A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
The purpose of this study is to demonstrate the clinical efficacy of rozanolixizumab in maintenance treatment and assess safety and tolerability of rozanolixizumab in adult study participants with primary immune thrombocytopenia (ITP).
Inclusion Criteria:
Study participant must be ≥18 years of age at the time of the Screening Visit
Study participant has a diagnosis of persistent (>3 months duration) or chronic (>12 months duration) primary immune thrombocytopenia (ITP) at the Screening Visit
Study participant has a documented intolerance or insufficient response to two or more appropriate standard of care ITP treatments prior to Screening
Study participants must have prior history of a response to a previous ITP therapy
If taking allowed drugs, study participant must be on stable doses during defined time periods prior to Baseline (Day 1)
Study participant has a documented history of low platelet count (<30×10^9/L) prior to Screening
Study participant has a platelet count measurement at Screening and at Baseline (Day 1) with an average of the two <30×10^9/L and no single count may be >35×10^9/L (using local laboratories)
Study participant has a current or history of a peripheral blood smear consistent with ITP
Study participants may be male or female:
Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 3 months after the dose of study treatment
Exclusion Criteria:
Iruma-gun, Japan
Shibuya-ku, Japan