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A Study to Evaluate Safety and Efficacy of BIIB091 in Participants With Relapsing Forms of Multiple Sclerosis

Primary Purpose

Relapsing Forms of Multiple Sclerosis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BIIB091
DRF
Placebo
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Forms of Multiple Sclerosis focused on measuring Multiple Sclerosis, Diroximel fumarate, BIIB091

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: Diagnosis of RMS [relapsing-remitting multiple sclerosis (RRMS) or active secondary progressive multiple sclerosis (SPMS)] in accordance with the 2017 Revised McDonald criteria. Time since MS symptom onset is <20 years. Must have expanded disability status scale (EDSS) score of 0 through 5.0 at screening. Must have at least 1 of the following occurring prior to Baseline (Day 1): ≥2 clinical relapses in the last 24 months (but not within 30 days prior to Baseline [Day 1]) with at least 1 relapse during the last 12 months prior to randomization. ≥1 clinical relapse within the past 24 months (but not within 30 days prior to Baseline [Day 1]) and ≥1 new brain MRI lesion (Gd positive and/or new or enlarging T2 hyperintense lesion) within the past 12 months prior to randomization. The screening MRI could be used to satisfy this criterion (if needed for inclusion, local read is required). For new or enlarging T2 hyperintense lesions, the reference scan cannot be >12 months prior to randomization. ≥1 GdE lesion on brain MRI within 6 months prior to randomization. Key Exclusion Criteria: Diagnosis of primary progressive multiple sclerosis (PPMS) in accordance with the 2017 Revised McDonald criteria. An MS relapse that has occurred within 30 days prior to Baseline (Day 1) or the participant has not stabilized from a previous relapse at the time of screening. History of severe allergic, anaphylactic reactions or hypersensitivity reaction to BIIB091 or DRF, the excipients contained in the formulation, and if appropriate, any diagnostic agents to be administered during the study, including the following: Known hypersensitivity to any components of the study treatment Known hypersensitivity to previous fumarate or bruton's tyrosine kinase (BTK) inhibitor treatments History of hypersensitivity to parenteral administration of Gd-based contrast agents Evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within the past 4 weeks prior to Baseline. History or positive test result at screening for human immunodeficiency virus (HIV). Current or history of hepatitis C infection regardless of viral load. Current or possible hepatitis B. Current enrollment or plan to enroll in any other drug, biological, device, clinical study, or treatment with an investigational drug or approved therapy for investigational use within 90 days prior to randomization or 5 half-lives of the drug or therapy, whichever is longer. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • HonorHealth NeurologyRecruiting
  • University of Colorado School of MedicRecruiting
  • Fort Wayne Neurological CenterRecruiting
  • International Neurorehabilitation InstituteRecruiting
  • Washington UniversityRecruiting
  • The Boster Center for Multiple SclerosisRecruiting
  • Neurology Clinic, PCRecruiting
  • Fondazione Istituto G.Giglio di CefalùRecruiting
  • Caribbean Center for Clinical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Experimental

Active Comparator

Arm Label

Part 1: BIIB091 High Dose + Matching Placebo for DRF

Part 1: BIIB091 Low Dose + Matching Placebo for DRF

Part 1: DRF + Matching Placebo for BIIB091

Part 2: BIIB091 + DRF Standard Dose

Part 2: BIIB091 + DRF Low Dose

Part 2: DRF + Matching Placebo for BIIB091

Arm Description

Participants will receive BIIB091 high dose and matching placebo for DRF, orally, for up to 48 weeks.

Participants will receive BIIB091 low dose and matching placebo for DRF, orally, for up to 48 weeks.

Participants will receive DRF standard dose and matching placebo for BIIB091, orally, for up to 48 weeks.

Participants will receive selected dose of BIIB091 (based on Part 1 data) and DRF standard dose, orally, for up to 48 weeks.

Participants will receive selected dose of BIIB091 (based on Part 1 data) and DRF low dose, orally, for up to 48 weeks.

Participants will receive DRF standard dose and matching placebo for BIIB091, orally, for up to 48 weeks.

Outcomes

Primary Outcome Measures

Part 1: Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product or auxiliary medicinal product, whether or not related to the medicinal (investigational) product or auxiliary medicinal product.
Part 1: Number of Participants With Serious Adverse Events (SAEs)
SAE is any untoward medical occurrence that at any dose results in death, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or is a medically important event.
Part 2: Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions

Secondary Outcome Measures

Part 1: Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions
Part 1: Cumulative Number of New or Enlarging T2 Hyperintense Lesions
Part 1: Cumulative Volume of New or Enlarging T2 Hyperintense Lesions
Part 1: Mean Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF), RR, PR, QRS, and QT Intervals
Part 1: Number of Participants With Change From Baseline in Heart Rate
Part 1: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Part 2: Cumulative Number of New or Enlarging T2 Hyperintense Lesions
Part 2: Cumulative Volume of New or Enlarging T2 Hyperintense Lesions
Part 2: Number of Participants With AEs
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product or auxiliary medicinal product, whether or not related to the medicinal (investigational) product or auxiliary medicinal product.
Part 2: Number of Participants With SAEs
SAE is any untoward medical occurrence that at any dose results in death, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or is a medically important event.
Part 2: Number of Participants With Change From Baseline in QTcF, RR, PR, QRS, and QT intervals
Part 2: Number of Participants With Change From Baseline in Heart Rate
Part 2: Number of Participants With ECG Abnormalities as Assessed by 12-Lead ECG Measurements

