Ianalumab Clinical Trials (2026): 17 Studies for Systemic Lupus Erythematosus & Primary Immune Thrombocytopenia
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
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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 3,688 total planned enrollment. 9 Phase 3 Ianalumab trials and 5 Phase 2 are listed. 5 Ianalumab clinical trials are actively recruiting at 42 U.S. sites across 15 states. Most recent activity: NCT06711887 (Aug 2035).
Where to Participate: All Ianalumab Trial Sites in the U.S. (42 sites across 15 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.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| AL | Pinnacle Research Group Llc | Anniston36207 | NCT06133972 | Map |
| AZ | Arizona Arthritis and Rheumatology Research PLLC | Mesa85202 | NCT06470048 | Map |
| CA | Providence Medical Center | Burbank91505 | NCT06133972 | Map |
| CA | Advanced Medical Research | La Palma90623 | NCT06133972 | Map |
| CA | UCLA | Los Angeles90095 | NCT06470048 | Map |
| CA | Hoag Hospital | Newport Beach92663 | NCT06470048 | Map |
| CO | University of Colorado Denver | Aurora80045 | NCT06133972 | Map |
| CT | Stamford Hospital | Stamford06902 | NCT07421167 | Map |
| FL | Clinical Res Of W Florida | Clearwater33765 | NCT06470048 | Map |
| FL | Clinical Res Of W Florida | Clearwater33765 | NCT06133972 | Map |
| FL | GNP Research | Cooper City33024 | NCT06470048 | Map |
| FL | GNP Research | Cooper City33024 | NCT06133972 | Map |
| FL | Baptist MD Anderson Cancer Center | Jacksonville32207 | NCT07421167 | Map |
| FL | DH Cancer Research Center LLC | Margate33063 | NCT07421167 | Map |
| FL | IRIS Research and Development | Plantation33324 | NCT06470048 | Map |
| FL | IRIS Research and Development | Plantation33324 | NCT06133972 | Map |
| FL | Sarasota Arthritis Res Ctr | Sarasota34239 | NCT06470048 | Map |
| FL | Clinical Research of West Florida Inc | Tampa33603 | NCT06133972 | Map |
| GA | Parris and Associates Rheumatology | Lawrenceville30044 | NCT06133972 | Map |
| IL | University of Chicago Hospitals | Chicago60637 | NCT06470048 | Map |
| IL | Hope And Healing Care | Hinsdale60521 | NCT07421167 | Map |
| IL | Robert A Hozman MD SC | Skokie60076 | NCT06133972 | Map |
| IL | Willow Rheumatology Wellness | Willowbrook60527 | NCT06133972 | Map |
| LA | Accurate Clinical Research | Lake Charles70601 | NCT06133972 | Map |
| LA | UMC New Orleans | New Orleans70112 | NCT06470048 | Map |
| MI | Uni Of Michigan Health System | Ann Arbor48109 | NCT06470048 | Map |
| MI | Henry Ford Health | Detroit48202 | NCT06133972 | Map |
| MI | Wayne State University | Detroit48201 | NCT06470048 | Map |
| MI | Ahmed Arif Medical Research Center | Grand Blanc48439 | NCT06133972 | Map |
| MI | Clinical Research Inst of MI | Saint Clair Shores48081 | NCT06470048 | Map |
| NJ | Summit Medical Group | Summit07901 | NCT07421167 | Map |
| NY | Hospital for Special Surgery | New York10021 | NCT06470048 | Map |
| NY | Circuit Clinical | Orchard Park14127 | NCT06711887 | Map |
| OH | Paramount Med Rsrch and Consult LLC | Middleburg Heights44130 | NCT06133972 | Map |
| TN | West Tennessee Research Institute | Jackson38305 | NCT06470048 | Map |
| TN | West Tennessee Research Institute | Jackson38305 | NCT06133972 | Map |
| TN | Shelby Research LLC | Memphis38121 | NCT06133972 | Map |
| TX | Arthritis and Rheumatology Ins | Allen75035 | NCT06470048 | Map |
| TX | Novel Research LLC | Bellaire77401 | NCT06470048 | Map |
| TX | Prolato Clinical Research Center | Houston77054 | NCT06470048 | Map |
| TX | Accurate Clinical Research | League City77573 | NCT06133972 | Map |
| TX | Epic Medical Research | Red Oak75154 | NCT06133972 | Map |
Ianalumab clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | completed | withdrawn | available | Total |
|---|---|---|---|---|---|---|
| P1 | 1 | 1 | 2 | |||
| P2 | 3 | 1 | 1 | 5 | ||
| P3 | 2 | 7 | 9 | |||
| N/A | 1 | 1 |
Recruiting Ianalumab clinical trials (5)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT06711887 | SIRIUS-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) | P3 | Lupus Nephritis | 348 | May 2025 |
| NCT06470048 | A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis | P2 | Diffuse Cutaneous Systemic Sclerosis | 200 | Oct 2024 |
