Rozanolixizumab (Rystiggo®) 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 Terminated NCT048759752019-004778-25 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 NCT038614812016-002411-17 LINKLINK Querol L., de Sèze J., Dysgaard T., et al. Journal of neurology, neurosurgery, and psychiatry 2024; 95(9):845–54 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 NCT040519442018-004392-12 LINK[LINK 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 Completed NCT05643794 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 NCT030527512016-002698-36 LINKLINK 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 NCT039714222019-000968-18 LINK PDF Bril V. Lancet Neurol 2023; 22(5):383–94 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 NCT041249652019-000969-21 LINK 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 of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis (roMyG) Phase 3 MG0006 Ongoing NCT061495592022-502074-16-00 Myasthenia Gravis A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis Phase 3 MG0007 Completed NCT046508542020-003230-20 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 NCT056817152022-003870-21 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 NCT050631622021-000352-192023-509237-39-00 Thrombocytopenia Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia Phase 2 TP0001 Completed NCT027187162015-003984-12 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 Terminated NCT042004562019-000884-26 LINKLINK PDF 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 NCT045969952019-000883-40 LINKLINK 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 NCT042246882019-003451-11 LINKLINK 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 Myasthenia Gravis Phase 3 MG0008 Ongoing NCT065401442022-502075-34-00
