Avonex (recombinant IFN-β-1a) / Biogen - LARVOL DELTA

CONNECT: Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) (clinicaltrials.gov) - P3 | N=142 | Recruiting | Sponsor: Biogen Idec

New P3 trial • CNS Disorders • Immunology • Multiple Sclerosis • Pediatrics

CONNECT: Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) (clinicaltrials.gov) - P3 | N=142 | Recruiting | Sponsor: Biogen | Trial primary completion date: Sep 2020 ➔ May 2020

Trial primary completion date • CNS Disorders • Multiple Sclerosis • Pediatrics

CONNECT: Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) (clinicaltrials.gov) - P3 | N=142 | Recruiting | Sponsor: Biogen | Trial completion date: Jan 2025 ➔ May 2025 | Trial primary completion date: May 2020 ➔ Sep 2020

Trial completion date • Trial primary completion date • Multiple Sclerosis • Pediatrics

CONNECT: Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) (clinicaltrials.gov) - P3 | N=156 | Completed | Sponsor: Biogen | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Multiple Sclerosis • Pediatrics

CONNECT: Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) (clinicaltrials.gov) - P3 | N=156 | Active, not recruiting | Sponsor: Biogen | Trial completion date: May 2025 ➔ Sep 2025 | Trial primary completion date: Sep 2020 ➔ Sep 2025

Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis • Pediatrics

CONNECT: Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) (clinicaltrials.gov) - P3 | N=142 | Active, not recruiting | Sponsor: Biogen | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Multiple Sclerosis • Pediatrics

The Efficacy and Safety of Sampeginterferon β-1a: Two-year study in Relapsing-Remitting Multiple Sclerosis Patients (ECTRIMS 2025) - P2/3 | "This was a two-year, international, multicenter, randomized, double-blind, placebo-controlled study (NCT02744222) to compare samPEG-IFNβ-1a and non-pegylated IFNβ-1a (Avonex®)... SamPEG-IFNβ-1a showed superior efficacy over non-pegylated IFNβ-1a with sustained benefits over two years of treatment."

Clinical • CNS Disorders • Multiple Sclerosis • IFNB1

Evaluating Efficacy Outcomes in Pediatric Multiple Sclerosis Patients While Using Avonex or Plegridy via USNPMSC Registry. (PubMed, J Child Neurol) - "Despite the lack of formal approval for pediatric multiple sclerosis, these outcomes indicate that patients may benefit from treatment with Avonex or Plegridy. Understanding efficacy of specific disease-modifying therapies in pediatric multiple sclerosis is essential to making informed treatment decisions."

Journal • CNS Disorders • Multiple Sclerosis • Pediatrics

DELIVER-MS: Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS (clinicaltrials.gov) - P4 | N=800 | Active, not recruiting | Sponsor: The Cleveland Clinic | Trial completion date: Sep 2030 ➔ Jul 2027

Trial completion date • CNS Disorders • Multiple Sclerosis

TREAT-MS: Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial (clinicaltrials.gov) - P=N/A | N=900 | Active, not recruiting | Sponsor: Johns Hopkins University | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2025 ➔ Aug 2026 | Trial primary completion date: Aug 2025 ➔ Aug 2026

Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

Immunomodulators and immunosuppressants for progressive multiple sclerosis: a network meta-analysis. (PubMed, Cochrane Database Syst Rev) - "The number of people with PMS with relapses is probably slightly reduced with rituximab at two years, and interferon beta-1b at three years, compared to placebo. Both drugs are also probably associated with a slightly higher proportion of withdrawals due to adverse events, as are immunoglobulins, glatiramer acetate, natalizumab, fingolimod, siponimod, and ocrelizumab; we have high confidence that this is the case with interferon beta-1a. We found only low or very low certainty evidence relating to disability progression for the included disease-modifying treatments compared to placebo, largely due to imprecision. We are also uncertain about the effect of interventions on serious adverse events, also because of imprecision. These findings are due in part to the short follow-up of the included RCTs, which lacked detection of less common severe adverse events. Moreover, the funding source of many included studies may have introduced bias into the results. Future research on..."

Clinical • Immunomodulating • Journal • Retrospective data • Review • CNS Disorders • Multiple Sclerosis

DELIVER-MS: Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS (clinicaltrials.gov) - P4 | N=800 | Active, not recruiting | Sponsor: The Cleveland Clinic | Trial primary completion date: Apr 2030 ➔ Jul 2027

Trial primary completion date • CNS Disorders • Multiple Sclerosis

A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis (clinicaltrials.gov) - P3 | N=142 | Active, not recruiting | Sponsor: Biogen | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jul 2024 ➔ May 2027

Enrollment closed • Trial primary completion date • CNS Disorders • Multiple Sclerosis • Pediatrics

