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NCT06684847 · ClinicalTrials.gov registry record · Phase 3
A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome
A Phase 3 study of Primary Sjogren's Disease, sponsored by argenx.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 580
- Enrollment target
- 20
- Study locations
NCT06684847: Recruiting Phase 3 study of Primary Sjogren's Disease, sponsored by argenx.
NCT06684847 is a Phase 3 study of Primary Sjogren's Disease that is actively recruiting participants, run by argenx. The registered enrollment target is 580 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06684847, a Phase 3 study of Primary Sjogren's Disease, is actively recruiting participants, sponsored by argenx.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 580 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The ESSDAI was designed to measure systemic disease activity in patients with PSjD and consists of 12 domains. The score varies between 0 (no disease activity) and 123 (max disease activity). The clinESSDAI includes all ESSDAI domains except the biological domain.
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 |
What NCT06684847 shows while recruiting
NCT06684847 is an interventional study that assigns participants to a tested intervention. The registered 580 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower).
The record links to 1 condition, with Primary Sjogren's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo PH20 SC is the first listed.
NCT06684847 names 20 study sites across 7 states, led by Florida, Illinois, Arizona.
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 Sjogren's Disease.
What interventions are being tested in trial NCT06684847?
The interventions under investigation include: Placebo PH20 SC (OTHER), Efgartigimod PH20 SC (BIOLOGICAL).
Who is sponsoring clinical trial NCT06684847?
This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Primary Sjogren's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06684847's enrollment target sits among peer trials
580 656th of 2000 higher than 1,343 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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