RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (Japan), Priority Review (United States)

Structure/Sequence

Sequence Code 155090L

Source: *****

Sequence Code 155096H

Source: *****

Clinical Trials associated with Ianalumab

NCT07660172

/ Not yet recruitingPhase 2

A Phase 2, Open-label, Single-arm Study of Ianalumab in Addition to Eltrombopag in Pediatric Patients With Primary Immune Thrombocytopenia Who Had an Insufficient Response to or Relapsed After First-line Corticosteroid Treatment (VAYHIT-P).

The purpose of this study is to assess the efficacy, safety and pharmacokinetics (PK) of ianalumab (VAY736) in addition to eltrombopag treatment; and to inform the dose of ianalumab in pediatric patients (5 to <18 years of age) with primary ITP who have had an insufficient response to or relapsed after first-line treatment with corticosteroids.

Start Date08 Feb 2027

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT07621809

/ RecruitingPhase 3

A Randomized, Double-blind, Placebo-controlled, 2-arm Multicenter Phase III Study to Assess the Efficacy and Safety of Ianalumab in Participants With Sjogren's Disease With High Symptom Burden (THALASSA)

The purpose of this study is to demonstrate the efficacy and safety of ianalumab (VAY736) 300 mg administered subcutaneously (s.c.) monthly for 52 weeks in adult participants with Sjögren's disease who have high symptom burden.

Start Date15 Jul 2026

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT07421167

/ RecruitingPhase 2

A Phase 2 Open-label Study to Evaluate the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least One Treatment (VAY2EXPLORE)

The purpose of this study is to investigate the tolerability of ianalumab (9 mg/kg) with investigator's choice thrombopoietin receptor agonist (IC TPO-RA) in participants diagnosed with primary immune thrombocytopenia (ITP) who have been treated with at least one but no more than four prior treatments, and with no change in IC TPO-RA dose in at least the last 14 days prior to the start of ianalumab.

Start Date29 Jun 2026

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

100 Clinical Results associated with Ianalumab

100 Translational Medicine associated with Ianalumab

100 Patents (Medical) associated with Ianalumab

Literatures (Medical) associated with Ianalumab

01 Jun 2026·CURRENT OPINION IN IMMUNOLOGY

Clinical trials and new therapies in Sjögren’s disease

Review

Author: Grader-Beck, Thomas ; Salas, Antonio ; Patel, Vishal

Despite major advances in understanding Sjögren's disease (SjD), no approved disease-modifying therapies have been approved. Management remains largely symptomatic with the use of off-label immunomodulators for systemic features. This gap highlights the substantial unmet need for targeted treatment. Encouragingly, the therapeutic landscape is shifting. Several phase 2 trials have shown meaningful efficacy signals, and for the first time, phase 3 programs with ianalumab and telitacicept have demonstrated positive outcomes, particularly when systemic activity is assessed using the EULAR Sjögren's Syndrome Disease Activity Index. These successes reflect both the maturation of the therapeutic pipeline and important refinements in trial design. Insights from earlier negative studies have underscored the importance of enrolling patients with active disease, incorporating biomarker-defined subgroups, and development of composite endpoints that integrate systemic, symptomatic, and functional domains. Together, these developments suggest that SjD may finally be approaching an era of effective, disease-modifying therapy.

16 Apr 2026·NEW ENGLAND JOURNAL OF MEDICINE

Ianalumab plus Eltrombopag in Immune Thrombocytopenia

Article

Author: Yoon, Jae-Ho ; Cuker, Adam ; Sun, Jing ; Schutgens, Roger ; Rossi, Elena ; Cooper, Nichola ; Weill, Marine ; Michel, Marc ; Ghanima, Waleed ; Nath, Uttam Kumar ; Zander, Thomas ; Sharif, Azizan ; Foster, Matthew ; Ruchutrakool, Theera ; Al-Samkari, Hanny ; Zhang, Lei ; Iino, Masaki ; Červinek, Libor ; Hou, Ming ; Urban, Patrick ; Zaja, Francesco ; Stauch, Thomas ; Fronczek, Justyna ; Chang, Hung ; Goto, Tatsunori ; Deleu, Lien

BACKGROUND:

Current second-line treatments for immune thrombocytopenia (ITP) require long-term administration. Ianalumab, a monoclonal antibody targeting B cells, is being assessed as a short-course second-line therapy in ITP.

