
facility: Farmington Hills Clinical Site 126
state: Michigan
city: Lebanon
country: United States
facility: Lebanon Clinical Site 115
state: New Hampshire
city: Albuquerque
country: United States
facility: Albuquerque Clinical Site 106
state: New Mexico
city: Rochester
country: United States
facility: Rochester Clinical Site 108
state: New York
city: Charlotte
country: United States
facility: Charlotte Clinical Site 125
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Clinical Site 103
state: North Carolina
city: Akron
country: United States
facility: Akron Clinical Site 112
state: Ohio
city: Philadelphia
country: United States
facility: Philadelphia Clinical Site 120
state: Pennsylvania
city: Knoxville
country: United States
facility: Knoxville Clinical Site 134
state: Tennessee
city: Round Rock
country: United States
facility: Round Rock Clinical Site 107
state: Texas
city: Brugge
country: Belgium
facility: Brugge Clinical Site 203
city: La Louviere
country: Belgium
facility: La Louviere Clinical Site 201
city: Vancouver
country: Canada
facility: Vancouver Clinical Site 131
state: British Columbia
city: Gatineau
country: Canada
facility: Gatineau Clinical Site 114
state: Quebec
city: Greenfield Park
country: Canada
facility: Greenfield park Clinical Site 109
state: Quebec
city: Montreal
country: Canada
facility: Montreal Clinical Site 101
state: Quebec
city: Montreal
country: Canada
facility: Montreal Clinical Site 102
city: Olomouc
country: Czech Republic
facility: Olomouc Clinical Site 212
city: Pardubice
country: Czech Republic
facility: Pardubice Clinical Site 211
city: Praha 5
country: Czech Republic
facility: Praha 5 Clinical Site 213
city: Glessen
country: Germany
facility: Glessen Clinical Site 221
city: Leipzig
country: Germany
facility: Leipzig Clinical Site 229
city: Marburg
country: Germany
facility: Marburg Clinical Site 228
city: Tubingen
country: Germany
facility: Tubingen Clinical Site 226
city: Athens
country: Greece
facility: Athens Clinical Site 243
city: Kanto
country: Japan
facility: Kanto Region Clinical Site 404
city: Kanto
country: Japan
facility: Kanto Region Clinical Site 405
city: Kanto
country: Japan
facility: Kanto Region Clinical Site 406
city: Kanto
country: Japan
facility: Kanto Region Clinical Site 409
city: Kinki
country: Japan
facility: Kinki Region Clinical Site 401
city: Kinki
country: Japan
facility: Kinki Region Clinical Site 407
city: Kinki
country: Japan
facility: Kinki Region Clinical Site 408
city: Tohoku
country: Japan
facility: Tohoku Region Clinical Site 403
city: Tohoku
country: Japan
facility: Tohoku Region Clinical Site 410
city: Bialystok
country: Poland
facility: Bialystok Clinical Site 305
city: Czeladz
country: Poland
facility: Czeladz Clinical Site 303
city: Gdansk
country: Poland
facility: Gdansk Clinical Site 302
city: Katowice
country: Poland
facility: Katowice Clinical Site 309
city: Krakow
country: Poland
facility: Krakow Clinical Site 307
city: Lodz
country: Poland
facility: Lodz Clinical Site 306
city: Plewiska
country: Poland
facility: Plewiska Clinical Site 304
city: Warszawa
country: Poland
facility: Warszawa Clinical Site 308
city: Kazan
country: Russian Federation
facility: Kazan Clinical Site 333
city: Moscow
country: Russian Federation
facility: Moscow Clinical Site 332
city: Moscow
country: Russian Federation
facility: Moscow Clinical Site 330
city: Nizhniy Novgorod
country: Russian Federation
facility: Nizhniy Novgorod Clinical Site 321
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Clinical Site 324
city: Samara
country: Russian Federation
facility: Samara Clinical Site 329
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Clinical Site 325
city: Ufa
country: Russian Federation
facility: Ufa Clinical Site 326
city: Barcelona
country: Spain
facility: Barcelona Clinical Site 252
city: Barcelona
country: Spain
facility: Barcelona Clinical Site 253
city: Bilbao
country: Spain
facility: Bilbao Clinical Site 255
city: Girona
country: Spain
facility: Girona Clinical Site 254
city: Hospitalet de Llobregat
country: Spain
facility: Hospitalet de Llobregat Clinical Site 251
city: Sevilla
country: Spain
facility: Sevilla Clinical Site 256
city: Dnipropetrovsk
country: Ukraine
facility: Dnipropetrovsk Clinical Site 341
city: Kyiv
country: Ukraine
facility: Kyiv Clinical Site 344
city: Lviv
country: Ukraine
facility: Lviv Clinical Site 343
city: Vinnytsya
country: Ukraine
facility: Vinnytsya Clinical Site 342
Study officials:
affiliation: EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
affiliation: Ono Pharmaceutical Co. Ltd
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: Effect of Ceralifimod (ONO-4641), a Sphingosine-1-Phosphate Receptor-1 and -5 Agonist, on Magnetic Resonance Imaging Outcomes in Patients with Multiple Sclerosis: Interim Results from the Extension of the DreaMS Study (P3.161) Amit Bar-Or, Frauke Zipp, Matthew Scaramozza, Timothy Vollmer, Bryan Due, Karthinathan Thangavelu, Tanya Fischer, and Krzysztof Selmaj April 8, 2014 82:10 Supplement P3.161; 1526-632X