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Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06684847

Public ClinicalTrials.gov record NCT06684847. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 5:25 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3 Randomized, Double-Blinded, Placebo-Controlled Multicenter Trial With Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 Subcutaneous Administered by Prefilled Syringe in Adult Patients With Primary Sjögren's Disease

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06684847
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
argenx
Industry
Enrollment
631 participants

Conditions and interventions

Interventions

Biological · Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 15, 2025 (Actual)
Primary completion
Jul 2027 (Estimated)
Completion
Jul 2028 (Estimated)
Last update posted
Apr 16, 2026

2025 – 2028

United States locations

U.S. sites
42
U.S. states
16
U.S. cities
39
Facility City State ZIP Site status
One of a Kind Clinical Research Center LLC Scottsdale Arizona 85258 —
Arizona Arthritis & Rheumatology Research, PLLC Sun City Arizona 85351 —
Arizona Arthritis & Rheumatology Research, PLLC Tucson Arizona 85748 —
Providence Medical Foundation Fullerton California 92835 —
Stanford University School of Medicine Stanford California 94305 —
University of Colorado Aurora Colorado 80045 —
Clinical Research of West Florida, Inc. Clearwater Florida 33765 —
Centre for Rheumatology, Immunology and Arthritis Fort Lauderdale Florida 33309 —
Finlay Medical Research Corp Greenacres City Florida 33647 —
University of Florida College of Medicine Jacksonville Jacksonville Florida 32256 —
Life Clinical Trials Margate Florida 33063 —
Clinical Research of West Florida, Inc. Tampa Florida 33606 —
Conquest Research Winter Park Florida 32789 —
Piedmont Healthcare, Inc. Atlanta Georgia 30318 —
St. Luke's Clinic - Rheumatology Boise Idaho 83702 —
Chicago Clinical Research Institute Chicago Illinois 60607 —
Great Lakes Clinical Trials, LLC Ravenswood dba Flourish Research Chicago Illinois 60640 —
Chicago Arthritis & Regenerative Medicine Chicago Illinois 60657 —
Greater Chicago Specialty Physicians LLC Orland Park Illinois 60467 —
Arizona Arthritis & Rheumatology Research, PLLC Willowbrook Illinois 60527 —
Lake Cumberland Rheumatology New Albany Indiana 47150 —
University of Iowa Hospital and Clinics Iowa City Iowa 52242 —
Accurate Clinical Research Inc. Lake Charles Louisiana 70605 —
The Johns Hopkins Hospital Baltimore Maryland 21224 —
Arthritis and Rheumatism Associates Rockville Maryland 20850 —
Washington University School of Medicine St Louis Missouri 63110 —
Joseph S. and Diane H. Steinberg Ambulatory Care Center Brooklyn New York 11201 —
Samaritan Health Services Corvallis Oregon 97330 —
East Penn Rheumatology Associates, P.C. Bethlehem Pennsylvania 18105 —
Rheumatic Disease Associates, Ltd. Willow Grove Pennsylvania 19090 —
Allen Arthritis Allen Texas 75013 —
Accurate Clinical Management Baytown Texas 77521 —
Novel Research LLC Bellaire Texas 77401 —
Precision Comprehensive Clinical Research Solution Colleyville Texas 76034-5913 —
Southwest Family Medicine Associates Dallas Texas 75235 —
Arizona Arthritis & Rheumatology Research, PLLC Fort Worth Texas 76109 —
Accurate Clinical Research, Inc. Houston Texas 77089 —
North Houston Arthritis Center Houston Texas 77090 —
Arizona Arthritis & Rheumatology Research, PLLC Irving Texas 75039 —
R and H Clinical Research Katy Texas 77450 —
Simcare Medical Research LLC Sugar Land Texas 77478 —
Velocity Clinical Research Waco Waco Texas 76712 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 261 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06684847, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 16, 2026 · Synced Oct 21, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06684847 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →