Multiple Sclerosis Research

CLINICAL SUPPORT

Brandi Carrico, Sr. Administrative Assistant
Jim Jemelka, Research Coordinator

If you wish to participate in any of the trials or have general questions please contact our research coordinator at 713-500-7045.


CURRENT CLINICAL RESEARCH

(December 16, 2021)

Studies Open for New Subjects

ATA188-MS-101, Atara Biotherapeutics

A Phase 1, Two-part, Open-label Dose-escalation and 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
Investigator: J. William Lindsey, MD
Treatment being tested:  Immune cells specific for Epstein-Barr virus
Purpose:  The long term goal is to use white blood cells specific for EBV as a treatment for MS.  This is a phase I study in progressive MS, and the main objective is to assess safety and tolerability of the treatment.  The results from the first 4 groups of subjects are encouraging. Age 18 to 55.
Status:  Enrollment is ongoing as of December, 2021

Fenebrutinib, Genentech

A phase III multicenter, randomized, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of fenebrutinib compared with ocrelizumab in adult patients with primary progressive multiple sclerosis
Investigator: J. William Lindsey, MD
Treatment being tested:  Fenebrutinib, an agent that inhibits B lymphocytes and macrophages
Purpose:  Phase III study to compare the effect of fenebrutinib, a new oral agent, to Ocrevus, an approved medicine for PPMS.
Key inclusion criteria:  Primary progressive MS.  Age 18 to 65.
Status:  enrollment open as of  December, 2021

ANK-700, Anokion

A Phase 1 Study of the Safety and Tolerability of Single and Multiple Doses of ANK-700 in Patients with Relapsing-Remitting Multiple Sclerosis
Investigator: J. William Lindsey, MD
Treatment being tested:  ANK-700, an agent to induce immune tolerance to myelin proteins
Purpose:  Phase I study to test safety and tolerability
Key inclusion criteria:  Relapsing MS, age 18 to 55, EDSS up to 6.5, can be on one of the fumarates or on no MS treatment.
Status:  enrollment open as of December, 2021

Grant under review at NIH and National MS Society

Understanding early pathological pathways in MS:  Insights from CSF and T cells responding to brain antigens
Investigator: J. William Lindsey, MD
Treatment being tested:  none
Purpose:  To see if the T lymphocytes from blood that respond to brain antigens are the same as the lymphocytes found in the cerebrospinal fluid.  This study could teach us a lot about the disease process in MS.
Key inclusion criteria:  Patients presenting with the first symptoms of MS, still in the process of diagnosis, and not yet given any MS treatment.


Ongoing Studies with Completed Enrollment

Ocarina:  Subcutaneous ocrelizumab, Genentech

Investigator:  J. William Lindsey, MD
Treatment being tested:  Ocrevus, given subcutaneously
Purpose:  To see if Ocrevus can be given sc rather than iv.  Ocrelizumab is a very effective agent for treating MS, and is approved for treatment of both relapsing and progressive disease since March, 2017.  This study will test whether it can be given by injection under the skin instead of by intravenous infusion, and determine the best dose.
Status:  Enrolled

Evobrutinib, EMD Serono

Investigator: J. William Lindsey, MD
Treatment being tested:  Evobrutinib, an agent that inhibits B lymphocytes and macrophages
Purpose:  Phase III study to compare the effect of evobrutinib, a new oral agent, to Aubagio, an approved oral medicine.  The phase II results were promising.  Subjects will be randomized to one of the two groups.
Key inclusion criteria:  Relapsing MS.  Age 18 to 55.
Status:  Enrolled