| NCT06133972 | SIRIUS-SLE LTEPhase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension). | P3 | Systemic Lupus Erythematosus | 550 | May 2024 |
| NCT07039422 | VAY RE-HITStudy of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab | P2 | Primary Immune Thrombocytopenia | 60 | Jun 2026 |
| NCT07421167 | VAY2EXPLOREA 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) | P2 | Primary Immune Thrombocytopenia (ITP) | 164 | Jun 2026 |
Ianalumab clinical trials by indication
Primary Immune Thrombocytopenia (ITP) (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07421167 | VAY2EXPLORE | P2 | recruiting | 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) |
| NCT05885555 | VAY736 | P2 | active not recruiting | A Study of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least Two Lines of Therapies |
| NCT05653349 | VAYHIT1 | P3 | active not recruiting | Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP) |
Primary Immune Thrombocytopenia (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07039422 | VAY RE-HIT | P2 | recruiting | Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab |
| NCT05653219 | VAYHIT2 | P3 | active not recruiting | A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids |
| NCT07244289 | — | N/A | available | Managed Access Programs for VAY736, Ianalumab |
Systemic Lupus Erythematosus (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06133972 | SIRIUS-SLE LTE | P3 | recruiting | Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension). |
| NCT05624749 | SIRIUS-SLE 2 | P3 | active not recruiting | Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2) |
| NCT05639114 | SIRIUS-SLE 1 | P3 | active not recruiting | 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) |
Lupus Nephritis (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06711887 | SIRIUS-LN ext | P3 | recruiting | Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension) |
| NCT05126277 | SIRIUS-LN | P3 | active not recruiting | Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis |
Sjogren Disease (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06411639 | — | P1 | withdrawn | Pharmacokinetics Study of Ianalumab in Chinese Participants With Autoimmune Diseases |
Diffuse Cutaneous Systemic Sclerosis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06470048 | — | P2 | recruiting | A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis |
Sjogrens Syndrome (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05985915 | NEPTUNUS-Ext | P3 | active not recruiting | A 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)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05648968 | VAYHIA | P3 | active not recruiting | A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia |
Sjogren Syndrome (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05124925 | — | P2 | completed | Biopsy Based Study to Understand Mechanism of Action of Ianalumab in Salivary Glands and Explore Relationships With Clinical Assessments. |
Rheumatoid Arthritis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03574545 | — | P1 | completed | Study 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.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| SIRIUS-LN ext | NCT06711887 | P3 | recruiting | Lupus Nephritis | 348 | PMID 40465397 |
| NEPTUNUS-Ext | NCT05985915 | P3 | active not recruiting | Sjogrens Syndrome | 612 | — |
| SIRIUS-SLE LTE | NCT06133972 | P3 | recruiting | Systemic Lupus Erythematosus | 550 | — |
| SIRIUS-LN | NCT05126277 | P3 | active not recruiting | Lupus Nephritis | 452 | — |
| SIRIUS-SLE 2 | NCT05624749 | P3 | active not recruiting | Systemic Lupus Erythematosus | 288 | — |
| SIRIUS-SLE 1 | NCT05639114 | P3 | active not recruiting | Systemic Lupus Erythematosus | 436 | — |
| VAYHIT1 | NCT05653349 | P3 | active not recruiting | Primary Immune Thrombocytopenia (ITP) | 226 | — |
| VAYHIA | NCT05648968 | P3 | active not recruiting | Warm Autoimmune Hemolytic Anemia (wAIHA) | 90 | — |
| VAYHIT2 | NCT05653219 | P3 | active not recruiting | Primary Immune Thrombocytopenia | 152 | PMID 41363800 |
| VAY RE-HIT | NCT07039422 | P2 | recruiting | Primary Immune Thrombocytopenia | 60 | — |
| VAY2EXPLORE | NCT07421167 | P2 | recruiting | Primary Immune Thrombocytopenia (ITP) | 164 | — |
| VAY736 | NCT05885555 | P2 | active not recruiting | Primary 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.
