Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis
NCT05285891 · Multiple Sclerosis
RecruitingThis study is a prospective, multi-center, randomized, double blinded, placebo-controlled study of OCR treatment-discontinuation in patients with early RMS. All eligible participants will be initiated on OCR using the standard approved administration schedule of two 300 mg infusions separated by 14 days (i.e., Days 0 and 14) for a total of 600 mg, followed by 600 mg infusions at Month 6,12, 18, and 24. At Month 24, participants will be randomized (2:1) to one of two Arms with randomized treatment beginning at Month 30: Arm 1: placebo infusions every 6 months; or Arm 2: OCR infusions every 6 months. The treatment period will be for a total of 48 months.
PhasePhase 4
TypeInterventional
Age18 Years – 55 Years
WhereNew Haven, Connecticut, United States + 11 more
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
▾Tap for detailsClick for full details — eligibility, all locations, contacts Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
NCT06141486 · Multiple Sclerosis
RecruitingThe purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to 36 months double-blind administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: * This event-driven study will end when the target number of 6-month cCDP events is achieved, and the study is expected to last 43 months from randomization of the first participant to the common study end. * The number of scheduled visits will be up to 25 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months. * If the prespecified number of events for 6-month cCDP is not reached by V21/W180, scheduled visits will continue every 3 months.
PhasePhase 3
TypeInterventional
Age18 Years – 60 Years
WhereBirmingham, Alabama, United States + 337 more
SponsorSanofi
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis
NCT07225504 · Secondary Progressive Multiple Sclerosis (SPMS)
RecruitingThe purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)
PhasePhase 3
TypeInterventional
Age18 Years – 65 Years
WhereBirmingham, Alabama, United States + 89 more
SponsorNovartis Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO
NCT03816345 · Autoimmune Disease, Crohn Disease, Dermatomyositis
RecruitingThis phase Ib trial studies the side effects of nivolumab and to see how well it works alone and in combination with other treatments, such as ipilimumab, cabozantinib, platinum containing therapy, and fluoropyrimidine, in treating patients with autoimmune disorders and cancer that has spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced), to other places in the body (metastatic) or cannot removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Cabozantinib is a type of tyrosine kinase inhibitor and a type of angiogenesis inhibitor. Chemotherapy drugs, such as platinum containing therapies and fluoropyrimidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab alone and in combination with other treatments, including ipilimumab, cabozantinib, platinum containing therapy, or fluoropyrimidine, may be safe, tolerable, and/or effective in treating patients with autoimmune disorders and advanced, metastatic, or unresectable cancer.
PhasePhase 1
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 51 more
SponsorNational Cancer Institute (NCI)
▾Tap for detailsClick for full details — eligibility, all locations, contacts Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis
NCT06441617 · Multiple Sclerosis, Fatigue
RecruitingCAFE-MS will assess the effectiveness of two online programs for fatigue in multiple sclerosis (MS). Although they differ, both of these online programs contain information about MS and fatigue intended to help people with MS understand and manage their fatigue. This large-scale, decentralized clinical trial is projected to enroll 2,000 people with MS. The collaboration between iConquerMS and 5 Veterans Affairs (VA) sites in the MS Centers of Excellence is designed to ensure sufficient representation of people with MS from populations traditionally under-represented in MS clinical trials. The study is a 3-arm, randomized controlled clinical trial with study participation lasting 1 year. Two of the trial arms will include one of two online programs for managing fatigue in MS added to the trial participants' usual MS treatment, and the third arm will include usual MS treatment alone. The online program phase of the trial lasts for 6 months after randomization followed by a final study visit at 12 months. Participants in the usual MS treatment alone arm for the first 6 months will have an opportunity to choose one of the online programs for the final 6 months of the trial.
PhaseNA
TypeInterventional
Age22 Years
WhereWashington D.C., District of Columbia, United States + 5 more
SponsorAccelerated Cure Project for Multiple Sclerosis
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab
NCT05877963 · Relapsing Multiple Sclerosis
RecruitingThe primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK in Part B along with efficacy of ublituximab as measured by T1 Gd-enhancing lesions in participants who had a suboptimal experience on prior anti-CD20 therapy in Part C. The study consists of 3 parts: Part A is single-armed and open-label, Part B is randomized, double-blind, placebo-controlled, and Part C is single-armed and open-label.
PhasePhase 3
TypeInterventional
Age18 Years – 65 Years
WhereBirmingham, Alabama, United States + 45 more
SponsorTG Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
NCT06433752 · Relapsing Multiple Sclerosis, Multiple Sclerosis
RecruitingThe purpose of this study is to evaluate safety, effiectiveness, and to gain insight into the treatment experience of participants prescribed BRIUMVI® (ublituximab-xiiy) in the real-world setting
Phase—
TypeObservational
Age18 Years
WhereBirmingham, Alabama, United States + 84 more
SponsorTG Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
NCT06846281 · Relapsing Multiple Sclerosis
RecruitingThe purpose of this Phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS).
PhasePhase 3
TypeInterventional
Age40 Years – 70 Years
WhereScottsdale, Arizona, United States + 94 more
SponsorNovartis Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts AMX0114 in Adult Participants With Amyotrophic Lateral Sclerosis
NCT06665165 · ALS
RecruitingThis study is a placebo-controlled Phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the antisense oligonucleotide (ASO) AMX0114 in adult participants with amyotrophic lateral sclerosis (ALS).
PhasePhase 1
TypeInterventional
Age18 Years
WhereLa Jolla, California, United States + 13 more
SponsorAmylyx Pharmaceuticals Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis
NCT06141473 · Multiple Sclerosis
RecruitingThe purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years at the time of enrollment). People diagnosed with relapsing forms of multiple sclerosis are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: * This event-driven study will have variable duration depending on the recruitment rate, the event rate, the study discontinuation rate and the 12-month minimum treatment duration. Different participants will have different study durations. The last participant randomized will have at least 12 months of study duration, and assuming a 28-month recruitment period, the first participant randomized will have 40 months or longer of study duration. * The study intervention duration will vary similarly as the study duration. * The assessment of scheduled visits will include 1 common end of study \[EOS\] visit and 3 follow-up visits) with a visit frequency of every 4 weeks for the first 6 months and then every 3 months.
PhasePhase 3
TypeInterventional
Age18 Years – 55 Years
WhereBirmingham, Alabama, United States + 383 more
SponsorSanofi
▾Tap for detailsClick for full details — eligibility, all locations, contacts An Open-label Study of AZD0120 in Adults With Multiple Sclerosis
NCT07224373 · Multiple Sclerosis
RecruitingThis trial is a Phase 1b, open-label, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with Multiple Sclerosis.
PhasePhase 1
TypeInterventional
Age18 Years – 75 Years
WhereTucson, Arizona, United States + 12 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts