Clinical trial • Phase II • Neurology
FREXALIMAB for Multiple sclerosis
Phase II trial of FREXALIMAB for Multiple sclerosis.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Multiple sclerosis
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 10-07-2024
- First CTIS Authorization Date
- 08-08-2024
Trial design
Randomised, matched placebo for test product frexalimab (placebo arm); no placebo dose or schedule specified in the available data-controlled Phase II trial across 13 sites in Spain, Bulgaria, France and others.
- Randomised
- Yes
- Comparator
- Matched Placebo for test product Frexalimab (placebo arm); no placebo dose or schedule specified in the available data
- Target Sample Size
- 104
- Trial Duration For Participant
- 2212
Eligibility
Recruits 104 Vulnerable population flag is set (isVulnerablePopulationSelected: true). Participants must be capable of giving signed informed consent. Subject information and informed consent forms are provided (multiple language versions and partner/pregnancy/child-data addenda are included), but no specific assent procedures for minors are described in the available data..
- Vulnerable Population
- Vulnerable population flag is set (isVulnerablePopulationSelected: true). Participants must be capable of giving signed informed consent. Subject information and informed consent forms are provided (multiple language versions and partner/pregnancy/child-data addenda are included), but no specific assent procedures for minors are described in the available data.
Inclusion criteria
- {"criterion_text":"- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.\n- The participant must have been diagnosed with RMS (relapsing-remitting MS and secondary progressive MS participants with relapses) according to the 2017 revision of the McDonald diagnostic criteria.\n- The participant must have at least 1 documented relapse within the previous year, or ≥2 documented relapses within the previous 2 years, or ≥1 active Gdenhancing brain lesion on an MRI scan in the past 6 months and prior to screening.\n- Body weight within 45 to 120 kg (inclusive) and body mass index (BMI) within the range 18.0 to 35.0 kg/m2 (inclusive) at Screening.\n- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n- Capable of giving signed informed consent."}
Exclusion criteria
- {"criterion_text":"- The participant has been diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria or with non-relapsing SPMS.\n- Positive human immunodeficiency virus (HIV) serology (anti HIV1 and anti HIV2 antibodies) or a known history of HIV infection, active or in remission.\n- Abnormal laboratory test(s) at Screening.\n- Presence of Hepatitis B surface antigen (HBsAg) or anti-Hepatitis B core antibodies (antiHBc Ab) at screening or within 3 months prior to first dose of study intervention.\n- Positive Hepatitis C antibody test result at screening or within 3 months prior to starting study intervention.\n- The participant has conditions or situations that would adversely affect participation in this study.\n- The participant has a history of or currently has concomitant medical or clinical conditions that would adversely affect participation in this study.\n- History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke and/or antiphosholipid syndrome and any participants requiring antithrombotic treatment.\n- Allergies to humanized monoclonal antibodies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions other than localized injection site reaction, to any biological molecule.\n- The participant has received any of the forbidden medications/treatments within the specified time frame before any baseline assessment.\n- The participant has taken other investigational drug within 3 months or 5- halflive, whichever is longer, before the screening visit.\n- The participant has an EDSS score >5.5 at the first screening visit.\n- The participant has had a relapse in the 30 days prior to randomization."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Number of new Gadolinium (Gd)-enhancing T1hyperintense (GdE T1) lesions at week 12","definition_or_measurement_approach":"Count of new gadolinium-enhancing T1 hyperintense brain lesions assessed by MRI at Week 12."}