METHODS:

In this phase 3, randomized, double-blind trial, we assigned, in a 1:1:1 ratio, adults with primary ITP and an insufficient response or a relapse after first-line glucocorticoid therapy to receive ianalumab at a dose of 9 mg or 3 mg per kilogram of body weight or placebo once monthly for 4 months. Eltrombopag, an oral thrombopoietin-receptor agonist, was administered once daily in each group according to local prescribing information; the dose was tapered until discontinuation by the end of week 24 in eligible patients. The primary end point was freedom from treatment failure, as determined in a time-to-event analysis, with treatment failure defined by a platelet count of less than 30×10⁹ per liter more than 8 weeks after randomization, initiation of rescue therapy more than 8 weeks after randomization, initiation of new ITP therapy, inability to taper or discontinue eltrombopag because of an inadequate platelet count, or death from any cause, whichever occurred first. The key secondary end point was a stable response at 6 months, defined by a platelet count of at least 50×10⁹ per liter in at least 75% of the measurements between weeks 19 and 25 without use of rescue therapy or new ITP therapy. Safety was assessed.

RESULTS:

A total of 152 patients underwent randomization: 50 to the 9-mg ianalumab group, 51 to the 3-mg ianalumab group, and 51 to the placebo group. The estimated probability of being free from treatment failure at 12 months was 54% (95% confidence interval [CI], 39 to 67) in the 9-mg group, 51% (95% CI, 36 to 64) in the 3-mg group, and 30% (95% CI, 18 to 43) in the placebo group. The time to treatment failure was significantly longer with ianalumab plus eltrombopag than with placebo plus eltrombopag; the estimated hazard ratio for treatment failure (ianalumab vs. placebo) was 0.55 (P = 0.04) in the 9-mg group and 0.58 (P = 0.045) in the 3-mg group. The percentage of patients with a stable response at 6 months was significantly higher in the 9-mg group than in the placebo group (62% vs. 39%; P = 0.045). The overall frequency of adverse events during the treatment period was generally similar in the three groups. The frequency of serious adverse events was 16% in the 9-mg group, 6% in the 3-mg group, and 4% in the placebo group.

CONCLUSIONS:

Ianalumab plus eltrombopag led to a longer time to treatment failure than placebo plus eltrombopag. (Funded by Novartis; VAYHIT2 ClinicalTrials.gov number, NCT05653219.).

01 Mar 2026·ANNALS OF THE RHEUMATIC DISEASES

B cell depletion and BAFF receptor blockade with ianalumab (VAY736) for the treatment of moderate-to-severe systemic lupus erythematosus: a phase 2 randomised, double-blind, placebo-controlled trial with subsequent open-label treatment

Article

Author: Tarr, Tunde ; Koolvisoot, Ajchara ; Ignatenko, Stanislav ; Leszczynski, Piotr ; Ciferská, Hana ; Rojkovich, Bernadette ; Kaneko, Yuko ; Lee, Shin-Seok ; Sips, Carole ; Zotkin, Eugeny ; López, Berta Paula Magallares ; Romanowska-Próchnicka, Katarzyna ; Kodera, Masanari ; Wojciechowski, Rafal ; Okada, Masato ; Hoi, Alberta ; Lie, Dai ; Kaneko, Hiroshi ; Avrameas, Alexandre ; Lau, Carol ; Cortés-Hernández, Josefina ; Narongroeknawin, Pongthorn ; Finzel, Stephanie ; Chen, Yi-Hsing ; Vishneva, Elena ; Shen, Nan ; Ghanshani, Swati Aashish ; Oliver, Stephen John ; Agmon-Levin, Nancy ; Sun, Lingyun ; Viallard, Jean-Francoise ; Cheng-Chung, Wei J ; Gordienko, Alexander ; Lan, Joung-Liang ; Mysler, Eduardo

OBJECTIVES:

B cell depletion or B cell activating factor (BAFF) blockade has shown benefits in systemic lupus erythematosus (SLE). We compared ianalumab, a monoclonal antibody targeting BAFF receptor (BAFF-R)-expressing B cells to lyse B cells and block BAFF-R, with placebo for SLE treatment combined with standard therapies.

METHODS:

Patients with active SLE were randomised (1:1) to monthly subcutaneous ianalumab 300 mg or placebo. The primary outcome was a composite of SLE Responder Index (SRI)-4 at week 28 in patients successfully achieving corticosteroid (CS) tapering criteria. Patients subsequently received open-label (OL) ianalumab until week 48, followed by exploratory assessments at week 52 and off-treatment to week 68. Safety monitoring continued until B cell recovery. This report describes interim analyses conducted on the week 68 dataset.

