A Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis

NCT01081782 | Completed Phase 2 DMC

• 1 other identifier: ONO-4641POU006
• Study Type: interventional
• Target: 407
• Locations: 11 countries
• Sites: 86

Brief Summary

The objective of this study is to evaluate the safety and efficacy of ONO-4641 in patients with relapsing-remitting multiple sclerosis over a 26-week treatment period.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; ONO-4641

Outcome Measures

Primary Outcomes (1)

• Total number of T-1-weighted Gd-enhanced lesions obtained with MRI at 4-week intervals for 26 weeks.

  26 weeks

Secondary Outcomes (1)

• Total volume of Gd-enhanced lesions

  26 weeks

Study Arms (4)

E1

EXPERIMENTAL

Drug: ONO-4641

E2

EXPERIMENTAL

Drug: ONO-4641

E3

EXPERIMENTAL

Drug: ONO-4641

P

PLACEBO COMPARATOR

Drug: ONO-4641 placebo

Interventions

ONO-4641 DRUG

0.15 mg once per day for 26 weeks

E1

ONO-4641 placebo DRUG

Placebo once per day for 26 weeks

P

Eligibility Criteria

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

You may qualify if:

• Adult male or female aged 18-55 years inclusive at screening
• Patients who have a definite diagnosis of relapsing-remitting Multiple Sclerosis

You may not qualify if:

• Multiple Sclerosis course other than relapsing-remitting multiple sclerosis
• History of malignancy
• History of clinically significant chronic disease of the immune system (other than Multiple Sclerosis)
• Inability to undergo Gd-enhanced MRI scans
• Diagnosis of diabetes mellitus (type I or type II)

Sponsors & Collaborators

• Ono Pharma USA Inc: lead

Study Sites (86)

