臨床研究等提出・公開システム

A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Multicenter, Investigator-Initiated Study to Evaluate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants With Primary Sjogren's Disease-Associated Dryness Symptoms

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

Kawakami Atsushi

Nagasaki University Hospital

1-7-1 Sakamoto, Nagasaki, Nagasaki 852-8501, Japan

sjdefa@ml.nagasaki-u.ac.jp

Endo Yushiro

Nagasaki University Hospital

1-7-1 Sakamoto, Nagasaki, Nagasaki 852-8501, Japan

+81-95-819-8527

sjdefa@ml.nagasaki-u.ac.jp

Recruiting

Aug. 01, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-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

-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)

Both

Primary Sjogren's Disease-Associated Dryness Symptoms

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.

Sjogren's Disease

-Change from baseline in ESSPRI-dryness at week 24

-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

+81-95-819-7256

June. 26, 2025

No

none