Ianalumab Clinical Trials (2026): 17 Studies for Systemic Lupus Erythematosus & Primary Immune Thrombocytopenia

Hipa.ai Research · Source: ClinicalTrials.gov / AACT

Synced daily from ClinicalTrials.gov via AACT. Last sync: .

17 Ianalumab clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 10 indications (including Systemic Lupus Erythematosus & Primary Immune Thrombocytopenia) and 3,655 total planned enrollment. 9 Phase 3 Ianalumab trials and 5 Phase 2 are listed. 5 Ianalumab clinical trials are actively recruiting at 40 U.S. sites across 14 states. Most recent activity: NCT06470048 (Jul 2034).

Where to Participate: All Ianalumab Trial Sites in the U.S. (40 sites across 14 states)

Every actively recruiting Ianalumabtrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.

StateFacilityCityTrialMap
ALPinnacle Research Group LlcAnniston36207NCT06133972Map
AZArizona Arthritis and Rheumatology Research PLLCMesa85202NCT06470048Map
CAProvidence Medical CenterBurbank91505NCT06133972Map
CAAdvanced Medical ResearchLa Palma90623NCT06133972Map
CAUCLALos Angeles90095NCT06470048Map
CAHoag HospitalNewport Beach92663NCT06470048Map
CAMillennium Clinical TrialsWestlake Village91361NCT06133972Map
COUniversity of Colorado DenverAurora80045NCT06133972Map
FLClinical Res Of W FloridaClearwater33765NCT06133972Map
FLClinical Res Of W FloridaClearwater33765NCT06470048Map
FLGNP ResearchCooper City33024NCT06133972Map
FLGNP ResearchCooper City33024NCT06470048Map
FLDH Cancer Research Center LLCMargate33063NCT07421167Map
FLIRIS Research and DevelopmentPlantation33324NCT06133972Map
FLIRIS Research and DevelopmentPlantation33324NCT06470048Map
FLSarasota Arthritis Res CtrSarasota34239NCT06470048Map
GAParris and Associates RheumatologyLawrenceville30044NCT06133972Map
ILUniversity of Chicago HospitalsChicago60637NCT06470048Map
ILHope And Healing CareHinsdale60521NCT07421167Map
ILRobert A Hozman MD SCSkokie60076NCT06133972Map
ILWillow Rheumatology WellnessWillowbrook60527NCT06133972Map
LAAccurate Clinical ResearchLake Charles70601NCT06133972Map
LAUMC New OrleansNew Orleans70112NCT06470048Map
MDUniversity Of MarylandBaltimore21201NCT06133972Map
MIUni Of Michigan Health SystemAnn Arbor48109NCT06470048Map
MIHenry Ford HealthDetroit48202NCT06133972Map
MIWayne State UniversityDetroit48201NCT06470048Map
MIAhmed Arif Medical Research CenterGrand Blanc48439NCT06133972Map
MIClinical Research Inst of MISaint Clair Shores48081NCT06470048Map
NYHospital for Special SurgeryNew York10021NCT06470048Map
OHParamount Med Rsrch and Consult LLCMiddleburg Heights44130NCT06133972Map
TNWest Tennessee Research InstituteJackson38305NCT06133972Map
TNWest Tennessee Research InstituteJackson38305NCT06470048Map
TNShelby Research LLCMemphis38119NCT06133972Map
TXArthritis and Rheumatology InsAllen75013NCT06470048Map
TXNovel Research LLCBellaire77401NCT06133972Map
TXNovel Research LLCBellaire77401NCT06470048Map
TXProlato Clinical Research CenterHouston77054NCT06470048Map
TXAccurate Clinical ResearchLeague City77573NCT06133972Map
TXEpic Medical ResearchRed Oak75154NCT06133972Map

Ianalumab clinical trials at a glance: phase × recruitment status

Phaserecruitingactive not recruitingcompletedwithdrawnavailableTotal
P1112
P23115
P3279
N/A11

Recruiting Ianalumab clinical trials (5)

Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).

