Clinical trials: Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis
Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab
The 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…
- Trial name
- ENHANCE (NCT05877963)
- Testing
- Ublituximab
- Where
- 51 sites in United States, Poland
- Volunteers
- 800 people
- Sponsor
- TG Therapeutics, Inc.
Relapsing Multiple Sclerosis
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)
The purpose of this study is to assess the pharmacokinetics of ublituximab when administered subcutaneously (SC) compared to intravenous (IV) administration in participants with RMS.
- Trial name
- NCT07211633
- Testing
- Ublituximab
- Where
- 48 sites in Bosnia and Herzegovina, Bulgaria and 7 more
- Volunteers
- 360 people
- Sponsor
- TG Therapeutics, Inc.
Relapsing-remitting Multiple Sclerosis
A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)
The main purpose of this study is to evaluate the pharmacokinetics (PK) of ocrelizumab administered subcutaneously (SC) in children and adolescents aged 10 to <18 years with RRMS.
- Trial name
- Operetta III (NCT07503340)
- Testing
- Ocrelizumab co-formulated with rHuPH20
- Volunteers
- 25 people
- Sponsor
- Hoffmann-La Roche
Relapsing Multiple Sclerosis
A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)
This open label, single arm study will evaluate the PK and PD effects of fenebrutinib in children and adolescents with RMS aged between 10 and < 18 years.
- Trial name
- FENerations1 (NCT07161258)
- Testing
- Fenebrutinib
- Where
- 17 sites in Argentina, Brazil and 5 more
- Volunteers
- 12 people
- Sponsor
- Hoffmann-La Roche
Relapsing Multiple Sclerosis
A Study of Subcutaneously Administered RO7845860 in Participants With Relapsing Multiple Sclerosis
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and, pharmacodynamics (PD) of subcutaneously administered RO7845860 in participants with relapsing multiple sclerosis (RMS).
- Trial name
- NOVA-BEAM (NCT07749157)
- Testing
- RO7845860
- Volunteers
- 85 people
- Sponsor
- Hoffmann-La Roche
Multiple Sclerosis, Relapsing-Remitting
Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis
Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-2)
- Trial name
- ENSURE-2 (NCT05201638)
- Testing
- IMU-838 tablets
- Where
- 101 sites in United States, Armenia and 12 more
- Volunteers
- 1,100 people
- Sponsor
- Immunic AG
Relapsing Multiple Sclerosis, Primary Progressive Multiple Sclerosis
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Participants With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis
The main purpose of this study is to evaluate the efficacy of ocrelizumab in participants with relapsing multiple sclerosis (RMS) and to characterize the ocrelizumab pharmacodynamic (PD) profile in Chinese participants with…
- Trial name
- NCT07483450
- Testing
- Ocrelizumab
- Where
- 17 sites in China
- Volunteers
- 60 people
- Sponsor
- Hoffmann-La Roche
Multiple Sclerosis
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)
This is a randomized, double-blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and PK of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks (Q24W) in participants with RMS…
- Trial name
- MUSETTE (NCT04544436)
- Testing
- Ocrelizumab, Antihistamine, Methylprednisolone
- Where
- 120 sites in United States, Argentina and 19 more
- Volunteers
- 864 people
- Sponsor
- Hoffmann-La Roche
Relapsing-Remitting Multiple Sclerosis
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
The main purpose of the study is to assess patient-reported satisfaction with subcutaneous (s.c.) ocrelizumab administration in participants with relapsing-remitting multiple sclerosis (RRMS) who are treatment-naive, switching…
- Trial name
- SONATA-MS (NCT07827586)
- Testing
- Ocrelizumab
- Where
- Slovenia
- Volunteers
- 1,800 people
- Sponsor
- Hoffmann-La Roche
Relapsing Multiple Sclerosis
A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)
This is a study evaluating the effect of fenebrutinib on brain magnetic resonance imaging (MRI) in participants with RMS. The safety and pharmacokinetics of fenebrutinib will also be evaluated.
