Multiple Sclerosis, Chronic ProgressivePhase 1NCT00411723
Safety Study of RTL1000 (Recombinant T Cell Receptor Ligand) in Subjects With Multiple Sclerosis
A Phase 1 study testing RTL1000 (recombinant T cell receptor ligand) in people with Multiple Sclerosis, Chronic Progressive and Multiple Sclerosis, Relapsing-Remitting, run by Artielle ImmunoTherapeutics at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- RTL1000 (recombinant T cell receptor ligand)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2006to May 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Indiana University, Dept. of Neurology
Indianapolis, Indiana, 46202
University of Kansas Medical Center, Landon Center on Aging
Kansas City, Kansas, 66160
MS Center at Evergreen
Kirkland, Washington, 98034
Yale Center for MS Treatment and Research
New Haven, Connecticut, 06510
MS Center of Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Phase 1 Safety Study of RTL1000 (Recombinant T Cell Receptor Ligand) in Subjects With Multiple Sclerosis
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.
Read the detailed description
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.
- Being tested
- RTL1000 (recombinant T cell receptor ligand), RTL1000 Placebo
- Keywords
- multiple sclerosis, chronic-progressive, relapsing-remitting
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
RTL1000 PlaceboDrug
Dosage form: IV infusion. Dosage: Same volume as Experimental. Frequency: Single dose. Duration: 1 - 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: RTL1000 (recombinant T cell receptor ligand) |
| 2 | Placebo comparator | Not described Receives: Drug: RTL1000 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionFeb 2009
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Chronic ProgressiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artielle ImmunoTherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jana Preiningerova, M.D., Principal investigator, Yale Center for MS Treatment and ResearchDavid Mattson, M.D., Ph.D., Principal investigator, University of Indiana, Department of NeurologySharon Lynch, M.D., Principal investigator, University of Kansas Medical Center, Landon Center on AgingChristopher Bever, Jr., M.D., M.B.A., Principal investigator, University of Maryland, BaltimoreTheodore R Brown, M.D., Principal investigator, MS Center at EvergreenVijayshree Yadav, M.D., Principal investigator, MS Center of Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411723
- Sponsor's protocol ID
- RTL1000-1.0001
- Status last verified
- Feb 2009
- First submitted
- 12 Dec 2006
- Last updated
- 20 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Safety Study of RTL1000 (Recombinant T Cell Receptor Ligand) in Subjects With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00411723
- Acronym / sponsor ID
- RTL1000-1.0001
- Keywords
- multiple sclerosis, chronic-progressive, relapsing-remitting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Artielle ImmunoTherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- May 2009 (estimated)
- First posted
- 14 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RTL1000 (recombinant T cell receptor ligand) |
| 2 | Placebo comparator | Drug: RTL1000 Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RTL1000 (recombinant T cell receptor ligand)Dosage form: IV infusion. Dosage: Single dose @ 2, 6, 20, 60, 100 or 200mg. Duration: 1 - 2 hours. | Drug | 1 |
| RTL1000 PlaceboDosage form: IV infusion. Dosage: Same volume as Experimental. Frequency: Single dose. Duration: 1 - 2 hours. | Drug | 2 |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RTL1000 (recombinant T cell receptor ligand) in people with Multiple Sclerosis, Chronic Progressive and Multiple Sclerosis, Relapsing-Remitting, run by Artielle ImmunoTherapeutics at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2009.