Multiple SclerosisEarly Phase 1NCT03887065
Magnetic Resonance Imaging Study of JM-4 in Multiple Sclerosis/Clinically Patients
A Early Phase 1 study testing JM-4 in people with Multiple Sclerosis, run by Cook, Stuart, MD.
Trial summary
This is a Phase 0/1 study of MS patients to determine the safety and potential efficacy of a novel, small human peptide designated as JM-4. The study will involve treatment for 5-7 days with JM-4 to determine the effects of Gadolinium(+) lesion number and volume in the brains of patients. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- JM-4
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2019to 15 Mar 2020
- Phase
- Early 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Definite MS (McDonald criteria) or CIS
- GAD(+) MRI brain lesion on screening exam, with or without clinical activity followed by a baseline MRI
- EDSS of 0-5.5 inclusive
- Weight of 40-115 kg
- Females must be post-menopausal or surgically sterilized or use a hormonal contraceptive, intra-uterine device or diaphragm with spermicide during the study
- Not be pregnant or breast feeding
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- Males must be willing to use contraception during each day of the study
- Be willing to comply with study procedures and protocols for the duration of the study
- Voluntarily provide informed consent
- Be wiling and physically able to attend the study center as required for all study screening and procedures
Who cannot join
- Taking Tysabri, Gilenya, Tecfidera, Aubagio, Ocrevus or other immunosuppressive drugs within the prior 3 months
- Received Mitoxantrone or Lemtrada at any time
- Consumption of corticosteroids within the past 30 days
- Current or less than 5 years prior malignancy (excluding basal cell or squamous cell skin cancer)
- Serious systemic disorder which might, in the opinion of the investigators, interfere with safety, compliance, treatment or evaluation of efficacy. Conditions would include but not be limited to significant cardiac, liver, kidney, lung or cerebrovascular disease, HIV, serious infections, serous psychiatric disease or poorly controlled diabetes mellitus
- aversion, intolerance or allergy to repeated MRI with gadolinium administration
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Magnetic Resonance Imaging 12 Day Study for Multiple Sclerosis/Clinically Isolated Syndrome Trial of JM-4 Novel Human Peptide
This is a Phase 0/1 study of MS patients to determine the safety and potential efficacy of a novel, small human peptide designated as JM-4. The study will involve treatment for 5-7 days with JM-4 to determine the effects of Gadolinium(+) lesion number and volume in the brains of patients.
Read the detailed description
This study is the first study of JM-4 in patients with Multiple Sclerosis and is intended to show safety and potential efficacy in changing the size and/or number of GAD(+) lesions in the brain. The initial dose level of 1 mg/kg/ will establish safety of JM-4 treatment after 5-7 days of treatment via intravenous infusion over 30 minutes daily in3-5 patients with Multiple Sclerosis. MRI examinations will be conducted prior to treatment with JM-4 and 8 days after the initiation of treatment for the purpose of quantitating GAD(+) brain lesions. Once initial safety is established, the next group of 3-5 patients will receive 4 mg/kg/ of JM-4 daily for 5-7 days via 30 minute intravenous infusions, with MRI scans conducted prior to treatment and 8 days after the initial dose of JM-4. Once safety is established in this cohort of patients, a third group of patients may receive 9 mg/kg/ of JM-4 daily for 5-7 days via 30 minute infusions, with MRI scans conducted prior to the initial treatment and 8 days after the initial treatment.
- Conditions
- Multiple Sclerosis
- Being tested
- JM-4
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JM-4Drug
Novel small human peptide derived from erythropoietin
| Study group | Role | What they receive |
|---|---|---|
| Starting dose | Experimental | Three to five patients will receive a daily dose of 1 mg/kg JM-4 (in normal saline) delivered via intravenous infusion for no more than 30 minutes for up to 7 consecutive days. Receives: Drug: JM-4 |
| Intermediate dose of JM-4 | Experimental | Three to five patients will receive a daily dose of 4 mg/kg of JM-4 (in normal saline) via intravenous infusion for no more than 30 minutes for up to 7 consecutive days. Receives: Drug: JM-4 |
| High dose of JM-4 | Experimental | Three to five patients will receive a daily dose of 9 mg/kg of JM-4 (in normal saline) via intravenous infusion for no more than 30 minutes for up to 7 consecutive days. Receives: Drug: JM-4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with treatment-related adverse events
To determine the incidence of adverse events and any abnormal laboratory values
Measured: From initial dose through 8 days after initiation of dosing
Change in GAD(+) brain lesions measured via MRI scan
Measurement of the number and size of GAD(+) brain lesions from baseline to post-dosing 8 days after initiation of treatment
Measured: From initial dose through 8 days after initiation of dosing
Secondary outcomes (3)
Changes in the ability of patients to complete a timed 25-foot walk
To determine changes in timed 25 foot walk prior to treatment or 8 days after treatment
Measured: From initial dosing through 8 days post-initiation of dosing
Treatment-induced changes in Expanded Disability Status Score in patients
Measurement of Expanded Disability Status scores in patients prior to treatment and after completion of treatment
Measured: Prior to initial dose through 8 days post-initial treatment
Changes in neurological exam
Neurological examination of patients to check for optic nerve changes and vision changes
Measured: Prior to initial dose through 8 days post-initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start15 Jun 2019 (estimated)
- Primary completion15 Dec 2019 (estimated)
- Study completion15 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cook, Stuart, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Cook, MD, Cook, Stuart, MD
- Investigators
- Stuart Cook, MD, Principal investigator, VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887065
- Sponsor's protocol ID
- JM-4-001
- Status last verified
- Mar 2019
- First submitted
- 10 Mar 2019
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging 12 Day Study for Multiple Sclerosis/Clinically Isolated Syndrome Trial of JM-4 Novel Human Peptide
- ClinicalTrials.gov ID
- NCT03887065
- Acronym / sponsor ID
- JM-4-001
- Conditions
- Multiple Sclerosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Cook, Stuart, MDUniversity, hospital or other
- Study start
- 15 Jun 2019 (estimated)
- Primary completion
- 15 Dec 2019 (estimated)
- Study completion
- 15 Mar 2020 (estimated)
- First posted
- 22 Mar 2019 (actual)
- 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.
