NCT03887065

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at P25-P50 for early_phase_1 multiple-sclerosis

Timeline
Completed

Started Jun 2019

Shorter than P25 for early_phase_1 multiple-sclerosis

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

June 15, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
Last Updated

May 7, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

March 10, 2019

Last Update Submit

May 5, 2019

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

  • Number of patients with treatment-related adverse events

    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

    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 Outcomes (3)

  • Changes in the ability of patients to complete a timed 25-foot walk

    From initial dosing through 8 days post-initiation of dosing

  • Treatment-induced changes in Expanded Disability Status Score in patients

    Prior to initial dose through 8 days post-initial treatment

  • Changes in neurological exam

    Prior to initial dose through 8 days post-initial treatment

Study Arms (3)

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.

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.

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.

Drug: JM-4

Interventions

JM-4DRUG

Novel small human peptide derived from erythropoietin

High dose of JM-4Intermediate dose of JM-4Starting dose

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Stuart Cook, MD

    VA Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stuart Cook, MD

CONTACT

(201) 213-5052cookstu@comcast.net

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 10, 2019

First Posted

March 22, 2019

Study Start

June 15, 2019

Primary Completion

December 15, 2019

Study Completion

March 15, 2020

Last Updated

May 7, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share