RESULTS:

Sixty-seven patients were randomised and received blinded treatments until week 28. The primary composite endpoint was more frequently achieved with ianalumab vs placebo: 15/34 (44.1%) vs 3/33 (9.1%), with responses sustained to week 52 and replicated by placebo transitioned to OL ianalumab: 15/33 (45.5%) and 13/32 (40.6%). Positive treatment effects were consistently observed across other lupus disease activity outcomes (SRI-6, Definition of Remission in SLE, Lupus Low Disease Activity State, flare reduction, and CS use) at week 28, with clinical benefits until weeks 52 and 68. Ianalumab was not associated with increased serious adverse events or serious infections. Nonserious local injection site reactions occurred more frequently with ianalumab.

CONCLUSIONS:

At week 28, reduced disease activity was observed in patients with SLE receiving ianalumab plus standard therapies compared with those receiving standard therapies alone, with sustained benefits with further treatment until 1 year, which was well tolerated.

News (Medical) associated with Ianalumab

08 Jun 2026

·allsci.com

RemeGen beats Novartis to punch with China approval for telitacicept in Sjögren’s disease

China’s NMPA has approved telitacicept for the treatment of adult patients with Sjögren’s disease — marking the first regulatory approval of any therapy specifically indicated for this condition anywhere in the world. The approval, granted to RemeGen Co., Ltd. (HKEX: 9995), represents the fifth NMPA-approved indication for telitacicept and positions the dual cytokine inhibitor as the only approved systemic disease-modifying option for a condition where multiple candidates have failed in late-stage development over the past decade, leaving physicians limited largely to symptomatic treatments. Telitacicept is a recombinant fusion protein that simultaneously neutralizes BLyS (BAFF) and APRIL, two cytokines critical to the survival and activation of B cells and plasma cells. By blocking both ligands, the molecule suppresses autoreactive B cell populations and reduces autoantibody production — pathological processes central to Sjögren’s disease. The approved dosing and administration schedule were not specified in the announcement, though the Phase III program evaluated 80 mg and 160 mg dose groups. The NMPA approval was supported by a nationwide, multicenter, randomized, double-blind, placebo-controlled Phase III trial evaluating telitacicept in patients with Sjögren’s disease. The primary endpoint was change from baseline in the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) score at Week 24. Both the 80 mg and 160 mg groups demonstrated statistically significant reductions in ESSDAI versus placebo, with efficacy sustained through Week 48. Telitacicept also demonstrated improvements in the EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI), capturing patient-reported symptom burden alongside objective disease activity measures. The dual BAFF/APRIL inhibition mechanism places telitacicept in a broader class of agents targeting B cell survival pathways in autoimmunity. Vertex Pharmaceuticals is advancing povetacicept, another TACI-Fc fusion protein with the same dual BAFF/APRIL inhibition mechanism, in multiple autoimmune indications — representing a direct mechanistic parallel, though in earlier global development for Sjögren’s disease specifically. Remegen’s telitacicept approval arrives ahead of potential regulatory filings for Novartis’s ianalumab, an anti-BAFF-R monoclonal antibody that depletes B cells via a complementary but distinct mechanis. Ianalumab recently generated positive Phase III data and has been widely viewed as one of the leading contenders in Sjögren’s disease. For RemeGen, the approval extends a pattern of multi-indication NMPA success, having previously secured approvals for telitacicept in systemic lupus erythematosus, rheumatoid arthritis, and generalized myasthenia gravis. Vor Bio (Nasdaq: VOR), which holds exclusive rights to develop and commercialize telitacicept outside of Greater China, is advancing global Phase III programs in generalized myasthenia gravis and Sjögren’s disease targeting potential approvals in the US, Europe, and Japan. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

Phase 3Drug ApprovalClinical Result

01 Jun 2026

·www.biospace.com

Novartis data at EULAR 2026 demonstrates momentum for broad immunology portfolio for complex, high unmet need diseases

