NCT07823790

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
28mo left

Started Oct 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 16, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

September 16, 2026

Status Verified

September 1, 2026

Enrollment Period

2.3 years

First QC Date

September 3, 2026

Last Update Submit

September 13, 2026

Conditions

Sjogren's Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to week 24

Secondary Outcomes (39)

  • ESSPRI total score

    up to week 32

  • Subjective symptom score of Sjogren's disease

    up to week 32

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

    up to week 32

  • Joint counts

    up to week 32

  • Physician's Global Assessment (PGA) score

    up to week 32

  • +34 more secondary outcomes

Study Arms (2)

ONO-4915

EXPERIMENTAL
Drug: ONO-4915

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ONO-4915DRUG

Subcutaneous administration

ONO-4915
PlaceboDRUG

Subcutaneous administration

Placebo

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Project Leader

    Ono Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Central Study 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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2026

First Posted

September 16, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Last Updated

September 16, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share