Peginterferon Beta-1a for Multiple Sclerosis

Recruiting at 177 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

142 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis (RRMS) and to assess the pharmacokinetics (PK) of BIIB017 in pediatric participants with RRMS in Part 1. In Part 2, the study will evaluate the long-term safety of BIIB017 and further describe safety and the long-term multiple sclerosis (MS) outcomes after BIIB017 treatment in participants who completed the study treatment at Week 96 in Part 1 of the study.

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.

What data supports the effectiveness of the drug peginterferon beta-1a for multiple sclerosis?

Research shows that peginterferon beta-1a, given every 2 or 4 weeks, effectively reduces the annual relapse rate in people with relapsing-remitting multiple sclerosis compared to a placebo. The drug also shows better outcomes in reducing new brain lesions and slowing disability progression, especially with the every 2-week dosing. ^{1 2 3 4 5}

Is peginterferon beta-1a safe for humans?

Peginterferon beta-1a has been studied for safety in people with multiple sclerosis, showing an acceptable safety profile similar to other interferon treatments. Common side effects include mild to moderate injection site reactions and flu-like symptoms, but it does not increase the risk of autoimmune disorders, depression, infections, or seizures. ^{2 6 7 8 9}

What makes peginterferon beta-1a unique for treating multiple sclerosis?

Peginterferon beta-1a is unique because it is a pegylated form of interferon beta-1a, which means it has a longer half-life and requires less frequent dosing compared to other interferon treatments for multiple sclerosis. This can lead to better adherence and satisfaction among patients. ^{2 3 10 11 12}

Research Team

Medical Director

Principal Investigator

Biogen

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

An update on the evidence base for peginterferon β1a in the treatment of relapsing-remitting multiple sclerosis. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Pegylated interferon β-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomised, phase 3, double-blind study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Peginterferon beta-1a was associated with high adherence and satisfaction in patients with multiple sclerosis in a German real-world study. [2022]

4. Netherlands 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. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Matching-adjusted comparisons demonstrate better clinical outcomes with SC peginterferon beta-1a every two weeks than with SC interferon beta-1a three times per week. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Peginterferon beta-1a in multiple sclerosis: 2-year results from ADVANCE. [2022]

7. England 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. [2018]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Peginterferon beta-1a: a review of its use in patients with relapsing-remitting multiple sclerosis. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Bioequivalence of intramuscular and subcutaneous peginterferon beta-1a: results of a phase I, open-label crossover study in healthy volunteers. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Incidence, characterization, and clinical impact analysis of peginterferon beta1a immunogenicity in patients with multiple sclerosis in the ADVANCE trial. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Peginterferon beta-1a concentrations in breast milk of lactating multiple sclerosis patients. [2022]

12. England pubmed.ncbi.nlm.nih.gov

An update on Peginterferon beta-1a Management in Multiple Sclerosis: results from an interdisciplinary Board of German and Austrian Neurologists and dermatologists. [2022]