A Study of the Efficacy and Safety of Efgartigimod in Patients with Primary Sjögren's Syndrome (pSjD) (UNITY)

Phase 3

Recruiting

• Conditions: Primary Sjögren’s Disease

• Registration Number: 2024-516609-22-00
• Lead Sponsor: Argenx

Brief Summary

To evaluate the efficacy of efgartigimod PH20 SC compared with placebo PH20 SC on systemic disease activity as measured by clinESSDAI.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-10
• Study First Submitted QC: 2024-11-10
• Study First Posted: 2024-11-12
• Study Start: 2025-01-15
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-19
• Last Update Posted: 2025-09-22
• Primary Completion: 2027-07
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 208

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in clinESSDAI score at week 48		Change from baseline in clinESSDAI score at week 48

Secondary Outcome Measures

Name	Time	Method
Change from baseline in ESSDAI score at week 48		Change from baseline in ESSDAI score at week 48
Proportion of participants with low disease activity (clinESSDAI < 5) at week 48		Proportion of participants with low disease activity (clinESSDAI < 5) at week 48
Proportion of responders on STAR (defined as ≥ 5 points) at week 48		Proportion of responders on STAR (defined as ≥ 5 points) at week 48
Change from baseline in DiSSA joint pain item at week 48		Change from baseline in DiSSA joint pain item at week 48
Change from baseline in DiSSA total score at week 48		Change from baseline in DiSSA total score at week 48
Change from baseline in DiSSA sicca domain at week 48		Change from baseline in DiSSA sicca domain at week 48
Proportion of participants with MCII (minimal clinically important improvement) in ESSDAI (defined as improvement of ≥ 3 points) at week 48		Proportion of participants with MCII (minimal clinically important improvement) in ESSDAI (defined as improvement of ≥ 3 points) at week 48
Change from baseline in clinESSDAI score at week 24		Change from baseline in clinESSDAI score at week 24

Trial Locations

Locations (212)

One of a Kind Clinical Research Center LLC; 🇺🇸 Scottsdale, Arizona, United States

Arizona Arthritis & Rheumatology Research, PLLC; 🇺🇸 Irving, Texas, United States

Providence Medical Foundation; 🇺🇸 Fullerton, California, United States

Clinical Research of West Florida, Inc.; 🇺🇸 Tampa, Florida, United States

Centre for Rheumatology, Immunology and Arthritis; 🇺🇸 Fort Lauderdale, Florida, United States

Finlay Medical Research Corp; 🇺🇸 Greenacres City, Florida, United States

Conquest Research; 🇺🇸 Winter Park, Florida, United States

Piedmont Healthcare, Inc.; 🇺🇸 Atlanta, Georgia, United States

St. Luke's Clinic - Rheumatology; 🇺🇸 Boise, Idaho, United States

Chicago Clinical Research Institute; 🇺🇸 Chicago, Illinois, United States

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