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Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple Sclerosis

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status

Terminated

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

GSK1223249

Saline placebo

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring Multiple Sclerosis, Secondary-Progressive with relapses

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosed with a relapsing form of MS .
Using one of the following ongoing MS treatment strategies, defined as
1. 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
2. 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

Exclusion Criteria:

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.

Sites / Locations

GSK Investigational Site
GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

GSK1223249 slow (60 minutes) intravenous infusion

Saline slow (60 minutes) intravenous infusion

Outcomes

Primary Outcome Measures

Safety

• Changes in vital signs, ECG monitoring, blood chemistry, haematology, urinalysis, monitoring of AEs and MS relapses (number, incidence, severity)

Secondary Outcome Measures

Cmax values and AUC(0-∞)

Profile of Pharamcokinetics

Immunogenicity of GSK1223249 in MS patients

• Presence of antibodies to GSK1223249 to be assessed in serum samples using validated ECL assays.

Pharmacokinetics of GSK1223249 in cerebro-spinal fluid (CSF) in MS patients

Measurement of GSK1223249 in CSF

Full Information

NCT ID

NCT01435993

First Posted

August 25, 2011

Last Updated

November 20, 2020

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01435993

Brief Title

Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple Sclerosis

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.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Terminated

Study Start Date

September 8, 2011 (Actual)

Primary Completion Date

January 23, 2012 (Actual)

Study Completion Date

January 23, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis, Secondary-Progressive with relapses

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active

Arm Type

Experimental

Arm Description

GSK1223249 slow (60 minutes) intravenous infusion

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Saline slow (60 minutes) intravenous infusion

Intervention Type

Drug

Intervention Name(s)

GSK1223249

Intervention Description

Intravenous infusion

Intervention Type

Other

Intervention Name(s)

Saline placebo

Intervention Description

placebo intravenous infusion

Primary Outcome Measure Information:

Title

Safety

Description

• Changes in vital signs, ECG monitoring, blood chemistry, haematology, urinalysis, monitoring of AEs and MS relapses (number, incidence, severity)

Time Frame

every 2-4 weeks over 7 months

Secondary Outcome Measure Information:

Title

Cmax values and AUC(0-∞)

Description

Profile of Pharamcokinetics

Time Frame

Pre-dose; 1hr; 6hr; 12hr; 48hr; Day7; Day13; Follow-up

Title

Immunogenicity of GSK1223249 in MS patients

Description

• Presence of antibodies to GSK1223249 to be assessed in serum samples using validated ECL assays.

Time Frame

Predose; Day 85; Day169; Day197

Title

Pharmacokinetics of GSK1223249 in cerebro-spinal fluid (CSF) in MS patients

Description

Measurement of GSK1223249 in CSF

Time Frame

Day7; or Day 29; or Day 35; or Day 85

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Verona

State/Province

Veneto

ZIP/Postal Code

37134

Country

Italy

Facility Name

GSK Investigational Site

City

Lørenskog

ZIP/Postal Code

1478

Country

Norway

12. IPD Sharing Statement

Learn more about this trial

Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple Sclerosis

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