A Study to Learn About the Safety of BIIB091 and Its Effect on Brain Inflammation When Taken Alone or With Diroximel Fumarate (DRF) in Adults With Relapsing Forms of Multiple Sclerosis (MS) (FUSION)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Biogen Idec Research Limited

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

3 Oct 2023 → 10 Feb 2026

Decision date (initial)

2023-10-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Biogen Idec Research Limited

External identifiers

EU CT number

2022-502552-31-00

ClinicalTrials.gov

NCT05798520

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

(Part 1)

To investigate the safety and tolerability of BIIB091 monotherapy in participants with relapsing multiple sclerosis (RMS),

(Part 2)

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

Secondary objectives 3

1. To evaluate the effects of BIIB091 monotherapy on the MRI measures of active CNS inflammation
2. To evaluate the effects of BIIB091 combination therapy with DRF compared with the DRF monotherapy arm on additional MRI measures of active CNS inflammation
3. To investigate the safety and tolerability of BIIB091 combination therapy with DRF in participants with RMS.

Conditions and MedDRA coding

Relapsing Forms of Multiple Sclerosis

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

In accordance with Biogen’s Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/ Supporting Information: IPD Sharing Url https://vivli.org/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Diagnosis of RMS [relapsing—remitting multiple sclerosis (RRMS) or active secondary progressive multiple sclerosis (SPMS] in accordance with the 2017 Revised McDonald criteria.
2. Time since MS symptom onset is < 20 years
3. Must have expanded disability status scale (EDSS) score of 0 through 5.0 at Screening and Baseline
4. 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 reading 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.

Exclusion criteria 8

1. Diagnosis of primary progressive multiple sclerosis (PPMS) in accordance with the 2017 Revised McDonald criteria.
2. 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.
3. 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
4. Evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within the past 4 weeks prior to Baseline.
5. History of human immunodeficiency virus (HIV) or a positive or indeterminate test result at screening for HIV
6. Current or history of hepatitis C infection regardless of viral load
7. Current or possible hepatitis B infection
8. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

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

Secondary endpoints 13

1. Part 1: Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions
2. Part 1: Cumulative Number of New or Enlarging T2 Hyperintense Lesions
3. Part 1: Cumulative Volume of New or Enlarging T2 Hyperintense Lesions
4. Part 1: Mean Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF), RR, PR, QRS, and QT Intervals
5. Part 1: Number of Participants With Change From Baseline in Heart Rate
6. Part 1: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
7. Part 2: Cumulative Number of New or Enlarging T2 Hyperintense Lesions
8. Part 2: Cumulative Volume of New or Enlarging T2 Hyperintense Lesions
9. Part 2: Number of Participants With AEs
10. Part 2: Number of Participants With SAEs
11. Part 2: Number of Participants With Change From Baseline in QTcF, RR, PR, QRS, and QT intervals
12. Part 2: Number of Participants With Change From Baseline in Heart Rate
13. Part 2: Number of Participants With ECG Abnormalities as Assessed by 12-Lead ECG Measurements

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 2

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Biogen Idec Research Limited

Sponsor organisation

Biogen Idec Research Limited

Address

Building 5 Foundation Park, Roxborough Way Roxborough Way

City

Maidenhead

Postcode

SL6 3UD

Country

United Kingdom

Scientific contact point

Organisation

Biogen Idec Research Limited

Contact name

Clinical Trials Information Desk

Public contact point

Organisation

Biogen Idec Research Limited

Contact name

Clinical Trials Information Desk

Third parties 15

Locations

7 EU/EEA countries · 47 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 263 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

21 submissions — initial application plus substantial / non-substantial modifications