A multicentre, open-label, randomised ITP study
Research type
Research Study
Full title
A multicentre, open-label, multiple-dose study to evaluate the safety, tolerability and efficacy of UCB7665 in subjects with primary immune thrombocytopenia
IRAS ID
197312
Contact name
Sirjana Gurung
Contact email
Sponsor organisation
UCB Biopharma SPRL
Eudract number
2015-003984-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
Platelets are cells in the blood that help the blood to clot and prevent bleeding. When the number of platelets in the body decreases to a certain level, a tendency may occur to develop bruising or bleeding. Primary immune thrombocytopenia (ITP) is a disease which is characterised by an isolated low platelet count (thrombocytopenia). ITP is an autoimmune disease which means the immune system produces specific proteins called antibodies, which are directed against the platelets and destroy these. These antibodies are part of the immunoglobulin G, which also contains the specific antibodies the body produces against viruses and bacteria. There is no causal treatment for ITP. Treatment options include suppressing the immune system (immunosuppressive therapy), treatment with immunoglobulin (immunoglobulin therapy), and removing the spleen (splenectomy). There is an unmet medical need for new treatment options due to significant side effects, significant risks, and significant complexity of existing therapies. The purpose of this study is to assess whether the study medication (UCB7665) can safely be given to ITP patients and assess whether it is effective in treating ITP. The study medication being tested is an antibody (type of protein) that aims to lower levels of Immunoglobulin G, which includes the antibodies directed against platelets. In this way the study medication can limit the destruction of platelets. UCB Biopharma SPRL is sponsoring this study and is planned to be conducted at approximately 25 sites in Europe and Australia. A total of 30 subjects are planned to enter the Dosing Period in the study. The maximum study duration for study participation for an individual subject is approximately 16 weeks
REC name
London - Riverside Research Ethics Committee
REC reference
16/LO/0443
Date of REC Opinion
18 Mar 2016
REC opinion
Favourable Opinion