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Biogen
Traitements, essais et publications liés.
Traitements39programmes
Essais20liés
Publications22liées
SourceDBlocale
Traitements
39| Molécule | Indication / population | Phase | Objectif | Pays | Résultat |
|---|---|---|---|---|---|
| A Study to Assess New Participant's Perspectives Beyond Clinical Efficacy of Monoclonal Antibody-Based Relapsing Remitting Multiple Sclerosis (RRMS) TreatmentsThe primary objective of the study is to understand what the added value of natalizumab (Tysabri®) treatment is from a participant's perspective at a given time, based on a one-shot survey. The secondary objectives of the study also aim to characterize the participant's decision-making process to get the treatment; the burden of treatment, characterization of the study population, assessment of the quality of life (QoL), and fatigue dimension. | SEP | À vérifier | Traitement symptomatique | United States | À vérifier |
| AvonexThe primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with MCMs in women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the first trimester of pregnancy with the following: i) women with MS who were unexposed to disease modifying therapies (DMTs) and, ii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries). The secondary objective of the study is to evaluate pregnancy outcomes in women with DRF exposure at any time from 2 weeks after the first day of their LMP through the end of pregnancy compared with the following: i) women with MS who were unexposed to DMTs, ii) women with dimethyl fumarate (DMF) exposure, iii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), and iv) women without MS (e.g., women from external, general population comparators). | SEP | À vérifier | À vérifier | United States, Australia, Germany, Ireland, Spain, Switzerland, United Kingdom | À vérifier |
| BIIB017 (peginterferon beta-1a)This study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis (RRMS) and to assess the pharmacokinetics (PK) of BIIB017 in pediatric participants with RRMS in Part 1. In Part 2, the study will evaluate the long-term safety of BIIB017 and further describe safety and the long-term multiple sclerosis (MS) outcomes after BIIB017 treatment in participants who completed the study treatment at Week 96 in Part 1 of the study. | SEP | Phase 3 | À vérifier | United States, Argentina, Australia, Belgium, Bulgaria, Croatia, Czechia, France, … | À vérifier |
| BIIB033The main purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic profile of two intravenous infusions of BIIB033 administered two weeks apart in subjects with MS. Approximately 42 MS subjects are planned to be enrolled in the study in 7 separate groups (i.e., 6 subjects per group). Each subsequent group will be administered a higher dose of BIIB033. Before a higher dose group is allowed to start, a Drug Safety Review Committee will review all safety data from previous groups enrolled, as well as data from another study where BIIB033 is being administered to healthy volunteers (215HV101). | SEP | Phase 1 | À vérifier | United States | À vérifier |
| BIIB033 (opicinumab)The primary objective of Part 1 of this study is to evaluate the effects of BIIB033 versus placebo on disability improvement over 72 weeks. The primary objective of Part 2 of this study is to evaluate the long-term safety profile of BIIB033 as an add-on therapy in participants with MS. The secondary objective of Part 1 is to evaluate the effects of BIIB033 versus placebo on additional measures of disability improvement. The secondary objective of Part 2 is to investigate long-term efficacy (disability improvement) and additional safety measures of BIIB033 as an add-on therapy in participants with MS. | SEP | Phase 2 | À vérifier | United States, Australia, Belgium, Canada, Czechia, France, Germany, Hungary, … | À vérifier |
| BIIB059 (litifilimab)In this study, researchers will learn more about a study drug called BIIB059 (litifilimab) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue. The study will enroll only those participants who have completed treatment with litifilimab in the parent study, 230LE301. The main objective of the study is to learn more about the long-term safety of litifilimab. The main question researchers want to answer is: * How many participants have adverse events and serious adverse events after taking litifilimab? Adverse events are health problems that may or may not be caused by the study drug. Researchers will also learn more about the effect of litifilimab on CLE. They will do this by measuring the symptoms of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI). Researchers will look at how litifilimab and CLE affect the quality of life of participants using a group of questionnaires. They will also look at how litifilimab affects laboratory tests and how participants' immune systems respond to litifilimab. The study will be done as follows: * The last visit of parent study 230LE301 will be the first visit of study 230LE305. * All participants will receive litifilimab as an injection under the skin once every 4 weeks. Both researchers and participants will know the dose and identity of the study drug. * Globally, the treatment period will last up to 208 weeks, or 4 years. Participants will have up to 53 study visits during this time. | Lupus | Phase 3 | Traitement symptomatique | United States, Argentina, Brazil, Bulgaria, Canada, Chile, China, Colombia, … | À vérifier |
