Print Download. The EU Clinical Trials Register currently displays clinical trials with a EudraCT protocol, of which are clinical trials conducted with subjects less than 18 years old. Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan PIP are not publicly available see Frequently Asked Questions.
Examples: Cancer AND drug name. Pneumonia AND sponsor name. How to search [pdf]. For these items you should use the filters and not add them to your search terms in the text field. Print Download Summary.
Expand All Collapse All. Review by the Competent Authority or Ethics Committee in the country concerned. For support, Contact us. The status and protocol content of GB trials is no longer updated since 1 January EU Clinical Trials Register. Search tools. Select Date Range: to. Select Rare Disease:. IMP with orphan designation in the indication. Orphan Designation Number:.
Results Status: Trials with results Trials without results. Clear advanced search filters. Date on which this record was first entered in the EudraCT database:. View results. Title of the trial for lay people, in easily understood, i. Extension study to evaluate the long-term efficacy, safety and tolerability of BYM in patients with sporadic inclusion body myositis.
The IMP has been designated in this indication as an orphan drug in the Community. Committee on Advanced therapies CAT has issued a classification for this product. Combination product that includes a device, but does not involve an Advanced Therapy. Sporadic Inclusion Body Myositis. Tolerability, immunogenicity and quality of life. Treatment Period 2 epoch of the study is open-label without placebo. The trial involves single site in the Member State concerned.