- NCT06411639withdrawnPharmacokinetics Study of Ianalumab in Chinese Participants With Autoimmune Diseases
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 ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT06711887 | SIRIUS-LN ext | Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension) | P3 | recruiting | 348 | Novartis Pharmaceuticals | May 2025 |
| NCT06470048 | A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis | P2 | recruiting | 200 | Novartis Pharmaceuticals | Oct 2024 | |
| NCT05985915 | NEPTUNUS-Ext | A 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. | P3 | active not recruiting | 612 | Novartis Pharmaceuticals | Oct 2023 |
| NCT06133972 | SIRIUS-SLE LTE | Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension). | P3 | recruiting | 550 | Novartis Pharmaceuticals | May 2024 |
| NCT05126277 | SIRIUS-LN | Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis | P3 | active not recruiting | 452 | Novartis Pharmaceuticals | Jul 2022 |
| NCT07039422 | VAY RE-HIT | Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab | P2 | recruiting | 60 | Novartis Pharmaceuticals | Jun 2026 |
| NCT07421167 | VAY2EXPLORE | 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) | P2 | recruiting | 164 | Novartis Pharmaceuticals | Jun 2026 |
| NCT05624749 | SIRIUS-SLE 2 | Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2) | P3 | active not recruiting | 288 | Novartis Pharmaceuticals | Apr 2023 |
| NCT05639114 | SIRIUS-SLE 1 | 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) | P3 | active not recruiting | 436 | Novartis Pharmaceuticals | Mar 2023 |
| NCT05885555 | VAY736 | A Study of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least Two Lines of Therapies | P2 | active not recruiting | 41 | Novartis Pharmaceuticals | Aug 2023 |
| NCT05653349 | VAYHIT1 | Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP) | P3 | active not recruiting | 226 | Novartis Pharmaceuticals | Feb 2023 |
| NCT05648968 | VAYHIA | A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia | P3 | active not recruiting | 90 | Novartis Pharmaceuticals | Dec 2022 |
| NCT06411639 | Pharmacokinetics Study of Ianalumab in Chinese Participants With Autoimmune Diseases | P1 | withdrawn | 0 | Novartis Pharmaceuticals | Nov 2024 | |
| NCT05653219 | VAYHIT2 | A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids | P3 | active not recruiting | 152 | Novartis Pharmaceuticals | Feb 2023 |
| NCT05124925 | Biopsy Based Study to Understand Mechanism of Action of Ianalumab in Salivary Glands and Explore Relationships With Clinical Assessments. | P2 | completed | 21 | Novartis Pharmaceuticals | Jul 2022 | |
| NCT07244289 | Managed Access Programs for VAY736, Ianalumab | — | available | 0 | Novartis Pharmaceuticals | — | |
| NCT03574545 | Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis | P1 | completed | 48 | Novartis Pharmaceuticals | Dec 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 42 U.S. sites across 15 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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