A Study of the Efficacy and Safety of Efgartigimod in Patients with Primary Sjögren's Syndrome
- Conditions
- Primary Sjogrens Disease
- Interventions
- Biological: Efgartigimod PH20 SCOther: Placebo PH20 SC
- Registration Number
- NCT06684847
- Lead Sponsor
- argenx
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 580
- 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)
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Double-blinded treatment period: Efgartigimod PH20 SC Efgartigimod PH20 SC Participants receiving efgartigimod PH20 SC during the double-blinded treatment period Double-blinded treatment period: Placebo PH20 SC Placebo PH20 SC Participants receiving placebo PH20 SC during the double-blinded treatment period Open-label treatment period Efgartigimod PH20 SC Participants receiving efgartigimod PH20 SC during the open-label treatment period
- Primary Outcome Measures
Name Time Method Change from baseline in clinESSDAI score at week 48 Up to 48 weeks The ESSDAI was designed to measure systemic disease activity in patients with PSjD and consists of 12 domains. The score varies between 0 (no disease activity) and 123 (max disease activity). The clinESSDAI includes all ESSDAI domains except the biological domain.
- Secondary Outcome Measures
Name Time Method Change from baseline in DiSSA total score at week 48 Up to 48 weeks Diary of Sjögren's Symptoms Assessment (DiSSA) is a patient-reported symptom severity diary that includes 6 PSjD symptoms. Each symptom is rated from 0 (no symptoms) to 10 (worst).
Change from baseline in DiSSA sicca domain at week 48 Up to 48 weeks Diary of Sjögren's Symptoms Assessment (DiSSA) is a patient-reported symptom severity diary that includes 6 PSjD symptoms. Each symptom is rated from 0 (no symptoms) to 10 (worst).
Change from baseline in ESSDAI score at week 48 Up to 48 weeks The ESSDAI was designed to measure systemic disease activity in patients with PSjD and consists of 12 domains. The score varies between 0 (no disease activity) and 123 (max disease activity).
Proportion of participants with low disease activity (clinESSDAI < 5) at week 48 Up to 48 weeks The ESSDAI was designed to measure systemic disease activity in patients with PSjD and consists of 12 domains. The score varies between 0 (no disease activity) and 123 (max disease activity). The clinESSDAI includes all ESSDAI domains except the biological domain.
Proportion of responders on STAR (defined as ≥ 5 points) at week 48 Up to 48 weeks Sjögren's Tool for Assessing Response ( STAR) has been developed as a composite score to assess the efficacy of treatments for PSjD in 5 domains. Patients are classified as STAR responders when they reach ≥ 5 of 9 points.
Change from baseline in DiSSA joint pain item at week 48 Up to 48 weeks Diary of Sjögren's Symptoms Assessment (DiSSA) is a patient-reported symptom severity diary that includes 6 PSjD symptoms. Each symptom is rated from 0 (no symptoms) to 10 (worst).
Proportion of participants with MCII (minimal clinically important improvement) in ESSDAI (defined as improvement of ≥ 3 points) at week 48 Up to 48 weeks The ESSDAI was designed to measure systemic disease activity in patients with PSjD and consists of 12 domains. The score varies between 0 (no disease activity) and 123 (max disease activity).
Change from baseline in clinESSDAI score at week 24 Up to 24 weeks The ESSDAI was designed to measure systemic disease activity in patients with PSjD and consists of 12 domains. The score varies between 0 (no disease activity) and 123 (max disease activity). The clinESSDAI includes all ESSDAI domains except the biological domain.
Trial Locations
- Locations (5)
Clinical Research of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
Chicago Clinical Research Institute
🇺🇸Chicago, Illinois, United States
Accurate Clinical Research Inc.
🇺🇸Lake Charles, Louisiana, United States
Accurate Clinical Management
🇺🇸Baytown, Texas, United States
Accurate Clinical Research, Inc.
🇺🇸Houston, Texas, United States