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Monoclonal Antibodies

A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab Administration

Phase 3

Waitlist Available

Research Sponsored by Biogen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up part 2: baseline (week 108) up to week 180

Awards & highlights

All Individual Drugs Already Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial is evaluating the efficacy of natalizumab extended interval dosing (EID) in participants who have previously been treated with natalizumab standard interval dosing (SID) for at least 12 months, in relation to continued SID treatment. The trial will also evaluate relapse-based clinical efficacy measures, disability worsening, additional Magnetic resonance imaging (MRI)-lesion efficacy measures and safety of EID in participants who have previously been treated with natalizumab SID for at least 12 months, in relation to continued SID treatment.

Eligible Conditions

Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ part 2: baseline (week 108) up to week 180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~part 2: baseline (week 108) up to week 180

This trial's timeline: 3 weeks for screening, Varies for treatment, and part 2: baseline (week 108) up to week 180 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1: Mean Number of New or Newly Enlarging T2 Hyperintense Lesions at Week 72

Secondary study objectives

Part 1: Annualized Relapse Rate at Week 72

Part 1: Mean Number of New Gadolinium (Gd) Enhancing Lesions at Weeks 24, 48, and 72

Part 1: Mean Number of New T1 Hypointense Lesions at Weeks 24, 48, and 72

+12 more

Side effects data

From 2011 Phase 4 trial • 19 Patients • NCT01144052

44%

Injection site reaction

33%

Infection

100%

80%

60%

40%

20%

Study treatment Arm

Interferon-beta-1b

Natalizumab

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Part 2: Run-in Period: IV Q6WExperimental Treatment1 Intervention

Participants who completed Part 1 or were newly enrolled in Part 2 received natalizumab 300 mg IV infusion Q6W from Week 72 through Week 102.

Group II: Part 2: Crossover Period: SC Q6W, then IV Q6WExperimental Treatment1 Intervention

Participants who completed run-in period of Part 2 were randomized to receive natalizumab 300 mg SC injection Q6W from Week 108 through Week 126 followed by natalizumab 300 mg IV infusion Q6W from Week 132 through Week 150 along with a single dose of natalizumab 300 mg SC injection or IV infusion as per participant's choice at Week 156.

Group III: Part 2: Crossover Period: IV Q6W, then SC Q6WExperimental Treatment1 Intervention

Participants who completed run-in period of Part 2 were randomized to receive natalizumab 300 mg IV infusion Q6W from Week 108 through Week 126 followed by natalizumab 300 mg subcutaneous (SC) injection Q6W from Week 132 through Week 150 along with a single dose of natalizumab 300 mg SC injection or IV infusion as per participant's choice at Week 156.

Group IV: Part 1: IV Q6WExperimental Treatment1 Intervention

Participants received natalizumab 300 mg IV infusion once Q6W up to Week 72.

Group V: Part 1: IV Q4WExperimental Treatment1 Intervention

Participants received natalizumab 300 mg intravenous (IV) infusion once Q4W up to Week 72.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Natalizumab

FDA approved

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