Secondary endpoints
- {"endpoint_text":"- Total number of GdE T1 lesions at week 12","definition_or_measurement_approach":"Total count of gadolinium-enhancing T1 lesions on MRI at Week 12."}
- {"endpoint_text":"- Adverse events (AEs) and serious adverse events (SAEs) until week 316","definition_or_measurement_approach":"Safety monitoring through AE/SAE reporting up to Week 316 (collection of reported adverse events and serious adverse events)."}
- {"endpoint_text":"- Antidrug antibodies (ADA) until week 316","definition_or_measurement_approach":"Serologic testing for anti-drug antibodies conducted through scheduled immunogenicity assays up to Week 316."}
- {"endpoint_text":"- Pharmacokinetic (PK) parameters: Cmax until week 316","definition_or_measurement_approach":"PK sampling and analysis to determine Cmax through scheduled blood draws up to Week 316."}
- {"endpoint_text":"- PK parameter: tmax until week 316","definition_or_measurement_approach":"PK sampling to determine time to Cmax (tmax) from plasma concentration-time profiles up to Week 316."}
- {"endpoint_text":"- PK parameter: AUC0-tau until week 316","definition_or_measurement_approach":"PK sampling and calculation of area under the concentration-time curve over dosing interval (AUC0-tau) up to Week 316."}
- {"endpoint_text":"- PK parameter: t1/2z until week 316","definition_or_measurement_approach":"PK sampling to estimate terminal half-life (t1/2z) from concentration-time profiles up to Week 316."}
Recruitment
- Planned Sample Size
- 104
- Recruitment Window Months
- 74
- Consent Approach
- Participants must provide signed informed consent. Subject information and informed consent forms are available in multiple languages (documents present in English, Bulgarian, French, Spanish, German, Russian, Czech and language-specific addenda including partner/pregnancy and child-data forms). No details on assent for minors are provided; inclusion requires capacity to sign consent.
Geography
- Total Number Of Sites
- 13
- Total Number Of Participants
- 72
Spain
- Earliest CTIS Part Ii Submission Date
- 25-07-2024
- Latest Decision Or Authorization Date
- 23-04-2025
- Processing Time Days
- 272
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Neurology Department
- Principal Investigator Name
- Xavier Montalban
- Principal Investigator Email
- xavier.montalban@cem-cat.org
- Contact Person Name
- Xavier Montalban
- Contact Person Email
- xavier.montalban@cem-cat.org
- Site Name
- Hospital Alvaro Cunqueiro
- Department Name
- Neurology Department
- Principal Investigator Name
- Ines Maria Gonzalez Suarez
- Principal Investigator Email
- igonsua@gmail.com
- Contact Person Name
- Ines Maria Gonzalez Suarez
- Contact Person Email
- igonsua@gmail.com
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 25-07-2024
- Latest Decision Or Authorization Date
- 24-04-2025
- Processing Time Days
- 273
- Number Of Sites
- 3
- Number Of Participants
- 23
Sites
- Site Name
- University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
- Department Name
- Clinic of Neurology
- Principal Investigator Name
- Maya Danovska-Mladenova
- Principal Investigator Email
- mdanovska@yahoo.com
- Contact Person Name
- Maya Danovska-Mladenova
- Contact Person Email
- mdanovska@yahoo.com
- Site Name
- Acibadem City Clinic Tokuda University Hospital EAD
- Department Name
- Clinic of Neurology and Sleep Medicine
- Principal Investigator Name
- Ivan Staikov
- Principal Investigator Email
- ivanstaikov@hotmail.com
- Contact Person Name
- Ivan Staikov
- Contact Person Email
- ivanstaikov@hotmail.com
- Site Name
- Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
- Department Name
- Department of Multiple Sclerosis
- Principal Investigator Name
- Ivan MILANOV
- Principal Investigator Email
- acad_prof_ivan_milanov@yahoo.com
- Contact Person Name
- Ivan MILANOV
- Contact Person Email
- acad_prof_ivan_milanov@yahoo.com
France
- Earliest CTIS Part Ii Submission Date
- 25-07-2024
- Latest Decision Or Authorization Date
- 28-04-2025
- Processing Time Days
- 277
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Centre Hospitalier Dr Jean Eric Techer
- Department Name
- service de Neurologie
- Principal Investigator Name
