A Study of Otelixizumab, a New Treatment for Thyroid Eye Disease

2014-08-27 03:14:01 | BioPortfolio


The purpose of this study is to investigate the safety and tolerability of otelixizumab in patients with Graves' ophthalmopathy (thyroid eye disease). There is currently no alternative therapy available for this condition other than treatment with steroids, or radiotherapy and surgery. The study also includes a comparison of the current steroid treatment, methylprednisolone, with the proposed new otelixizumab treatment.


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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Graves Ophthalmopathy


Otelixizumab - 10.1 mg, Otelixizumab - 3.1 mg, Otelixizumab - 7.1 mg, Otelixizumab - 4.6 mg, Otelixizumab, Methylprednisolone


Not yet recruiting



Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:14:01-0400

Clinical Trials [147 Associated Clinical Trials listed on BioPortfolio]

Subcutaneous Administration of Otelixizumab to T1DM Patients

This study will assess the subcutaneous administration of otelixizumab to T1DM patients. The study will provide safety, tolerability, pharmacodynamic and pharmacokinetic information which ...

TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM)

The purpose of this study is to optimize several multi-dose regimens of otelixizumab, determine the highest biologically active dose, evaluate biomarkers and surrogates of efficacy, and to...

Safety, Pharmacodynamics and Pharmacokinetics of GSK2136525 Repeat Dose in Rheumatoid Arthritis

The assessment of otelixizumab in rheumatoid arthritis subjects will provide safety, tolerability, pharmacodynamic and pharmacokinetic information which will enable the identification of a...

Repeat Dose Subcutaneous Rhumatoid Arthritis Efficacy Study

This study is a randomised, single-blind, placebo-controlled, repeat dose study of otelixizumab administered subcutaneously in rheumatoid arthritis patients. One cohort will receive a sing...

Treatment of Graves´Ophthalmopathy With Diclofenac or Simvastatin (GO-DS)

In an investigator initiated multicenter trial (Malmö, Odense, Århus) the investigators aim at evaluating activity of Graves´ophthalmopathy (GO) and progress to severe GO in patients wi...

PubMed Articles [111 Associated PubMed Articles listed on BioPortfolio]

Methimazole-induced liver injury overshadowed by methylprednisolone pulse therapy: Case report.

Treatment choices are limited, when deciding how to manage thyrotoxicosis and moderate to severe Graves ophthalmopathy (GO) with suspected optic nerve damage in patients with elevated liver transamina...

Evaluation of the outcomes following endonasal endoscopic orbital decompression in patients with Graves' ophthalmopathy.

Influence of glucocorticoid therapy on intratherapeutic biodistribution of 131I radioiodine therapy in Graves' disease.

Radioiodine therapy (RIT) is an important therapeutic method in the definitive treatment of Graves' disease (GD). However, RIT may trigger development of Graves' ophthalmopathy (GO) or exacerbate a pr...

A case of Graves' ophthalmopathy associated with pembrolizumab (Keytruda) therapy.

Regulation of orbital fibrosis and adipogenesis by pathogenic Th17 cells in Graves' orbitopathy.

Th17 cells are correlated with many human autoimmune disorders including Graves' disease, and may play key roles in the pathogenesis of Graves' orbitopathy (GO).

Medical and Biotech [MESH] Definitions

An autoimmune disorder of the EYE, occurring in patients with Graves disease. Subtypes include congestive (inflammation of the orbital connective tissue), myopathic (swelling and dysfunction of the extraocular muscles), and mixed congestive-myopathic ophthalmopathy.

A common form of hyperthyroidism with a diffuse hyperplastic GOITER. It is an autoimmune disorder that produces antibodies against the THYROID STIMULATING HORMONE RECEPTOR. These autoantibodies activate the TSH receptor, thereby stimulating the THYROID GLAND and hypersecretion of THYROID HORMONES. These autoantibodies can also affect the eyes (GRAVES OPHTHALMOPATHY) and the skin (Graves dermopathy).

A water-soluble ester of METHYLPREDNISOLONE used for cardiac, allergic, and hypoxic emergencies.

A PREDNISOLONE derivative with similar anti-inflammatory action.

Immune-mediated inflammation of the PITUITARY GLAND often associated with other autoimmune diseases (e.g., HASHIMOTO DISEASE; GRAVES DISEASE; and ADDISON DISEASE).

More From BioPortfolio on "A Study of Otelixizumab, a New Treatment for Thyroid Eye Disease"

Quick Search


Relevant Topics

Thyroid Disorders
The thyroid is a butterfly-shaped gland in the neck, just above thecollarbone and is an endocrine gland that make hormones. These Thyroid hormones control the rate of many activities in the body, including how fast the body burns calories and how fast th...

An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...

Searches Linking to this Trial