Primary Sjogren's Disease-Associated Dryness Symptoms Sjogren's Disease
Conditions
Interventions
Screening period (<=4 weeks): Participants will attend a baseline visit within 4 weeks after the screening visit.
Double-blinded treatment period (24 weeks): Following randomization, participants wil
Sponsors
Kawakami Atsushi
Eligibility
Sex/Gender
All
Inclusion criteria
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: a.Medical history of ACR/EULAR classification criteria 2016 pSjD b.clinESSDAI =5 and ESSPRI-dryness >=5 at screening d.Anti-Ro/SS-A positive at central laboratory at screening e.Residual UWSF >0.01 mL/min at screening
Exclusion criteria
Exclusion criteria: -Besides the indication under study, has a known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of pSjD or puts the participant at undue risk -Active fibromyalgia that is not adequately controlled in the investigator's clinical judgment or is receiving fibromyalgia treatment that has not been stable for at least 12 weeks before screening -Any severe systemic pSjD manifestation that is not adequately controlled at baseline and that may put the participant at undue risk based on the investigator's clinical judgment -Secondary (also referred to as Associated) Sjogren's disease, defined as overlap with another autoimmune rheumatic or systemic inflammatory condition (eg, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, or idiopathic inflammatory myopathy) -Use of cyclophosphamide <6 months before and during the screening period -Anti-CD20 or anti-CD19 antibody received <6 months before and during the screening period -Current participation in another interventional study (participation in observational studies is permitted)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Change from baseline in ESSPRI-dryness at week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| -Change from baseline in ESSPRI-total score at week 24 -Change from baseline in ESSPRI-fatigue score at week 24 -Change from baseline in ESSPRI-pain score at week 24 -Proportion of responders (improvement of ESSPRI-total score >1.0 point/15%) at week 24 -The proportion of responders in STAR at week 24 -Change from baseline in DiSSA total score at week 24 -Change from baseline in DiSSA joint pain at week 24 -Change from baseline in DiSSA fatigue at week 24 -Change from baseline in DiSSA dryness at week 24 | — |
Contacts
Public ContactYushiro Endo
Nagasaki University Hospital
Outcome results
None listed