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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	LINK LINK		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	LINK		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 Ongoing	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	LINK LINK		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	LINK		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	LINK [LINK
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	LINK
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 Ongoing	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	LINK LINK	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	NCT04596995 2019-000883-40	LINK LINK	PDF
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	LINK LINK