| BIIB061The primary objective of the study is to assess the pharmacokinetic (PK) profile of BIIB061 in the new oral formulation in the fasted state in healthy male and female volunteers. The secondary objective of this study is to evaluate the safety and tolerability of BIIB061 in the new formulation in this study population. | SEP | Phase 1 | Remyélinisation | United States | À vérifier |
| BIIB100Description non affichée : incohérence de maladie détectée. Consultez l’essai clinique officiel associé. | Sclérose latérale amyotrophique | Phase 1 | À vérifier | United States | À vérifier |
| BIIB147Description non affichée : incohérence de maladie détectée. Consultez l’essai clinique officiel associé. | Sclérose latérale amyotrophique | Phase 1/2 | À vérifier | United States | À vérifier |
| dimethyl fumarateThe primary objective of the study is to determine if dimethyl fumarate (DMF) causes changes in the abundance and diversity of commensal microbiota. The secondary objectives of this study are as follows: To identify if there are differences in the gut microbiota composition between patients that do or do not develop gastro intestinal (GI) adverse events (AEs), both pre- and post DMF treatment and to examine if the resolution of GI AEs in DMF treated patients is reflected in the gut microbiota. | SEP | À vérifier | À vérifier | United States, Australia, Germany, Ireland, Spain, Switzerland, United Kingdom | À vérifier |
| Diroximel FumarateThe primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with MCMs in women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the first trimester of pregnancy with the following: i) women with MS who were unexposed to disease modifying therapies (DMTs) and, ii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries). The secondary objective of the study is to evaluate pregnancy outcomes in women with DRF exposure at any time from 2 weeks after the first day of their LMP through the end of pregnancy compared with the following: i) women with MS who were unexposed to DMTs, ii) women with dimethyl fumarate (DMF) exposure, iii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), and iv) women without MS (e.g., women from external, general population comparators). | SEP | À vérifier | À vérifier | United States | À vérifier |
| Glatiramer acetatePrimary Objective: To evaluate the efficacy, safety, and tolerability of alemtuzumab intravenously (IV) in pediatric participants from 10 to less than (\<) 18 years of age with Relapsing Remitting Multiple Sclerosis (RRMS) who have disease activity on prior DMT. Secondary Objective: To assess the pharmacokinetics (PK), pharmacodynamics (PD), anti-drug antibody (ADA) formation, and potential effects of alemtuzumab on other multiple sclerosis (MS) disease characteristics such as cognition and quality of life (QoL). | SEP | À vérifier | Remyélinisation | United States | À vérifier |
| injectable MS DMTThe primary objective of the study is to determine if dimethyl fumarate (DMF) causes changes in the abundance and diversity of commensal microbiota. The secondary objectives of this study are as follows: To identify if there are differences in the gut microbiota composition between patients that do or do not develop gastro intestinal (GI) adverse events (AEs), both pre- and post DMF treatment and to examine if the resolution of GI AEs in DMF treated patients is reflected in the gut microbiota. | SEP | Phase 4 | À vérifier | Norway | À vérifier |
| Interferon betaIn this study, researchers will learn more about the effects of diroximel fumarate (DRF), also known as VUMERITY®, when taken during pregnancy in people with multiple sclerosis, also known as MS. In MS, the immune system attacks the nerves in the brain and spinal cord. The affected areas are called lesions. The damage makes it difficult for the brain and spinal cord to function and send messages throughout the body. MS can be a progressive disease, which means it may get worse over time. In relapsing forms of MS (RMS), new symptoms may happen, and existing symptoms may get better or worse over time. DRF is an approved drug that is used to treat people with RMS. This is known as an "observational" study, which collects health information about study participants without changing their medical care. The main goal of this study is to collect birth and health information from 3 groups of participants and their babies. These groups are: * Those who took DRF during their pregnancy * Those who took disease-modifying therapies (DMTs) for RMS during their pregnancy, but not DRF. DMTs are drugs that slow how the disease develops over time, not just relieve symptoms. * Those who did not take any drugs for RMS during their pregnancy The main question researchers want to learn about in this study is: • How many participants' babies were born with major congenital malformations (MCMs)? MCMs are problems with how a baby's body forms before birth. In this study, researchers will measure how often the following outcomes happen and compare them between groups: * Loss of pregnancy before 20 weeks * Loss of pregnancy at or after 20 weeks (stillbirth) * Babies born early (before 37 weeks) * Babies who are smaller than expected for the stage of pregnancy * Live births This study will be done as follows: * The study includes data in adult women with multiple sclerosis on pregnancies happening between October 29th, 2019 and July 31st, 2030. Information will start being collected when the participant decides to join the study. * Medical records and clinical notes will be reviewed at the end of the study. * The study will include information from pregnancy through delivery, and for babies up to 1 year after birth. * The study is planned to end by 30th April 2031. | SEP | À vérifier | Traitement symptomatique | United States | À vérifier |
| Interferon beta type 1aThis study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis (RRMS) and to assess the pharmacokinetics (PK) of BIIB017 in pediatric participants with RRMS in Part 1. In Part 2, the study will evaluate the long-term safety of BIIB017 and further describe safety and the long-term multiple sclerosis (MS) outcomes after BIIB017 treatment in participants who completed the study treatment at Week 96 in Part 1 of the study. | SEP | Phase 3 | À vérifier | United States, Argentina, Australia, Belgium, Bulgaria, Croatia, Czechia, France, … | À vérifier |
| Interferon-beta1The primary objectives of the study are to evaluate the safety of BIIB061 versus placebo in participants with Relapsing Multiple Sclerosis (RMS), and to evaluate the efficacy of BIIB061 to improve disability outcome versus placebo in participants with RMS. The secondary objectives of the study are to evaluate the effects of BIIB061 versus placebo on brain magnetic resonance imaging (MRI) markers of remyelination and axon preservation in chronic Multiple Sclerosis lesions and to evaluate the effects of BIIB061 versus placebo on additional measures of improved disability outcome. | SEP | Phase 2 | Remyélinisation | À vérifier | |
| LitifilimabIn this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. This is an extension study of 230LE303 and 230LE304 (TOPAZ-1 and TOPAZ-2). It will enroll participants who completed the treatment periods of either one of the parent studies. The main objective of the study is to learn more about the long-term safety of litifilimab. The main question researchers want to answer is: \- How many participants have adverse events and serious adverse events? Researchers will also learn about the effect litifilimab has on controlling symptoms of SLE and lowering its activity. They will measure symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the British Isles Lupus Activity Group-2004 (BILAG-2004), among others. Researchers will also study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires. The study will be done as follows: * The Week 52 visit of studies 230LE303 and 230LE304 will be Day 1 of this study. * Participants who were receiving either a high or low dose of litifilimab in the parent studies will continue receiving the same doses. * Participants who were receiving placebo in the parent studies will be randomized to receive either a high or low dose of litifilimab. * All participants will receive litifilimab as injections under the skin once every 4 weeks. The treatment period will last 156 weeks. Participants may continue to take their standard of care medications. * Neither the researchers nor the participants will know which doses of litifilimab the participants are receiving. * There will be a follow-up safety period that lasts up to 24 weeks. * In total, participants will have up to 47 study visits. The total study duration for participants will be up to 180 weeks. Optional Substudy: Some participants may be invited to join an optional substudy after being in the main study for at least 4 months. This substudy will test a new injector device for giving litifilimab. The injector device is an automatic device that delivers the full dose in one injection without needing to push a plunger. Researchers will compare the safety and tolerability of the injector device and how the body reacts to it to the current prefilled syringe method. The substudy will last 3 months and will include about 120 participants. | Lupus | Phase 2/3 | Traitement symptomatique | United States, Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, China, … | À vérifier |