This is a Phase 0/1 study of MS patients to determine the safety and potential efficacy of a novel, small human peptide designated as JM-4. The study will involve treatment for 5-7 days with JM-4 to determine the effects of Gadolinium(+) lesion number and volume in the brains of patients.
Detailed description
This study is the first study of JM-4 in patients with Multiple Sclerosis and is intended to show safety and potential efficacy in changing the size and/or number of GAD(+) lesions in the brain. The initial dose level of 1 mg/kg/ will establish safety of JM-4 treatment after 5-7 days of treatment via intravenous infusion over 30 minutes daily in3-5 patients with Multiple Sclerosis. MRI examinations will be conducted prior to treatment with JM-4 and 8 days after the initiation of treatment for the purpose of quantitating GAD(+) brain lesions. Once initial safety is established, the next group of 3-5 patients will receive 4 mg/kg/ of JM-4 daily for 5-7 days via 30 minute intravenous infusions, with MRI scans conducted prior to treatment and 8 days after the initial dose of JM-4. Once safety is established in this cohort of patients, a third group of patients may receive 9 mg/kg/ of JM-4 daily for 5-7 days via 30 minute infusions, with MRI scans conducted prior to the initial treatment and 8 days after the initial treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Starting dose | Experimental | Drug: JM-4Three to five patients will receive a daily dose of 1 mg/kg JM-4 (in normal saline) delivered via intravenous infusion for no more than 30 minutes for up to 7 consecutive days. |
| Intermediate dose of JM-4 | Experimental | Drug: JM-4Three to five patients will receive a daily dose of 4 mg/kg of JM-4 (in normal saline) via intravenous infusion for no more than 30 minutes for up to 7 consecutive days. |
| High dose of JM-4 | Experimental | Drug: JM-4Three to five patients will receive a daily dose of 9 mg/kg of JM-4 (in normal saline) via intravenous infusion for no more than 30 minutes for up to 7 consecutive days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Definite MS (McDonald criteria) or CIS
- GAD(+) MRI brain lesion on screening exam, with or without clinical activity followed by a baseline MRI
- EDSS of 0-5.5 inclusive
- Weight of 40-115 kg
- Females must be post-menopausal or surgically sterilized or use a hormonal contraceptive, intra-uterine device or diaphragm with spermicide during the study
Key exclusion criteria (6 listed)
- Taking Tysabri, Gilenya, Tecfidera, Aubagio, Ocrevus or other immunosuppressive drugs within the prior 3 months
- Received Mitoxantrone or Lemtrada at any time
- Consumption of corticosteroids within the past 30 days
- Current or less than 5 years prior malignancy (excluding basal cell or squamous cell skin cancer)
- Serious systemic disorder which might, in the opinion of the investigators, interfere with safety, compliance, treatment or evaluation of efficacy. Conditions would include but not be limited to significant cardiac, liver, kidney, lung or cerebrovascular disease, HIV, serious infections, serous psychiatric disease or poorly controlled diabetes mellitus
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 |
|---|---|---|
| JM-4Novel small human peptide derived from erythropoietin | Drug | High dose of JM-4, Intermediate dose of JM-4, Starting dose |
Primary outcome
Number of patients with treatment-related adverse events
Time frame: From initial dose through 8 days after initiation of dosing
To determine the incidence of adverse events and any abnormal laboratory values
Change in GAD(+) brain lesions measured via MRI scan
Time frame: From initial dose through 8 days after initiation of dosing
Measurement of the number and size of GAD(+) brain lesions from baseline to post-dosing 8 days after initiation of treatment
3 secondary outcomes
Changes in the ability of patients to complete a timed 25-foot walk
Time frame: From initial dosing through 8 days post-initiation of dosing
Treatment-induced changes in Expanded Disability Status Score in patients
Time frame: Prior to initial dose through 8 days post-initial treatment
Changes in neurological exam
Time frame: Prior to initial dose through 8 days post-initial treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Individual participant dataSharing planned: No
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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.
Stuart Cook, MD principal investigator
VA Medical Center
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing JM-4 in people with Multiple Sclerosis, run by Cook, Stuart, MD.
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 10 inclusion and 6 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 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Contact Stuart Cook, MD ((201) 213-5052, cookstu@comcast.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with treatment-related adverse events (time frame: From initial dose through 8 days after initiation of dosing). The study lists 2 primary outcomes in all. 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 7 May 2019.