Magnetic Resonance Imaging Study of JM-4 in Multiple Sclerosis/Clinically Patients

May 5, 2019 updated by: Stuart Cook, MD, Cook, Stuart, MD

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Starting dose
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.
Drug: JM-4
Novel small human peptide derived from erythropoietin
Experimental: Intermediate dose of JM-4
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.
Drug: JM-4
Novel small human peptide derived from erythropoietin
Experimental: High dose of JM-4
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.
Drug: JM-4
Novel small human peptide derived from erythropoietin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From initial dose through 8 days after initiation of dosing
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
From initial dose through 8 days after initiation of dosing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
To determine changes in timed 25 foot walk prior to treatment or 8 days after treatment
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
Measurement of Expanded Disability Status scores in patients prior to treatment and after completion of treatment
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
Neurological examination of patients to check for optic nerve changes and vision changes
Prior to initial dose through 8 days post-initial treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook, Stuart, MD

Investigators

  • Principal Investigator: Stuart Cook, MD, VA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 15, 2019

Primary Completion (Anticipated)

December 15, 2019

Study Completion (Anticipated)

March 15, 2020

Study Registration Dates

First Submitted

March 10, 2019

First Submitted That Met QC Criteria

March 21, 2019

First Posted (Actual)

March 22, 2019

Study Record Updates

Last Update Posted (Actual)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JM-4-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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