Trial record 1 of 1 for:    NCT01764737
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Evaluation of Safety, Tolerability, and PK of VX15/2503 In Patients With MS

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
Vaccinex Inc.
ClinicalTrials.gov Identifier:
NCT01764737
First received: January 3, 2013
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to evaluate the safety and tolerability of IV administration of VX15/2503 in patients with multiple sclerosis. The escalation part of the study will determine the maximum tolerated dose (MTD) or the Maximum Administered Dose if no MTD is found.


Condition Intervention Phase
Multiple Sclerosis
Drug: VX15/2503
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study Of The Safety, Tolerability, And Pharmacokinetics Of Intravenous VX15/2503 In Patients With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Vaccinex Inc.:

Primary Outcome Measures:
  • Safety/Tolerability as determined by number of patients with adverse events [ Time Frame: Up to 12 weeks depending on dose cohort ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Half-life of VX15/2503 [ Time Frame: Up to 12 weeks depending on dose cohort ] [ Designated as safety issue: No ]
  • Peak plasma concentration (Cmax) of VX15/2503 [ Time Frame: Up to 12 weeks depending on dose cohort ] [ Designated as safety issue: No ]
  • Area under the plasma concentration versus time curve (AUC) of VX15/2503 [ Time Frame: Up to 12 weeks depending on dose cohort ] [ Designated as safety issue: No ]
  • Number of patients who develop anti-drug antibody [ Time Frame: Up to 12 weeks depending on dose cohort ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Cellular Semaphorin 4D (SEMA4D; CD100) percent saturation [ Time Frame: Up to 12 weeks depending on dose cohort ] [ Designated as safety issue: No ]
  • VX15/2503 dose level vs serum SEMA4D levels [ Time Frame: Up to 12 weeks depending on dose cohort ] [ Designated as safety issue: No ]
  • Change in magnetic resonance imaging (MRI) parameters as compared to VX15/2503 dose level [ Time Frame: Screening to 4 weeks post-dose ] [ Designated as safety issue: Yes ]

    MRI parameters:

    • Number of T1 gadolinium (Gd)-enhancing lesions
    • Number of T2 lesions
    • Total volume of T1 and T2 lesions if the investigational site has the imaging processing capability

  • VX15/2503 dose vs the change in Kurtzke Expanded Disability Status Scale [ Time Frame: Up to 12 weeks depending on dose cohort ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VX15/2503 Drug: VX15/2503
single dose intravenous administration
Experimental: Placebo Drug: Placebo
single dose intravenous administration

Detailed Description:

VX15/2503-N-101 is a single ascending dose-escalation, randomized, double-blinded, placebo-controlled study to evaluate the safety and tolerability of IV-administered VX15/2503 in patients with multiple sclerosis. This will be accomplished by using a dose escalation procedure starting at a low dose of VX15/2503 and will continue based on predefined parameters until the maximum tolerated dose is identified. Patients will be randomized at a 4:1 ratio to receive VX15/2503 to placebo. The patients and the study team will be blinded to the treatment that each patient receives.

The study drug, VX15/2503, is a humanized monoclonal antibody that binds to the semaphorin 4D (SEMA4D; CD100) antigen. Experimental evidence suggest that antibody neutralization of SEMA4D may represent a new therapeutic strategy for treating multiple sclerosis.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 18-60 years of age who have been diagnosed with MS for at least 1 year as defined by the 2010 revisions to the McDonald criteria
  • Has an EDSS score of 0 to 6.5 inclusive at screening
  • Has a body mass index of 18 to 32 kg/m2
  • Is willing to undergo and has no contraindications to brain MRI
  • Willing to use a medically acceptable method of contraception throughout the study period and for 6 months after the dose of VX15/2503, unless patient is surgically sterile or postmenopausal. Women of childbearing potential must have started using adequate contraception at least 2 months before the Day 1 visit.
  • Male patients must agree to defer from donating sperm for 6 months after VX15/2503 administration
  • Women of childbearing potential must have a negative serum pregnancy test at screening, which will be confirmed at baseline using a urine test before administration of VX15/2503
  • Is willing to forego other forms of experimental treatment during the study

Exclusion Criteria:

  • Had an MS relapse that did not stabilize within the 30 days before the start of screening.
  • Has any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic/gynecologic, pulmonary, neurologic, psychiatric, or renal conditions; has a history of relevant clinically significant allergic or anaphylactic reactions; or has any other clinically significant major disease that, as assessed by the investigator, would pose a risk to patient safety or interfere with the study evaluations, procedures, or completion
  • Has any clinically significant laboratory value outside the normal range for MS patients at screening, or has abnormal hematologic, renal, or hepatic function based on laboratory tests
  • Is a pregnant or breastfeeding woman
  • Has received treatment with any MS disease-modifying therapy other than interferon beta or glatiramer acetate within 3 months prior to dosing
  • Has been treated with natalizumab, daclizumab, or fingolimod for any indication within 6 months prior to dosing
  • Has had any prior treatment with alemtuzumab, rituximab, mitoxantrone, total lymphoid irradiation, bone marrow transplantation, or T cell or T cell receptor vaccination
  • Has received any experimental agent within 6 months prior to dosing, or within a period equivalent to 5 half-lives of the agent (whichever is longer); or is currently involved in any other research study
  • Has undergone any major surgical procedure within the 4 weeks prior to dosing
  • Has a history of congestive heart failure (New York Heart Association Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 6 months prior to dosing
  • Has a clinically significant ECG finding at screening
  • Has a known or suspected human immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection
  • Has a known or suspected allergy to Gd or other contraindication to brain MRI
  • Has a history of an opportunistic infection or a history of acute infection requiring systemic antibiotics, antivirals, or antifungals within 6 weeks prior to dosing (antiinfective therapy must have been completed at least 4 weeks prior to dosing)
  • Has any other intercurrent illness or condition, including alcohol or drug dependence as determined by the investigator, which could impact the patient's compliance with or ability to complete the study
  • History of seizure disorder or unexplained blackouts or history of seizure within 3 months of screening
  • History of suicidal ideation within 3 months prior to screening, episode of severe depression within 3 months prior to screening
  • Has a sensitivity to VX15/2503 or the ingredients or excipients of VX15/2503, or known or suspected sensitivity to mammalian cell-derived products
  • Has donated or lost more than 1 unit of blood in the 60 days prior to screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764737

Locations
United States, Alabama
North Central Neurology Associates, PC
Cullman, Alabama, United States, 35058
United States, Colorado
University of Colorado Hospital, Aschutz Inpatient Pavilion
Aurora, Colorado, United States, 80045
United States, Indiana
Indiana University Health Neuroscience Center
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Michigan
Wayne State University - University Health Center
Detroit, Michigan, United States, 48201
United States, New York
MS Center of Northeastern NY/Empire Neurology
Latham, New York, United States, 12110
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
The Neurological Institute, PA
Charlotte, North Carolina, United States, 28204
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Vaccinex Inc.
PRA Health Sciences
Investigators
Study Director: John Leonard, PhD Vaccinex Inc.
Principal Investigator: Keith R Edwards, MD, FAAD MS Center of Northeastern NY/Empire Neurology
Principal Investigator: Christopher C LaGanke, MD North Central Neurology Associates, PC
Principal Investigator: T H Rao, MD The Neurological Institute, PA
Principal Investigator: Lawrence M Samkoff, MD University of Rochester
Principal Investigator: Lael A Stone, MD The Cleveland Clinic
Principal Investigator: Omar Khan, MD Wayne State University - University Health Center
Principal Investigator: Sharon Lynch, MD University of Kansas
Principal Investigator: David H Mattson, MD Indiana University Health Neuroscience Center
Principal Investigator: Timothy Vollmer, MD University of Colorado Hospital, Anschutz Inpatient Pavilion
Principal Investigator: Pavle Repovic, MD Swedish Medical Center
  More Information

No publications provided by Vaccinex Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vaccinex Inc.
ClinicalTrials.gov Identifier: NCT01764737     History of Changes
Other Study ID Numbers: VX15/2503-N-101
Study First Received: January 3, 2013
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Vaccinex Inc.:
VX15/2503
Semaphorin 4D
SEMA4D
CD100
safety
tolerability
pharmacokinetics
immunogenicity
multiple sclerosis
monoclonal antibody

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014