A study of otelixizumab for Thyroid Eye Disease (Version 1)

• Research type

  Research Study

• Full title

  A randomised, comparator controlled, two part, open-label study to evaluate the safety, tolerability and pharmacodynamics of multiple doses of otelixizumab in patients with thyroid orbitopathy

• IRAS ID

  45388

• Contact name

  Simon Pearce

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2009-016747-19

• ISRCTN Number

  N/A

• Research summary

  This is a study of otelixizumab, a monoclonal antibody (MAb) directed against the human lymphocyte antigen CD3 (a protein found on a certain type of white blood cell). This will be an open-label, comparator-controlled, two part study to evaluate the safety and tolerability of otelixizumab in patients with Graves’ ophthalmopathy (GO). It will also look to see if otelixizumab affects GO and how it works compared to methylprednisolone (the standard treatment for active GO). In Part A, between one and four groups of 5 patients will receive doses of otelixizumab administered over 8 days. The first dose level will provide a cumulative 3.1mg dose; this dose has been safely administered in previous studies. Safety and clinical response data will be reviewed after 8 weeks, if no clinical response is seen and there are no safety concerns, the dose of otelixizumab will be increased and a new group of subjects will enter Part A. In subsequent groups cumulative doses of 4.6, 7.1 and 10.1mg may be investigated. However if a clinical response is seen at the lowest dose the study will move directly to Part B. In Part B, patients will receive either otelixizumab at the dose set from Part A, over 8 days (5 patients) or methylprednisolone weekly for 12 weeks (5 patients). All dosing will be by intravenous infusion. All participants will undergo long term safety evaluation for 48 months. Key assessments include vital signs, 12-lead ECG, liver function tests, thyroid function, viral monitoring, monitoring of cortisol and ACTH levels, laboratory safety tests and adverse event (side effect) data. Assessment of GO severity will be evaluated using recommended assessments including clinical activity assessments and quality of life questionnaires. Measurements of exploratory biomarkers (proteins found naturally in the blood) are also included in this study.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  10/H0906/15

• Date of REC Opinion

  21 Apr 2010

• REC opinion

  Further Information Favourable Opinion