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Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT00411723
Date of registration:	12/12/2006
Prospective Registration:	No
Primary sponsor:	Artielle ImmunoTherapeutics
Public title:	Safety Study of RTL1000 (Recombinant T Cell Receptor Ligand) in Subjects With Multiple Sclerosis
Scientific title:	Phase 1 Safety Study of RTL1000 (Recombinant T Cell Receptor Ligand) in Subjects With Multiple Sclerosis
Date of first enrolment:	December 2006
Target sample size:	34
Recruitment status:	Active, not recruiting
URL:	http://clinicaltrials.gov/show/NCT00411723
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Phase:	Phase 1

Countries of recruitment
United States

Contacts

Name:	Jana Preiningerova, M.D.
Address:
Telephone:
Email:
Affiliation:	Yale Center for MS Treatment and Research

Name:	Sharon Lynch, M.D.
Address:
Telephone:
Email:
Affiliation:	University of Kansas Medical Center, Landon Center on Aging

Name:	Theodore R Brown, M.D.
Address:
Telephone:
Email:
Affiliation:	MS Center at Evergreen

Name:	Christopher Bever, Jr., M.D., M.B.A.
Address:
Telephone:
Email:
Affiliation:	University of Maryland

Name:	Vijayshree Yadav, M.D.
Address:
Telephone:
Email:
Affiliation:	MS Center of Oregon Health and Science University

Name:	David Mattson, M.D., Ph.D.
Address:
Telephone:
Email:
Affiliation:	University of Indiana, Department of Neurology

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Chronic Progressive

Multiple Sclerosis, Relapsing-Remitting

Intervention(s)

Drug: RTL1000 (recombinant T cell receptor ligand)

Drug: RTL1000 Placebo

Primary Outcome(s)

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. [Time Frame: Day 28]

Secondary Outcome(s)

Secondary ID(s)

RTL1000-1.0001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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