A Randomized, Double-blind 2-arm, Followed by an Open-label 1-arm, NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.

Conditions

• Sjogrens Syndrome

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Ianalumab (VAY736) — DRUG
  Ianalumab 300 mg / 2 mL, PFS or AI, monthly or every 3 months, solution for injection for subcutaneous use
• Placebo — OTHER
  Placebo 0 mg/2 mL PFS or AI, once monthly between doses of Ianalumab 3 monthly , solution for injection for subcutaneous Use

Study Details

The purpose of this study is to measure the long-term safety and tolerability of ianalumab in participants with Sjögren's syndrome who have previously completed treatment from one of two NEPTUNUS 1 year core studies (CVAY736A2301 \[NCT05350072\] or CVAY736A2302 \[NCT05349214\]).

Key Dates

Start date

Oct 27, 2023

Status verified

Apr 2026

Primary completion

Apr 22, 2033

Completion

Apr 22, 2033

Study Design

Enrollment

612 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ianalumab Monthly
  Ianalumab 300 mg s.c. monthly during initial double-blind treatment period. Open-label treatment and receive ianalumab 300 mg monthly.
• Experimental: Ianalumab 3 Monthly
  Ianalumab 300 mg s.c. every three months and placebo once monthly between doses during initial double-blind treatment period. Open-label treatment and receive ianalumab 300 mg monthly.

Primary Outcome Measure

Number of Treatment-emergent AEs (TEAEs)/SAEs [ Time Frame: Week 52 to Week 464 ]

Locations (32)

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