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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01435993
• Date of registration: 25/08/2011
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple Sclerosis
• Scientific 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.
• Date of first enrolment: September 8, 2011
• Target sample size: 3
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01435993
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Germany, Italy, Norway

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Relapsing-Remitting

Intervention(s)

Other: Saline placebo

Drug: GSK1223249

Primary Outcome(s)

Safety [Time Frame: every 2-4 weeks over 7 months]

Secondary Outcome(s)

Immunogenicity of GSK1223249 in MS patients [Time Frame: Predose; Day 85; Day169; Day197]

Cmax values and AUC(0-8) [Time Frame: Pre-dose; 1hr; 6hr; 12hr; 48hr; Day7; Day13; Follow-up]

Pharmacokinetics of GSK1223249 in cerebro-spinal fluid (CSF) in MS patients [Time Frame: Day7; or Day 29; or Day 35; or Day 85]

Secondary ID(s)

114840

2010-022664-12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors