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: ACR/EULAR classification criteria 2016 PSjD; clinESSDAI ≥ 6; Anti-Ro/SS-A positive at central laboratory; Unstimulated residual salivary flow (≥ 0.01 mL/min)
Exclusion Criteria
- Secondary Sjögren's disease where another confirmed autoimmune rheumatic or systemic inflammatory condition (eg, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, and inflammatory bowel disease) is the primary diagnosis. - 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 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
Arizona Arthritis & Rheumatology Research, PLLC
Sun City, Arizona 85351
Sun City, Arizona 85351
Arizona Arthritis & Rheumatology Research, PLLC
Tucson, Arizona 85748
Tucson, Arizona 85748
Clinical Research of West Florida, Inc.
Clearwater, Florida 33765
Clearwater, Florida 33765
Finlay Medical Research Corp
Greenacres, Florida 33647
Greenacres, Florida 33647
Clinical Research of West Florida, Inc.
Tampa, Florida 33606
Tampa, Florida 33606
St. Luke's Clinic - Rheumatology
Boise, Idaho 83702
Boise, Idaho 83702
Chicago Clinical Research Institute
Chicago, Illinois 60607
Chicago, Illinois 60607
Arizona Arthritis & Rheumatology Research, PLLC
Willowbrook, Illinois 60527
Willowbrook, Illinois 60527
Accurate Clinical Research Inc.
Lake Charles, Louisiana 70605
Lake Charles, Louisiana 70605
Samaritan Health Services
Corvallis, Oregon 97330
Corvallis, Oregon 97330
East Penn Rheumatology Associates, P.C.
Bethlehem, Pennsylvania 18105
Bethlehem, Pennsylvania 18105
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
- NCT ID
- NCT06684847
- Status
- Recruiting
- Sponsor
- argenx