Summary: Investigators at six sites across the United States are enrolling participants in a clinical trial evaluating the safety of a single dose of an intravenous drug called RTL1000 (Artielle ImmunoTherapeutics, Inc.) compared to inactive placebo in 36 people with relapsing-remitting or secondary-progressive multiple sclerosis.
Rationale: The immune attack on brain and spinal cord tissues in MS is thought to be launched by T cells that are directed at protein components of the myelin sheath that insulates nerve fibers. Over several years, Arthur Vandenbark, PhD, and colleagues have been attempting to create treatments for MS based on blocking interactions between T cells and myelin, with funding from the National MS Society. To this end, Dr. Vandenbark’s team developed molecules called recombinant TCR ligands (RTLs), which are designed to inhibit the ability of specific T cells to bind to and cause damage to myelin. Artielle ImmunoTherapeutics, Inc., is developing one of these molecules, RTL1000, as a potential treatment for MS.
Eligibility and Details: To be considered for participation in the 3-month study, individuals must be 18-65 years of age with definite relapsing-remitting MS (a course of MS characterized by clearly defined flare-ups followed by partial or complete recovery periods), or secondary-progressive MS (disease that starts with a relapsing-remitting course and then transitions to a steadily worsening disease course with or without occasional flare-up). There are other specific inclusion criteria.
The primary outcome of this study is to evaluate the safety profile of a single intravenous dose of RTL1000, and to determine the maximum tolerated dose of RTL1000 that can be given as a single dose. Secondary goals include the evaluation of the drug’s pharmacokinetics (how the drug is absorbed in the body) and the feasibility of assessing the drug’s effects on immune system activity.
Enrollment Information: Six sites are currently enrolling patients. For information, contact the site in your local area:
1) Sarah Henry
Yale Center for MS Treatment and Research
New Haven, CT
2) Lee Hayward
3) Lisa Schmidt
University of Kansas Medical Center
Kansas City, KS
4) Kerry Naunton
University of Maryland School of Medicine, Baltimore
5) Stacey Schroeder-Moultrie
MS Center of Oregon Health & Science University
6) Yuriko Courtney
MS Center Evergreen