Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia

• Status: Completed
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to check if an subcutaneous (sc) infusion of UCB7665 is safe and tolerated in subjects with primary immune thrombocytopenia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Biopharma S.P.R.L.
• Collaborator: Parexel
• Treatments: Rozanolixizumab

Criteria

Inclusion Criteria:

• Subject has a diagnosis of primary immune thrombocytopenia (ITP) 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 responded to previous ITP therapy (according to the judgment of the investigator)

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 defined as:

• Serum creatinine level of >=1.4 mg/dL for females and >=1.5 mg/dL for males at Screening Visit

• Subject has planned an elective surgical procedure in the coming 6 months

• Subject has evidence of a secondary cause of primary immune thrombocytopenia purpura

• 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 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 Visit

• Subject has not completed the washout period for the immunosuppressants, biologics and other therapies