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Monoclonal Antibodies
BIIB091 for Relapsing Multiple Sclerosis (FUSION Trial)
Phase 2
Recruiting
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8 to week 16
Awards & highlights
FUSION Trial Summary
This trial will test the safety and effectiveness of a drug to reduce inflammation in the brains of people with relapsing multiple sclerosis.
Who is the study for?
This trial is for people with relapsing forms of Multiple Sclerosis (RMS) diagnosed per the 2017 McDonald criteria, who've had symptoms for less than 20 years. Participants should have experienced at least one MS flare-up in the past two years but not within the last month before starting the trial. They must also have an EDSS score between 0 and 5.0, indicating a certain level of disability.Check my eligibility
What is being tested?
The study tests BIIB091 alone or combined with Diroximel Fumarate (DRF) against DRF alone to see how well they control brain inflammation in RMS, as shown by MRI scans. Part one focuses on BIIB091's safety and tolerability; part two compares its effectiveness when added to DRF versus DRF treatment alone.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to either BIIB091 or DRF, infusion-related responses such as fever or chills, possible liver issues indicated by hepatitis B exclusion, and general risks associated with immune-modulating therapies like increased infection risk.
FUSION Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 8 to week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8 to week 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 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
+10 moreFUSION Trial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: Part 2: BIIB091 + DRF Standard DoseExperimental Treatment2 Interventions
Participants will receive selected dose of BIIB091 (based on Part 1 data) and DRF standard dose, orally, for up to 48 weeks.
Group II: Part 2: BIIB091 + DRF Low DoseExperimental Treatment2 Interventions
Participants will receive selected dose of BIIB091 (based on Part 1 data) and DRF low dose, orally, for up to 48 weeks.
Group III: Part 1: BIIB091 Low Dose + Matching Placebo for DRFExperimental Treatment2 Interventions
Participants will receive BIIB091 low dose and matching placebo for DRF, orally, for up to 48 weeks.
Group IV: Part 1: BIIB091 High Dose + Matching Placebo for DRFExperimental Treatment2 Interventions
Participants will receive BIIB091 high dose and matching placebo for DRF, orally, for up to 48 weeks.
Group V: Part 1: DRF + Matching Placebo for BIIB091Active Control2 Interventions
Participants will receive DRF standard dose and matching placebo for BIIB091, orally, for up to 48 weeks.
Group VI: Part 2: DRF + Matching Placebo for BIIB091Active Control2 Interventions
Participants will receive DRF standard dose and matching placebo for BIIB091, orally, for up to 48 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BIIB091
2019
Completed Phase 1
~130
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
BiogenLead Sponsor
639 Previous Clinical Trials
467,047 Total Patients Enrolled
226 Trials studying Multiple Sclerosis
141,943 Patients Enrolled for Multiple Sclerosis
Medical DirectorStudy DirectorBiogen
2,777 Previous Clinical Trials
8,064,129 Total Patients Enrolled
136 Trials studying Multiple Sclerosis
126,084 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with RMS according to the 2017 criteria.I have been diagnosed with primary progressive multiple sclerosis.I have had an MS flare-up within the last 30 days or am still recovering from one.I have or had hepatitis C.I've had 1 relapse and 1 new brain MRI finding in the last year, but no relapses in the last 30 days.I am allergic to fumarate or BTK inhibitor treatments.I've had 2 flare-ups of my condition in the last 2 years, but none in the last month.My MS symptoms started less than 20 years ago.I have or might have hepatitis B.I am not currently in, nor plan to join, another clinical study within the next 90 days or until 5 half-lives of any investigational drug I've taken have passed, whichever is longer.I have tested positive for COVID-19 in the last 4 weeks.My disability level is moderate or better.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1: DRF + Matching Placebo for BIIB091
- Group 2: Part 1: BIIB091 Low Dose + Matching Placebo for DRF
- Group 3: Part 2: DRF + Matching Placebo for BIIB091
- Group 4: Part 2: BIIB091 + DRF Standard Dose
- Group 5: Part 2: BIIB091 + DRF Low Dose
- Group 6: Part 1: BIIB091 High Dose + Matching Placebo for DRF
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the program allow for octogenarians to participate?
"This medical trial is recruiting participants ranging from 18 to 55 years of age. There are 42 studies available for younger individuals and 398 trials catered towards those 65 or older."
Answered by AI
Is it possible for me to participate in this research initiative?
"In order to meet the eligibility requirements of this trial, potential participants must be afflicted with multiple sclerosis and between 18 - 55 years. Ultimately, 275 individuals will take part in the study."
Answered by AI
Has the administration sanctioned Part 2: BIIB091 + DRF Standard Dose?
"Due to limited data on efficacy, Part 2: BIIB091 + DRF Standard Dose was assigned a score of 2 based on the available safety information."
Answered by AI
Are recruitment efforts still open for this experiment?
"Affirmative! According to the clinicaltrials.gov website, this research is currently accepting participants; it was first posted on July 25th 2023 and revised most recently on August 17th 2023. A total of 275 patients are needed from two sites for enrolment in this trial."
Answered by AI
How many volunteers are enrolled in this trial?
"Indeed, according to clinicaltrials.gov, this study is actively seeking participants; it was initially posted on July 25th 2023 and the data was recently updated last month. The trial hopes to enroll 275 patients across 2 centres."
Answered by AI
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