CLINICAL TRIALS PROFILE FOR PLEGRIDY

All Clinical Trials for PLEGRIDY

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02230969 ↗	Plegridy Observational Program	Active, not recruiting	Biogen		2014-11-12	The primary objectives of the study are to determine the incidence of serious adverse events (SAEs) in participants with relapsing forms of multiple sclerosis (MS) in routine clinical practice and to assess the overall long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice. The secondary objectives of this study in this study population are to describe Plegridy prescription and utilization adherence patterns in routine clinical practice; to assess the specific long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice; to monitor the safety and tolerability of Plegridy in routine clinical practice by assessing the incidence of adverse events (AEs) of flu-like symptoms (FLS), injection site reactions (ISRs), and AEs (including laboratory abnormalities) leading to treatment discontinuation; to assess the effect of FLS on participant-reported effectiveness of, and satisfaction with, prophylactic management using a FLS-Visual Analog Scale (FLS-VAS); to evaluate the change in health-related quality of life (HRQoL), FLS, FLS-VAS, healthcare resource consumption, and treatment adherence over time.
NCT02269930 ↗	Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers	Completed	Biogen	Phase 1	2014-10-01	The primary outcome of the study is to evaluate the cumulative area under the concentration time curve (AUC) over 2 weeks, as measured by AUC from time 0 to 336 hours post dose (AUC0-336h), for serum concentrations of BIIB017 and Rebif. The secondary outcomes are to evaluate the maximum observed serum concentrations (Cmax) of BIIB017 and Rebif and to evaluate the safety and tolerability of BIIB017 and Rebif over 2 weeks in healthy volunteers.
NCT01939002 ↗	Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-β) Therapies to Peginterferon Beta-1a (BIIB017)	Completed	Biogen	Phase 3	2013-11-01	The primary objective of this study is to determine the proportion of participants with relapsing multiple sclerosis who experience new and/or increased flu-like symptoms (FLS) after transitioning from nonpegylated IFN-β therapies to peginterferon beta-1a (BIIB017). Secondary objectives are: to determine the severity and frequency (measured by flu-like symptom score [FLS-S]) of FLS in these participants; to determine the duration (measured in number of hours) of FLS in these participants; to determine the effect of BIIB017 on other participant-reported outcomes, including treatment satisfaction (measured with the Treatment Satisfaction Questionnaire for Medication [TSQM]) and disability status (measured with the Patient Determined Disease Steps [PDDS]) over a 56-week period; to determine whether interferon-related FLS result in missed days of work/daily activities (e.g., absenteeism); to assess the use of additional medications (in addition to current medications used to treat FLS) to relieve BIIB017-related FLS; to determine the incidence of adverse events throughout the study period; to characterize the immunogenicity profiles of participants switching from prior IFN-β therapy to BIIB017.
NCT01911767 ↗	Biogen Multiple Sclerosis Pregnancy Exposure Registry	Recruiting	Biogen		2013-10-30	The primary objective of the study is to prospectively evaluate pregnancy outcomes in women with multiple sclerosis who were exposed to a Registry-specified Biogen Multiple Sclerosis product during the eligibility window for that product. The Registry-specified Biogen MS products being studied are dimethyl fumarate, and Pegylated human interferon beta-1a. The secondary objective of the study is to prospectively evaluate pregnancy outcomes in women with MS who were unexposed to disease-modifying therapies (DMTs).
NCT01332019 ↗	Long-Term Safety and Efficacy Study of Peginterferon Beta-1a	Completed	Biogen	Phase 3	2011-04-01	The primary objective of this study is to evaluate the long-term safety and tolerability of peginterferon beta-1a (BIIB017) in participants originally treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment. The secondary objective of this study is to describe long-term multiple sclerosis (MS) outcomes in participants originally treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment.
NCT00906399 ↗	Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis	Completed	Biogen	Phase 3	2009-06-01	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 relapsing multiple sclerosis (RMS) at 1 year. The secondary objectives of this study are to determine whether peginterferon beta-1a, at 1 year when compared with placebo, is effective in reducing the total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans, reducing the proportion of participants who relapse, and slowing the progression of disability.

