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Rozanolixizumab (Rystiggo®)

Disease area studied Abbreviated title Phase Study ID Registry database Study results Plain language summary Publication (if available)
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
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Bril V. Neurology 2021, 96(6):e853-e865
Myasthenia Gravis A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis Phase 3 MG0003
Completed
NCT03971422
2019-000968-18
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Bril V. Lancet Neurol 2023; 22(5):383–94
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
Terminated
NCT04875975
2019-004778-25
Dubey D., Titulaer M., Koul A.D., Yates S., Irani S.R. , Neurology 2022; 99(23 suppl.2):S42-S43, AAN 2022
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
NCT03861481
2016-002411-17
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Querol L., de Seze J., Dysgaard T., Levine T., Rao T.H. et al. , J Periph Nerv Syst 2022; 27(S3 suppl.):S110-111, 2022 Peripheral Nerve Society Annual Meeting, May 14-17, 2022; Miami, Fl, USA
Thrombocytopenia Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia Phase 2 TP0001
Completed
NCT02718716
2015-003984-12
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Robak T., Blood advances 2020; 4(17):4136–46
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
Completed
NCT04051944
2018-004392-12
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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
Completed
NCT04124965
2019-000969-21
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Bril V., et al. Neurology 2024; 102(17 Suppl.1) 76th Annual Meeting of American Academy of Neurology (AAN), April 13-18, 2024; Denver, USA
Myasthenia Gravis A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis Phase 3 MG0007
Completed
NCT04650854
2020-003230-20
Vu T., Grosskreutz J., Gayfieva M., Boehnlein M., Pulido-Valdeolivas I. et al, Muscle and Nerve 2023; 68(4):626. AANEM
Myasthenia Gravis A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG) Phase 3 MG0020
Completed
NCT05681715
2022-003870-21
Myelin oligodendrocyte glycoprotein antibody-associated disease A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOG-AD) (cosMOG) Phase 3 MOG001
Ongoing
NCT05063162
2021-000352-19
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
Terminated
NCT04200456
2019-000884-26
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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
Completed
NCT04596995
2019-000883-40
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Fibromyalgia A Proof-of-concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome Phase 2 FM0001
Ongoing
NCT05643794
Myasthenia Gravis A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Rozanolixizumab Administered Subcutaneously Via Manual Push Versus Syringe Driver to Healthy Participants Phase 1 UP0106
Completed
NCT04828343 PDF
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
Terminated
NCT04224688
2019-003451-11
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