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

NCT05817669 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-07-18

Study results available
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Summary

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.

Conditions

  • Primary Sjögren's Syndrome

Interventions

BIOLOGICAL

Efgartigimod

Patients receiving efgartigimod infusions

BIOLOGICAL

Placebo

Patients receiving placebo infusions

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • argenx

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-04
Primary Completion
2024-01-29
Completion
2024-02-12

Countries

  • Belgium
  • Hungary
  • Netherlands
  • Poland

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05817669 on ClinicalTrials.gov