Tucson Clinical Site 133

Tucson, Arizona, 85741, United States

Location

Aurora Clinical Site 132

Aurora, Colorado, 80045, United States

Location

Fort Collins Clinical Site 123

Fort Collins, Colorado, 80528, United States

Location

Fairfield Clinical Site 110

Fairfield, Connecticut, 06824, United States

Location

Ormond Beach Clinical Site 129

Ormond Beach, Florida, 32174, United States

Location

Sarasota Clinical Site 116

Sarasota, Florida, 34243, United States

Location

Sarasota Clinical Site 117

Sarasota, Florida, 34243, United States

Location

Northbrook Clinical Site 135

Northbrook, Illinois, 60062, United States

Location

Fort Wayne Clinical Site 111

Fort Wayne, Indiana, 46805, United States

Location

Indianapolis Clinical Site 121

Indianapolis, Indiana, 46202, United States

Location

Detroit Clinical Site 104

Detroit, Michigan, 48202, United States

Location

Farmington Hills Clinical Site 126

Farmington Hills, Michigan, 48334, United States

Location

Lebanon Clinical Site 115

Lebanon, New Hampshire, 03756, United States

Location

Albuquerque Clinical Site 106

Albuquerque, New Mexico, 87131, United States

Location

Rochester Clinical Site 108

Rochester, New York, 14642, United States

Location

Charlotte Clinical Site 125

Charlotte, North Carolina, 28204, United States

Location

HighPoint Clinical Site 128

HighPoint, North Carolina, 27265, United States

Location

Raleigh Clinical Site 103

Raleigh, North Carolina, 27607, United States

Location

Akron Clinical Site 112

Akron, Ohio, 44320, United States

Location

Philadelphia Clinical Site 120

Philadelphia, Pennsylvania, 19104, United States

Location

Knoxville Clinical Site 134

Knoxville, Tennessee, 37934, United States

Location

Round Rock Clinical Site 107

Round Rock, Texas, 78681, United States

Location

Seattle Clinical Site 118

Seattle, Washington, 98101, United States

Location

Brugge Clinical Site 203

Bruges, 8000, Belgium

Location

La Louviere Clinical Site 201

La Louvière, 7100, Belgium

Location

Sijsele Clinical Site 202

Sijsele, 8340, Belgium

Location

Gatineau Clinical Site 114

Gatineau, Quebec, Canada

Location

Greenfield Park Clinical Site 109

Greenfield Park, Quebec, J4V2J2, Canada

Location

Vancouver Clinical Site 131

British Columbia, V6T 2B5, Canada

Location

Montreal Clinical Site 113

Québec, H1T 2M4, Canada

Location

Montreal Clinical Site 102

Québec, H9X 3Z9, Canada

Location

Olomouc Clinical Site 212

Olomouc, 775 20, Czechia

Location

Ostrava Clinical Site 214

Ostrava, 702 00, Czechia

Location

Pardubice Clinical Site 211

Pardubice, 532 03, Czechia

Location

Praha 5 Clinical Site 213

Prague, 150 06, Czechia

Location

Berlin Clinical Site 223

Berlin, 13347, Germany

Location

Essen Clinical Site 222

Essen, 45147, Germany

Location

Giessen Clinical Site 221

Giessen, 35385, Germany

Location

Leipzig Clinical Site 229

Leipzig, 04103, Germany

Location

Mainz Clinical Site 231

Mainz, 55101, Germany

Location

Marburg Clinical Site 228

Marburg, 35033, Germany

Location

Munster Clinical Site 225

Münster, 48149, Germany

Location

Tubingen Clinical Site 226

Tübingen, 72076, Germany

Location

Ulm Clinical Site 230

Ulm, 89081, Germany

Location

Athens Clinical Site 243

Athens, 11529, Greece

Location

Thessaloniki Clinical Site 245

Thessaloniki, 57010, Greece

Location

Kanto Region Clinical Site 404

Kanto, Japan

Location

Kanto Region Clinical Site 405

Kanto, Japan

Location

Kanto Region Clinical Site 406

Kanto, Japan

Location

Kanto Region Clinical Site 409

Kanto, Japan

Location

Kinki Region Clinical Site 401

Kinki, Japan

Location

Kinki Region Clinical Site 407

Kinki, Japan

Location

Kinki Region Clinical Site 408

Kinki, Japan

Location

Tohoku Region Clinical Site 403

Tōhoku, Japan

Location

Tohoku Region Clinical Site 410

Tōhoku, Japan

Location

Bialystok Clinical Site 305

Bialystok, 15-402, Poland

Location

Czeladz Clinical Site 303

Czeladź, 41-250, Poland

Location

Gdansk Clinical Site 302

Gdansk, 80-803, Poland

Location

Katowice Clinical Site 309

Katowice, 40-594, Poland

Location

Krakow Clinical Site 307

Krakow, 31-530, Poland

Location

Lodz Clinical Site 306

Lodz, 90-153, Poland

Location

Plewiska Clinical Site 304

Plewiska, 62-064, Poland

Location

Warszawa Clinical Site 308

Warsaw, 04-749, Poland

Location

Chelyabinsk Clinical Site 322

Chelyabinsk, 454136, Russia

Location

Kaluga Clinical Site 328

Kaluga, 428007, Russia

Location

Kazan Clinical Site 333

Kazan', 420103, Russia

Location

Moscow Clinical Site 332

Moscow, 107150, Russia

Location

Nizhniy Novgorod Clinical Site 321

Nizhny Novgorod, 603155, Russia

Location

Novosibirsk Clinical Site 324

Novosibirsk, 630091, Russia

Location

St. Petersburg Clinical Site 325

Saint Petersburg, 428007, Russia

Location

St. Petersburg Clinical Site 327

Saint Petersburg, 428007, Russia

Location

Samara Clinical Site 328

Samara, 443095, Russia

Location

Ufa Clinical Site 326

Ufa, 450005, Russia

Location

Yaroslavl Clinical Site 331

Yaroslavl, 150030, Russia

Location

Barcelona Clinical Site 252

Barcelona, 08025, Spain

Location

Barcelona Clinical Site 253

Barcelona, 08025, Spain

Location

Bilbao Clinical Site 255

Bilbao, 48013, Spain

Location

Girona Clinical Site 254

Girona, 17007, Spain

Location

Hospitalet de Llobregat Clinical Site 251

L'Hospitalet de Llobregat, 08907, Spain

Location

Sevilla Clinical Site 256

Seville, 41071, Spain

Location

Dnipropetrovsk Clinical Site 341

Dnipropetrovsk, 49027, Ukraine

Location

Donetsk Clinical Site 345

Donetsk, 83000-490, Ukraine

Location

Kharkiv Clinical Site 346

Kharkiv, 61068, Ukraine

Location

Kyiv Clinical Site 344

Kyiv, 03110, Ukraine

Location

Lviv Clinical Site 343

Lviv, 79010, Ukraine

Location

Vinnytsya Clinical Site 342

Vinnytsia, 21005, Ukraine

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ceralifimod

Condition Hierarchy (Ancestors)

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

Study Officials

• Ono Pharma USA, Inc.

  Ono Pharmaceutical Co. Ltd

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: March 5, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 25, 2013

Record last verified: 2013-11

Locations

JP (9); CA (5); BE (3); RU (11); UA (6); US (23); DE (9); GR (2); PL (8); ES (6); CZ (4)