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

Conditions

Relapsing Forms of Multiple Sclerosis

Brief summary

Part 1: Number of Participants With Adverse Events (AEs), Part 1: Number of Participants With Serious Adverse Events (SAEs), Part 2: Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions

Detailed description

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, Part 2: Number of Participants With SAEs, 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

Related papers

No related papers found yet.

Interventions

DRUGUse of placebo is for masking purposes only in this study. all participants will be randomized to one of the active treatment arms. this study does not have a placebo control group

DRUGi.e.

DRUGno participant will receive placebo treatment only.

DRUGSolu-Moderín 125 mg polvo y disolvente para solución inyectable

DRUGClariscan 0

DRUG5 mmol/ml Injektionslösung

DRUGBIIB091

DRUGVumerity 231 mg gastro-resistant hard capsules

DRUGUse of placebo is for masking purposes only in this study. All participants will be randomized to one of the active treatment arms. This study does not have a placebo control group

DRUGno participant will receive placebo treatment only.

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Part 1: Number of Participants With Adverse Events (AEs), Part 1: Number of Participants With Serious Adverse Events (SAEs), Part 2: Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions	—

Secondary

Measure	Time frame
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, Part 2: Number of Participants With SAEs, 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 M	—

Measure

Time frame

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, Part 2: Number of Participants With SAEs, 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 M

—

Countries

Bulgaria, Czechia, Germany, Italy, Poland, Romania, Spain

Outcome results

None listed