🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT06684847
Active, not recruiting Phase 3

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

NCT06684847 · tracked via the Priya Life Science UK tracker
Sponsor
argenx
Phase
Phase 3
Started
2025-01-15
Last updated
2026-04-16

Condition(s) studied

Primary Sjogrens Disease

Investigational drug(s) / intervention(s)

Efgartigimod PH20 SCPlacebo PH20 SC

Efgartigimod PH20 SC: subcutaneous efgartigimod PH20 SC given by prefilled syringe

Placebo PH20 SC: subcutaneous placebo PH20 SC given by prefilled syringe

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF. * Meets the following criteria at screening: fulfilled ACR/EULAR classification criteria 2016 PSjD criteria before screening; clinESSDAI ≥ 6 at screening; Anti-Ro/SS-A positive at central laboratory; Unstimulated residual salivary flow (≥ 0.01 mL/min) Exclusion Criteria: * Secondary (also referred to as associated) Sjögren's disease, defined as overlap with another autoimmune rheumatic or systemic inflammatory condition (eg, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, or idiopathic inflammatory myopathy * Active fibromyalgia which is not adequately controlled in the judgment of the investigator, or participant is receiving fibromyalgia treatment that has not been stable treatment for at least 12 weeks before screening. * Any severe systemic pSjD manifestation that is not adequately controlled at screening or baseline that may put the participant at undue risk based on the investigator's opinion. * Use of cyclophosphamide ≤ 24 weeks prior to screening * Anti-CD20 or anti-CD19 antibody received \< 6 months before screening

Primary outcome measure(s)

Trial sites (303)

FacilityCityRegionStatus
One of a Kind Clinical Research Center LLC Scottsdale Arizona
Arizona Arthritis & Rheumatology Research, PLLC Sun City Arizona
Arizona Arthritis & Rheumatology Research, PLLC Tucson Arizona
Providence Medical Foundation Fullerton California
Stanford University School of Medicine Stanford California
University of Colorado Aurora Colorado
Clinical Research of West Florida, Inc. Clearwater Florida
Centre for Rheumatology, Immunology and Arthritis Fort Lauderdale Florida
Finlay Medical Research Corp Greenacres City Florida
University of Florida College of Medicine Jacksonville Jacksonville Florida
Life Clinical Trials Margate Florida
Clinical Research of West Florida, Inc. Tampa Florida
Conquest Research Winter Park Florida
Piedmont Healthcare, Inc. Atlanta Georgia
St. Luke's Clinic - Rheumatology Boise Idaho
Chicago Clinical Research Institute Chicago Illinois
Great Lakes Clinical Trials, LLC Ravenswood dba Flourish Research Chicago Illinois
Chicago Arthritis & Regenerative Medicine Chicago Illinois
Greater Chicago Specialty Physicians LLC Orland Park Illinois
Arizona Arthritis & Rheumatology Research, PLLC Willowbrook Illinois
Lake Cumberland Rheumatology New Albany Indiana
University of Iowa Hospital and Clinics Iowa City Iowa
Accurate Clinical Research Inc. Lake Charles Louisiana
The Johns Hopkins Hospital Baltimore Maryland
Arthritis and Rheumatism Associates Rockville Maryland
Washington University School of Medicine St Louis Missouri
Joseph S. and Diane H. Steinberg Ambulatory Care Center Brooklyn New York
Samaritan Health Services Corvallis Oregon
East Penn Rheumatology Associates, P.C. Bethlehem Pennsylvania
Rheumatic Disease Associates, Ltd. Willow Grove Pennsylvania
Allen Arthritis Allen Texas
Accurate Clinical Management Baytown Texas
Novel Research LLC Bellaire Texas
Precision Comprehensive Clinical Research Solution Colleyville Texas
Southwest Family Medicine Associates Dallas Texas
Arizona Arthritis & Rheumatology Research, PLLC Fort Worth Texas
Accurate Clinical Research, Inc. Houston Texas
North Houston Arthritis Center Houston Texas
Arizona Arthritis & Rheumatology Research, PLLC Irving Texas
R and H Clinical Research Katy Texas

+ 263 more sites — see the full list on the official registry below.

More argenx trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06684847 on ClinicalTrials.gov ↗ ← All trials in the UK