NOGO-A in Multiple Sclerosis FTIH

NCT01424423 | Terminated Phase 1

• 1 other identifier: 112988
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The drug being tested in this study is GSK1223249. The drug works by inhibiting a protein that prevents nerve growth. The trial is expected to involve approximately 36 patients. The study objective is to investigate the tolerability, safety and the way the body handles GSK1223249 after a range of single doses in patients with Multiple Sclerosis (MS).

Conditions

Multiple Sclerosis

Keywords

Safety; GSK1223249; Pharmacokinetics; Single dose escalation; anti-GSK1223249 antibodies; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• The preliminary safety and tolerability of single doses of GSK1223249

  changes in Vital signs, Electocardiogram, safety laboratory samples, adverse event (AE), neurological examination and MS relapses

  screening, baseline (pre-dose) and up to 84 days post dose

Secondary Outcomes (1)

• Single dose pharmacokinetics.

  screening, baseline (pre-dose) and up to 84 days post dose

Study Arms (10)

Subjects receiving GSK1223249 in cohort 1

EXPERIMENTAL

Eligible subjects will receive intravenous infusion of GSK1223249 with a starting dose of 0.02 milligrams per kilograms, followed by 0.2, 2, 10 and 30 milligrams per kilograms, administered by a programmable syringe pump.

Drug: GSK1223249

Subjects receiving placebo in cohort 1

PLACEBO COMPARATOR

Eligible subjects will receive intravenous infusion of placebo, administered by a programmable syringe pump.

Drug: Placebo

Subjects receiving GSK1223249 in cohort 2

EXPERIMENTAL

Eligible subjects will receive intravenous infusion of GSK1223249 with a dose of 0.2 milligrams per kilograms administered by a programmable syringe pump.

Drug: GSK1223249

Subjects receiving placebo in cohort 2

PLACEBO COMPARATOR

Eligible subjects will receive intravenous infusion of placebo, administered by a programmable syringe pump.

Drug: Placebo

Subjects receiving GSK1223249 in cohort 3

EXPERIMENTAL

Eligible subjects will receive intravenous infusion of GSK1223249 with a dose of 2 milligrams per kilograms administered by a programmable syringe pump.

Drug: GSK1223249

Subjects receiving placebo in cohort 3

PLACEBO COMPARATOR

Eligible subjects will receive intravenous infusion of placebo, administered by a programmable syringe pump.

Drug: Placebo

Subjects receiving GSK1223249 in cohort 4

EXPERIMENTAL

Eligible subjects will receive intravenous infusion of GSK1223249 with a dose of 10 milligrams per kilograms administered by a programmable syringe pump.

Drug: GSK1223249

Subjects receiving placebo in cohort 4

PLACEBO COMPARATOR

Eligible subjects will receive intravenous infusion of placebo, administered by a programmable syringe pump.

Drug: Placebo

Subjects receiving GSK1223249 in cohort 5

EXPERIMENTAL

Eligible subjects will receive intravenous infusion of GSK1223249 with a dose of 30 milligrams per kilograms administered by a programmable syringe pump.

Drug: GSK1223249

Subjects receiving placebo in cohort 5

PLACEBO COMPARATOR

Eligible subjects will receive intravenous infusion of placebo, administered by a programmable syringe pump.

Drug: Placebo

Interventions

Placebo DRUG

Placebo

Subjects receiving placebo in cohort 1; Subjects receiving placebo in cohort 2; Subjects receiving placebo in cohort 3; Subjects receiving placebo in cohort 4; Subjects receiving placebo in cohort 5

GSK1223249 DRUG

I.V. Infusion

Subjects receiving GSK1223249 in cohort 1; Subjects receiving GSK1223249 in cohort 2; Subjects receiving GSK1223249 in cohort 3; Subjects receiving GSK1223249 in cohort 4; Subjects receiving GSK1223249 in cohort 5

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Suitable as determined by the Principal Investigator, based on his/her overall evaluation. A patient with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
• Diagnosed with a relapsing form of MS defined as either
• Relapsing Remitting MS according to revised McDonald Criteria \[McDonald, 2001; Polman, 2005\] plus any one of the following:
• Occurrence of at least one relapse in the previous 12 months OR at least 2 relapses in the previous 24 months OR at least one documented Gd-enhancing lesion by magnetic resonance imaging (MRI) within 12 months prior to screening.
• Secondary Progressive MS, plus any one of the following: Occurrence of at least one relapse in the previous 12 months OR at least 2 relapses in the previous 24 months OR at least one documented Gd-enhancing lesion by magnetic resonance imaging (MRI) within 12 months prior to screening.
• Expanded Disability Status Scale (EDSS) score ≤5.5
• Male or female between 18 and 55 years of age inclusive, at the time of signing the informed consent.

You may not qualify if:

• Abnormal baseline blood tests
• Treatment with interferon-beta-1b (Betaferon), interferon-beta-1a (Rebif or Avonex), or glatiramer acetate (Copaxone) within 90 days of dosing.
• Treatment with methylprednisolone or any other systemic steroids within 60 days of dosing.
• Treatment within the past 12 months or currently with any of the following agents: cyclosporine, azathioprine, methotrexate, cladribine, natalizumab (Tysabri®) or other monoclonal antibodies, murine protein, T-cell vaccination, plasmapheresis, IVI gG, ,stem cell transplantation.
• History of intolerance to acetominophen, ibuprofen, naproxen or any other non-steroidal anti-inflammatory agent which would preclude use of at least one of these during the study.
• Previous history of anaphylaxis, severe allergic reaction, or hypersensitivity to albumin or a protein-based therapeutic, including natalizumab (Tysabri) or any other monoclonal antibody. History of hypersensitivity to any of the components of the formulation.
• A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result.
• Patients with evidence of dementia or psychiatric illness which, in the Investigator's opinion, is likely to prevent them from a full understanding of and/or compliance with the study requirements and procedures.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Heidelberg, Victoria, VIC 3084, Australia

Location

Related Links

• Results for study 112988 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ozanezumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: August 29, 2011
• Study Start: February 11, 2010
• Primary Completion: August 26, 2010
• Study Completion: August 26, 2010
• Last Updated: September 20, 2017

Record last verified: 2017-09

Locations

AU (1)