A randomized, double-blind 2-arm NEPTUNUS extension study to assess the long-term safety and efficacy of ianalumab in patients with Sjögren’s syndrome

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502966-26-01

Acronym

CVAY736A2301E1

Enrollment

271

Registered

2023-10-09

Start date

2023-10-27

Completion date

Unknown

Last updated

2026-01-16

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

Incidence of treatment-emergent AEs (TEAEs)/SAEs

Detailed description

ESSDAI change from baseline, Proportion of participants achieving ≥1 point reduction from baseline or ≥15% reduction from baseline in ESSPRI score over time up to Week 204, Proportion of participants achieving meaningful improvement in the SSSD score over time up to Week 204, Ianalumab serum concentrations collected pre-dose (i.e., Ctrough) at Week 48 (from core studies) and Week 64, Ianalumab serum concentrations during treatment (e.g., Ctrough) and follow-up after last dose, B-cell count measurement

Interventions

DRUGENTECAVIR

DRUGPlacebo to VAY736 300 mg/2 mL Solution for injection in pre-filled pen

DRUGVAY736

DRUGLAMIVUDINE

DRUG-

DRUGTENOFOVIR ALAFENAMIDE

DRUGPlacebo to VAY736 300 mg/2 mL Solution for injection in pre-filled syringe

DRUGTENOFOVIR DISOPROXIL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of treatment-emergent AEs (TEAEs)/SAEs	—

Secondary

Measure	Time frame
ESSDAI change from baseline, Proportion of participants achieving ≥1 point reduction from baseline or ≥15% reduction from baseline in ESSPRI score over time up to Week 204, Proportion of participants achieving meaningful improvement in the SSSD score over time up to Week 204, Ianalumab serum concentrations collected pre-dose (i.e., Ctrough) at Week 48 (from core studies) and Week 64, Ianalumab serum concentrations during treatment (e.g., Ctrough) and follow-up after last dose, B-cell count measurement	—

Measure

Time frame

—

Countries

Austria, Belgium, Bulgaria, Czechia, France, Germany, Greece, Hungary, Italy, Lithuania, Poland, Portugal, Romania, Slovakia, Spain, Sweden

Outcome results

None listed

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