ONO-4915 in Patients With Primary Sjogren's Disease

Phase 2Not Yet RecruitingNCT07823790

Ono Pharmaceutical Co., Ltd.60 enrolled

Overview

To evaluate the efficacy and safety of ONO-4915 in patients with primary Sjogren's disease

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Sjogren's Disease

Interventions

ONO-4915DRUG

Subcutaneous administration

PlaceboDRUG

Subcutaneous administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 74 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age (at the time of informed consent): \>=18 and \<75 years * Patients who meet the criteria for primary Sjogren's disease defined by the 2016 ACR/EULAR Classification Criteria for Primary Sjogren's Syndrome * Patients with positive anti-SS-A/Ro antibody in the screening period * Patients with ESSPRI score of \>=5 and dry symptom score of \>=5 in the screening period * Patients with stimulated salivary secretion rate of \>=0.1 mL/min by the Saxon test in the screening period. * Patients diagnosed with primary Sjogren's disease within 10 years Exclusion Criteria: * Patients with other concurrent autoimmune diseases * Patients who may overlap with the clinical symptoms of primary Sjogren's disease or interfere with the evaluation of the clinical symptoms * Patients with any disease that may interfere with the evaluation of dry symptoms of primary Sjogren's disease * Patients with any disease that may interfere with the evaluation of pain of primary Sjogren's disease * Patients with severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, psychiatric, cardiac, endocrine, neurologic, or cerebral disease unrelated to the primary disease * Patients with current malignancy or history of malignancy within 5 years before the start of screening * Patients with active infection

Outcomes

Primary Outcomes

Change from baseline in the Patients with EULAR Sjogren's Syn drome Patient Reported Index (ESSPRI) score at Week 24

Patient-reported assessment of dryness, fatigue, and pain, each scored from 0 to 10. The total ESSPRI score is calculated as the mean of the three domain scores and ranges from 0 to 10, with higher scores indicating worse symptoms.

Time frame: up to week 24

Secondary Outcomes

ESSPRI total score

Time frame: up to week 32

Subjective symptom score of Sjogren's disease

Each symptom is scored daily on a numerical scale, with higher scores indicating worse symptoms.

Time frame: up to week 32

EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) score

Symptoms are evaluated across 12 organ/system domains using a 4-point scale (0 = no activity to 3 = severe activity). Each domain score is weighted according to its clinical importance, and the weighted scores are summed to yield a total score ranging from 0 to 123, with higher scores indicating greater disease activity.

Time frame: up to week 32

Joint counts

Time frame: up to week 32

Physician's Global Assessment (PGA) score

Evaluated by physician on a numerical scale. Higher scores indicate worse symptoms.

Time frame: up to week 32

Stimulated salivary secretion rate

Central Contacts

North America Clinical Trial Support Desk

CONTACT

+18665877745(Toll-Free)clinical_trial@ono-pharma.com

International Clinical Trial Support Desk

CONTACT

+17162141777(Standard)clinical_trial@ono-pharma.com

Data from ClinicalTrials.gov

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