Phase 2 Extension Trial in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)

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 \[NCT01081782\]).

Conditions

• Multiple Sclerosis

Interventions

DRUG

ONO-4641

Subjects will be administered with ONO-4641 at a dose of 0.15 milligram (mg) in the core study will be administered with ONO-4641 0.15 mg in this extension study for a duration of 225 weeks.

DRUG

ONO-4641

Subjects will be administered with ONO-4641 at a dose of 0.10 mg in the core study will be administered with ONO-4641 0.10 mg in this extension study for a duration of 225 weeks.

DRUG

ONO-4641

Subjects will be administered with ONO-4641 at a dose of 0.05 mg in the core study will be administered with ONO-4641 0.05 mg in this extension study for a duration of 225 weeks.

DRUG

ONO-4641

Subjects will receive placebo in the core study will be administered with ONO-4641 0.15 mg in this extension study for a duration of 225 weeks.

DRUG

ONO-4641

Subjects will receive placebo in the core study will be administered with ONO-4641 0.10 mg in this extension study for a duration of 225 weeks.

DRUG

ONO-4641

Subjects will receive placebo in the core study will be administered with ONO-4641 0.05 mg in this extension study for a duration of 225 weeks.

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany

  collaborator INDUSTRY

• Ono Pharmaceutical Co. Ltd

  collaborator INDUSTRY

• EMD Serono

  lead INDUSTRY

Principal Investigators

• Medical Responsible · EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany

• Medical Responsible · Ono Pharmaceutical Co. Ltd

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-10-31

Primary Completion

2015-01-31

Completion

2015-01-31

Countries

• United States
• Belgium
• Canada
• Czechia
• Germany
• Greece
• Japan
• Poland
• Russia
• Spain
• Ukraine

Study Locations