Evaluation of Safety, Tolerability, and PK of VX15/2503 In Patients Wi
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
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Pepinemab
Semaphorin-4D inhibitor
Placebo
- Placebo
What it measured
Main measures
Safety/Tolerability as determined by number of patients with adverse events
Up to 12 weeks depending on dose cohort
Safety
Other measures (4)
Half-life of VX15/2503
Up to 12 weeks depending on dose cohort
How the body handles the medicinePeak plasma concentration (Cmax) of VX15/2503
Up to 12 weeks depending on dose cohort
How the body handles the medicineArea under the plasma concentration versus time curve (AUC) of VX15/2503
Up to 12 weeks depending on dose cohort
How the body handles the medicineNumber of patients who develop anti-drug antibody
Up to 12 weeks depending on dose cohort
Immune response
Who could take part
MS (type not specified) · 18 to 60 · EDSS 0 to 6.5
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Saturation monitoring of VX15/2503, a novel semaphorin 4D-specific antibody, in clinical trials.Cytometry B Clin Cytom · 2016
Results
LaGanke C, Samkoff L, Edwards K, Jung Henson L, Repovic P, Lynch S, Stone L, Mattson D, Galluzzi A, Fisher TL, Reilly C, Winter LA, Leonard JE, Zauderer M. Safety/tolerability of the anti-semaphorin 4D Antibody VX15/2503 in a randomized phase 1 trial. Neurol Neuroimmunol Neuroinflamm. 2017 Jun 16;4(4):e367. doi: 10.1212/NXI.0000000000000367. eCollection 2017 Jul.Results
Worzfeld T, Offermanns S. Semaphorins and plexins as therapeutic targets. Nat Rev Drug Discov. 2014 Aug;13(8):603-21. doi: 10.1038/nrd4337.
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History
Started
Dec 2012
Main results due
Nov 2014
Finished
Nov 2014