| natalizumabThe primary objective of this study is to compare the pharmacokinetic (PK) and pharmacodynamics (PD) of single subcutaneous (SC) and intramuscular (IM) doses of 300 mg natalizumab to intravenous (IV) administration of 300 mg natalizumab in multiple sclerosis (MS) participants. The secondary objectives are to investigate the safety, tolerability and PK of repeated natalizumab doses administered SC and IM, to investigate the immunogenicity of repeated natalizumab doses administered SC and IM, to explore proof of concept within the secondary progressive multiple sclerosis (SPMS) population using change from baseline in clinical measures including: expanded disability status scale (EDSS), multiple sclerosis functional composite scale (MSFC), symbol digit modalities test (SDMT), visual analogue scale (VAS), and visual function test; and brain magnetic resonance imaging (MRI) measures including: number of new or newly-enlarging T2 hyperintense lesions, number of new T1 hypointense lesions, number of new gadolinium-enhancing (Gd+) lesions, whole brain atrophy, magnetization transfer ratio (MTR), and diffusion tensor imaging (DTI) and to observe the effect of natalizumab administered IV and SC on brain MRI measures in participants with relapsing forms of MS. | SEP | Phase 1 | United States | À vérifier | |
| TofersenDescription non affichée : incohérence de maladie détectée. Consultez l’essai clinique officiel associé. | Sclérose latérale amyotrophique | Phase 3 | À vérifier | United States, Australia, Belgium, Brazil, Canada, France, Germany, Italy, … | À vérifier |
| TYGRIS — TYSABRI Global Observational Program in SafetyThe Primary objective of this study is to determine the incidence and pattern of serious infections, malignancies, and other serious adverse events (SAE) in participants with multiple sclerosis (MS) treated with Tysabri (natalizumab). | SEP | À vérifier | À vérifier | United States | À vérifier |
| dimethyl fumarateThe primary objective of the study is to determine if dimethyl fumarate (DMF) causes changes in the abundance and diversity of commensal microbiota. The secondary objectives of this study are as follows: To identify if there are differences in the gut microbiota composition between patients that do or do not develop gastro intestinal (GI) adverse events (AEs), both pre- and post DMF treatment and to examine if the resolution of GI AEs in DMF treated patients is reflected in the gut microbiota. | SEP | Phase 4 | À vérifier | Norway | À vérifier |
| A Study to Assess New Participant's Perspectives Beyond Clinical Efficacy of Monoclonal Antibody-Based Relapsing Remitting Multiple Sclerosis (RRMS) TreatmentsThe primary objective of the study is to understand what the added value of natalizumab (Tysabri®) treatment is from a participant's perspective at a given time, based on a one-shot survey. The secondary objectives of the study also aim to characterize the participant's decision-making process to get the treatment; the burden of treatment, characterization of the study population, assessment of the quality of life (QoL), and fatigue dimension. | SEP | À vérifier | Traitement symptomatique | United States | À vérifier |
| BIIB100Description non affichée : incohérence de maladie détectée. Consultez l’essai clinique officiel associé. | Sclérose latérale amyotrophique | Phase 1 | À vérifier | United States | À vérifier |
| TYGRIS — TYSABRI Global Observational Program in SafetyThe Primary objective of this study is to determine the incidence and pattern of serious infections, malignancies, and other serious adverse events (SAE) in participants with multiple sclerosis (MS) treated with Tysabri (natalizumab). | SEP | À vérifier | À vérifier | United States | À vérifier |
| Diroximel FumarateThe primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with MCMs in women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the first trimester of pregnancy with the following: i) women with MS who were unexposed to disease modifying therapies (DMTs) and, ii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries). The secondary objective of the study is to evaluate pregnancy outcomes in women with DRF exposure at any time from 2 weeks after the first day of their LMP through the end of pregnancy compared with the following: i) women with MS who were unexposed to DMTs, ii) women with dimethyl fumarate (DMF) exposure, iii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), and iv) women without MS (e.g., women from external, general population comparators). | SEP | À vérifier | À vérifier | United States, Australia, Germany, Ireland, Spain, Switzerland, United Kingdom | À vérifier |
| BIIB061The primary objective of the study is to assess the pharmacokinetic (PK) profile of BIIB061 in the new oral formulation in the fasted state in healthy male and female volunteers. The secondary objective of this study is to evaluate the safety and tolerability of BIIB061 in the new formulation in this study population. | SEP | Phase 1 | Remyélinisation | United States | À vérifier |
