Multiple Sclerosis, Relapsing-RemittingPhase 1NCT01435993
Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple Sclerosis
A Phase 1 study testing GSK1223249 in people with Multiple Sclerosis, Relapsing-Remitting, run by GlaxoSmithKline at 2 sites in 2 countries.
Trial summary
This study will investigate an experimental new drug, GSK1223249 in patients diagnosed with relapsing forms of multiple sclerosis. The study will specifically investigate safety (vital signs like heart rate, blood pressure, Magnetic Resonance Imaging (MRI), and other markers of health from blood samples), tolerability… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- GSK1223249
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 8 Sep 2011to 23 Jan 2012
- 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
- Diagnosed with a relapsing form of MS .
- Using one of the following ongoing MS treatment strategies, defined as
- Currently receiving Beta-interferon/Copaxone for treatment of MS and have been receiving the current course of therapy for 3 or more months prior to screening, OR
- Not currently receiving disease modifying therapies for treatment of MS, and has not received such therapies for at least 3 months prior to screening.
- Demonstrated clinical activity in 2 years prior to screening, whilst receiving current/previous treatment regimen or prior to any treatment regimen
- Expanded Disability Status Scale (EDSS) score ≤6.0 at either the screening or baseline visit.
- Male or female between 18 and 60 years of age inclusive, at the time of signing the informed consent.
- Body weight equal to or greater than: 50 kilogrammes
Who cannot join
- Complications/History of other diseases that may impact on safety of patients enroling into the study.
- Liver function test outside normal range for patient population
- Treatment with methylprednisolone or any other systemic steroid, for a relapse or otherwise, within 30 days of screening
- Treatment in the past 6 months with any of the following agents: Fingolimod (Gilenya), methotrexate, mitoxantrone, azathioprine, or other small molecule immunosuppressants.
- History of anaphilaxis to protein based therapeutics or mono-clonal antibodies.
- Positive result for Hapatitis B, HIV, and/or drugs of abuse, or excessive alcohol consumption.
- Not able to undergo MRI scanning safely, or Gadolinium (contrast enhancing agents) during MRI.
- Other significant infections e.g. Tuberculosis.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomized, Single Blind, Placebo-controlled, Single Ascending Dose/Repeat Dose Cohort Study to Assess Safety, Tolerability, Pharmacokinetics and Immunogenicity of GSK1223249 in Patients With Relapsing Forms of Multiple Sclerosis.
This study will investigate an experimental new drug, GSK1223249 in patients diagnosed with relapsing forms of multiple sclerosis. The study will specifically investigate safety (vital signs like heart rate, blood pressure, Magnetic Resonance Imaging (MRI), and other markers of health from blood samples), tolerability (any side effects that occur, if any), and pharmacokinetics (how the body processes the drug and how long the drug stays in the blood, and in cerebro-spinal fluid). The study will also investigate if patients' own immune system interacts with GSK1223249.
Read the detailed description
This study will be a randomised, placebo-controlled, single-blind (Investigator and Subject), single and repeat ascending dose protocol, in multiple sclerosis patients. The study is designed to evaluate the safety, tolerability, pharmacokinetics, and any potential for immunogenicity of GSK1223249 (a monoclonal antibody raised against Nogo-A), given intravenously in Multiple Sclerosis patients. The study will also evaluate exploratory endpoints including para-clinical activity via magnetic resonance imaging, cerebrospinal fluid pharmacokinetics, and effect of repeat dose administration of GSK1223249 on disability. Furthermore MS symptoms, such as relapses and individual symptom severity will be closely monitored.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- GSK1223249, Saline placebo
- Keywords
- Multiple Sclerosis, Secondary-Progressive with relapses
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1223249Drug
Intravenous infusion
Saline placeboOther
placebo intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | GSK1223249 slow (60 minutes) intravenous infusion Receives: Drug: GSK1223249 |
| Placebo | Placebo comparator | Saline slow (60 minutes) intravenous infusion Receives: Other: Saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
- Changes in vital signs, ECG monitoring, blood chemistry, haematology, urinalysis, monitoring of AEs and MS relapses (number, incidence, severity)
Measured: every 2-4 weeks over 7 months
Secondary outcomes (3)
Cmax values and AUC(0-∞)
Profile of Pharamcokinetics
Measured: Pre-dose; 1hr; 6hr; 12hr; 48hr; Day7; Day13; Follow-up
Immunogenicity of GSK1223249 in MS patients
- Presence of antibodies to GSK1223249 to be assessed in serum samples using validated ECL assays.
