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Rozanolixizumab (UCB7665)

 

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Disease area
studied
Abbreviated title Phase Study ID Registry database Study results Plain language summary Publication (if available)
Autoimmune Encephalitis A Study to Test the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis Phase 2 AIE001
Ongoing
     
Chronic Inflammatory Demyelinating Polyradiculoneuropathy A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy Phase 2 CIDP01
Completed
     
Chronic Inflammatory Demyelinating Polyradiculoneuropathy A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy Phase 2 CIDP04 
Ongoing
     
Myasthenia Gravis A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis Phase 2 MG0002
Completed
NCT03052751
2016-002698-36
LINK   Bril V. Neurology 2020 [ePub]
Myasthenia Gravis A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis Phase 3 MG0003
Ongoing
     
Myasthenia Gravis A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis Phase 3 MG0004
Ongoing
NCT04124965      
Myasthenia Gravis A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis Phase 3 MG0007
Ongoing
     
Thrombocytopenia Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia Phase 2 TP0001
Completed
NCT02718716
2015-003984-12

LINK
  Robak T., Blood advances 2020; 4(17):4136–46
Primary Immune Thrombocytopenia The Purpose of This Study is to Demonstrate the Clinical Efficacy of Rozanolixizumab in Maintenance Treatment and Asses Safety and Tolerability of Rozanolixizumab in Adult Study Participants with Primary Immune Thrombocytopenia (ITP). Phase 3 TP0003
Ongoing
     
Primary Immune Thrombocytopenia A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)  Phase 3 TP0004
Ongoing
NCT04596995
2019-000883-40
     
Persistent or Chronic Primary Immune Thrombocytopenia (ITP) A Study to Assess the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) (myOpportunITy2) Phase 3 TP0006
Ongoing