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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05798520
Other study ID # 257MS201
Secondary ID 2022-502552-31
Status Recruiting
Phase Phase 2
First received
Last updated
Start date July 25, 2023
Est. completion date November 9, 2026

Study information

Verified date May 2024
Source Biogen
Contact US Biogen Clinical Trial Center
Phone 866-633-4636
Email clinicaltrials@biogen.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objectives are to investigate the safety and tolerability of BIIB091 monotherapy in participants with relapsing multiple sclerosis (RMS) (Part 1), 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 (Part 2). The secondary objectives are to evaluate the effects of BIIB091 monotherapy on the MRI measures of active CNS inflammation, to evaluate the effects of BIIB091 combination therapy with DRF compared with the DRF monotherapy arm on additional MRI measures of active CNS inflammation, to investigate the safety and tolerability of BIIB091 combination therapy with DRF in participants with RMS.


Recruitment information / eligibility

Status Recruiting
Enrollment 275
Est. completion date November 9, 2026
Est. primary completion date July 10, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Key Inclusion Criteria: 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. Key Exclusion Criteria: 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 or positive test result at screening for human immunodeficiency virus (HIV). 6. Current or history of hepatitis C infection regardless of viral load. 7. Current or possible hepatitis B. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BIIB091
Administered as specified in the treatment arm.
DRF
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.

