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Ianalumab

BIOLOGICAL16 trials

Sponsors

Novartis Pharmaceuticals

Conditions

Diffuse Cutaneous Systemic SclerosisLupus NephritisPrimary Evans Syndrome (ES)Primary Immune ThrombocytopeniaPrimary Immune Thrombocytopenia (ITP)Rheumatoid ArthritisSjogren DiseaseSjogren Syndrome

Phase 1

Phase 2

Biopsy Based Study to Understand Mechanism of Action of Ianalumab in Salivary Glands and Explore Relationships With Clinical Assessments.
CompletedNCT05124925
Novartis PharmaceuticalsSjogren Syndrome
Start: 2022-07-27End: 2026-01-05Updated: 2026-02-02
A Study of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least Two Lines of Therapies
Active, not recruitingNCT05885555
Novartis PharmaceuticalsPrimary Immune Thrombocytopenia (ITP)
Start: 2023-08-16End: 2029-03-19Updated: 2026-04-13
A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
RecruitingNCT06470048
Novartis PharmaceuticalsDiffuse Cutaneous Systemic Sclerosis
Start: 2024-10-09End: 2034-07-31Target: 200Updated: 2026-07-10
Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab
RecruitingNCT07039422
Novartis PharmaceuticalsPrimary Immune Thrombocytopenia, Warm Autoimmune Hemolytic Anemia
Start: 2026-06-26End: 2030-08-30Target: 60Updated: 2026-07-17
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
RecruitingNCT07421167
Novartis PharmaceuticalsPrimary Evans Syndrome (ES), Primary Immune Thrombocytopenia (ITP)
Start: 2026-06-29End: 2030-08-10Target: 164Updated: 2026-07-14
A Study of Ianalumab in Addition to Eltrombopag in Pediatric Patients With Primary ITP Who Failed Corticosteroids.
Not yet recruitingNCT07660172
Novartis PharmaceuticalsPrimary Immune Thrombocytopenia (ITP)
Start: 2027-02-08End: 2033-04-22Target: 36Updated: 2026-06-25

Phase 3

Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)
Active, not recruitingNCT05624749
Novartis PharmaceuticalsSystemic Lupus Erythematosus
Start: 2023-04-21End: 2029-04-09Updated: 2026-06-03
Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)
Active, not recruitingNCT05639114
Novartis PharmaceuticalsSystemic Lupus Erythematosus
Start: 2023-03-02End: 2029-03-21Updated: 2026-06-03
A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia
Active, not recruitingNCT05648968
Novartis PharmaceuticalsWarm Autoimmune Hemolytic Anemia (wAIHA)
Start: 2022-12-30End: 2028-12-19Updated: 2026-06-08
A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids
Active, not recruitingNCT05653219
Novartis PharmaceuticalsPrimary Immune Thrombocytopenia
Start: 2023-02-02End: 2028-04-08Updated: 2026-06-16
Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)
Active, not recruitingNCT05653349
Novartis PharmaceuticalsPrimary Immune Thrombocytopenia (ITP)
Start: 2023-02-03End: 2029-01-05Updated: 2026-06-15
Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
RecruitingNCT06133972
Novartis PharmaceuticalsSystemic Lupus Erythematosus
Start: 2024-05-21End: 2032-04-05Target: 550Updated: 2026-07-08
Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)
RecruitingNCT06711887
Novartis PharmaceuticalsLupus Nephritis
Start: 2025-05-19End: 2035-08-01Target: 348Updated: 2026-07-10

Unknown Phase

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