Full Information

First Posted
March 23, 2023
Last Updated
October 10, 2023
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT05798520
Brief Title
A Study to Evaluate Safety and Efficacy of BIIB091 in Participants With Relapsing Forms of Multiple Sclerosis
Official Title
A 2-Part, Multicenter, Randomized, Blinded, Active-Controlled Phase 2 Study to Sequentially Evaluate the Safety and Efficacy of BIIB091 Monotherapy and BIIB091 Combination Therapy With Diroximel Fumarate in Participants With Relapsing Forms of Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2023 (Actual)
Primary Completion Date
July 10, 2025 (Anticipated)
Study Completion Date
November 9, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objectives are to investigate the safety and tolerability of BIIB091 monotherapy in participants with relapsing multiple sclerosis (RMS) (Part 1), and to evaluate the effects of BIIB091 combination therapy with Diroximel Fumarate (DRF) compared with the DRF monotherapy arm, on the key Magnetic Resonance Imaging (MRI) measure of active Central Nervous System (CNS) inflammation (Part 2). The secondary objectives are to evaluate the effects of BIIB091 monotherapy on the MRI measures of active CNS inflammation, to evaluate the effects of BIIB091 combination therapy with DRF compared with the DRF monotherapy arm on additional MRI measures of active CNS inflammation, to investigate the safety and tolerability of BIIB091 combination therapy with DRF in participants with RMS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Forms of Multiple Sclerosis
Keywords
Multiple Sclerosis, Diroximel fumarate, BIIB091

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
275 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1: BIIB091 High Dose + Matching Placebo for DRF
Arm Type
Experimental
Arm Description
Participants will receive BIIB091 high dose and matching placebo for DRF, orally, for up to 48 weeks.
Arm Title
Part 1: BIIB091 Low Dose + Matching Placebo for DRF
Arm Type
Experimental
Arm Description
Participants will receive BIIB091 low dose and matching placebo for DRF, orally, for up to 48 weeks.
Arm Title
Part 1: DRF + Matching Placebo for BIIB091
Arm Type
Active Comparator
Arm Description
Participants will receive DRF standard dose and matching placebo for BIIB091, orally, for up to 48 weeks.
Arm Title
Part 2: BIIB091 + DRF Standard Dose
Arm Type
Experimental
Arm Description
Participants will receive selected dose of BIIB091 (based on Part 1 data) and DRF standard dose, orally, for up to 48 weeks.
Arm Title
Part 2: BIIB091 + DRF Low Dose
Arm Type
Experimental
Arm Description
Participants will receive selected dose of BIIB091 (based on Part 1 data) and DRF low dose, orally, for up to 48 weeks.
Arm Title
Part 2: DRF + Matching Placebo for BIIB091
Arm Type
Active Comparator
Arm Description
Participants will receive DRF standard dose and matching placebo for BIIB091, orally, for up to 48 weeks.
Intervention Type
Drug
Intervention Name(s)
BIIB091
Intervention Description
Administered as specified in the treatment arm.
Intervention Type
Drug
Intervention Name(s)
DRF
Intervention Description
Administered as specified in the treatment arm.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered as specified in the treatment arm.
Primary Outcome Measure Information:
Title
Part 1: Number of Participants With Adverse Events (AEs)
Description
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product or auxiliary medicinal product, whether or not related to the medicinal (investigational) product or auxiliary medicinal product.
Time Frame
Day 1 up to Week 50
Title
Part 1: Number of Participants With Serious Adverse Events (SAEs)
Description
SAE is any untoward medical occurrence that at any dose results in death, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or is a medically important event.
Time Frame
From signing the informed consent form (ICF) to Week 50
Title
Part 2: Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions
Time Frame
Week 8 to Week 16
Secondary Outcome Measure Information:
Title
Part 1: Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions
Time Frame
Week 8 to Week 16
Title
Part 1: Cumulative Number of New or Enlarging T2 Hyperintense Lesions
Time Frame
Week 8 to Week 16
Title
Part 1: Cumulative Volume of New or Enlarging T2 Hyperintense Lesions
Time Frame
Week 8 to Week 16
Title
Part 1: Mean Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF), RR, PR, QRS, and QT Intervals
Time Frame
Up to Week 50
Title
Part 1: Number of Participants With Change From Baseline in Heart Rate
Time Frame
Up to Week 50
Title
Part 1: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Time Frame
Up to Week 50
Title
Part 2: Cumulative Number of New or Enlarging T2 Hyperintense Lesions
Time Frame
Week 8 to Week 16
Title
Part 2: Cumulative Volume of New or Enlarging T2 Hyperintense Lesions
Time Frame
Week 8 to Week 16
Title
Part 2: Number of Participants With AEs
Description
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product or auxiliary medicinal product, whether or not related to the medicinal (investigational) product or auxiliary medicinal product.
Time Frame
Day 1 up to Week 50
Title
Part 2: Number of Participants With SAEs
Description
SAE is any untoward medical occurrence that at any dose results in death, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or is a medically important event.
Time Frame
From signing of ICF up to Week 50
Title
Part 2: Number of Participants With Change From Baseline in QTcF, RR, PR, QRS, and QT intervals
Time Frame
Up to Week 50
Title
Part 2: Number of Participants With Change From Baseline in Heart Rate
Time Frame
Up to Week 50
Title
Part 2: Number of Participants With ECG Abnormalities as Assessed by 12-Lead ECG Measurements
Time Frame
Up to Week 50