New Cosentyx ® (secukinumab) data from REPLENISH, largest ever global Phase III trial in polymyalgia rheumatica, to be highlighted in oral session New ianalumab interim results from Sjögren’s Phase III extension study up to week 108 and Phase II data in systemic lupus erythematosus will be presented Basel, June 1, 2026 – Novartis will present new data from 31 abstracts across its industry-leading immunology portfolio at the European Alliance of Associations for Rheumatology (EULAR) Congress on June 3-6 in London, advancing scientific insight into high-burden autoimmune diseases. “Novartis is committed to shaping the future of immunology. From small molecules to biologics and CAR-T cell therapy, our pioneering science is focused on where we can have the greatest impact on patient outcomes,” said Angelika Jahreis, Global Head, Immunology Development, Novartis. “At EULAR, we will share compelling new data for Cosentyx, ianalumab and our CAR-T therapy rap-cel across diseases where there is high unmet need. These data demonstrate how Novartis innovation can have meaningful impact for people living with autoimmune diseases like polymyalgia rheumatica, Sjogren’s disease, systemic lupus erythematosus and systemic sclerosis.” Key abstracts accepted by EULAR include: Molecule/Disease Abstract Title Number/Presentation Details Cosentyx ® (secukinumab) Polymyalgia Rheumatica Secukinumab in polymyalgia rheumatica: Results of the phase 3 REPLENISH trial OP0116 Oral Presentation June 3, 4:30pm-4:40pm BST Secukinumab in patients with polymyalgia rheumatica: Subgroup analyses of Week 52 results of a Phase 3, multicentre, randomised, double-blind, placebo-controlled trial (REPLENISH) POS0019 Poster Tour Presentation June 3, 3:30pm-4:30pm BST Psoriatic Arthritis Impact of Early Biologic Use With Secukinumab on Radiographic Progression in Psoriatic Arthritis: A Pooled Analysis of the FUTURE 1 and FUTURE 5 Trials POS0474 Poster Tour Presentation June 3, 3:30pm-4:50pm BST Rap-cel (rapcabtagene autoleucel, YTB323) Systemic Sclerosis and Severe Refractory Idiopathic Inflammatory Myopathies Safety and Early Efficacy of Rapcabtagene Autoleucel, an Autologous CD19 Directed Chimeric Antigen Receptor T-Cell Therapy, in Severe Refractory Idiopathic Inflammatory Myopathies and Diffuse Cutaneous Systemic Sclerosis: Preliminary Analysis of the Open-Label AUTOGRAPH-IIM and –SSC studies OP077 Oral Abstract Presentation June 3, 4:40pm-4:50pm BST Systemic Lupus Erythematosus Clinical, Cellular Kinetics, Pharmacodynamics and Biomarker Data Up to 24 Months After Rapcabtagene Autoleucel (YTB323), a Rapidly Manufactured CD19 CAR-T Therapy, From an Open-Label, Phase 1/2 Study in Severe Refractory SLE POS0303 Poster Tour Presentation June 5, 4:00pm-5:00pm BST Ianalumab Sjögren's Disease Efficacy and Safety of the Ianalumab Global Phase 3 Studies (NEPTUNUS-1 and NEPTUNUS-2) and Their Extension Study in Patients With Sjögren's Disease OP0126 Oral Presentation June 3, 4:50pm-5:00pm BST Systemic Lupus Erythematosus Safety and Efficacy of Subcutaneous Ianalumab (VAY736) Post-B Cell Recovery in Patients with Systemic Lupus Erythematosus: End of Study Results from a Phase 2 Study OP0335 Oral Presentation June 5, 8:15am-8:25am BST About Novartis Immunology At Novartis, we’re advancing bold science with the goal of bringing relief and a renewed sense of hope to people living with autoimmune diseases. Building on our legacy of first-in-class innovation across rheumatology, dermatology and allergy, and a diverse industry-leading pipeline, we’re committed to shaping what’s next in Immunology. Product Information For full prescribing information, including approved indications and important safety information about marketed products, please visit . Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 300 million people worldwide. Reimagine medicine with us: Visit us at and connect with us on LinkedIn , Facebook , X/Twitter and Instagram . # # # Novartis Media Relations E-mail: media.relations@novartis.com Novartis Investor Relations Central investor relations line: +41 61 324 7944 E-mail: investor.relations@novartis.com

Phase 3Phase 2ImmunotherapyCell TherapyClinical Result

27 May 2026

·allsci.com

Jade Bio starts first human study for BAFF-R antibody JADE201 in rheumatoid arthritis

