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NCT05350072: NEPTUNUS-1
Two-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome
Phase 3 trial testing VAY736 in Sjogren Syndrome in 275 participants. Participants enrolled and being followed up; not accepting new ones.
7 May 2025
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 275 |
| Start date | 28 July 2022 |
| Primary completion | 7 May 2025 |
| Estimated completion | 2 June 2026 |
| Sites | 78 locations across Brazil, Czechia, Poland, Belgium, Portugal, Turkey (Türkiye), Mexico, Austria |
Drugs / interventions tested
- VAY736 — full drug profile →
- Placebo
Conditions studied
- Sjogren Syndrome — all drugs for Sjogren Syndrome →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
Adults 18 to 100, any sex, with Sjogren Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A randomized, double-blind, placebo controlled, 2-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-1)
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Emerging treatment for Sjögren's disease: a review of recent phase II and III trials.
Fox RI, Fox CM, McCoy SS. · · 2023 · cited 9× · PMID 37127914 · DOI 10.1080/14728214.2023.2209720 -
The role of cytokines from salivary gland epithelial cells in the immunopathology of Sjögren's syndrome.
Dong Y, Wang T, Wu H. · · 2024 · cited 6× · PMID 39346911 · DOI 10.3389/fimmu.2024.1443455 -
The role of B cell-activating factor system in autoimmune diseases: mechanisms, disease implications, and therapeutic advances.
Li L, Shen S, Shao S, Dang E, et al · · 2025 · cited 4× · PMID 40547016 · DOI 10.3389/fimmu.2025.1538555 -
Antibodies to watch in 2026.
Crescioli S, Kaplon H, Chenoweth A, Hsu YS, et al · · 2026 · PMID 41560619 · DOI 10.1080/19420862.2026.2614669
Verify or expand the search:
- PubMed search for NCT05350072
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of VAY736
Trials testing the same drug.
- NCT05349214 — Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome · Phase 3 · active not recruiting
- NCT04903197 — Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lympho · Phase 1 · terminated
- NCT03827798 — Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 2 · active not recruiting
- NCT03656562 — Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients · Phase 2 · completed
- NCT03400176 — VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib · Phase 1 · terminated
Other recruiting trials for Sjogren Syndrome
Currently open trials in the same condition.
- NCT07153276 — TREATMENT OF VAGINAL DRYNESS IN SJÖGREN'S DISEASE WITH CO2-LASER VERSUS TOPICAL PROMESTRIENE · Phase 4 · recruiting
- NCT06828042 — Safety and Efficacy of Universal CD19-targeting CAR-γδT Cells in Refractory Autoimmune Diseases · Phase 1, PHASE2 · recruiting
- NCT06794008 — BCMA-CD19 CAR-T Therapy for Refractory Autoimmune Diseases · Phase 2 · recruiting
- NCT06931041 — Comparing Efficacy of Autologous Serum Eye Drops With and Without Insulin in Autoimmune Dry Eye: A Randomized Clinical T · Phase 3 · active not recruiting
- NCT05349214 — Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome · Phase 3 · active not recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
- NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
- NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
- NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
- NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
- NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05350072 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
- Last refreshed: 11 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05350072.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing