A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjögren’s syndrome (NEPTUNUS-2)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511068-10-00

Acronym

CVAY736A2302

Enrollment

150

Registered

2024-07-09

Start date

2022-08-04

Completion date

Unknown

Last updated

2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sjögren’s Syndrome

Brief summary

The primary efficacy endpoint is change from baseline in ESSDAI score at week 48

Detailed description

ESSDAI response at Week 48, Low systemic disease activity (ESSDAI < 5), ESSPRI response at Week 48, Changes from baseline in sSF at Week 48, Changes from baseline in PhGA at Week 48, Changes from baseline in PaGA at Week 48, Changes from baseline in FACIT-F at Week 48, SSSD response at Week 48, Change from baseline in ESSPRI score at Week 48

Interventions

DRUGVAY736

DRUG-

DRUGPlacebo to VAY736 150 mg/1 mL Solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint is change from baseline in ESSDAI score at week 48	—

Secondary

Measure	Time frame
ESSDAI response at Week 48, Low systemic disease activity (ESSDAI < 5), ESSPRI response at Week 48, Changes from baseline in sSF at Week 48, Changes from baseline in PhGA at Week 48, Changes from baseline in PaGA at Week 48, Changes from baseline in FACIT-F at Week 48, SSSD response at Week 48, Change from baseline in ESSPRI score at Week 48	—

Countries

Bulgaria, France, Germany, Greece, Hungary, Italy, Poland, Romania, Slovakia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026