Primary immune thrombocytopenia (ITP) MedDRA version: 18.1 Level: PT Classification code 10043554 Term: Thrombocytopenia System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Sponsors
UCB Biopharma SPRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Subject has a diagnosis of primary immune thrombocytopenia for a minimum of 3 months prior to Screening Visit -Subject has a platelet count =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: -Subject has an immunoglobulin G (IgG) level =1.5x upper limit of normal (ULN) or International Normalized Ratio (INR)> =1.5 at Screening Visit -Subject has renal and/or liver impairment -Subject has planned an elective surgical procedure in the coming 6 months -Subject has evidence of a secondary cause of immune thrombocytopenia -Subject has a history of clinically relevant ongoing chronic infections -Subject has a family history of primary immunodeficiency -Subject has a clinically relevant active infection or has had a serious infection within 6 weeks prior to the first dose of IMP -Subject has a history of known inflammatory bowel disease, diverticular disease, and gastric or esophageal ulceration -Subject has experienced gastrointestinal bleed in the last 6 months prior to Screening Visit and/or has current gastritis or esophagitis -Subject has a medical history of thrombosis -Subject has a history of coagulopathy disorders -Subject has received a live vaccination within 8 weeks prior to the Baseline Visit; or intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of IMP -Subject has had prior treatment with rituximab in the 6 months prior to the Baseline -Subject has not completed the washout period for the immune suppressants, biologics and other therapies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of UCB7665 administered by subcutaneous (sc) infusion in patients with immune thrombocytopenia (ITP); Secondary Objective: To assess the clinical efficacy of UCB7665 as measured by the change in platelet count To assess the pharmacodynamic (PD) effect of UCB7665 as measured by the change in total immunoglobulin G (IgG) concentration in blood ;Primary end point(s): Number of Subjects experiencing at least one Treatment Emergent Adverse Event (TEAE);Timepoint(s) of evaluation of this end point: From Visit2 (Week1) until End of Study Visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -;Timepoint(s) of evaluation of this end point: - | — |
Countries
Australia, Belgium, Bulgaria, Czech Republic, France, Germany, Italy, Lithuania, Moldova, Republic of, Poland, Romania, Spain, United Kingdom
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB Biosciences GmbH
Outcome results
None listed