Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03574545
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • ianalumab — BIOLOGICAL
    Human monoclonal antibody (mAb) of type IgG1/κ binding to B-cell activating-receptor (BAFF-R)

Study Details

This study will assess the safety and pharmacokinetic comparability of two VAY736 drug products in patients with rheumatoid arthritis.

Key Dates

Start date
Dec 19, 2018
Status verified
Nov 2025
Primary completion
Jul 18, 2024
Completion
Jul 18, 2024

Study Design

Enrollment
48 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Reference VAY736 Drug Product
    Powder for solution for injection / infusion
  • Experimental: Test VAY736 Drug Product
    Solution for injection

Primary Outcome Measure

Safety and tolerability as measured by the number of patients with adverse events [ Time Frame: Week 0 - 112 ]

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