Peginterferon Beta-1a for Multiple Sclerosis

Not currently recruiting at 203 trial locations

Overseen By Global Biogen Clinical Trial Center

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Biogen

Must not be taking: PEGylated IFN β-1a

Disqualifiers: Progressive MS, Severe allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 96 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called BIIB017 (peginterferon beta-1a) for children with relapsing-remitting multiple sclerosis (RRMS), a condition where the immune system attacks the brain and spinal cord, causing intermittent symptoms. The study evaluates the safety, effectiveness, and behavior of this treatment in the body. It compares BIIB017 with another treatment, Avonex. Children diagnosed with RRMS who have experienced at least one relapse in the past year might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that peginterferon beta-1a, the treatment used in this trial, is safe and well-tolerated in patients with relapsing multiple sclerosis. Studies have found it to be as effective as interferon beta-1a, with similar safety results over 96 weeks.

Earlier studies reported that side effects were usually mild and similar to those of other interferon treatments. These can include flu-like symptoms after injection, which typically decrease over time as the body adjusts to the treatment.

This trial tests peginterferon beta-1a in children to confirm its safety for them. Since peginterferon beta-1a is already approved for adults with multiple sclerosis, some level of safety is already known. This trial aims to ensure it is safe and effective for children as well. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple sclerosis?

Peginterferon beta-1a is unique because it is a long-acting version of interferon beta, a standard treatment for multiple sclerosis (MS). Unlike typical interferon treatments that require frequent dosing, peginterferon beta-1a is designed to be administered every two weeks, potentially making it more convenient for patients. This extended dosing schedule may also lead to more consistent therapeutic levels in the body, providing effective management of MS symptoms with fewer injections. Researchers are excited about its potential to improve patient adherence and quality of life while maintaining control over the disease.

What evidence suggests that BIIB017 (peginterferon beta-1a) might be an effective treatment for multiple sclerosis?

Research has shown that peginterferon beta-1a, also known as BIIB017, helps manage relapsing multiple sclerosis. Earlier studies found that patients using this treatment experienced fewer flare-ups each year. This medication works by adjusting the immune system to reduce inflammation in the brain and spinal cord, which multiple sclerosis affects. In this trial, participants will receive either peginterferon beta-1a or Avonex, an active comparator. Studies have found that patients on peginterferon beta-1a achieved better results than those who took a placebo. Overall, peginterferon beta-1a has a history of benefiting people with this condition. ^{1 2 4 6 7}

Who Is on the Research Team?

Medical Director

Principal Investigator

Biogen

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Participants who completed the study treatment in Part 1 (Week 96 Visit), as per protocol

My disability score is between 0.0 and 5.5.

My condition has worsened or shown activity recently.

Exclusion Criteria

I could not tolerate BIIB017 in an earlier part of the study.

Any significant changes in medical history occurring after enrollment in Part 1, including laboratory test abnormalities or current clinically significant conditions that, in the opinion of the Investigator, would have excluded the participant's participation in Part 1. The Investigator must re-assess the participant's medical fitness for participation and consider any factors that would preclude treatment

History of severe allergic or anaphylactic reactions or known drug hypersensitivity

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BIIB017 or Avonex for the treatment of relapsing-remitting multiple sclerosis

96 weeks

Every 2 weeks for BIIB017, weekly for Avonex

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of BIIB017 treatment long-term

96 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BIIB017 (peginterferon beta-1a)

Trial Overview 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.

How Is the Trial Designed?

Group I: BIIB017 (peginterferon beta-1a) Experimental Treatment 1 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: Avonex Active Control 1 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.

Who Is Running the Clinical Trial?

Biogen

Lead Sponsor

Trials

655

Recruited

468,000+

Daniel Quirk

Biogen

Chief Medical Officer

MD

Christopher A. Viehbacher

Biogen

Chief Executive Officer since 2022

Graduated from Queen's University, Kingston, Ontario, Canada

Published Research Related to This Trial

In a comparison of 512 patients treated with peginterferon beta-1a and 731 patients treated with teriflunomide, peginterferon beta-1a was associated with a significantly lower rate of 24-week confirmed disability worsening (CDW) at 108 weeks (8.4% vs 12.6%).

Patients newly diagnosed with relapsing multiple sclerosis who received peginterferon beta-1a had numerically lower annualized relapse rates (ARR) compared to those treated with teriflunomide, with this trend continuing for up to 5 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Matching-adjusted comparisons demonstrate better clinical outcomes in patients with relapsing multiple sclerosis treated with peginterferon beta-1a than with teriflunomide. Newsome, SD., Mokliatchouk, O., Castrillo-Viguera, C., et al.[2021]

In a study involving 2,940 patients with HCV, high-dose peginterferon alfa-2a (360 μg/week) did not significantly increase serious adverse events or treatment discontinuations compared to the standard dose (180 μg/week) during the first 12 weeks of treatment.

While more patients on the high-dose experienced weight loss as an adverse event (7.7% vs. 3.3%), the overall safety profile was similar, indicating that high doses can be managed effectively without increasing safety risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of standard- vs. high-dose peginterferon alfa-2a plus standard-dose ribavirin in HCV genotype 1/4 patients: pooled analysis from 5 randomized studies. Marcellin, P., Roberts, SK., Reddy, KR., et al.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38784791/

Safety and clinical effectiveness of peginterferon beta-1a ... Peginterferon beta-1a is an effective therapy for managing relapsing multiple sclerosis. The identification of predictors of discontinuation can help inform ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03958877

NCT03958877 | A Study to Evaluate the Safety, Tolerability ... This study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4512519/

Peginterferon beta-1a in multiple sclerosis: 2-year results from ... Patients starting peginterferon beta-1a from Y1 displayed improved efficacy versus patients initially assigned placebo, with reductions in ARR (every 2 weeks: ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00906399

NCT00906399 | Efficacy and Safety Study of Peginterferon ... The primary objective of this study is to determine the efficacy of peginterferon beta-1a in reducing the annualized relapse rate (ARR) in participants with ...

5. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT03958877

BIIB017 (Peginterferon Beta-1a) in Pediatric Participants ... This study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39217809/

Efficacy and safety of peginterferon beta-1a compared to ... The results demonstrate the non-inferiority of peginterferon beta-1a to interferon beta-1a with similar efficacy in 96-week ARR in RRMS patients.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211034824004164

Efficacy and safety of peginterferon beta-1a compared to ... These findings support considering peginterferon beta-1a as a safe, efficient, and convenient option in patients with relapsing remitting multiple sclerosis.