INFORM: An Observational Study to Learn About the Interferon-beta Exposure of Pregnant Women During the Second and Third Trimester in Finland and Sweden (clinicaltrials.gov) - P=N/A | N=4 | Active, not recruiting | Sponsor: Bayer | Not yet recruiting ➔ Active, not recruiting | N=100 ➔ 4 | Initiation date: Sep 2024 ➔ Mar 2024

Enrollment change • Enrollment closed • Trial initiation date • CNS Disorders • Multiple Sclerosis

Interferon-Beta-1a (FP-1201) to Prevent Toxicities After CD19-Directed CAR T-Cell Therapy (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Fred Hutchinson Cancer Center | N=24 ➔ 0 | Not yet recruiting ➔ Withdrawn

CAR T-Cell Therapy • Enrollment change • Trial withdrawal • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis (clinicaltrials.gov) - P3 | N=142 | Recruiting | Sponsor: Biogen | Trial completion date: Nov 2029 ➔ May 2027 | Trial primary completion date: Nov 2029 ➔ Jul 2024

Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis • Pediatrics

PRTOECT: A Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-a (clinicaltrials.gov) - P4 | N=0 | Withdrawn | Sponsor: Biogen | N=50 ➔ 0

Enrollment change • CNS Disorders • Multiple Sclerosis

DELIVER-MS: Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS (clinicaltrials.gov) - P4 | N=800 | Active, not recruiting | Sponsor: The Cleveland Clinic | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Multiple Sclerosis

INFORM: An Observational Study to Learn About the Interferon-beta Exposure of Pregnant Women During the Second and Third Trimester in Finland and Sweden (clinicaltrials.gov) - P=N/A | N=100 | Not yet recruiting | Sponsor: Bayer | Initiation date: May 2024 ➔ Sep 2024

Trial initiation date • CNS Disorders • Multiple Sclerosis

Interferon-Beta-1a (FP-1201) to Prevent Toxicities After CD19-Directed CAR T-Cell Therapy (clinicaltrials.gov) - P1/2 | N=24 | Not yet recruiting | Sponsor: Fred Hutchinson Cancer Center | Trial completion date: Nov 2026 ➔ Oct 2027 | Initiation date: May 2024 ➔ Apr 2025 | Trial primary completion date: Nov 2026 ➔ Oct 2027

CAR T-Cell Therapy • Trial completion date • Trial initiation date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Evaluating the Use and Efficacy of Avonex and Plegridy in Pediatric Patients (AAN 2024) - "Objective:Summarize the demographic/clinical characteristics and efficacy outcomes of individuals with pediatric-onset multiple sclerosis (POMS) who were treated with Avonex or PlegridyBackground:IM interferon beta-1a (Avonex®) and peginterferon beta-1a (Plegridy®) have been shown to be effective in placebo-controlled randomized trials and real-world evidence for adults with relapsing forms of multiple sclerosis (MS). The data from this registry are consistent with previously reported clinical and MRI effects of approved interferon beta therapies more traditionally utilized in adult populations. Biogen provided funding for this study."

Clinical • CNS Disorders • Multiple Sclerosis • Pediatrics

A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis (clinicaltrials.gov) - P2 | N=220 | Completed | Sponsor: Genentech, Inc. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Multiple Sclerosis

Evaluating the Use and Efficacy of Avonex and Plegridy in Pediatric Patients (ACTRIMS Forum 2024) - "Background: IM interferon beta-1a (Avonex®) and peginterferon beta-1a (Plegridy®) have been shown to be effective in placebo-controlled randomized trials and real-world evidence for adults with relapsing forms of multiple sclerosis (MS). The data from this registry are consistent with previously reported clinical and MRI effects of approved interferon beta therapies more traditionally utilized in adult populations."

Clinical • CNS Disorders • Multiple Sclerosis • Pediatrics

Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis. (PubMed, Cochrane Database Syst Rev) - "We are highly confident that, compared to placebo, two-year treatment with natalizumab, cladribine, or alemtuzumab decreases relapses more than with other DMTs. We are moderately confident that a two-year treatment with natalizumab may slow disability progression. Compared to those on placebo, people with RRMS treated with most of the assessed DMTs showed a higher frequency of treatment discontinuation due to AEs: we are moderately confident that this could happen with fingolimod, teriflunomide, interferon beta-1a, laquinimod, natalizumab and daclizumab, while our certainty with other DMTs is lower. We are also moderately certain that treatment with alemtuzumab is associated with fewer discontinuations due to adverse events than placebo, and moderately certain that interferon beta-1b probably results in a slight reduction in people who experience serious adverse events, but our certainty with regard to other DMTs is lower. Insufficient evidence is available to evaluate..."

Immunomodulating • Journal • Retrospective data • Review • CNS Disorders • Multiple Sclerosis

Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate) (clinicaltrials.gov) - P=N/A | N=908 | Recruiting | Sponsor: Biogen | Not yet recruiting ➔ Recruiting | N=454 ➔ 908

Enrollment change • Enrollment open • CNS Disorders • Multiple Sclerosis