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Interferon

Peginterferon Beta-1a for Multiple Sclerosis

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

Must have an EDSS score between 0.0 and 5.5

Must have experienced >= 1 relapse in the 12 months prior to randomization (Day 1) or >= 2 relapses in the 24 months prior to randomization (Day 1) or have evidence of asymptomatic disease activity (Gd-enhancing lesions) on brain MRI in the 6 months prior to randomization (Day 1)

Must not have

Occurrence of an MS relapse that has occurred within 30 days prior to randomization (Day 1) and/or the participant has not stabilized from a previous relapse prior to randomization (Day 1)

Primary progressive, secondary progressive, or progressive relapsing. These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Participants with these conditions may also have superimposed relapses but are distinguished from relapsing participants by the lack of clinically stable periods or clinical improvement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 96), weeks 108, 120, 132, 144,156, 168, 180, 192, and 196

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will study a new MS drug in children to see if it is safe and effective. Part 1 will assess how the drug works in the body, and Part 2 will evaluate long-term safety and effectiveness.

Who is the study for?

This trial is for children with relapsing-remitting multiple sclerosis (RRMS). They should have had at least one MS flare-up in the past year or show signs of disease activity on an MRI. Participants must be able to walk (EDSS score 0.0-5.5) and not have progressive forms of MS, severe allergies, or recent relapses.

What is being tested?

The study tests BIIB017's safety and how well it works in kids with RRMS over two parts: first assessing its immediate effects and pharmacokinetics, then looking at long-term safety and MS outcomes after completing initial treatment.

What are the potential side effects?

Possible side effects include reactions similar to flu symptoms, injection site reactions, liver problems, depression or mood swings, blood cell count changes, seizures, heart problems like congestive heart failure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My disability score is between 0.0 and 5.5.

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My condition has worsened or shown activity recently.

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I have been diagnosed with relapsing-remitting MS.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had an MS flare-up within the last 30 days or haven't recovered from a recent one.

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My condition has been getting worse continuously for at least 3 months.

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I have been treated with PEGylated human IFN β-1a before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 96), weeks 108, 120, 132, 144,156, 168, 180, 192, and 196

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 96), weeks 108, 120, 132, 144,156, 168, 180, 192, and 196

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 96), weeks 108, 120, 132, 144,156, 168, 180, 192, and 196 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: Annualized Relapse Rate (ARR) at Week 48

Part 2: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Treatment Discontinuation

Secondary study objectives

Part 1: ARR at Week 96

Part 1: Change from Baseline in Cognition at Weeks 24, 48, 72, and 96 as Measured by the Symbol Digit Modality Test (SDMT)

Part 1: Change from Baseline in Depression as Assessed by Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) at Weeks 12, 24, 36, 48, 60, 72, 84, 96, and 100

+14 more

Side effects data

From 2013 Phase 3 trial • 1516 Patients • NCT00906399

56%

Injection Site Erythema

47%

Influenza Like Illness

44%

Pyrexia

41%

Headache

22%

Multiple Sclerosis Relapse

19%

Myalgia

18%

Chills

14%

Nasopharyngitis

14%

Asthenia

13%

Back Pain

13%

Injection Site Pain

11%

Pain In Extremity

11%

Arthralgia

11%

Injection Site Pruritus

11%

Fatigue

Nausea

Body Temperature Increased

Vomiting

Hypoaesthesia

Pain

Vertigo

Urinary Tract Infection

Muscular Weakness

Hyperthermia

Cough

Depression

Oropharyngeal Pain

Dizziness

Alanine Aminotransferase Increased

Insomnia

Paraesthesia

Diarrhoea

Upper Respiratory Tract Infection

100%

80%

60%

40%

20%

Study treatment Arm

Year 1: Placebo

Year 1: Peginterferon Beta-1a Q4W

Year 1: Peginterferon Beta-1a Q2W

Year 2: Placebo Followed by Peginterferon Beta-1a Q4W

Year 2: Placebo Followed by Peginterferon Beta-1a Q2W

Year 2: Peginterferon Beta-1a Q4W

Year 2: Peginterferon Beta-1a Q2W

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BIIB017 (peginterferon beta-1a)Experimental Treatment1 Intervention

Participants will receive subcutaneous (SC) injection of BIIB017 (peginterferon beta-1a) 63 microgram (μg) on Day 1, followed by 94 μg at Week 2, followed by 125 μg at Week 4, and then 125 μg SC injection every 2 weeks up to Week 96 in Part 1 of the study. Eligible participants who enter optional Part 2 of the study will receive 125 μg SC injections of BIIB017 every 2 weeks for 96 Weeks.

Group II: AvonexActive Control1 Intervention

Participants will receive Avonex (interferon beta type 1a) starting at a dose of 7.5 μg on Day 1, followed by an increase of 7.5 μg each week for 3 weeks, followed by 30 μg intramuscular (IM) injections every week up to Week 96 in Part 1 of the study. Eligible participants who enter optional Part 2 of the study will receive 125 μg SC injections of BIIB017 every 2 weeks for 96 Weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BIIB017 (peginterferon beta-1a)

2009

Completed Phase 3

~1520

0 / 6Eligibility criteria met