NIPH Clinical Trials Search

An Investigator-Initiated Study of Efgartigimod PH20 SC in Adult Patients with Primary Sjogren's Disease (pSjD) with Moderate to Severe Dryness

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Primary Sjogren's Disease-Associated Dryness Symptoms
Date of first enrollment	01/08/2025
Target sample size	45
Countries of recruitment
Study type	Interventional
Intervention(s)	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 will enter a 24-week double-blinded treatment period, during which efgartigimod PH20 SC or placebo PH20 SC will be injected subcutaneously starting on day 1 (baseline) and continuing until week 23. Follow-up observational period or open-label extension period (48 weeks): At the end of the double-blinded treatment period (week 24), participants will be given the option to roll over to the open-label extension treatment period. If they choose not to roll over, they will be monitored during a 56-day treatment-free safety follow-up period.

Outcome(s)

Primary Outcome

-Change from baseline in ESSPRI-dryness at week 24

Secondary Outcome

-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

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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 <6 at screening c.ESSPRI-total >=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
Exclude 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)