Safety Study of RTL1000 (Recombinant T Cell Receptor Ligand) in Subjects With Multiple Sclerosis

NCT00411723 | Unknown Phase 1

• 1 other identifier: RTL1000-1.0001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis, Relapsing-Remitting

Keywords

multiple sclerosis, chronic-progressive, relapsing-remitting

Outcome Measures

Primary Outcomes (1)

• Adverse events, safety, laboratory parameters, vital signs, ECG and physical exam results. Disease parameters (neurologic exam, EDSS, 25 foot timed walk, 9-hole PEG test, MRI). Antibodies to drug.

  Day 28

Study Arms (2)

1

EXPERIMENTAL

Drug: RTL1000 (recombinant T cell receptor ligand)

2

PLACEBO COMPARATOR

Drug: RTL1000 Placebo

Interventions

RTL1000 (recombinant T cell receptor ligand) DRUG

Dosage form: IV infusion. Dosage: Single dose @ 2, 6, 20, 60, 100 or 200mg. Duration: 1 - 2 hours.

1

RTL1000 Placebo DRUG

Dosage form: IV infusion. Dosage: Same volume as Experimental. Frequency: Single dose. Duration: 1 - 2 hours.

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Artielle ImmunoTherapeutics: lead

Study Sites (6)

Yale Center for MS Treatment and Research

New Haven, Connecticut, 06510, United States

Location

Indiana University, Dept. of Neurology

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Medical Center, Landon Center on Aging

Kansas City, Kansas, 66160, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

MS Center of Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MS Center at Evergreen

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jana Preiningerova, M.D.

  Yale Center for MS Treatment and Research

  PRINCIPAL INVESTIGATOR

• David Mattson, M.D., Ph.D.

  University of Indiana, Department of Neurology

  PRINCIPAL INVESTIGATOR

• Sharon Lynch, M.D.

  University of Kansas Medical Center, Landon Center on Aging

  PRINCIPAL INVESTIGATOR

• Christopher Bever, Jr., M.D., M.B.A.

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

• Theodore R Brown, M.D.

  MS Center at Evergreen

  PRINCIPAL INVESTIGATOR

• Vijayshree Yadav, M.D.

  MS Center of Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 12, 2006
• First Posted: December 14, 2006
• Study Start: December 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: May 1, 2009
• Last Updated: February 20, 2009

Record last verified: 2009-02

Locations

US (6)