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 |
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 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 |
NCT04051944 2018-004392-12 |
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 |
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 | |
| 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
|
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 |
NCT06149559 2022-502074-16-00 |
|||
| 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 2023-509237-39-00 |
|||
| 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
Terminated |
NCT04200456 2019-000884-26 |
LINK LINK |
||
| 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 |
||
| 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 |
||
| 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 |