13 completed, 4 terminated, 3 active not recruiting, 3 recruiting. 12 Phase 3, 7 Phase 2, 3 Phase 1, 1 Phase 4.
By phase and status
Follow rozanolixizumab: new trials by email Literature Review of rozanolixizumab trials Research Report on rozanolixizumab
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|
A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Rozanolixizumab - Ocular Myasthenia Gravis | Phase 3 | Recruiting | 100 | 2026-09-16 | 2026-11-06 |
Monitor the Evolution of Myasthenia Gravis Symptoms in Real-life in Patients With Anti-AChR and Anti-MUSK Generalised Myasthenia Gravis in Therapy With RYSTIGGO® (Rozanolixizumab)
Patients diagnosed with generalized myasthenia gravis and treated with Rozanolixizumab - Generalized Myasthenia Gravis | | Recruiting | 50 | 2026-06-15 | 2026-09-01 |
A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Rozanolixizumab, Placebo - Ocular Myasthenia Gravis | Phase 3 | Recruiting | 120 | 2026-05-27 | 2026-11-06 |
Phase 4 Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myasthenia Gravis
Rozanolixizumab - Myasthenia Gravis | Phase 4 | Active not recruiting | 40 | 2025-12-01 | 2026-10-29 |
A Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women
Rozanolixizumab - Healthy Participants | Phase 1 | Completed | 15 | 2024-12-03 | 2026-06-04 |
An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
rozanolixizumab - Generalized Myasthenia Gravis | Phase 3 | Active not recruiting | 13 | 2024-10-08 | 2026-11-06 |
A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis
rozanolixizumab - Generalized Myasthenia Gravis | Phase 2 / Phase 3 | Completed | 14 | 2024-06-14 | 2026-10-27 |
A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG)
Rozanolixizumab - Generalized Myasthenia Gravis | Phase 3 | Completed | 62 | 2023-04-17 | 2025-11-06 |
A Proof-of-concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome
rozanolixizumab, Placebo - Fibromyalgia | Phase 2 | Completed | 63 | 2022-12-21 | 2025-07-01 |
A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOGAD)
Rozanolixizumab, Placebo - Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD) | Phase 3 | Active not recruiting | 113 | 2022-02-02 | 2026-10-27 |
A Study to Test the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis
Rozanolixizumab, Placebo - Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis | Phase 2 | Terminated | 12 | 2021-09-27 | 2025-05-31 |
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Rozanolixizumab Administered Subcutaneously Via Manual Push Versus Syringe Driver to Healthy Participants
rozanolixizumab, Placebo - Healthy Study Participants | Phase 1 | Completed | 32 | 2021-04-22 | 2024-03-07 |
A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis
Rozanolixizumab - Generalized Myasthenia Gravis | Phase 3 | Completed | 165 | 2021-02-03 | 2026-08-20 |
A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
Rozanolixizumab - Primary Immune Thrombocytopenia | Phase 3 | Terminated | 43 | 2021-01-06 | 2024-02-05 |
A Study to Assess the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
Rozanolixizumab, Placebo - Primary Immune Thrombocytopenia | Phase 3 | Terminated | 30 | 2020-06-03 | 2023-08-08 |
A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
Rozanolixizumab, Placebo - Primary Immune Thrombocytopenia | Phase 3 | Terminated | 33 | 2020-01-31 | 2025-03-18 |
A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
Rozanolixizumab - Generalized Myasthenia Gravis | Phase 3 | Completed | 71 | 2019-10-29 | 2026-08-20 |
A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Rozanolixizumab - Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | Phase 2 | Completed | 21 | 2019-08-21 | 2022-11-03 |
A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
Rozanolixizumab, Placebo - Generalized Myasthenia Gravis | Phase 3 | Completed | 200 | 2019-06-03 | 2026-08-20 |
A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Rozanolixizumab, Placebo - Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | Phase 2 | Completed | 34 | 2019-03-26 | 2023-08-01 |
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Conditions studied
Myasthenia Gravis (11) · Polyradiculoneuropathy, Chronic Inflammatory Demyelinating (3) · Purpura, Thrombocytopenic, Idiopathic (3) · Fibromyalgia (1) · Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (1) · Thrombocytopenia (1)
Sponsors
UCB Biopharma SRL (20) · UCB Biopharma S.P.R.L. (3) · Centre Hospitalier Universitaire de Nice (1)
Countries
United States (15) · Spain (14) · Germany (13) · Poland (13) · United Kingdom (13) · France (12) · Italy (11) · Japan (11) · Georgia (8) · Belgium (6) · Canada (6) · Czechia (6) · Denmark (6) · Russia (6) · Taiwan (6)
Results publications
PMID 37059507, PMID 42388397, PMID 30130439, PMID 33219142, PMID 38099334, PMID 38729747, PMID 40105996, PMID 32886753, PMID 35674086, PMID 37166675, PMID 38978809, PMID 39297052, PMID 39552477, PMID 40755069, PMID 41074934, PMID 41205003, PMID 42748952
NIH funding
2019 (6), 2016 (2), 2018 (2), 2025 (2), 2023 (1)