Jade Biosciences (Nasdaq: JBIO), a San Francisco-based clinical-stage biotechnology company, has dosed the first participant in a first-in-human Phase I clinical trial of JADE201, a half-life extended, afucosylated monoclonal antibody targeting the B cell activating factor receptor (BAFF-R). The Jade Biosciences Phase I trial is enrolling participants with rheumatoid arthritis (RA) in a randomized, placebo-controlled, single ascending dose design, with interim data expected in 2027. The trial will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics, with key biomarkers including BAFF-R occupancy, soluble BAFF levels, and B cell profiling. Jade said interim Phase I data in RA will inform indication prioritization across multiple autoimmune diseases supported by BAFF-R biology. BAFF-R is the primary receptor through which B cell activating factor (BAFF) delivers pro-survival signals to mature B cells, activating both classical and non-canonical NF-κB pathways and driving expression of anti-apoptotic proteins including Bcl-2. In autoimmune diseases, BAFF is chronically overexpressed, sustaining autoreactive B cells that would otherwise be eliminated through peripheral tolerance mechanisms. This overexpression has been documented across SLE, Sjögren’s syndrome, and RA, where elevated BAFF levels correlate with autoantibody production and disease activity. Current B cell-directed therapies address this biology only partially. Rituximab, the established anti-CD20 agent used in RA after failure of conventional and biologic disease-modifying therapies, depletes circulating B cells but does not reach tissue-resident populations effectively, and plasma cells — the long-lived autoantibody-secreting cells responsible for sustained pathology — do not express CD20 and are therefore spared. Belimumab, approved for SLE, neutralizes soluble BAFF but does not directly kill B cells, limiting the depth of depletion achievable. JAK inhibitors, while broadly immunosuppressive, carry FDA black box warnings for cardiovascular events, malignancy, and thrombosis that constrain their use in older or higher-risk patients. JADE201’s design attempts to address these limitations through two simultaneous mechanisms. As an anti-BAFF-R antibody, it blocks the survival signal that sustains autoreactive B cells. As an afucosylated antibody — meaning the fucose residue has been removed from the Fc region — it binds FcγRIIIa on NK cells and macrophages with substantially higher affinity, driving enhanced antibody-dependent cellular cytotoxicity and phagocytosis. Preclinical studies demonstrated dose-dependent BAFF-R occupancy and sustained B cell depletion in non-human primates. The half-life extension is intended to support infrequent subcutaneous dosing, a potential convenience advantage over rituximab’s intravenous regimen. The most clinically advanced asset sharing JADE201’s mechanism is ianalumab (VAY736), developed by Novartis. Ianalumab is also an afucosylated anti-BAFF-R monoclonal antibody with a dual mechanism of BAFF-R blockade and enhanced ADCC-mediated B cell depletion. It has progressed through multiple Phase III trials across Sjögren’s disease, immune thrombocytopenia (ITP), and SLE, with positive top-line results reported from both Phase III trials in Sjögren’s disease and a Phase III trial in ITP. Those readouts constitute the most direct clinical validation of the BAFF-R target in autoimmunity to date. JADE201 is positioned as a next-generation improvement over ianalumab, with the half-life extension as the primary engineering differentiator. Jade’s lead asset, JADE101, targets APRIL and is in Phase II development for IgA nephropathy, positioning the company across two nodes of the BAFF/APRIL signaling axis. The company’s pipeline, built on assets licensed from Paragon Therapeutics, reflects a focused strategy around B cell survival pathways in autoimmunity. Interim Phase I data in 2027 will be the first human evidence for JADE201’s pharmacokinetic profile and B cell depletion kinetics, and will be read against the clinical benchmark that ianalumab’s Phase III program has now established for the class. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

