Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex (SYNERGY)

Biogen

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis

Treatments: Other: Placebo; Drug: BIIB033; Drug: Avonex

Study type: Interventional

Funder types: Industry

Identifiers

NCT01864148

2011-006262-40 (EudraCT Number)

215MS201

Details and patient eligibility

About

The primary objective of the study is to evaluate the efficacy of BIIB033 in participants with active relapsing multiple sclerosis (MS) when used concurrently with Avonex.

Secondary objectives of this study in this study population are to assess the safety, tolerability, and population pharmacokinetics of BIIB033 when used concurrently with Avonex.

Enrollment: 419 patients

Sex: All

Ages: 18 to 58 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Diagnosis of relapsing remitting MS (RRMS) or onset of secondary progressive MS (SPMS)
• RRMS and SPMS subjects must have evidence of ongoing disease activity within 12 months of enrollment.
• All male and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment

Key Exclusion Criteria:

• A MS relapse that has occurred within the 90 days prior to Day 1/Baseline and/or the subject has not stabilized from a previous relapse prior to Screening
• Previous history of clinically significant disease.
• Plans to undergo elective major procedures/surgeries at any time during the study.
• Treatment with any investigational MS drugs within 3 weeks or 5 times the half life (whichever is longer) prior to Day 1/Baseline
• RRMS subjects with any history of inadequate response to any approved interferon β preparation
• History of human immunodeficiency virus (HIV), hepatitis C virus antibody, or hepatitis B virus
• History or evidence of drug or alcohol abuse within 2 years prior to randomization

Note: Other protocol defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

419 participants in 5 patient groups, including a placebo group

BIIB033, 3 mg/kg

Experimental group

Description:

BIIB033 3 mg/kg once every 4 weeks intravenous (IV) infusion up to Week 72. Avonex once-weekly intramuscular (IM) injection up to Week 84.

Treatment:

Drug: Avonex

Drug: BIIB033

BIIB033, 10 mg/kg

Experimental group

Description:

BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84.

Treatment:

Drug: Avonex

Drug: BIIB033

BIIB033, 30 mg/kg

Experimental group

Description:

BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84.

Treatment:

Drug: Avonex

Drug: BIIB033

BIIB033, 100 mg/kg

Experimental group

Description:

BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84.

Treatment:

Drug: Avonex

Drug: BIIB033

Placebo

Placebo Comparator group

Description:

Placebo once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84.

Treatment:

Other: Placebo

Drug: Avonex