A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)

Sponsor
argenx
Study ID
NCT05817669
Phase
PHASE2
Status
Completed

Conditions

  • Primary Sjögren's Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Efgartigimod — BIOLOGICAL
    Patients receiving efgartigimod infusions
  • Placebo — BIOLOGICAL
    Patients receiving placebo infusions

Study Details

The purpose of this study is to assess the efficacy and safety of human FcRn blocking therapy with efgartigimod compared to placebo, in participants with pSS.

Key Dates

Start date
Apr 4, 2023
Status verified
Jun 2025
Primary completion
Jan 29, 2024
Completion
Feb 12, 2024

Study Design

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

Arms

  • Experimental: Efgartigimod IV arm
    patients receiving infusions of Efgartigimod IV
  • Placebo Comparator: Placebo arm
    patients receiving infusions of placebo IV

Primary Outcome Measure

Percentage of Participants Meeting Overall CRESS Response of at Least 3 of 5 Items at Week 24 [ Time Frame: Week 24 ]

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