A study to test the safety of UCB7665 in patients with low levels of platelets.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 66

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 <30x10^9/L at Screening and <35x10^9/L at Baseline (Visit 2)
• Subject has a current or history of a peripheral blood smear consistent with ITP
• Subject has adequate peripheral venous access
• Subject has responded to previous ITP therapy (according to the judgment of the investigator)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br>• To assess the pharmacodynamic (PD) effect of UCB7665 as measured by the change in total immunoglobulin G (IgG) concentration in serum<br>;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 Outcome Measures

Name	Time	Method
Secondary end point(s): -;Timepoint(s) of evaluation of this end point: -

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