Biopsy Based Study to Understand Mechanism of Action of Ianalumab in Salivary Glands and Explore Relationships With Clinical Assessments.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05124925
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Ianalumab — BIOLOGICAL
    Ianalumab VAY736 150mg/1ml Solution for injection

Study Details

This study aims at elucidating the mechanism of action of ianalumab in salivary glands and explore relationships with clinical assessments

Key Dates

Start date
Jul 27, 2022
Status verified
Jan 2026
Primary completion
Jun 26, 2024
Completion
Jan 5, 2026

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    Ianalumab 300 mg subcutaneous monthly

Primary Outcome Measure

Change in logarithm of salivary gland B/B+T cell ratio [ Time Frame: Week 25 ]

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