Multiple Sclerosis and Neuroimmunology Clinical Trials

Project BIG: The Stanford Brain Immune Gut Research Initiative
Status: Active, Enrolling
PI: Jeffrey Dunn, MD
Research Coordinators:  Anna Tomczak and Julia Sumera
Contact: atomc96@stanford.edu, jsumera@stanford.edu

North American Registry for Care and Research in Multiple Sclerosis (NARCRMS) Study
PI: Jeffrey Dunn, MD
Study Status: Active, Enrolling
Research Coordinator: Anna Tomczak
Contact: atomc96@stanford.edu

A Phase IIIB Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis (BN42082)
PI: Lucas Kipp, MD
NCT04544436
Study Status: Active, Enrolling
Research Coordinator: Julia Sumera and Anna Tomczak
Contact: jsumera@stanford.eduatomc96@stanford.edu

A Phase IIIB Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis (BN42083)
PI: Lucas Kipp, MD
NCT04548999
Study Status: Active, Enrolling
Research Coordinator: Julia Sumera and Anna Tomczak
Contact: jsumera@stanford.eduatomc96@stanford.edu

A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Teriflunomide in Adult Patients with Relapsing Multiple Sclerosis (GN42272)
PI: Lucas Kipp, MD
NCT04586023
Study Status: Active, Enrolling
Research Coordinator: Julia Sumera and Anna Tomczak
Contact: jsumera@stanford.eduatomc96@stanford.edu

A Randomized, Double-blind, Double-dummy, Parallel-group Study to Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif ®) in Patients with Relapsing Multiple Sclerosis
PI:  Jeffrey Dunn, MD
NCT01412333
Study Status: Closed to Enrollment
Research Coordinator: Yamuna Joseph

Multicenter, Randomized, Double-Blind, Parallel-Group Extension to Study AC-058B201 to Investigate the Long-Term Safety, Tolerability, and Efficacy of 10, 20, and 40 mg/day ACT-128800, an Oral S1P1 Receptor Agonist, in Patients with Relapsing-Remitting Multiple Sclerosis
PI: Jeffrey Dunn, MD
NCT01093326
Study Status: Closed to Enrollment
Research Coordinator: Yamuna Joseph

An open-label, multicenter, biomarker study to explore the mechanism of action of ocrelizumab and B-cell biology in patients with relapsing multiple sclerosis
PI: Christopher Lock, MD
NCT02688985
Study Status: Closed to Enrollment
Research Coordinator: Yamuna Joseph

A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects with Relapsing-Remitting Multiple Sclerosis Switching from Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment (101MS329)
PI: Lucas Kipp, MD
NCT03689972
Study Status: Closed to Enrollment
Research Coordinator: Julia Sumera

 A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety and Efficacy of Elezanumab when Added to Standard of Care in Progressive Forms of Multiple Sclerosis (M14-397)
PI: Christopher Lock, MD
NCT03737812
Study Status: Closed to Enrollment
Research Coordinator: Julia Sumera

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety and Efficacy of Elezanumab when Added to Standard of Care in Relapsing Forms of Multiple Sclerosis (M18-918)
PI: Christopher Lock, MD
NCT03737851
Study Status: Closed to Enrollment
Research Coordinator: Julia Sumera

1A Phase 2, Open-label, Multicenter study to evaluate the safety and efficacy of repeated administration of NurOwn® (Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors; MSC-NTF cells) in participants with Progressive Multiple Sclerosis (MS) (BCT-101-US)
PI: Christopher Lock, MD
NCT03799718
Study Status: Study Closed

A Multicenter, Randomized, Double Blind, Placebo Controlled Parallel Group, Pilot Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Relapsing-Remitting Multiple Sclerosis (MNK14274069)
PI: Christopher Lock, MD
NCT03126760
Study Status: Study Closed

A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis
PI: Christopher Lock, MD
NCT02792218
Study Status: Study Closed

A Phase 3, Randomized, Multi-center, Double-blinded, Active-controlled Study to Assess the Efficacy and Safety/Tolerability of Ublituximab (TG-1101; UTX) as Compared to Teriflunomide in Subjects With Relapsing Multiple Sclerosis (RMS) (ULTIMATE 1)
PI: Christopher Lock, MD
NCT03277261
Study Status: Study Closed

 

Upcoming Clinical Trials:

 

A Multicenter Randomized Controlled Trial of Best Available Therapy versus Autologous Hematopoietic Stem Cell Transplant for Treatment-Resistant Relapsing Multiple Sclerosis (BEAT-MS-ITN077AI)
PI: Jeffrey Dunn, MD
Research Coordinator: Yamuna Joseph
Contact: yamuna@stanford.edu

A Phase 1, Double-blind, Placebo-controlled Dose-expansion Study with an Open-label Extension to Evaluate the Safety and Efficacy of ATA188 in Subjects with Progressive Multiple Sclerosis (ATA188) )
PI: Lawrence Steinman, MD
Research Coordinator: Anna Tomczak
Contact: atomc96@stanford.edu

A Phase 3B, multicenter, open-label study to evaluate the immune response to, and the safety of, vaccines in participants with relapsing forms of multiple sclerosis who receive oral ozanimod compared to non-pegylated interferon-β or no disease modifying therapy
PI: Jeffrey Dunn, MD

CorEvitas SPHERES (Synergy of Prospective Health & Experimental Research for Emerging Solutions) Registry for Neuromyelitis Optica Spectrum Disorder (NMOSD)
PI: May Han, MD

An open-label, multicenter study to evaluate the efficacy and safety of satralizumab in patients with early stage Neuromyelitis Optica Spectrum Disorder (NMOSD)
PI: May Han, MD

A phase 4, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy of ocrelizumab in patients with radiologically isolated syndrome
PI: Christopher Lock, MD

Neuroimmunology Clinical Trials Contact

Yamuna Joseph
Clinical Research Coordinator
Department of Neurosurgery and Neurology
Stanford University School of Medicine
yamuna@stanford.edu
Office: (650) 497-6810
Cell: (650) 529-5524
Fax: (650) 721-5113