A randomized, double-blind, placebo controlled, 2-armmulticenter phase 3 study to assess the efficacy and safetyof ianalumab in patients with active Sjögren’s syndrome(NEPTUNUS-1)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511069-12-00

Acronym

CVAY736A2301

Enrollment

128

Registered

2024-07-08

Start date

2022-07-28

Completion date

Unknown

Last updated

2025-09-10

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.

Detailed description

ESSDAI response at Week 48, Low systemic disease activity (ESSDAI < 5), ESSPRI response, changes from baseline in sSF, changes from baseline in PhGA, changes from baseline in PaGA, changes from baseline in FACIT-F, SSSD response at Week 48, ESSDAI response at Week 24

Interventions

DRUG-

DRUGVAY736

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.	—

Secondary

Measure	Time frame
ESSDAI response at Week 48, Low systemic disease activity (ESSDAI < 5), ESSPRI response, changes from baseline in sSF, changes from baseline in PhGA, changes from baseline in PaGA, changes from baseline in FACIT-F, SSSD response at Week 48, ESSDAI response at Week 24	—

Countries

Austria, Belgium, Czechia, France, Germany, Lithuania, Poland, Portugal, Spain

Outcome results

None listed

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