Locations

Country Name City State
Bulgaria 'MHAT Avis - Medica' OOD Pleven
Bulgaria UMHAT 'Dr. Georgi Stranski', EAD Pleven
Bulgaria UMHAT 'Sv. Georgi', EAD Plovdiv
Bulgaria Acibadem City Clinic Tokuda University Hospital Ead Sofia
Bulgaria DCC Neoclinic EAD Sofia
Bulgaria Diagnostic Consultation Center CONVEX EOOD Sofia
Bulgaria MHATNP 'Sv.Naum', EAD Sofia
Bulgaria UMHAT "Sv. Ivan Rilski", EAD Sofia
Bulgaria University First MHAT-Sofia, 'St. Joan Krastitel' EAD Sofia
Czechia Fakultni nemocnice u sv. Anny v Brne Brno
Czechia Fakultni nemocnice Hradec Kralove Hradec Kralove
Czechia Nemocnice Jihlava p.o. Jihlava
Czechia Fakultni Thomayerova nemocnice Praha 4-Krc
Czechia Krajska zdravotni a.s. - Nemocnice Teplice o.z. Teplice
Germany Klinikum Bayreuth GmbH- Hohe Warte Bayreuth Bayern
Germany Studienzentrum fur Neurologie und Psychiatrie Boeblingen Baden Wuerttemberg
Germany Universitaetsklinikum Carl Gustav Carus TU Dresden Dresden
Germany Universitaetsklinikum Duesseldorf AoeR Duesseldorf Nordrhein Westfalen
Germany ZNS - Zentrum fuer Neurologisch-Psychiatrische Studien Siegen Nordrhein Westfalen
Germany Neuropraxis Muenchen Sued Unterhaching Bayern
Italy Fondazione Istituto G.Giglio di Cefalù Cefalù Palermo
Italy IRCCS Ospedale Policlinico San Martino Genova
Italy Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" Napoli
Italy Fondazione Istituto Neurologico Casimiro Mondino Pavia
Italy I.R.C.C.S. Neuromed-Istituto Neurologico Mediterraneo Pozzilli Isernia
Italy Azienda Ospedaliera Universitaria Policlinico Tor Vergata Roma
Italy Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza Roma
Poland COPERNICUS Podmiot Leczniczy Sp. z o. o., Gdansk
Poland Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. Jana Pawla II Grodzisk Mazowiecki
Poland Centrum Medyczne Pratia Katowice Katowice
Poland M.A. - LEK A.M.Maciejowscy SC. Katowice
Poland Nzoz Novo-Med Katowice
Poland Resmedica Sp.z o.o Kielce
Poland MCD Medical Krakow
Poland Szpital Uniwersytecki w Krakowie Krakow
Poland Centrum Neurologii K. Selmaj Lodz
Poland Instytut Zdrowia dr Boczarska-Jedynak sp.z.o.o, Sp.K Oswiecim
Poland Med-Polonia Sp. z o.o. Poznan
Poland NZOZ 'NEURO-KARD', 'Ilkowski i Partnerzy' Sp. Partn. Lek. Poznan
Poland Nzoz Palomed Rzeszów
Poland NeuroProtect Sp. z o.o. Warszawa
Poland Wielospecjalistyczne Centrum Medyczne Ibismed Zabrze
Puerto Rico Caribbean Center for Clinical Research Guaynabo
Romania S.C Neurocity S.R.L Bucure?ti
Romania Spitalul Universitar de Urgenta Elias Bucuresti
Romania S.C Clubul Sanatatii SRL Campulung Muscel
Spain Hospital del Mar Barcelona
Spain Hospital Universitario Reina Sofia Cordoba
Spain Hospital Universitario Virgen de la Arrixaca El Palmar Murcia
Spain Hospital Universitario Ramon y Cajal Madrid
Spain Hospital Regional Universitario de Malaga Malaga
Spain Hospital Universitario Quironsalud Madrid Pozuelo de Alarcon Madrid
Switzerland Inselspital - Universitaetsspital Bern Bern
Switzerland Ospedale Regionale di Lugano Lugano Ticino
Switzerland Universitaetsspital Zuerich Zuerich
United States University of New Mexico Albuquerque New Mexico
United States University of Colorado School of Medic Aurora Colorado
United States Alta Bates Summit Medical Center Berkeley California
United States The Cleveland Clinic Foundation Cleveland Ohio
United States The Boster Center for Multiple Sclerosis Columbus Ohio
United States Neurology Clinic, PC Cordova Tennessee
United States Fort Wayne Neurological Center Fort Wayne Indiana
United States University of Kansas Medical Center Research Institute, Inc. Kansas City Kansas
United States International Neurorehabilitation Institute Lutherville Maryland
United States University of Wisconsin Hospital and Clinics Madison Wisconsin
United States University of California at Irvine Medical Center Orange California
United States South Shore Neurologic Associates, P.C. Patchogue New York
United States Washington University Saint Louis Missouri
United States The University of Texas Health Science Center San Antonio San Antonio Texas
United States HonorHealth Neurology Scottsdale Arizona
United States University of South Florida Tampa Florida
United States Holy Name Teaneck New Jersey
United States Vero Beach Neurology and Research Institute Vero Beach Florida
United States Wake Forest University - School of Medicine - Central Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  Germany,  Italy,  Poland,  Puerto Rico,  Romania,  Spain,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Part 1: Number of Participants With Adverse Events (AEs) An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product or auxiliary medicinal product, whether or not related to the medicinal (investigational) product or auxiliary medicinal product. Day 1 up to Week 50
Primary Part 1: Number of Participants With Serious Adverse Events (SAEs) SAE is any untoward medical occurrence that at any dose results in death, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or is a medically important event. From signing the informed consent form (ICF) to Week 50
Primary Part 2: Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions Week 8 to Week 16
Secondary Part 1: Cumulative Number of New T1 Gadolinium-Enhancing (GdE) Lesions Week 8 to Week 16
Secondary Part 1: Cumulative Number of New or Enlarging T2 Hyperintense Lesions Week 8 to Week 16
Secondary Part 1: Cumulative Volume of New or Enlarging T2 Hyperintense Lesions Week 8 to Week 16
Secondary Part 1: Mean Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF), RR, PR, QRS, and QT Intervals Up to Week 50
Secondary Part 1: Number of Participants With Change From Baseline in Heart Rate Up to Week 50
Secondary Part 1: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities Up to Week 50
Secondary Part 2: Cumulative Number of New or Enlarging T2 Hyperintense Lesions Week 8 to Week 16
Secondary Part 2: Cumulative Volume of New or Enlarging T2 Hyperintense Lesions Week 8 to Week 16
Secondary Part 2: Number of Participants With AEs An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product or auxiliary medicinal product, whether or not related to the medicinal (investigational) product or auxiliary medicinal product. Day 1 up to Week 50
Secondary Part 2: Number of Participants With SAEs SAE is any untoward medical occurrence that at any dose results in death, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or is a medically important event. From signing of ICF up to Week 50
Secondary Part 2: Number of Participants With Change From Baseline in QTcF, RR, PR, QRS, and QT intervals Up to Week 50
Secondary Part 2: Number of Participants With Change From Baseline in Heart Rate Up to Week 50
Secondary Part 2: Number of Participants With ECG Abnormalities as Assessed by 12-Lead ECG Measurements Up to Week 50
See also
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