NCT IDTitlePhaseIndicationEnrollmentStarted
NCT06470048A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic SclerosisP2Diffuse Cutaneous Systemic Sclerosis200Oct 2024
NCT06711887SIRIUS-LN extPhase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)P3Lupus Nephritis315May 2025
NCT06133972SIRIUS-SLE LTEPhase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).P3Systemic Lupus Erythematosus550May 2024
NCT07421167VAY2EXPLOREA 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)P2Primary Immune Thrombocytopenia (ITP)164Jun 2026
NCT07039422VAY RE-HITStudy of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From IanalumabP2Primary Immune Thrombocytopenia60Jun 2026

Ianalumab clinical trials by indication

Primary Immune Thrombocytopenia (ITP) (3)

NCTAcronymPhaseStatusTitle
NCT07421167VAY2EXPLOREP2recruitingA 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)
NCT05885555VAY736P2active not recruitingA Study of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least Two Lines of Therapies
NCT05653349VAYHIT1P3active not recruitingStudy of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)

Primary Immune Thrombocytopenia (3)

NCTAcronymPhaseStatusTitle
NCT07039422VAY RE-HITP2recruitingStudy of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab
NCT05653219VAYHIT2P3active not recruitingA Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids
NCT07244289N/AavailableManaged Access Programs for VAY736, Ianalumab

Systemic Lupus Erythematosus (3)

NCTAcronymPhaseStatusTitle
NCT06133972SIRIUS-SLE LTEP3recruitingPhase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
NCT05624749SIRIUS-SLE 2P3active not recruitingPhase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)
NCT05639114SIRIUS-SLE 1P3active not recruitingPhase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)

Lupus Nephritis (2)

NCTAcronymPhaseStatusTitle
NCT06711887SIRIUS-LN extP3recruitingPhase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)
NCT05126277SIRIUS-LNP3active not recruitingSafety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

Sjogren Disease (1)

NCTAcronymPhaseStatusTitle
NCT06411639P1withdrawnPharmacokinetics Study of Ianalumab in Chinese Participants With Autoimmune Diseases

Diffuse Cutaneous Systemic Sclerosis (1)

NCTAcronymPhaseStatusTitle
NCT06470048P2recruitingA Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis

Sjogrens Syndrome (1)

NCTAcronymPhaseStatusTitle
NCT05985915NEPTUNUS-ExtP3active not recruitingA Randomized, Double-blind 2-arm, Followed by an Open-label 1-arm, NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.

Warm Autoimmune Hemolytic Anemia (wAIHA) (1)

NCTAcronymPhaseStatusTitle
NCT05648968VAYHIAP3active not recruitingA Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia

Sjogren Syndrome (1)

NCTAcronymPhaseStatusTitle
NCT05124925P2completedBiopsy Based Study to Understand Mechanism of Action of Ianalumab in Salivary Glands and Explore Relationships With Clinical Assessments.

Rheumatoid Arthritis (1)

NCTAcronymPhaseStatusTitle
NCT03574545P1completedStudy Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis

Ianalumab pivotal trial highlights (Phase 2/3/4)

Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.

AcronymNCTPhaseStatusIndicationEnrollmentPubMed
NEPTUNUS-ExtNCT05985915P3active not recruitingSjogrens Syndrome612
SIRIUS-LN extNCT06711887P3recruitingLupus Nephritis315PMID 40465397
SIRIUS-SLE LTENCT06133972P3recruitingSystemic Lupus Erythematosus550
SIRIUS-LNNCT05126277P3active not recruitingLupus Nephritis452
SIRIUS-SLE 2NCT05624749P3active not recruitingSystemic Lupus Erythematosus288
SIRIUS-SLE 1NCT05639114P3active not recruitingSystemic Lupus Erythematosus436
VAYHIANCT05648968P3active not recruitingWarm Autoimmune Hemolytic Anemia (wAIHA)90
VAYHIT1NCT05653349P3active not recruitingPrimary Immune Thrombocytopenia (ITP)226
VAYHIT2NCT05653219P3active not recruitingPrimary Immune Thrombocytopenia152PMID 41363800
VAY2EXPLORENCT07421167P2recruitingPrimary Immune Thrombocytopenia (ITP)164
VAY RE-HITNCT07039422P2recruitingPrimary Immune Thrombocytopenia60
VAY736NCT05885555P2active not recruitingPrimary Immune Thrombocytopenia (ITP)41

Terminated and withdrawn Ianalumab trials (1)

Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.

