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A Safety and Tolerability Study of Otelixizumab in Thyroid Eye Disease

NCT01114503 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2020-10-30

Study results available
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Summary

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.

Conditions

  • Graves Ophthalmopathy

Interventions

DRUG

Otelixizumab - low dose

8 day dose rising intravenous infusions of a low dose of otelixizumab

DRUG

Otelixizumab - medium low dose

8 day dose rising intravenous infusions of a medium low dose of otelixizumab

DRUG

Otelixizumab - medium high dose

8 day dose rising intravenous infusions of a medium high dose of otelixizumab

DRUG

Otelixizumab - high dose

8 day dose rising intravenous infusions of a high dose of otelixizumab

DRUG

Otelixizumab

8 day dose rising intravenous infusions of otelixizumab administered at a dose decided upon results from Part A.

DRUG

Methylprednisolone

Weekly intravenous infusions of methylprednisolone administered as 500 mg per week for 6 weeks and then 250 mg per week for 6 weeks

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-07
Primary Completion
2012-08-29
Completion
2012-08-29

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01114503 on ClinicalTrials.gov