Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren's Disease With High Symptom Burden

Conditions

• Sjögren´s Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• VAY736 — DRUG
  VAY736 once monthly solution for injection for subcutaneous use.
• Placebo — DRUG
  Placebo once monthly solution for injection for subcutaneous use.

Study Details

The purpose of this study is to demonstrate the efficacy and safety of ianalumab (VAY736) 300 mg administered subcutaneously (s.c.) monthly for 52 weeks in adult participants with Sjögren's disease who have high symptom burden.

Key Dates

First listed

Jun 2, 2026

Start date

Jul 16, 2026

Status verified

Aug 2026

Primary completion

Aug 14, 2029

Completion

Aug 13, 2033

Study Design

Enrollment

570 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: VAY736 - 300 mg
  VAY736 once monthly solution for injection for subcutaneous use.
• Placebo Comparator: Placebo
  Placebo once monthly solution for injection for subcutaneous use.

Primary Outcome Measure

Change from baseline in SSSD oral dryness score [ Time Frame: Baseline to Week 52 ]

Central Contacts

• Novartis Pharmaceuticals
  1-888-669-6682
  [email protected]
• Novartis Pharmaceuticals
  +41613241111

Locations (12)

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