Safety study of ATX-GD-59 in subjects with Graves’ disease
Research type
Research Study
Full title
Safety and proof of principle study of ATX-GD-59 in male and female subjects with Graves’ disease not currently treated with anti-thyroid therapy: An Open label study, with an upward titration over five dose levels administered by Intradermal injection.
IRAS ID
202599
Contact name
Simon Pearce
Contact email
Sponsor organisation
APITOPE International NV
Eudract number
2015-004030-10
Duration of Study in the UK
1 years, 9 months, 16 days
Research summary
The study drug (ATX-GD-59) is a new investigational drug being developed as treatment for Graves’ disease. The term ‘investigational drug’ means it has not been approved for general use by government health authorities, such as the United Kingdom, Medicines and Healthcare Products Regulatory Agency (MHRA) but it may be tested in research studies such as this one.
The study drug is a mixture of substances found naturally in the body called peptides. In animal studies, the study drug was shown to be effective in preventing the production of certain substances in the body called antibodies, certain types of which are responsible for symptoms caused by Graves’ disease.
The study drug will be administered every two weeks for eighteen weeks (a total of 10 doses) to patients with Graves’ disease. Each dose will consist of one or two injections into the skin. The study will involve 36 patients in total, with approximately 15 patients recruited in the UK, and a further 20 patients in Belgium and Germany.The purpose of this study is to determine:
• the safety of the study drug
• the effects of the study drug on the underlying cause of Graves’ disease
• the effects of the study drug on substances in the bloodREC name
East of England - Essex Research Ethics Committee
REC reference
16/EE/0133
Date of REC Opinion
6 Jun 2016
REC opinion
Further Information Favourable Opinion