Measured: Predose; Day 85; Day169; Day197
Pharmacokinetics of GSK1223249 in cerebro-spinal fluid (CSF) in MS patients
Measurement of GSK1223249 in CSF
Measured: Day7; or Day 29; or Day 35; or Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study start8 Sep 2011
- Primary completion23 Jan 2012
- Study completion23 Jan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435993
- Sponsor's protocol ID
- 114840
- Other IDs
- 2010-022664-12
- Status last verified
- Nov 2020
- First submitted
- 25 Aug 2011
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Blind, Placebo-controlled, Single Ascending Dose/Repeat Dose Cohort Study to Assess Safety, Tolerability, Pharmacokinetics and Immunogenicity of GSK1223249 in Patients With Relapsing Forms of Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT01435993
- Acronym / sponsor ID
- 114840
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple Sclerosis, Secondary-Progressive with relapses
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2011 (actual)
- Primary completion
- 23 Jan 2012 (actual)
- Study completion
- 23 Jan 2012 (actual)
- First posted
- 19 Sep 2011 (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.
This study will investigate an experimental new drug, GSK1223249 in patients diagnosed with relapsing forms of multiple sclerosis. The study will specifically investigate safety (vital signs like heart rate, blood pressure, Magnetic Resonance Imaging (MRI), and other markers of health from blood samples), tolerability (any side effects that occur, if any), and pharmacokinetics (how the body processes the drug and how long the drug stays in the blood, and in cerebro-spinal fluid). The study will also investigate if patients' own immune system interacts with GSK1223249.
Detailed description
This study will be a randomised, placebo-controlled, single-blind (Investigator and Subject), single and repeat ascending dose protocol, in multiple sclerosis patients. The study is designed to evaluate the safety, tolerability, pharmacokinetics, and any potential for immunogenicity of GSK1223249 (a monoclonal antibody raised against Nogo-A), given intravenously in Multiple Sclerosis patients. The study will also evaluate exploratory endpoints including para-clinical activity via magnetic resonance imaging, cerebrospinal fluid pharmacokinetics, and effect of repeat dose administration of GSK1223249 on disability. Furthermore MS symptoms, such as relapses and individual symptom severity will be closely monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: GSK1223249GSK1223249 slow (60 minutes) intravenous infusion |
| Placebo | Placebo comparator | Other: Saline placeboSaline slow (60 minutes) intravenous infusion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Diagnosed with a relapsing form of MS .
- Using one of the following ongoing MS treatment strategies, defined as
- Demonstrated clinical activity in 2 years prior to screening, whilst receiving current/previous treatment regimen or prior to any treatment regimen
- Expanded Disability Status Scale (EDSS) score ≤6.0 at either the screening or baseline visit.
- Male or female between 18 and 60 years of age inclusive, at the time of signing the informed consent.
Key exclusion criteria (8 listed)
- Complications/History of other diseases that may impact on safety of patients enroling into the study.
- Liver function test outside normal range for patient population
- Treatment with methylprednisolone or any other systemic steroid, for a relapse or otherwise, within 30 days of screening
- Treatment in the past 6 months with any of the following agents: Fingolimod (Gilenya), methotrexate, mitoxantrone, azathioprine, or other small molecule immunosuppressants.
- History of anaphilaxis to protein based therapeutics or mono-clonal antibodies.
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 |
|---|---|---|
| GSK1223249Intravenous infusion | Drug | Active |
| Saline placeboplacebo intravenous infusion | Other | Placebo |
Primary outcome
Safety
Time frame: every 2-4 weeks over 7 months
• Changes in vital signs, ECG monitoring, blood chemistry, haematology, urinalysis, monitoring of AEs and MS relapses (number, incidence, severity)
3 secondary outcomes
Cmax values and AUC(0-∞)
Time frame: Pre-dose; 1hr; 6hr; 12hr; 48hr; Day7; Day13; Follow-up
Immunogenicity of GSK1223249 in MS patients
Time frame: Predose; Day 85; Day169; Day197
Pharmacokinetics of GSK1223249 in cerebro-spinal fluid (CSF) in MS patients
Time frame: Day7; or Day 29; or Day 35; or Day 85
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK1223249 in people with Multiple Sclerosis, Relapsing-Remitting, run by GlaxoSmithKline at 2 sites in 2 countries.
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 8 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: stopped early, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Norway. 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. Some participants in this study may receive a placebo. 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 was stopped early. Results are not available in the source record.
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 (time frame: every 2-4 weeks over 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2020.