All Ianalumab trials (17)

Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.

NCT IDAcronymTitlePhaseStatusEnrollmentSponsorStarted
NCT06470048A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic SclerosisP2recruiting200Novartis PharmaceuticalsOct 2024
NCT05985915NEPTUNUS-ExtA Randomized, Double-blind 2-arm, Followed by an Open-label 1-arm, NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.P3active not recruiting612Novartis PharmaceuticalsOct 2023
NCT06711887SIRIUS-LN extPhase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)P3recruiting315Novartis PharmaceuticalsMay 2025
NCT06133972SIRIUS-SLE LTEPhase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).P3recruiting550Novartis PharmaceuticalsMay 2024
NCT05126277SIRIUS-LNSafety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus NephritisP3active not recruiting452Novartis PharmaceuticalsJul 2022
NCT07421167VAY2EXPLOREA 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)P2recruiting164Novartis PharmaceuticalsJun 2026
NCT07039422VAY RE-HITStudy of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From IanalumabP2recruiting60Novartis PharmaceuticalsJun 2026
NCT05624749SIRIUS-SLE 2Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)P3active not recruiting288Novartis PharmaceuticalsApr 2023
NCT05639114SIRIUS-SLE 1Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)P3active not recruiting436Novartis PharmaceuticalsMar 2023
NCT05885555VAY736A Study of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least Two Lines of TherapiesP2active not recruiting41Novartis PharmaceuticalsAug 2023
NCT05648968VAYHIAA Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic AnemiaP3active not recruiting90Novartis PharmaceuticalsDec 2022
NCT05653349VAYHIT1Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)P3active not recruiting226Novartis PharmaceuticalsFeb 2023
NCT06411639Pharmacokinetics Study of Ianalumab in Chinese Participants With Autoimmune DiseasesP1withdrawn0Novartis PharmaceuticalsNov 2024
NCT05653219VAYHIT2A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed SteroidsP3active not recruiting152Novartis PharmaceuticalsFeb 2023
NCT05124925Biopsy Based Study to Understand Mechanism of Action of Ianalumab in Salivary Glands and Explore Relationships With Clinical Assessments.P2completed21Novartis PharmaceuticalsJul 2022
NCT07244289Managed Access Programs for VAY736, Ianalumabavailable0Novartis Pharmaceuticals
NCT03574545Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid ArthritisP1completed48Novartis PharmaceuticalsDec 2018

Ianalumab clinical trials: frequently asked questions

How many Ianalumab clinical trials are there?
17 Ianalumab clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 5 are actively recruiting participants. 2 are marked completed.
Are Ianalumab clinical trials recruiting in 2026?
Yes — 5 Ianalumab trials are actively recruiting in 2026, with 40 U.S. sites across 14 states. See the recruiting trials and the per-state site list further down this page.
What conditions is Ianalumab being studied for?
Ianalumab is being studied for Systemic Lupus Erythematosus, Primary Immune Thrombocytopenia, Primary Immune Thrombocytopenia (ITP), Lupus Nephritis, Sjogren Disease and 8 more. The trials are grouped by indication on this page.
What phase is Ianalumab in?
Ianalumab clinical trials span 9 Phase 3, 5 Phase 2, 2 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
Who sponsors Ianalumab clinical trials?
The lead sponsor across the most Ianalumab trials is Novartis Pharmaceuticals. Each trial row links to the full study detail page including sponsor information.

Sources and methodology

Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Ianalumabas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.

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