- Trial name
- FENopta (NCT05119569)
- Testing
- Fenebrutinib
- Where
- 17 sites in United States, Bosnia and Herzegovina and 4 more
- Volunteers
- 109 people
- Sponsor
- Hoffmann-La Roche
Relapsing Remitting Multiple Sclerosis
Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects With Relapsing-Remitting Multiple Sclerosis
This is a randomized, double-blind study of PIPE-307 or placebo in subjects with relapsing-remitting multiple sclerosis. Subjects will be randomized into 1 of 3 separate cohorts (1:1:1 randomization ratio, PIPE-307 Dose…
- Trial name
- VISTA (NCT06083753)
- Testing
- PIPE-307 Dose A, PIPE-307 Dose B
- Where
- 21 sites in United States
- Volunteers
- 182 people
- Sponsor
- Janssen Research & Development, LLC
Multiple Sclerosis, Relapsing-Remitting
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
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…
- Trial name
- NCT03958877
- Testing
- BIIB017 (peginterferon beta-1a), Interferon beta type 1a
- Where
- 65 sites in United States, Argentina and 20 more
- Volunteers
- 152 people
- Sponsor
- Biogen
Relapsing Multiple Sclerosis
A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk
The primary objective of the lactation study is to characterize the presence and concentration of BRIUMVI™ in breast milk among breastfeeding participants who receive BRIUMVI™ therapeutically for the treatment of relapsing forms…
- Trial name
- PROVIDE (NCT06143514)
- Testing
- No intervention
- Where
- 5 sites in United States
- Volunteers
- 16 people
- Sponsor
- TG Therapeutics, Inc.
Relapsing Multiple Sclerosis (RMS)
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
The purpose of this study is to evaluate long-term safety and efficacy of ublituximab therapy in participants with relapsing multiple sclerosis (RMS).
- Trial name
- NCT04130997
- Testing
- Ublituximab
- Where
- 86 sites in United States, Belarus and 6 more
- Volunteers
- 1,100 people
- Sponsor
- TG Therapeutics, Inc.
Multiple Sclerosis
A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis
The main purpose of this study is to evaluate the safety and efficacy of LY3541860 in adult participants with multiple sclerosis that gets worse and gets better.
- Trial name
- NCT06220669
- Testing
- LY3541860
- Where
- 20 sites in United States, France and 5 more
- Volunteers
- 63 people
- Sponsor
- Eli Lilly and Company
Relapsing Multiple Sclerosis, Multiple Sclerosis
A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
The 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
- Trial name
- ENABLE (NCT06433752)
- Testing
- No Intervention
- Where
- 111 sites in United States, Puerto Rico and 1 more
- Volunteers
- 2,000 people
- Sponsor
- TG Therapeutics, Inc.
Relapsing-remitting Multiple Sclerosis (RRMS)
Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)
The Main objectives of the study are to demonstrate pharmacokinetic (PK) similarity between ABP 692 and ocrelizumab (US), as well as between ABP 692 and ocrelizumab (EU).
- Trial name
- NCT06700343
- Testing
- Ocrelizumab (US), Ocrelizumab (EU), ABP 692
- Where
- 109 sites in United States, Belgium and 20 more
- Volunteers
- 152 people
- Sponsor
- Amgen
Relapsing Multiple Sclerosis
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS.
- Trial name
- FENhance (NCT04586010)
- Testing
- Fenebrutinib, Teriflunomide
- Where
- 158 sites in United States, Argentina and 21 more
- Volunteers
- 746 people
- Sponsor
- Hoffmann-La Roche
Relapsing Multiple Sclerosis
Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis
The primary purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ublituximab in participants ages 10 to less than (<)18 years and body weight greater than or equal to (≥)25 kilograms (kg) to…
- Trial name
- NCT07220252
- Testing
- Ublituximab, Fingolimod
- Where
- 3 sites in Poland
- Volunteers
- 240 people
- Sponsor
- TG Therapeutics, Inc.
Relapsing Multiple Sclerosis
Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS.
- Trial name
- FENhance 2 (NCT04586023)
- Testing
- Fenebrutinib, Teriflunomide
- Where
- 106 sites in United States, Austria and 15 more
- Volunteers
- 751 people
- Sponsor
- Hoffmann-La Roche