Clinical Trial Conditions for PLEGRIDY

Condition Name

Condition Name for PLEGRIDY
Intervention	Trials
Multiple Sclerosis	4
Relapsing Multiple Sclerosis	3
Relapsing-Remitting Multiple Sclerosis (RRMS)	2
Multiple Sclerosis, Relapsing-Remitting	2

Condition MeSH

Condition MeSH for PLEGRIDY
Intervention	Trials
Multiple Sclerosis	13
Sclerosis	10
Multiple Sclerosis, Relapsing-Remitting	6
Erythema	2

Clinical Trial Locations for PLEGRIDY

Trials by Country

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Trials by Country for PLEGRIDY
Location	Trials
United States	86
India	21
France	20
Germany	20
United Kingdom	14

Trials by US State

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−

Trials by US State for PLEGRIDY
Location	Trials
North Carolina	7
Kentucky	4
Georgia	4
Tennessee	4
Ohio	4

Clinical Trial Progress for PLEGRIDY

Clinical Trial Phase

Clinical Trial Phase for PLEGRIDY
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	5
Phase 1	1

Clinical Trial Status

Clinical Trial Status for PLEGRIDY
Clinical Trial Phase	Trials
Completed	6
Recruiting	3
Withdrawn	1

Clinical Trial Sponsors for PLEGRIDY

Sponsor Name

Sponsor Name for PLEGRIDY
Sponsor	Trials
Biogen	12
New York University School of Medicine	1
NYU Langone Health	1

Sponsor Type

Sponsor Type for PLEGRIDY
Sponsor	Trials
Industry	12
Other	3

PLEGRIDY (Peginterferon Beta-1a): Clinical Trials, Market Analysis, and Projections

Introduction to PLEGRIDY

PLEGRIDY, developed by Biogen Idec, is a pegylated interferon beta-1a used for the treatment of relapsing forms of multiple sclerosis (MS) in adults. This drug has been approved in over 60 countries, including the U.S., Canada, Australia, and across the European Union, and has been used by over 61,000 patients worldwide[2].

Clinical Trials: The ADVANCE Study

The efficacy and safety of PLEGRIDY were established through the Phase 3 ADVANCE clinical trial. Here are the key points from this study:

Study Design

• The ADVANCE study was a global, multi-center, randomized, double-blind, parallel-group, placebo-controlled trial.
• It enrolled 1,516 patients with relapsing-remitting MS and was conducted over a period of two years[3][4].

Primary and Secondary Endpoints

• The primary endpoint was the reduction of the annualized relapse rate (ARR) at year one.
• Secondary endpoints included reducing the risk of 12-week confirmed disability progression, the proportion of patients who relapsed, and MRI assessments[3][4].

Key Findings

• PLEGRIDY met all primary and secondary endpoints by significantly reducing disease activity, including relapses, disability progression, and brain lesions compared to placebo.
• The drug demonstrated favorable safety and tolerability profiles at both one and two years[1][4].

Two-Year Data

• The two-year data from the ADVANCE study showed that the efficacy of PLEGRIDY dosed once every two weeks was maintained throughout the second year.
• The annualized relapse rate was further reduced, and the number of new or newly-enlarging T2 lesions was numerically lower in the second year compared to the first year.
• The safety and tolerability profile of PLEGRIDY remained consistent between years one and two[1].

Additional Analyses

• Post-hoc analyses from the first year of the ADVANCE study showed that PLEGRIDY increased the proportion of patients with freedom from measured disease activity (FMDA) compared to placebo.
• Treatment with PLEGRIDY was associated with improved recovery from relapses and reduced sustained disability progression[1].

Market Analysis

Current Market Position

• PLEGRIDY is part of Biogen's industry-leading portfolio of MS treatments and has been a significant player in the neurology market.
• As of now, Biogen dominates the neurology market, with PLEGRIDY being one of its key products[2][5].

Competitive Landscape

• The neurology market is expected to undergo significant changes by 2025. Roche is projected to expand its foothold in the neurology market with a strong compound annual growth rate (CAGR) of 21.4% over 2018-2025, potentially surpassing Biogen as the leading company in this segment[5].

Market Projections

• By 2025, Biogen’s historical leading position in the neurology market is expected to slip, leaving it as the second-largest neurology company.
• Pfizer, currently ranked second, is expected to see a decline in neurology sales, resulting in a drop to the tenth position in terms of sales by 2025[5].

Safety and Tolerability

Common Side Effects

• Clinical studies have shown that PLEGRIDY has a well-characterized safety profile, but it is associated with several side effects, including liver problems, depression or suicidal thoughts, serious allergic reactions, injection site reactions, cardiac problems, blood problems, autoimmune disorders, and seizures[2].

Long-Term Safety

• The two-year data from the ADVANCE study indicate that the safety profile of PLEGRIDY is consistent with other MS interferon therapies, with no new safety concerns emerging in the second year of the study[1].

Patient Experience and Preferences

Dosing Schedule

• PLEGRIDY’s dosing schedule, once every two weeks, is seen as an attractive option for many patients with relapsing forms of MS, offering a less frequent dosing regimen compared to other interferon treatments[1][4].

Global Availability

• Biogen continues to work towards making PLEGRIDY available in additional countries, expanding its global reach and providing more patients with access to this treatment[2].

Conclusion

PLEGRIDY has established itself as a significant treatment option for patients with relapsing forms of multiple sclerosis. The robust data from the ADVANCE study, demonstrating its efficacy and safety over two years, solidify its position in the market. However, the neurology market landscape is expected to change, with Roche poised to become a major competitor by 2025. Despite this, PLEGRIDY remains a crucial part of Biogen’s portfolio and continues to offer a valuable treatment option for MS patients worldwide.

Key Takeaways

• Efficacy and Safety: PLEGRIDY has shown significant reductions in MS relapses, disability progression, and brain lesions, with a favorable safety and tolerability profile over two years.
• Market Position: Currently, Biogen dominates the neurology market, but Roche is expected to surpass Biogen by 2025.
• Dosing Schedule: PLEGRIDY’s once every two weeks dosing schedule is an attractive option for many MS patients.
• Global Reach: PLEGRIDY is approved in over 60 countries and continues to expand its global availability.
• Side Effects: Common side effects include liver problems, depression, allergic reactions, and others, but the overall safety profile is well-characterized.

FAQs

Q: What is PLEGRIDY used for?

PLEGRIDY is used for the treatment of relapsing forms of multiple sclerosis (MS) in adults.

Q: What were the key findings of the ADVANCE study?

The ADVANCE study showed that PLEGRIDY significantly reduced disease activity, including relapses, disability progression, and brain lesions, with a favorable safety and tolerability profile over two years.

Q: How often is PLEGRIDY administered?

PLEGRIDY is administered subcutaneously once every two weeks.

Q: What are the common side effects of PLEGRIDY?

Common side effects include liver problems, depression or suicidal thoughts, serious allergic reactions, injection site reactions, cardiac problems, blood problems, autoimmune disorders, and seizures.

Q: How is the neurology market expected to change by 2025?

By 2025, Roche is expected to surpass Biogen as the leading company in the neurology market, with Biogen slipping to the second position and Pfizer experiencing a decline in sales.

Sources

1. Biogen Idec to present new two-year data from the PLEGRIDY Phase 3 ADVANCE study. MSCare.
2. Biogen Announces FDA Approval of PLEGRIDY® (peginterferon beta-1a). Biogen Investors.
3. Plegridy (peginterferon beta-1a) for the Treatment of Relapsing Multiple Sclerosis. Clinical Trials Arena.
4. US and EU Regulatory Authorities Accept PLEGRIDYTM (peginterferon beta-1a). Biogen Investors.
5. Roche and Biogen to go head-to-head in neurology market in 2025. Pharmaceutical Technology.