| LitifilimabIn this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. This is an extension study of 230LE303 and 230LE304 (TOPAZ-1 and TOPAZ-2). It will enroll participants who completed the treatment periods of either one of the parent studies. The main objective of the study is to learn more about the long-term safety of litifilimab. The main question researchers want to answer is: \- How many participants have adverse events and serious adverse events? Researchers will also learn about the effect litifilimab has on controlling symptoms of SLE and lowering its activity. They will measure symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the British Isles Lupus Activity Group-2004 (BILAG-2004), among others. Researchers will also study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires. The study will be done as follows: * The Week 52 visit of studies 230LE303 and 230LE304 will be Day 1 of this study. * Participants who were receiving either a high or low dose of litifilimab in the parent studies will continue receiving the same doses. * Participants who were receiving placebo in the parent studies will be randomized to receive either a high or low dose of litifilimab. * All participants will receive litifilimab as injections under the skin once every 4 weeks. The treatment period will last 156 weeks. Participants may continue to take their standard of care medications. * Neither the researchers nor the participants will know which doses of litifilimab the participants are receiving. * There will be a follow-up safety period that lasts up to 24 weeks. * In total, participants will have up to 47 study visits. The total study duration for participants will be up to 180 weeks. Optional Substudy: Some participants may be invited to join an optional substudy after being in the main study for at least 4 months. This substudy will test a new injector device for giving litifilimab. The injector device is an automatic device that delivers the full dose in one injection without needing to push a plunger. Researchers will compare the safety and tolerability of the injector device and how the body reacts to it to the current prefilled syringe method. The substudy will last 3 months and will include about 120 participants. | Lupus | Phase 3 | Traitement symptomatique | United States, Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, France, Greece, Hungary, Israel, Italy, Japan, Mexico, Peru, Philippines, Poland, … | À vérifier |
| LitifilimabIn this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. This is an extension study of 230LE303 and 230LE304 (TOPAZ-1 and TOPAZ-2). It will enroll participants who completed the treatment periods of either one of the parent studies. The main objective of the study is to learn more about the long-term safety of litifilimab. The main question researchers want to answer is: \- How many participants have adverse events and serious adverse events? Researchers will also learn about the effect litifilimab has on controlling symptoms of SLE and lowering its activity. They will measure symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the British Isles Lupus Activity Group-2004 (BILAG-2004), among others. Researchers will also study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires. The study will be done as follows: * The Week 52 visit of studies 230LE303 and 230LE304 will be Day 1 of this study. * Participants who were receiving either a high or low dose of litifilimab in the parent studies will continue receiving the same doses. * Participants who were receiving placebo in the parent studies will be randomized to receive either a high or low dose of litifilimab. * All participants will receive litifilimab as injections under the skin once every 4 weeks. The treatment period will last 156 weeks. Participants may continue to take their standard of care medications. * Neither the researchers nor the participants will know which doses of litifilimab the participants are receiving. * There will be a follow-up safety period that lasts up to 24 weeks. * In total, participants will have up to 47 study visits. The total study duration for participants will be up to 180 weeks. Optional Substudy: Some participants may be invited to join an optional substudy after being in the main study for at least 4 months. This substudy will test a new injector device for giving litifilimab. The injector device is an automatic device that delivers the full dose in one injection without needing to push a plunger. Researchers will compare the safety and tolerability of the injector device and how the body reacts to it to the current prefilled syringe method. The substudy will last 3 months and will include about 120 participants. | Lupus | Phase 2/3 | Traitement symptomatique | United States, Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, France, Germany, Hungary, Italy, Japan, Mexico, Peru, Philippines, Poland, Portugal, Puerto Rico, … | À vérifier |
