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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

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 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%
Arthralgia
11%
Pain In Extremity
11%
Injection Site Pruritus
11%
Fatigue
9%
Nausea
7%
Body Temperature Increased
7%
Vomiting
6%
Hypoaesthesia
6%
Pain
6%
Vertigo
6%
Urinary Tract Infection
5%
Hyperthermia
5%
Cough
5%
Depression
5%
Oropharyngeal Pain
5%
Muscular Weakness
4%
Alanine Aminotransferase Increased
4%
Insomnia
4%
Dizziness
4%
Paraesthesia
4%
Diarrhoea
3%
Upper Respiratory Tract Infection
100%
80%
60%
40%
20%
0%
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

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

Find a Location

Who is running the clinical trial?

BiogenLead Sponsor
642 Previous Clinical Trials
467,055 Total Patients Enrolled
226 Trials studying Multiple Sclerosis
141,864 Patients Enrolled for Multiple Sclerosis
Medical DirectorStudy DirectorBiogen
2,834 Previous Clinical Trials
8,079,638 Total Patients Enrolled
136 Trials studying Multiple Sclerosis
126,055 Patients Enrolled for Multiple Sclerosis

Media Library

BIIB017 (peginterferon beta-1a) (Interferon) Clinical Trial Eligibility Overview. Trial Name: NCT03958877 — Phase 3
Multiple Sclerosis Research Study Groups: BIIB017 (peginterferon beta-1a), Avonex
Multiple Sclerosis Clinical Trial 2023: BIIB017 (peginterferon beta-1a) Highlights & Side Effects. Trial Name: NCT03958877 — Phase 3
BIIB017 (peginterferon beta-1a) (Interferon) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03958877 — Phase 3
~50 spots leftby May 2027
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