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A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome

NCT06684847 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 631

Last updated 2026-04-16

No results posted yet for this study

Summary

The main purpose of the proposed study is to evaluate the efficacy of efgartigimod PH20 SC in patients with moderate-to-severe Primary Sjögren's Disease (pSjD). The study consists of a double-blinded placebo-controlled treatment period and an open-label treatment period. The maximum study duration for participants in both study parts is approximately 105 weeks.

Conditions

  • Primary Sjogrens Disease

Interventions

BIOLOGICAL

Efgartigimod PH20 SC

subcutaneous efgartigimod PH20 SC given by prefilled syringe

OTHER

Placebo PH20 SC

subcutaneous placebo PH20 SC given by prefilled syringe

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-15
Primary Completion
2027-07-31
Completion
2028-07-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Chile
  • China
  • Colombia
  • Estonia
  • France
  • Georgia
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Japan
  • Jordan
  • Lebanon
  • Lithuania
  • Mexico
  • Netherlands
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Saudi Arabia
  • Serbia
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Tunisia
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

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 NCT06684847 on ClinicalTrials.gov