| BIIB059 (litifilimab)In this study, researchers will learn more about a study drug called BIIB059 (litifilimab) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue. The study will enroll only those participants who have completed treatment with litifilimab in the parent study, 230LE301. The main objective of the study is to learn more about the long-term safety of litifilimab. The main question researchers want to answer is: * How many participants have adverse events and serious adverse events after taking litifilimab? Adverse events are health problems that may or may not be caused by the study drug. Researchers will also learn more about the effect of litifilimab on CLE. They will do this by measuring the symptoms of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI). Researchers will look at how litifilimab and CLE affect the quality of life of participants using a group of questionnaires. They will also look at how litifilimab affects laboratory tests and how participants' immune systems respond to litifilimab. The study will be done as follows: * The last visit of parent study 230LE301 will be the first visit of study 230LE305. * All participants will receive litifilimab as an injection under the skin once every 4 weeks. Both researchers and participants will know the dose and identity of the study drug. * Globally, the treatment period will last up to 208 weeks, or 4 years. Participants will have up to 53 study visits during this time. | Lupus | Phase 3 | Traitement symptomatique | United States, Argentina, Brazil, Bulgaria, Canada, Chile, China, Colombia, France, Germany, Hungary, Italy, Japan, Mexico, Philippines, Poland, Portugal, Serbia, Slovakia, South Korea, … | À vérifier |
| TofersenDescription non affichée : incohérence de maladie détectée. Consultez l’essai clinique officiel associé. | Sclérose latérale amyotrophique | Phase 4 | À vérifier | China | À vérifier |
| BIIB033The main purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic profile of two intravenous infusions of BIIB033 administered two weeks apart in subjects with MS. Approximately 42 MS subjects are planned to be enrolled in the study in 7 separate groups (i.e., 6 subjects per group). Each subsequent group will be administered a higher dose of BIIB033. Before a higher dose group is allowed to start, a Drug Safety Review Committee will review all safety data from previous groups enrolled, as well as data from another study where BIIB033 is being administered to healthy volunteers (215HV101). | SEP | Phase 1 | À vérifier | United States | À vérifier |
| natalizumabThe primary objective of this study is to compare the pharmacokinetic (PK) and pharmacodynamics (PD) of single subcutaneous (SC) and intramuscular (IM) doses of 300 mg natalizumab to intravenous (IV) administration of 300 mg natalizumab in multiple sclerosis (MS) participants. The secondary objectives are to investigate the safety, tolerability and PK of repeated natalizumab doses administered SC and IM, to investigate the immunogenicity of repeated natalizumab doses administered SC and IM, to explore proof of concept within the secondary progressive multiple sclerosis (SPMS) population using change from baseline in clinical measures including: expanded disability status scale (EDSS), multiple sclerosis functional composite scale (MSFC), symbol digit modalities test (SDMT), visual analogue scale (VAS), and visual function test; and brain magnetic resonance imaging (MRI) measures including: number of new or newly-enlarging T2 hyperintense lesions, number of new T1 hypointense lesions, number of new gadolinium-enhancing (Gd+) lesions, whole brain atrophy, magnetization transfer ratio (MTR), and diffusion tensor imaging (DTI) and to observe the effect of natalizumab administered IV and SC on brain MRI measures in participants with relapsing forms of MS. | SEP | Phase 1 | United States | À vérifier | |
| TofersenDescription non affichée : incohérence de maladie détectée. Consultez l’essai clinique officiel associé. | Sclérose latérale amyotrophique | Phase 2 | À vérifier | United States | À vérifier |
| BIIB061The primary objective of the study is to assess the pharmacokinetic (PK) profile of BIIB061 in the new oral formulation in the fasted state in healthy male and female volunteers. The secondary objective of this study is to evaluate the safety and tolerability of BIIB061 in the new formulation in this study population. | SEP | Phase 2 | Remyélinisation | À vérifier | |
| BIIB017 (peginterferon beta-1a)This study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis (RRMS) and to assess the pharmacokinetics (PK) of BIIB017 in pediatric participants with RRMS in Part 1. In Part 2, the study will evaluate the long-term safety of BIIB017 and further describe safety and the long-term multiple sclerosis (MS) outcomes after BIIB017 treatment in participants who completed the study treatment at Week 96 in Part 1 of the study. | SEP | Phase 3 | À vérifier | United States, Argentina, Australia, Belgium, Bulgaria, Croatia, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Kuwait, Portugal, Russia, Saudi Arabia, Serbia, Slovakia, Spain, … | À vérifier |
