Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia
Condition: Thrombocytopenia
MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic
Intervention: UCB7665
Intervention description: Intervention Type: Biological/Vaccine
Pharmaceutical Form: Powder for solution for infusion
Concentration: 100 mg/ml - Route of Administration:
Subcutaneous infusion
Intervention MeSH terms: Rozanolixizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ITP

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.
    

Eligibility 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