MedDRA version: 19.1 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 22
Exclusion criteria
Exclusion criteria: • Subject has an immunoglobulin G (IgG) level =6g/L at Screening Visit • Subject has a partial thromboplastin time (PTT) =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 or has a history of confirmed, duodenal, gastric or esophageal ulceration in the past 6 months • Subject has experienced a clinically symptomatic gastrointestinal bleed (positive hemoccult tests without any signs and symptoms of gastrointestinal bleedings will not be considered as “clinically symptomatic”) in the last 6 months prior to Screening Visit and/or has current gastritis or esophagitis and/or has a known risk for clinical relevant gastrointestinal bleeding beyond ITP • Subject has a medical history of thrombosis within the past 5 years or a history of thrombosis with unknown cause at any time or a significant known risk for thrombosis • Subject has a history of coagulopathy disorders other than ITP • 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);Timepoint(s) of evaluation of this end point: From Visit2 (Week1) until End of Study Visit; 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 serum ;Primary end point(s): Number of Subjects experiencing at least one Treatment Emergent Adverse Event (TEAE) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -;Timepoint(s) of evaluation of this end point: - | — |
Countries
Australia, Belgium, Bulgaria, Czech Republic, Georgia, 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