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A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome
NCT06684847 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- OTHER Placebo PH20 SC
- BIOLOGICAL Efgartigimod PH20 SC
Study Locations (20)
Florida
- Clinical Research of West Florida, Inc. — Clearwater
- Centre for Rheumatology, Immunology and Arthritis — Fort Lauderdale
- Finlay Medical Research Corp — Greenacres City
- University of Florida College of Medicine Jacksonville — Jacksonville
- Life Clinical Trials — Margate
- Clinical Research of West Florida, Inc. — Tampa
- Conquest Research — Winter Park
Illinois
- Chicago Clinical Research Institute — Chicago
- Great Lakes Clinical Trials, LLC Ravenswood dba Flourish Research — Chicago
- Chicago Arthritis & Regenerative Medicine — Chicago
- Greater Chicago Specialty Physicians LLC — Orland Park
- Arizona Arthritis & Rheumatology Research, PLLC — Willowbrook
Arizona
- One of a Kind Clinical Research Center LLC — Scottsdale
- Arizona Arthritis & Rheumatology Research, PLLC — Sun City
- Arizona Arthritis & Rheumatology Research, PLLC — Tucson
California
- Providence Medical Foundation — Fullerton
- Stanford University School of Medicine — Stanford
Colorado
- University of Colorado — Aurora
Georgia
- Piedmont Healthcare, Inc. — Atlanta
Idaho
- St. Luke's Clinic - Rheumatology — Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 580 participants |
| Start Date | 2025-01-15 |
| Est. Completion | 2028-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06684847
The ClinicalTrials.gov registry entry for NCT06684847 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 580 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is argenx, which has 96 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Primary Sjogrens Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo PH20 SC is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06684847 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, Illinois, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06684847 about?
NCT06684847 is a clinical study titled "A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome". 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 f...
What is the current status of trial NCT06684847?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 580 participants. The study started on 2025-01-15. Estimated completion is 2028-07.
What conditions does trial NCT06684847 study?
This clinical trial studies the following conditions: Primary Sjogrens Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06684847?
The interventions under investigation include: Placebo PH20 SC (OTHER), Efgartigimod PH20 SC (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06684847?
This trial is sponsored by argenx, which has 96 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06684847 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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