- Nemanan Sagno
- Principal Investigator Email
- n.sagno@ch-calais.fr
- Contact Person Name
- Nemanan Sagno
- Contact Person Email
- n.sagno@ch-calais.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 25-07-2024
- Latest Decision Or Authorization Date
- 24-04-2025
- Processing Time Days
- 273
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Universitaet Muenster
- Department Name
- Neurologie
- Principal Investigator Name
- Luisa Klotz
- Principal Investigator Email
- luisa.klotz@ukmuenster.de
- Contact Person Name
- Luisa Klotz
- Contact Person Email
- luisa.klotz@ukmuenster.de
- Site Name
- Universitaet Leipzig
- Department Name
- Neurologie
- Principal Investigator Name
- Florian Then Bergh
- Principal Investigator Email
- florian.thenbergh@medizin.uni-leipzig.de
- Contact Person Name
- Florian Then Bergh
- Contact Person Email
- florian.thenbergh@medizin.uni-leipzig.de
Czechia
- Earliest CTIS Part Ii Submission Date
- 25-07-2024
- Latest Decision Or Authorization Date
- 23-04-2025
- Processing Time Days
- 272
- Number Of Sites
- 5
- Number Of Participants
- 36
Sites
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Neurologická klinika
- Principal Investigator Name
- Pavel Hradilek
- Principal Investigator Email
- pavel.hradilek@seznam.cz
- Contact Person Name
- Pavel Hradilek
- Contact Person Email
- pavel.hradilek@seznam.cz
- Site Name
- Fakultni Nemocnice U Sv Anny V Brne
- Department Name
- Neurologická klinika
- Principal Investigator Name
- Michal Dufek
- Principal Investigator Email
- michal.dufek@fnusa.cz
- Contact Person Name
- Michal Dufek
- Contact Person Email
- michal.dufek@fnusa.cz
- Site Name
- Krajska zdravotni a.s.
- Department Name
- MS centrum při neurologickém oddělení
- Principal Investigator Name
- Marta Vachova
- Principal Investigator Email
- marta.vachova@kzcr.eu
- Contact Person Name
- Marta Vachova
- Contact Person Email
- marta.vachova@kzcr.eu
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Neurologická klinika
- Principal Investigator Name
- Zbysek Pavelek
- Principal Investigator Email
- zbysekpavelek@email.cz
- Contact Person Name
- Zbysek Pavelek
- Contact Person Email
- zbysekpavelek@email.cz
- Site Name
- Nemocnice Jihlava prispevkova organizace
- Department Name
- Neurologické oddělení
- Principal Investigator Name
- Radek Ampapa
- Principal Investigator Email
- ampapar@gmail.com
- Contact Person Name
- Radek Ampapa
- Contact Person Email
- ampapar@gmail.com
Sponsor
Primary sponsor
- Full Name
- Sanofi-Aventis Recherche & Developpement
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Contract research organisations
- Name
- Endpoint Clinical Inc.
- Responsibilities
- sponsorDuties codes: 3
- Name
- IQVIA Laboratories LLC
- Responsibilities
- sponsorDuties codes: 4
- Name
- Labcorp Early Development Laboratories Inc.
- Responsibilities
- sponsorDuties codes: 4
- Name
- Charles River Laboratories Inc.
- Responsibilities
- sponsorDuties codes: 4
- Name
- Azenta US Inc.
- Responsibilities
- sponsorDuties codes: 4
- Name
- ESMS Global Limited
- Responsibilities
- Centralized 24-Hour Emergency System: eSMS (sponsorDuties code 15)
- Name
- Neurorx Research Inc.
- Responsibilities
- Central Medical Reading or Imaging Reading (sponsorDuties code 15)
Third parties
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Cellcarta Biosciences Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"IQVIA Laboratories LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Charles River Laboratories Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System: eSMS (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Neurorx Research Inc.","duties_or_roles":"Central Medical Reading or Imaging Reading (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}
- {"country":"Czechia","full_name":"PHOENIX lekarensky velkoobchod s.r.o.","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Frexalimab
- Active Substance
- FREXALIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS (IV) OR SUBCUTANEOUS (SC)
- Route
- INTRAVENOUS (IV) OR SUBCUTANEOUS (SC)
- Maximum Dose
- 1800 mg
- Investigational Product Name
- Matched Placebo for test product Frexalimab
- Modality
- Other
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