HumRes65663
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SNCTP000006014
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BASEC2024-00336
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NCT06141473
A study comparing the efficacy and safety of Frexalimab versus Teriflunomide in adult participants with relapsing multiple sclerosis.
Descrizione riassuntiva dello studio
The investigational drug Frexalimab may help limit the abnormal immune response against brain tissue. The primary objective of this study is to assess the efficacy and safety of Frexalimab in reducing relapse frequency and slowing the progression of disability in RMS over time, compared to one of the usual treatments with Teriflunomide. Despite the disease-modifying therapies (DMTs) approved for relapsing multiple sclerosis, there remains a need for additional effective therapies. Current therapies cannot guarantee long-term suppression of inflammatory activity in multiple sclerosis (MS), including relapse and new lesion control via magnetic resonance imaging (MRI). While some medications delay the progression of relapsing multiple sclerosis, the disease can still not be fully controlled, and it impacts daily activities and well-being.
(BASEC)
Intervento studiato
Frexalimab: 1800 mg of frexalimab (Day 1), then 1200 mg
Teriflunomide 14mg
Placebo
Activated charcoal
Cholestyramine
MRI with contrast agent Gadolinium
(BASEC)
Malattie studiate
Multiple sclerosis (MS) is a chronic inflammatory disease. It affects the central nervous system. In patients with an autoimmune disease, such as multiple sclerosis, the body's immune system attacks brain tissue, causing your symptoms (as well as changes in specific tests such as magnetic resonance imaging -MRI-). Symptoms are varied, and the courses differ. It often begins with relapses and symptom-free phases, later the disease progresses to a secondary progressive course. However, there are also patients whose course is progressive from the outset. Multiple sclerosis is not curable, but the disease can be treated. The main treatment goals include reducing relapse frequency and slowing the progression of disability in RMS over time.
(BASEC)
Criteri di partecipazione
1- Participants must be between 18 and 55 years of age at the time of signing the informed consent form. 2- The participant must have been diagnosed with RMS according to the 2017 revised McDonald diagnostic criteria. 3- The participant has an EDSS score ≤ 5.5 at the first visit (screening visit). (BASEC)
Criteri di esclusione
1- The participant has been diagnosed with primary progressive MS according to the 2017 revised McDonald diagnostic criteria or secondary progressive MS without activity. 2- The participant has a history of infections or is potentially at risk for infection: • Known history of T-lymphocyte or T-lymphocyte receptor vaccination, transplantation (including solid organ transplantation, stem cells, and bone marrow) and/or anti-rejection therapy. • The participant has received a live (attenuated) vaccine within three months prior to the first treatment visit (including, but not limited to, Varicella-Zoster, oral Polio, and nasal Influenza vaccines). • The participant has at the screening visit a lymphocyte count below the lower limit of normal (Lower Limit of Normal, LLN). • A history of diagnosis of progressive multifocal leukoencephalopathy (PML) or imaging findings suggestive of PML on MRI at the screening visit. • Known history of infection with human immunodeficiency virus (HIV) (e.g., known positive HIV test or information from a conversation with the participant). • A history of active or latent tuberculosis (TB). Severe systemic viral, bacterial, or fungal infection (e.g., pneumonia, pyelonephritis); infection requiring hospitalization or intravenous antibiotic administration, or significant chronic viral, bacterial, or fungal infection (e.g., osteomyelitis) 30 days prior to and during the screening visit. • Participants with a history of invasive opportunistic infections, including, but not limited to, histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, Pneumocystis jirovecii, and aspergillosis. • Fever within 28 days after the screening visit (≥ 38 °C; however, if this is due to a brief and mild viral infection in the upper respiratory tract, the participant may be included at the discretion of the investigator). • Other active infections that, in the opinion of the investigator, would negatively affect participation or administration of the investigational drug in this study. 3- Presence of psychiatric disorders or substance abuse demonstrated by: • History of psychiatric illness, behavioral abnormalities, or depression requiring hospitalization within two years prior to the screening visit. • Documented history of a suicide attempt or suicidal thoughts in the six months prior to the screening visit or if, in the opinion of the investigator, the participant is at risk for a suicide attempt. • Active alcohol consumption or history of alcohol or drug abuse within 1 year prior to the first screening visit. (BASEC)
1- Participants must be between 18 and 55 years of age at the time of signing the informed consent form. 2- The participant must have been diagnosed with RMS according to the 2017 revised McDonald diagnostic criteria. 3- The participant has an EDSS score ≤ 5.5 at the first visit (screening visit). (BASEC)
Criteri di esclusione
1- The participant has been diagnosed with primary progressive MS according to the 2017 revised McDonald diagnostic criteria or secondary progressive MS without activity. 2- The participant has a history of infections or is potentially at risk for infection: • Known history of T-lymphocyte or T-lymphocyte receptor vaccination, transplantation (including solid organ transplantation, stem cells, and bone marrow) and/or anti-rejection therapy. • The participant has received a live (attenuated) vaccine within three months prior to the first treatment visit (including, but not limited to, Varicella-Zoster, oral Polio, and nasal Influenza vaccines). • The participant has at the screening visit a lymphocyte count below the lower limit of normal (Lower Limit of Normal, LLN). • A history of diagnosis of progressive multifocal leukoencephalopathy (PML) or imaging findings suggestive of PML on MRI at the screening visit. • Known history of infection with human immunodeficiency virus (HIV) (e.g., known positive HIV test or information from a conversation with the participant). • A history of active or latent tuberculosis (TB). Severe systemic viral, bacterial, or fungal infection (e.g., pneumonia, pyelonephritis); infection requiring hospitalization or intravenous antibiotic administration, or significant chronic viral, bacterial, or fungal infection (e.g., osteomyelitis) 30 days prior to and during the screening visit. • Participants with a history of invasive opportunistic infections, including, but not limited to, histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, Pneumocystis jirovecii, and aspergillosis. • Fever within 28 days after the screening visit (≥ 38 °C; however, if this is due to a brief and mild viral infection in the upper respiratory tract, the participant may be included at the discretion of the investigator). • Other active infections that, in the opinion of the investigator, would negatively affect participation or administration of the investigational drug in this study. 3- Presence of psychiatric disorders or substance abuse demonstrated by: • History of psychiatric illness, behavioral abnormalities, or depression requiring hospitalization within two years prior to the screening visit. • Documented history of a suicide attempt or suicidal thoughts in the six months prior to the screening visit or if, in the opinion of the investigator, the participant is at risk for a suicide attempt. • Active alcohol consumption or history of alcohol or drug abuse within 1 year prior to the first screening visit. (BASEC)
Luogo dello studio
Berna
(BASEC)
Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (T�rkiye), Ukraine, United Arab Emirates, United Kingdom, United States (ICTRP)
Sponsor
Sanofi-Aventis Recherche and Development Sanofi-Aventis Switzerland
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Hanka Klaus
+493025752442
CSU-CTA-EK@cluttersanofi.comSanofi- Aventis Switzerland
(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
08.08.2024
(BASEC)
ID di studio ICTRP
NCT06141473 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Master protocol of two independent, randomized, double-blind, Phase 3 studies comparing efficacy and safety of frexalimab (SAR441344) to teriflunomide in adult participants with relapsing forms of multiple sclerosis (BASEC)
Titolo accademico
Master Protocol of Two Independent, Randomized, Double-blind, Phase 3 Studies Comparing Efficacy and Safety of Frexalimab (SAR441344) to Teriflunomide in Adult Participants With Relapsing Forms of Multiple Sclerosis (ICTRP)
Titolo pubblico
Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis (ICTRP)
Malattie studiate
Multiple Sclerosis (ICTRP)
Intervento studiato
Drug: FrexalimabDrug: TeriflunomideDrug: Placebo infusionDrug: Placebo tabletDrug: MRI contrast-enhancing agentsDrug: CholestyramineDrug: Activated charcoal (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria:
- The participant must have been diagnosed with RMS according to the 2017 revision of
the McDonald diagnostic criteria.
- The participant has an EDSS score =5.5 at the first visit (Screening Visit)
- The participant must have at least 1 of the following prior to screening:
- =1 documented relapse within the previous year OR
- =2 documented relapses within the previous 2 years, OR
- =1 documented Gd enhancing lesion on an MRI scan within the previous year.
- Contraceptive use by men or women should be consistent with local regulations
regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria:
- The participant has been diagnosed with PPMS according to the 2017 revision of the
McDonald diagnostic criteria
- The participant has a history of infection or may be at risk for infection:
- The presence of psychiatric disturbance or substance abuse.
- 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.
- Current hypogammaglobulinemia defined by Ig levels below the LLN at Screening or a
history of primary hypogammaglobulinemia.
- A history or presence of disease that can mimic MS symptoms, such as, but not
limited to neuromyelitis optica spectrum disorder, systemic lupus erythematosus,
Sjogren's syndrome, acute disseminated encephalomyelitis, and myasthenia gravis.
- The participant has had a relapse in the 30 days prior to randomization.
- The participant has contraindication for MRI, ie, presence of pacemaker, metallic
implants in high risk areas (ie, artificial heart valves, aneurysm/vessel clips),
presence of metallic material (eg, shrapnel) in high risk areas, known history of
allergy to any contrast medium, or history of claustrophobia that would prevent
completion of all protocol scheduled MRI scans.
The above information is not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial. (ICTRP)
non disponibile
Endpoint primari e secondari
Annualized relapse rate (ARR) during the study period assessed by protocol defined adjudicated relapses (ICTRP)
Time to onset of composite confirmed disability worsening (cCDW);Time to onset of cCDW, confirmed over 3 months;Time to onset of individual components of the composite, confirmed over 3-months or 6-months;Time to onset of confirmed disability improvement (CDI);Progression independent of relapse activity defined as the time to onset of 6-month cCDW;Total number of new and/or enlarging T2 hyperintense lesions as detected by MRI;Total number of new Gd-enhancing T1hyperintense lesions per scan as detected by MRI;Percent change in brain volume loss as detected by brain MRI scans at the EOS compared to Month 6;Change in cognitive function at the EOS compared to baseline as assessed by the symbol digit modalities test (SDMT);Change from baseline in multiple sclerosis impact scale 29 version 2 (MSIS-29v2) questionnaire scores over time;Change from baseline in patient reported outcome measurement information system (PROMIS) Fatigue MS-8 over time;Number of participants with adverse events, SAEs, AEs leading to permanent study intervention discontinuation, AESIs and safety scales during the study period;Number of participants with potentially clinically significant abnormality (PCSAs) in laboratory tests, ECG and vital signs during the study period;Number of participants with antidrug (ADAs) over time;Change from baseline in plasma neurofilament light chain (NfL) levels over time;Frexalimab plasma concentration over time (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Trial Transparency email recommended (Toll free number for US & Canada), contact-us@sanofi.com, 800-633-1610 (ICTRP)
ID secondari
2023-504358-36, U1111-1290-9326, EFC17919 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT06141473 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile