Multiple SclerosisPhase 1NCT01764737
Evaluation of Safety, Tolerability, and PK of VX15/2503 In Patients With MS
A Phase 1 study testing VX15/2503 in people with Multiple Sclerosis, run by Vaccinex Inc. at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- VX15/2503
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 10 sitesUnited States
- Study dates
- Dec 2012to Nov 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Colorado Hospital, Aschutz Inpatient Pavilion
Aurora, Colorado, 80045
The Neurological Institute, PA
Charlotte, North Carolina, 28204
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
North Central Neurology Associates, PC
Cullman, Alabama, 35058
Wayne State University - University Health Center
Detroit, Michigan, 48201
Indiana University Health Neuroscience Center
Indianapolis, Indiana, 46202
University of Kansas Medical Center
Kansas City, Kansas, 66160
MS Center of Northeastern NY/Empire Neurology
Latham, New York, 12110
University of Rochester Medical Center
Rochester, New York, 14642
Swedish Medical Center
Seattle, Washington, 98122
About this study
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
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- VX15/2503, Placebo
- Keywords
- VX15/2503, Semaphorin 4D, SEMA4D, CD100, safety, tolerability, pharmacokinetics, immunogenicity, multiple sclerosis, monoclonal antibody
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VX15/2503Drug
single dose intravenous administration
PlaceboDrug
single dose intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| VX15/2503 | Experimental | Not described Receives: Drug: VX15/2503 |
| Placebo | Experimental | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/Tolerability as determined by number of patients with adverse events
Measured: Up to 12 weeks depending on dose cohort
Secondary outcomes (4)
Half-life of VX15/2503
Measured: Up to 12 weeks depending on dose cohort
Peak plasma concentration (Cmax) of VX15/2503
Measured: Up to 12 weeks depending on dose cohort
Area under the plasma concentration versus time curve (AUC) of VX15/2503
Measured: Up to 12 weeks depending on dose cohort
Number of patients who develop anti-drug antibody
Measured: Up to 12 weeks depending on dose cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vaccinex Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- John Leonard, PhD, Study director, Vaccinex Inc.Keith R Edwards, MD, FAAD, Principal investigator, MS Center of Northeastern NY/Empire NeurologyChristopher C LaGanke, MD, Principal investigator, North Central Neurology Associates, PCT H Rao, MD, Principal investigator, The Neurological Institute, PALawrence M Samkoff, MD, Principal investigator, University of RochesterLael A Stone, MD, Principal investigator, The Cleveland ClinicOmar Khan, MD, Principal investigator, Wayne State University - University Health CenterSharon Lynch, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764737
- Sponsor's protocol ID
- VX15/2503-N-101
- Status last verified
- Feb 2015
- First submitted
- 3 Jan 2013
- Last updated
- 6 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28642891Worzfeld T, Offermanns S. Semaphorins and plexins as therapeutic targets. Nat Rev Drug Discov. 2014 Aug;13(8):603-21. doi: 10.1038/nrd4337.
PubMed 25082288
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01764737
- Acronym / sponsor ID
- VX15/2503-N-101
- Conditions
- Multiple Sclerosis
- Keywords
- VX15/2503, Semaphorin 4D, SEMA4D, CD100, safety, tolerability, pharmacokinetics, immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vaccinex Inc.Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- Dec 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 10 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VX15/2503 | Experimental | Drug: VX15/2503 |
| Placebo | Experimental | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VX15/2503single dose intravenous administration | Drug | VX15/2503 |
| Placebosingle dose intravenous administration | Drug | Placebo |
Primary outcome
Safety/Tolerability as determined by number of patients with adverse events
Time frame: Up to 12 weeks depending on dose cohort
4 secondary outcomes
Half-life of VX15/2503
Time frame: Up to 12 weeks depending on dose cohort
Peak plasma concentration (Cmax) of VX15/2503
Time frame: Up to 12 weeks depending on dose cohort
Area under the plasma concentration versus time curve (AUC) of VX15/2503
Time frame: Up to 12 weeks depending on dose cohort
Number of patients who develop anti-drug antibody
Time frame: Up to 12 weeks depending on dose cohort
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2015.
- Derived from this study: PubMed 28642891LaGanke 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.
- Derived from this study: PubMed 25082288Worzfeld 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Leonard, PhD study director
Vaccinex Inc.
Keith R Edwards, MD, FAAD principal investigator
MS Center of Northeastern NY/Empire Neurology
Christopher C LaGanke, MD principal investigator
North Central Neurology Associates, PC
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VX15/2503 in people with Multiple Sclerosis, run by Vaccinex Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety/Tolerability as determined by number of patients with adverse events (time frame: Up to 12 weeks depending on dose cohort). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01764737, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2015.