Evaluation of Safety, Tolerability, and PK of VX15/2503 In Patients With MS
- Registration Number
- NCT01764737
- Lead Sponsor
- Vaccinex Inc.
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VX15/2503 VX15/2503 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Safety/Tolerability as determined by number of patients with adverse events Up to 12 weeks depending on dose cohort
- Secondary Outcome Measures
Name Time Method Half-life of VX15/2503 Up to 12 weeks depending on dose cohort Peak plasma concentration (Cmax) of VX15/2503 Up to 12 weeks depending on dose cohort Area under the plasma concentration versus time curve (AUC) of VX15/2503 Up to 12 weeks depending on dose cohort Number of patients who develop anti-drug antibody Up to 12 weeks depending on dose cohort
Trial Locations
- Locations (10)
Wayne State University - University Health Center
🇺🇸Detroit, Michigan, United States
University of Colorado Hospital, Aschutz Inpatient Pavilion
🇺🇸Aurora, Colorado, United States
North Central Neurology Associates, PC
🇺🇸Cullman, Alabama, United States
Indiana University Health Neuroscience Center
🇺🇸Indianapolis, Indiana, United States
MS Center of Northeastern NY/Empire Neurology
🇺🇸Latham, New York, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
The Neurological Institute, PA
🇺🇸Charlotte, North Carolina, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States