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FENopta: A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05119569
Collaborator
(none)
102
Enrollment
11
Locations
2
Arms
30.9
Anticipated Duration (Months)
9.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a study evaluating the effect of fenebrutinib on brain MRI in participants with RMS. The safety and pharmacokinetics of fenebrutinib will also be evaluated. Participants will be randomized to receive either fenebrutinib or placebo.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
102 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Sponsor will also be blinded.
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Nov 25, 2022
Anticipated Study Completion Date :
Sep 26, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: fenebrutinib

Participants will receive oral fenebrutinib.

Drug: fenebrutinib
fenebrutinib will be administered orally.
Placebo Comparator: placebo

Participants will receive oral placebo.

Drug: placebo
placebo will be administered orally.

Outcome Measures

Primary Outcome Measures

  1. Total number of new gadolinium-enhancing T1 lesions observed on MRI scans of the brain [12 weeks]

Secondary Outcome Measures

  1. Number of new or enlarging T2-weighted lesions observed on MRI scans of the brain [Weeks 4, 8 and 12]

  2. Percentage of Participants free from any new gadolinium-enhancing T1 lesions and new or enlarging T2-weighted lesions observed on MRI scans of the brain [Weeks 4, 8 and 12]

  3. Percentage of Participants with Adverse Events (AEs) [Up to 96 weeks]

  4. Plasma Concentrations of fenebrutinib at specified timepoints [Up to 96 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria.

  • Expanded Disability Status Scale (EDSS) score of 0 - 5.5 at screening.

  • For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating eggs.

  • For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating sperm.

Exclusion Criteria:

  • Disease duration of > 10 years from the onset of symptoms and an EDSS score at screening < 2.0.

  • Female participants who are pregnant or breastfeeding, or intending to become pregnant.

  • Male participants who intend to father a child during the study.

  • A diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or non-active Secondary Progressive Multiple Sclerosis (SPMS).

  • Any known or suspected active infection at screening, including but not limited to a positive screening tests for Hepatitis B and C, an active or latent or inadequately treated infection with tuberculosis (TB), a confirmed or suspected progressive multifocal leukoencephalopathy (PML).

  • History of cancer including hematologic malignancy and solid tumors within 10 years of screening.

  • Known presence of other neurological disorders, clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal disease.

  • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.

  • History of alcohol or other drug abuse within 12 months prior to screening.

  • History of or currently active primary or secondary (non-drug-related) immunodeficiency, including known history of HIV infection.

  • Inability to complete an MRI scan.

  • Adrenocorticotropic hormone or systemic corticosteroid therapy within 4 weeks prior to screening.

  • Receipt of a live-attenuated vaccine within 6 weeks prior to randomization.

  • Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fullerton Neurology and Headache Center Fullerton California United States 92835
2 University Clinical Centre of the Republic of Srpska Banja Luka Bosnia and Herzegovina 78000
3 Clinical Hospital Center Rijeka - PPDS Rijeka Croatia 51000
4 General Hospital Varazdin Varazdin Croatia 42000
5 Klinicki bolnicki centar Zagreb Zagreb Croatia 10000
6 Poliklinika Solmed Zagreb Croatia 10000
7 Fakultni nemocnice u sv. Anny v Brne Brno Czechia 656 91
8 Fakultni nemocnice Hradec Kralove Hradec Kralove Czechia 500 05
9 Nemocnice Jihlava Jihlava. Czechia 586 33
10 Univerzita Karlova v Praze a Vseobecna fakultni nemocnice v Praze - 1; Lekarska Fakulta - I Prague 2 Czechia 128 08
11 Univerzitna nemocnica Bratislava Bratislava Slovakia 813 69

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT05119569
Other Study ID Numbers:
  • GN43271
  • 2021-003772-14
First Posted:
Nov 15, 2021
Last Update Posted:
Aug 4, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis

Study Results

No Results Posted as of Aug 4, 2022