A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

F. Hoffmann-La Roche AG

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

25 Jan 2022 → ongoing

Decision date (initial)

2024-08-06

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

F. Hoffmann-La Roche AG

External identifiers

EU CT number

2022-502619-13-00

EudraCT number

2021-003772-14

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacokinetic, Safety

To evaluate the efficacy of fenebrutinib compared with placebo on the total number of new gadolinium-enhancing T1 magnetic resonance imaging (MRI) lesions

Secondary objectives 3

1. To evaluate the effect of fenebrutinib on MRI Lesions
2. To evaluate the safety of fenebrutinib compared with placebo
3. To characterize the fenebrutinib PK profile

Conditions and MedDRA coding

Relapsing Multiple Sclerosis

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

IPD plan description

N/A

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Participants who are aged 18 to 55 years inclusive at the time of signing Informed Consent Form
2. A diagnosis of relapsing MS (RMS) in accordance with the revised 2017 McDonald Criteria and one of the following: • At least two documented clinical relapses within the last 2 years or one documented clinical relapse within 12 months of screening (but not within the 30 days prior to screening) • Documented evidence of the presence of at least one T1 Gd+ lesion on MRI in the 6 months prior to randomization (may include the screening MRI)
3. Expanded Disability Status Scale (EDSS) at screening from 0 to 5.5 points
4. For women of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs during the treatment period and for 28 days after the final dose of fenebrutinib
5. For men: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 28 days after the final dose of fenebrutinib to avoid exposing the embryo

Exclusion criteria 6

1. Disease duration of >10 years from the onset of symptoms and an EDSS score at screening < 2.0
2. A diagnosis of primary progressive MS or non-active secondary progressive MS
3. Any known or suspected active infection at screening or baseline, or any major episode of infection requiring hospitalization or treatment with IV anti-microbials within 8 weeks prior to or during screening or treatment with oral anti-microbials within 2 weeks prior to or during screening
4. History of progressive multifocal leukoencephalopathy (PML)
5. History of cancer
6. Presence of other neurological disorders, that could interfere with the diagnosis of MS or with the assessments of efficacy or safety during the study, evidence of clinically significant psychiatric, pulmonary, renal, hepatic, metabolic, gastrointestinal (GI), or cardiovascular disease, or endocrine disease

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. Total number of new gadolinium-enhancing T1 lesions observed on MRI scans of the brain at Weeks 4, 8, and 12

Secondary endpoints 7

1. 1. Total number of new or enlarging T2- weighted lesions observed on brain MRI at Weeks 4, 8, and 12
2. 2. Proportion of participants free from any new gadolinium-enhancing T1 lesions and new or enlarging T2-weighted lesions observed on brain MRI at Weeks 4, 8, and 12
3. 3. Incidence and severity of adverse events
4. 4. Change from baseline in vital signs
5. 5. Change from baseline in targeted clinical laboratory test results
6. 6. Proportion of participants with suicidal ideation or behavior, as assessed by Columbia-Suicide Severity Rating Scale
7. 7. Plasma concentration of fenebrutinib at specified timepoints

Investigational products

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

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation

F. Hoffmann-La Roche AG

Address

Grenzacherstrasse 124

City

Basel

Postcode

4058

Country

Switzerland

Scientific contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Public contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Third parties 9

Locations

3 EU/EEA countries · 9 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 34 files

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

Application history

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