Primary Sjogrens Disease
Conditions
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.
Interventions
BIOLOGICALEfgartigimod PH20 SC
subcutaneous efgartigimod PH20 SC given by prefilled syringe
OTHERPlacebo PH20 SC
subcutaneous placebo PH20 SC given by prefilled syringe
Sponsors
argenx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| 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. |
Countries
Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, China, Colombia, Estonia, France, Georgia, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Lithuania, Mexico, Netherlands, Peru, Philippines, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, South Korea, Spain, Sweden, Tunisia, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed