Safety Study of RTL1000 (Recombinant T Cell Receptor Ligand) in
Subjects With Multiple Sclerosis
This study is currently recruiting patients.
Verified by Artielle ImmunoTherapeutics March 2007
Sponsored by: Artielle ImmunoTherapeutics
Information provided by: Artielle ImmunoTherapeutics
ClinicalTrials.

gov Identifier: NCT00411723

Purpose
RTL1000 is a new agent that has not been previously tested in humans.
It is thought that RTL may specifically control the abnormal immune
response or attack against the insulation on the nerves that occurs in
multiple sclerosis.
The purpose of this study is to evaluate the possible side effects of
a single intravenous dose of RTL1000 in subjects with multiple
sclerosis. Some subjects will also be asked to participate in one or
both of two substudies, one to test blood samples to see how the
body's immune system responds after administration of RTL1000, and the
other to test blood samples to see how the body absorbs and eliminates
the RTL1000.

Condition Intervention Phase
Multiple Sclerosis, Chronic Progressive
Multiple Sclerosis, Relapsing-Remitting Drug: RTL1000 (recombinant T
cell receptor ligand) Phase I

MedlinePlus related topics: Multiple Sclerosis
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control,
Single Group Assignment, Safety Study
Official Title: Phase 1 Safety Study of RTL1000 (Recombinant T Cell
Receptor Ligand) in Subjects With Multiple Sclerosis
Further study details as provided by Artielle ImmunoTherapeutics:

Total Enrollment: 30
Study start: December 2006
This is a double-blind, placebo-controlled treatment protocol with up
to six treatment cohorts, each of which receives a single intravenous
infusion of an escalating dose of RTL1000. Each dosing group will have
six subjects: two who will receive a single dose of placebo and four
who will receive a single dose of RTL1000. Subjects are observed in
the hospital during the infusion and for 24 hours afterward, and are
then followed weekly for 28 days and at 1 and 2 months post-infusion
to evaluate safety parameters.

Objectives of the study are to evaluate the safety profile of a single
dose of RTL1000 administered by intravenous infusion, to evaluate the
pharmacokinetic profile of RTL1000 in a subset of subjects, and to
evaluate the feasibility of assessing immunologic parameters in a
subset of subjects.

Endpoints include vital signs, electrocardiogram and physical
examination results, adverse events, and serious adverse events and
safety laboratory parameters (e.g., clinical chemistries and
hematology values). Disease parameters, such as neurological findings,
expanded disability status scale (EDSS), 25-ft timed walk, 9-hole peg
test, and magnetic resonance imaging (MRI) will be measured to ensure
that study treatment does not make disease worse. Subjects will also
be tested at the beginning and end of the study for antibodies to the
drug and its components.

Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible
for Study: Both
Criteria
A specific blood cell type called HLA-DR2 may be required in order for
RTL1000 to work. For that reason, all subjects will be tested for
HLA-DR2 and only those subjects who test positive (about 50%) will
undergo further tests to determine if they meet inclusion and
exclusion criteria.

Inclusion criteria:
• Fulfill McDonald criteria for multiple sclerosis
• Confirmed diagnosis of chronic progressive or relapsing-remitting
multiple sclerosis
• EDSS score of 0.0 to 6.5
• No clinical exacerbations within the 8 weeks before administration
of RTL1000
• HLA-DR2 positive, as confirmed by study reference laboratory
• Negative serum pregnancy test within 7 days of administration of
RTL1000 and negative urine pregnancy test on Day 0 for all women of
childbearing potential
• Agreement of sexually active men and women of childbearing potential
to practice a medically-approved form of contraception
• Capable of and willing to provide written informed consent
Exclusion Criteria:
• Exposure to alemtuzumab or dacluzimab any time in the 6 months
before administration of RTL1000
• Exposure to natalizumab or other drugs targeting alpha-4 integrin in
the 6 months before RTL1000 administration or more than 3 doses of
natalizumab or these drugs at any time.
• Any prior exposure to RTL1000
• Exposure to other MS disease-modifying drugs (e.g., recombinant
interferon beta and glatiramer acetate), immunosuppressant agents, or
systemic corticosteroids (other than replacement doses) within the 4
weeks prior to RTL1000 administration
• Exposure to chemotherapeutic immunosuppressants, including
azathioprine, mycophenolate mofetil, methotrexate, cladribine,
mitoxantrone, or cyclophosphamide, during the six months prior to
administration of RTL1000
• Total lymphoid irradiation or bone marrow transplantation at any time
• Known or suspected allergy to gadolinium
• Contraindication to MRI (e.g., subject has a pacemaker or other
contraindicated implanted metal devices or has claustrophobia that
cannot be medically managed)
• Clinically significant abnormalities in laboratory findings for
hematologic, hepatic, and renal function at screening.
• Significant medical diseases or conditions, including poorly
controlled hypertension, cardiovascular disease, inflammatory
disorders, immunodeficiency (e.g., HIV infection), renal failure,
liver dysfunction, cancer (except treated basal cell carcinoma), or
active infection.
• History of, or current, psychiatric illness likely to interfere with
ability to comply with protocol requirements or give informed consent
• History of alcohol or drug abuse likely to interfere with ability to
comply with protocol requirements
• Pregnancy or lactation

Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00411723

United States, Connecticut
Yale Center for MS Treatment and Research, New Haven,
Connecticut, 06510, United States; Recruiting
Sarah Henry 203-764-8160 sarah.henry@...
Jana Preiningerova, M.D., Principal Investigator

United States, Indiana
Indiana University, Dept. of Neurology, Indianapolis, Indiana,
46202, United States; Recruiting
Lee Hayward 317-278-7293 lhayward@...
David Mattson, M.D., Ph.D., Principal Investigator

United States, Kansas
University of Kansas Medical Center, Landon Center on Aging,
Kansas City, Kansas, 66160, United States; Recruiting
Lisa Schmidt 913-588-3968 lschmidt@...
Sharon Lynch, M.D., Principal Investigator

United States, Maryland
University of Maryland School of Medicine, Baltimore, Maryland,
21201, United States; Not yet recruiting
Kerry Naunton 410-328-1155 knaunton@...
Christopher Bever, Jr., M.D., M.B.A., Principal Investigator

United States, Oregon
MS Center of Oregon Health & Science University, Portland,
Oregon, 97239, United States; Recruiting
Stacey Schroeder 503-494-7241
Vijayshree Yadav, M.D., Principal Investigator

United States, Washington
MS Center at Evergreen, Kirkland, Washington, 98034, United
States; Not yet recruiting
Kathleen Butler, BA 425-899-5373 kbutler@...
James Bowen, M.D., Principal Investigator

Study chairs or principal investigators

Jana Preiningerova, M.D., Principal Investigator, Yale Center for MS
Treatment and Research
David Mattson, M.D., Ph.D., Principal Investigator, University of
Indiana, Department of Neurology
Sharon Lynch, M.D., Principal Investigator, University of Kansas
Medical Center, Landon Center on Aging
Christopher Bever, Jr., M.D., M.B.A., Principal Investigator,
University of Maryland School of Medicine
James Bowen, M.D., Principal Investigator, MS Center at Evergreen
Vijayshree Yadav, M.D., Principal Investigator, MS Center of Oregon
Health and Science University
More Information
Study ID Numbers: RTL1000-1.0001
Last Updated: March 14, 2007
Record first received: December 12, 2006
ClinicalTrials.gov Identifier: NCT00411723
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on May 31, 2007

http://clinicaltrials.gov/show/NCT00411723