Phase 1Phase 3ImmunotherapyPhase 2Drug Approval

100 Deals associated with Ianalumab

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-	Ianalumab	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Immune System Diseases	NDA/BLA	Canada	Novartis Pharmaceuticals Canada, Inc.	01 May 2026
Sjogren's Syndrome	NDA/BLA	China	Beijing Novartis Pharma Co. Ltd.	06 Feb 2026
Sjogren's Syndrome	NDA/BLA	China	Novartis Pharma Schweiz AG	06 Feb 2026
Sjogren's Syndrome	NDA/BLA	China	Novartis Pharma Stein AG	06 Feb 2026
Systemic Lupus Erythematosus	Phase 3	Japan	Novartis Pharma Stein AG	02 Mar 2023
Systemic Lupus Erythematosus	Phase 3	Japan	Novartis Pharmaceuticals Corp.	02 Mar 2023
Systemic Lupus Erythematosus	Phase 3	Japan	China Novartis Institutes for BioMedical Research Co., Ltd.	02 Mar 2023
Systemic Lupus Erythematosus	Phase 3	Japan	Novartis Pharma AG	02 Mar 2023
Systemic Lupus Erythematosus	Phase 3	Brazil	China Novartis Institutes for BioMedical Research Co., Ltd.	02 Mar 2023
Systemic Lupus Erythematosus	Phase 3	Brazil	Novartis Pharma Stein AG	02 Mar 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03656562 (EULAR2026)	Phase 2	Systemic Lupus Erythematosus	67	Ianalumab 300 mg s.c.	nunuqdhyqq(ffpejuegyb) = oepunxcqvk hpcrdfehnj (zvqhnhrkwm ) View more	Positive	11 Jun 2026
				Placebo	nunuqdhyqq(ffpejuegyb) = shevesaaxn hpcrdfehnj (zvqhnhrkwm ) View more
NCT05124925 (EULAR2026)	Phase 2	Sjogren's Syndrome	21	Ianalumab 300 mg	wwiygowdps(yxbrumykvs) = The proportion of participants with an OMERACT disease staging score of 0 or 1 for their worst PGs or SMGs increased on treatment from 12% to 24% and 30% for PGs, and from 18% to 29% and 41% for SMGs at BL, Week 13 and Week 25, respectively. rcuixmrpkl (qslcicuoot ) View more	Positive	11 Jun 2026
NCT05885555 (VAYHIT3, EHA2026)	Phase 2	Purpura, Thrombocytopenic, Idiopathic	41	Ianalumab	sivwvmvdwg(vndnsxyfco) = htyhwymrgh ayppajgkgq (mhlcfchzji ) View more	Positive	12 May 2026
NCT05653219 (VAYHIT2, EHA2026)	Phase 3	Purpura, Thrombocytopenic, Idiopathic	152	Ianalumab 9 mg/kg plus eltrombopag	qddpmbqvyy(nmvevmlmim) = hltajuzvlr krfpcqwcmf (agkxshslkq ) View more	Positive	12 May 2026
				Ianalumab 3 mg/kg plus eltrombopag	qddpmbqvyy(nmvevmlmim) = uvumzxxmzv krfpcqwcmf (agkxshslkq ) View more
NCT05885555 (VAYHIT3, EHA2026)	Phase 2	Purpura, Thrombocytopenic, Idiopathic	41	Ianalumab 9 mg/kg	ejqsmowzck(fpuxykjrdu) = nlryskhhny yeiobtvqzw (wzyohmmfzs ) View more	Positive	12 May 2026
NCT05653219 (VAYHIT2, N Engl J Med \| Company_Website) Manual	Phase 3	Purpura, Thrombocytopenic, Idiopathic Second line	152	Ianalumab 9 mg + Eltrombopag	azzkbvtyrv(klcaxdsifb) = qxyzcqbpko esofrotnap (etpamseuvp, 39 - 67) View more	Positive	09 Dec 2025
				Ianalumab 3 mg + Eltrombopag	azzkbvtyrv(klcaxdsifb) = buoddquzqn esofrotnap (etpamseuvp, 36 - 64) View more
NCT05653219 (VAYHIT2, Pubmed \| N Engl J Med)	Phase 3	Purpura, Thrombocytopenic, Idiopathic Second line	152	Ianalumab 9 mg	lslzbnbmwx(rirljbjvkn) = dmbwniabiq rcbhqkbqqq (taohngawny ) View more	Positive	09 Dec 2025
				Ianalumab 3 mg	pehnncwfee(ybvnrrqikd) = jvxvugfqcr wzqufbshyf (rigdrecchm, 36 - 64) View more
NCT05653219 (VAYHIT2, ASH2025)	Phase 3	Purpura, Thrombocytopenic, Idiopathic	152	Ianalumab 9mg/kg + Eltrombopag	qvyqwgajeo(zjbxlgeoja) = xyzisxqkne fzslfzentl (rxrkyrgurw ) View more	Positive	06 Dec 2025
				Ianalumab 3mg/kg + Eltrombopag	qvyqwgajeo(zjbxlgeoja) = bthuwvrbxe fzslfzentl (rxrkyrgurw ) View more
NCT05124925 (ACR2025)	Phase 2	Sjogren's Syndrome	21	Ianalumab 300 mg	slrmnwennu(jmdsnndkqn) = ujvqhamktf mmauwibuvt (kkvdmszhri )	Positive	24 Oct 2025
NCT05349214 (NEPTUNUS-2, Company_Website) Manual	Phase 3	Sjogren's Syndrome	504	ianalumab 300 mg s.c. monthly	gblwwjrmdh(mmlgbrxkgn) = met primary endpoint in patients with Sjögren’s disease. znlgvaevtb (kdsyddilvm ) Met View more	Positive	11 Aug 2025
				ianalumab every 3 months

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