A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome
Purpose
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.
Condition
- Primary Sjogrens Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Double-blinded treatment period: Efgartigimod PH20 SC |
Participants receiving efgartigimod PH20 SC during the double-blinded treatment period |
|
|
Placebo Comparator Double-blinded treatment period: Placebo PH20 SC |
Participants receiving placebo PH20 SC during the double-blinded treatment period |
|
|
Experimental Open-label treatment period |
Participants receiving efgartigimod PH20 SC during the open-label treatment period |
|
Recruiting Locations
One of a Kind Clinical Research Center LLC
Scottsdale, Arizona 85258
Scottsdale, Arizona 85258
Arizona Arthritis & Rheumatology Research, PLLC
Sun City, Arizona 85351
Sun City, Arizona 85351
Arizona Arthritis & Rheumatology Research, PLLC
Tucson, Arizona 85748
Tucson, Arizona 85748
Providence Medical Foundation
Fullerton, California 92835
Fullerton, California 92835
Stanford University School of Medicine
Stanford, California 94305
Stanford, California 94305
University of Colorado
Aurora, Colorado 80045
Aurora, Colorado 80045
Clinical Research of West Florida, Inc.
Clearwater, Florida 33765
Clearwater, Florida 33765
Centre for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida 33309
Fort Lauderdale, Florida 33309
Finlay Medical Research Corp
Greenacres City, Florida 33647
Greenacres City, Florida 33647
University of Florida College of Medicine Jacksonville
Jacksonville, Florida 32256
Jacksonville, Florida 32256
Clinical Research of West Florida, Inc.
Tampa, Florida 33606
Tampa, Florida 33606
Conquest Research
Winter Park, Florida 32789
Winter Park, Florida 32789
Piedmont Healthcare, Inc.
Atlanta, Georgia 30318
Atlanta, Georgia 30318
St. Luke's Clinic - Rheumatology
Boise, Idaho 83702
Boise, Idaho 83702
Chicago Clinical Research Institute
Chicago, Illinois 60607
Chicago, Illinois 60607
Great Lakes Clinical Trials, LLC Ravenswood dba Flourish Research
Chicago, Illinois 60640
Chicago, Illinois 60640
Chicago Arthritis & Regenerative Medicine
Chicago, Illinois 60657
Chicago, Illinois 60657
Greater Chicago Specialty Physicians LLC
Orland Park, Illinois 60467
Orland Park, Illinois 60467
Arizona Arthritis & Rheumatology Research, PLLC
Willowbrook, Illinois 60527
Willowbrook, Illinois 60527
Lake Cumberland Rheumatology
New Albany, Indiana 47150
New Albany, Indiana 47150
University of Iowa Hospital and Clinics
Iowa City, Iowa 52242
Iowa City, Iowa 52242
Accurate Clinical Research Inc.
Lake Charles, Louisiana 70605
Lake Charles, Louisiana 70605
The Johns Hopkins Hospital
Baltimore, Maryland 21224
Baltimore, Maryland 21224
Arthritis and Rheumatism Associates
Rockville, Maryland 20850
Rockville, Maryland 20850
Washington University School of Medicine
St Louis, Missouri 63110
St Louis, Missouri 63110
Joseph S. and Diane H. Steinberg Ambulatory Care Center
Brooklyn, New York 11201
Brooklyn, New York 11201
Samaritan Health Services
Corvallis, Oregon 97330
Corvallis, Oregon 97330
East Penn Rheumatology Associates, P.C.
Bethlehem, Pennsylvania 18105
Bethlehem, Pennsylvania 18105
Rheumatic Disease Associates, Ltd.
Willow Grove, Pennsylvania 19090
Willow Grove, Pennsylvania 19090
Allen Arthritis
Allen, Texas 75013
Allen, Texas 75013
Accurate Clinical Management
Baytown, Texas 77521
Baytown, Texas 77521
Novel Research LLC
Bellaire, Texas 77401
Bellaire, Texas 77401
Precision Comprehensive Clinical Research Solution
Colleyville, Texas 76034-5913
Colleyville, Texas 76034-5913
Southwest Family Medicine Associates
Dallas, Texas 75235
Dallas, Texas 75235
Arizona Arthritis & Rheumatology Research, PLLC
Fort Worth, Texas 76109
Fort Worth, Texas 76109
Accurate Clinical Research, Inc.
Houston, Texas 77089
Houston, Texas 77089
North Houston Arthritis Center
Houston, Texas 77090
Houston, Texas 77090
Arizona Arthritis & Rheumatology Research, PLLC
Irving, Texas 75039
Irving, Texas 75039
R and H Clinical Research
Katy, Texas 77450
Katy, Texas 77450
Simcare Medical Research LLC
Sugar Land, Texas 77478
Sugar Land, Texas 77478
Velocity Clinical Research Waco
Waco, Texas 76712
Waco, Texas 76712
More Details
- Status
- Recruiting
- Sponsor
- argenx