| BIIB147Description non affichée : incohérence de maladie détectée. Consultez l’essai clinique officiel associé. | Sclérose latérale amyotrophique | Phase 1/2 | À vérifier | United States | À vérifier |
| BIIB033 (opicinumab)The primary objective of Part 1 of this study is to evaluate the effects of BIIB033 versus placebo on disability improvement over 72 weeks. The primary objective of Part 2 of this study is to evaluate the long-term safety profile of BIIB033 as an add-on therapy in participants with MS. The secondary objective of Part 1 is to evaluate the effects of BIIB033 versus placebo on additional measures of disability improvement. The secondary objective of Part 2 is to investigate long-term efficacy (disability improvement) and additional safety measures of BIIB033 as an add-on therapy in participants with MS. | SEP | Phase 2 | À vérifier | United States, Australia, Belgium, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom | À vérifier |
| Diroximel FumarateThe primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with MCMs in women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the first trimester of pregnancy with the following: i) women with MS who were unexposed to disease modifying therapies (DMTs) and, ii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries). The secondary objective of the study is to evaluate pregnancy outcomes in women with DRF exposure at any time from 2 weeks after the first day of their LMP through the end of pregnancy compared with the following: i) women with MS who were unexposed to DMTs, ii) women with dimethyl fumarate (DMF) exposure, iii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), and iv) women without MS (e.g., women from external, general population comparators). | SEP | À vérifier | À vérifier | United States | À vérifier |
| TofersenDescription non affichée : incohérence de maladie détectée. Consultez l’essai clinique officiel associé. | Sclérose latérale amyotrophique | Phase 3 | Traitement symptomatique | United States, Australia, Belgium, Brazil, Canada, France, Germany, Italy, Japan, Poland, South Korea, Spain, Sweden, United Kingdom | À vérifier |
Essais cliniques
20| Molécule | Indication / population | Phase | NCT | Titre | Statut |
|---|---|---|---|---|---|
| Tofersen | Sclérose latérale amyotrophique | Phase 3 | NCT04856982 | ATLAS — Study to Learn If Tofersen (BIIB067) Can Delay ALS Symptoms and About Its Safety in Adults With a SOD1 Gene Mutation Who Have Not Yet Developed ALS Symptoms | ACTIVE_NOT_RECRUITING |
| Diroximel Fumarate | SEP | À vérifier | NCT05688436 | A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies | ACTIVE_NOT_RECRUITING |
| BIIB033 (opicinumab) | SEP | Phase 2 | NCT03222973 | AFFINITY — Efficacy and Safety of BIIB033 (Opicinumab) as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) | TERMINATED |
| BIIB147 | Sclérose latérale amyotrophique | Phase 1/2 | NCT07855211 | HORIZON — A Study to Learn About the Safety of BIIB147 and Its Effects in Adults With Amyotrophic Lateral Sclerosis (ALS) | RECRUITING |
| BIIB017 (peginterferon beta-1a) | SEP | Phase 3 | NCT03958877 | A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis | ACTIVE_NOT_RECRUITING |
| BIIB061 | SEP | Phase 2 | NCT04079088 | Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-β1) or Glatiramer Acetate in Relapsing Multiple Sclerosis (RMS) | WITHDRAWN |
| Tofersen | Sclérose latérale amyotrophique | Phase 2 | NCT07294144 | Tofersen in Non-SOD1 ALS | RECRUITING |
| natalizumab | SEP | Phase 1 | NCT00559702 | Safety Study of Natalizumab to Treat Multiple Sclerosis (MS) | COMPLETED |
| BIIB033 | SEP | Phase 1 | NCT01244139 | Safety Study of BIIB033 in Subjects With Multiple Sclerosis | COMPLETED |
| Tofersen | Sclérose latérale amyotrophique | Phase 4 | NCT07223723 | A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Chinese Participants With SOD-1 Amyotrophic Lateral Sclerosis (ALS) | ACTIVE_NOT_RECRUITING |
| BIIB059 (litifilimab) | Lupus | Phase 3 | NCT06044337 | AMETHYST LTE — A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus | ENROLLING_BY_INVITATION |
| Litifilimab | Lupus | Phase 2/3 | NCT05531565 | AMETHYST — A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus | ACTIVE_NOT_RECRUITING |
| Litifilimab | Lupus | Phase 3 | NCT05352919 | EMERALD — A Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and it's Effects on Symptoms in Adults With Systemic Lupus Erythematosus (SLE) | ENROLLING_BY_INVITATION |
| BIIB061 | SEP | Phase 1 | NCT02521545 | Single-Dose Study of a New Formulation of BIIB061 | COMPLETED |
| Diroximel Fumarate | SEP | À vérifier | NCT05658497 | Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate) | RECRUITING |
| TYGRIS — TYSABRI Global Observational Program in Safety | SEP | À vérifier | NCT00477113 | TYGRIS — TYSABRI Global Observational Program in Safety | COMPLETED |
| Interferon beta-1a | SEP | Phase 2 | NCT00912860 | Immunogenicity and Safety Study of Serum-Free Avonex | COMPLETED |
| BIIB100 | Sclérose latérale amyotrophique | Phase 1 | NCT03945279 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB100 Administered Orally to Adults With Amyotrophic Lateral Sclerosis | COMPLETED |
| A Study to Assess New Participant's Perspectives Beyond Clinical Efficacy of Monoclonal Antibody-Based Relapsing Remitting Multiple Sclerosis (RRMS) Treatments | SEP | À vérifier | NCT06127095 | A Study to Assess New Participant's Perspectives Beyond Clinical Efficacy of Monoclonal Antibody-Based Relapsing Remitting Multiple Sclerosis (RRMS) Treatments | COMPLETED |
| dimethyl fumarate | SEP | Phase 4 | NCT02471560 | TECONGUT — Tecfidera and the Gut Microbiota | COMPLETED |
Publications
22| Molécule | Indication / population | Titre | Journal | Date |
|---|---|---|---|---|
| Tofersen | Tofersen Treatment in -ALS: Real-World Evidence from a Retrospective Multicenter Study in France (FORSLA Study). | Mayo Clinic proceedings. Innovations, quality & outcomes | ||
| Tofersen | Therapeutic frontiers in ALS: iPSC-based drug discovery, cell therapy, and gene therapy-Advances through 2026. | Regenerative therapy | ||
| Litifilimab | Therapeutic Approaches for Cutaneous Lupus Erythematosus: a Changing Landscape of Clinical Trials. | Journal of inflammation research | ||
| BIIB033 | Assessment of Opicinumab in Acute Optic Neuritis Using Multifocal Visual Evoked Potential. | CNS drugs | ||
| Glatiramer acetate | Bridging the Pregnancy Knowledge Gap: A Real-World Analysis of Medication Use and Drug-Drug Interaction Risk in Crohn's Disease and Multiple Sclerosis. | Clinical and translational science | ||
| Glatiramer acetate | Mitochondrial bioenergetic remodeling underlies fingolimod-induced immunometabolic adaptation in multiple sclerosis. | Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie | ||
| Avonex | Evolution of Brain Volume Loss Rates in Early Stages of Multiple Sclerosis. | Neurology(R) neuroimmunology & neuroinflammation | ||
| Avonex | Electronic Health Diary Campaigns to Complement Longitudinal Assessments in Persons With Multiple Sclerosis: Nested Observational Study. | JMIR mHealth and uHealth | ||
| Diroximel Fumarate | Appendicitis and multiple sclerosis disease-modifying therapies: a disproportionality analysis of the FDA adverse event reporting system. | Multiple sclerosis and related disorders | ||
| dimethyl fumarate | Neuroprotective effects of glucotropaeolin as the major glucosinolate of cress seed on cuprizone-induced mouse model of multiple sclerosis. | Biochemistry and biophysics reports | ||
| dimethyl fumarate | Metabolic characteristic changes in local tissues after high-intensity focused ultrasound treatment for uterine fibroids. | International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group | ||
| BIIB059 (litifilimab) | Litifilimab (BIIB059), a promising investigational drug for cutaneous lupus erythematosus. | Expert opinion on investigational drugs | ||
| Litifilimab | Genetic Polymorphisms in Systemic Lupus Erythematosus and Their Clinical Implications: A Narrative Review. | International journal of molecular sciences | ||
| Litifilimab | Advances in the treatment of systemic lupus erythematosus: Biologicals, small-molecular agents, and cell-depleting therapies coming to the clinic. | Journal of internal medicine | ||
| Avonex | Evaluating Efficacy Outcomes in Pediatric Multiple Sclerosis Patients While Using Avonex or Plegridy via USNPMSC Registry. | Journal of child neurology | ||
| Diroximel Fumarate | Structure-Property Relationship Analysis of α-Keto Ester Prodrugs of Monomethyl Fumarate as NRF2 Activators. | ACS chemical neuroscience | ||
| injectable MS DMT | Real-world adherence to and persistence with ofatumumab, infusion, oral, and other self-injectable disease-modifying therapies in patients with multiple sclerosis. | Multiple sclerosis journal - experimental, translational and clinical | ||
| dimethyl fumarate | Correction to "Dimethyl Fumarate Suppresses Collagen-Induced Arthritis by Regulating Inflammatory Responses". | Journal of biochemical and molecular toxicology | ||
| TYGRIS — TYSABRI Global Observational Program in Safety | The 5-year Tysabri global observational program in safety (TYGRIS) study confirms the long-term safety profile of natalizumab treatment in multiple sclerosis. | Multiple sclerosis and related disorders | ||
| injectable MS DMT | Discontinuation of disease-modifying therapies in patients with multiple sclerosis: A retrospective case-control study. | Multiple sclerosis and related disorders | ||
| dimethyl fumarate | Pharmacological Modulation of Nrf2 Signaling Regulates Oxidative Stress, Inflammation, and Alveolar Bone Loss in Experimental Periodontitis. | Journal of periodontal research | ||
| dimethyl fumarate | Between-hospital variation in discontinuation of treatment with dimethyl fumarate in multiple sclerosis. | Multiple sclerosis and related disorders |