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Diagnosis of RMS [relapsing-remitting multiple sclerosis (RRMS) or active secondary progressive multiple sclerosis (SPMS)] in accordance with the 2017 Revised McDonald criteria. Time since MS symptom onset is <20 years. Must have expanded disability status scale (EDSS) score of 0 through 5.0 at screening. Must have at least 1 of the following occurring prior to Baseline (Day 1): ≥2 clinical relapses in the last 24 months (but not within 30 days prior to Baseline [Day 1]) with at least 1 relapse during the last 12 months prior to randomization. ≥1 clinical relapse within the past 24 months (but not within 30 days prior to Baseline [Day 1]) and ≥1 new brain MRI lesion (Gd positive and/or new or enlarging T2 hyperintense lesion) within the past 12 months prior to randomization. The screening MRI could be used to satisfy this criterion (if needed for inclusion, local read is required). For new or enlarging T2 hyperintense lesions, the reference scan cannot be >12 months prior to randomization. ≥1 GdE lesion on brain MRI within 6 months prior to randomization. Key Exclusion Criteria: Diagnosis of primary progressive multiple sclerosis (PPMS) in accordance with the 2017 Revised McDonald criteria. An MS relapse that has occurred within 30 days prior to Baseline (Day 1) or the participant has not stabilized from a previous relapse at the time of screening. History of severe allergic, anaphylactic reactions or hypersensitivity reaction to BIIB091 or DRF, the excipients contained in the formulation, and if appropriate, any diagnostic agents to be administered during the study, including the following: Known hypersensitivity to any components of the study treatment Known hypersensitivity to previous fumarate or bruton's tyrosine kinase (BTK) inhibitor treatments History of hypersensitivity to parenteral administration of Gd-based contrast agents Evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within the past 4 weeks prior to Baseline. History or positive test result at screening for human immunodeficiency virus (HIV). Current or history of hepatitis C infection regardless of viral load. Current or possible hepatitis B. Current enrollment or plan to enroll in any other drug, biological, device, clinical study, or treatment with an investigational drug or approved therapy for investigational use within 90 days prior to randomization or 5 half-lives of the drug or therapy, whichever is longer. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US Biogen Clinical Trial Center
Phone
866-633-4636
Email
clinicaltrials@biogen.com
First Name & Middle Initial & Last Name or Official Title & Degree
Global Biogen Clinical Trial Center
Email
clinicaltrials@biogen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
HonorHealth Neurology
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
602-406-6262
First Name & Middle Initial & Last Name & Degree
Suraj A. Muley
Facility Name
University of Colorado School of Medic
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
303-724-4172
First Name & Middle Initial & Last Name & Degree
Enrique Alvarez
Facility Name
Fort Wayne Neurological Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
260-460-3214
First Name & Middle Initial & Last Name & Degree
Ajay Gupta
Facility Name
International Neurorehabilitation Institute
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
410-828-4629
First Name & Middle Initial & Last Name & Degree
Daniel Becker
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
314-362-3293
First Name & Middle Initial & Last Name & Degree
Robert T. Naismith
Facility Name
The Boster Center for Multiple Sclerosis
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
614-304-3444
First Name & Middle Initial & Last Name & Degree
Aaron L. Boster
Facility Name
Neurology Clinic, PC
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
901-866-9252
First Name & Middle Initial & Last Name & Degree
Lee S. Stein
Facility Name
Fondazione Istituto G.Giglio di Cefalù
City
Cefalù
State/Province
Palermo
ZIP/Postal Code
90015
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
+39921920470
First Name & Middle Initial & Last Name & Degree
Luigi Grimaldi
Facility Name
Caribbean Center for Clinical Research
City
Guaynabo
ZIP/Postal Code
00968
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
Phone
7877937984
First Name & Middle Initial & Last Name & Degree
Angel R Chinea Martinez

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
IPD Sharing URL
https://vivli.org/

Learn more about this trial

A Study to Evaluate Safety and Efficacy of BIIB091 in Participants With Relapsing Forms of Multiple Sclerosis

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