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Sjogren's DiseasePhase 2NCT07823790

ONO-4915 in Patients With Primary Sjogren's Disease

A Phase 2 study testing ONO-4915 in people with Sjogren's Disease, run by Ono Pharmaceutical Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

To evaluate the efficacy and safety of ONO-4915 in patients with primary Sjogren's disease Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Sjogren's Disease
What is being tested?
ONO-4915
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
No sites listed yet
Study dates
Oct 2026to Feb 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

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

About this study

Official title: A Phase II Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Study in Patients With Primary Sjogren's Disease to Evaluate the Efficacy and Safety of Subcutaneously Administered ONO-4915

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

Being tested
ONO-4915, Placebo
Medical subject headings
Sjogren's Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ONO-4915Drug

    Subcutaneous administration

  • PlaceboDrug

    Subcutaneous administration

Study groups in NCT07823790
Study groupRoleWhat they receive
ONO-4915ExperimentalNot described
Receives: Drug: ONO-4915
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to week 24

Secondary outcomes (39)

  1. ESSPRI total score

    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.

    Measured: up to week 32

  2. Subjective symptom score of Sjogren's disease

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

    Measured: up to week 32

  3. 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.

    Measured: up to week 32

  4. Joint counts

    Measured: up to week 32

  5. Physician's Global Assessment (PGA) score

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

    Measured: up to week 32

  6. Stimulated salivary secretion rate

    Measured: up to week 24

  7. Unstimulated salivary secretion rate

    Measured: up to week 24

  8. Tear secretion rate

    Measured: up to week 24

  9. Adverse events and adverse reactions

    Measured: up to week 32

  10. Number of participants with abnormal laboratory tests (hematology)

    Measured: up to week 32

  11. 12-lead electrocardiogram (Heart rate)

    Measured: up to week 24

  12. Number of participants with abnormal Chest X-ray tests

    Measured: up to week 24

  13. Body Weight

    Measured: up to week 32

  14. Number of participants with abnormal laboratory tests (Immunological test)

    Measured: up to week 32

  15. Rate of PD-1/CD19 occupancy

    Measured: up to week 24

  16. Serum CXCL13 concentration

    Measured: up to week 32

  17. T-cell markers (immunophenotyping)

    Measured: up to week 32

  18. Anti-SS-A/Ro antibody titer

    Measured: up to week 32

  19. Plasma ONO-4915 concentration

    Measured: up to week 32

  20. Number of Participants with anti-ONO-4915 antibody

    Measured: up to week 24

  21. Anti-SS-B/La antibody titer

    Measured: up to week 32

  22. Anti-centromere antibody titer

    Measured: up to week 32

  23. Antinuclear antibody titer

    Measured: up to week 32

  24. Concentration of Rheumatoid factor

    Measured: up to week 32

  25. ESSPRI domain scores

    Scores for the dryness, pain, and fatigue symptoms comprising the ESSPRI. Higher scores indicate worse symptom severity.

    Measured: up to week 32

  26. ESSPRI responder rate

    Measured: up to week 32

  27. Serum BAFF concentration

    Measured: up to week 32

  28. B-cell markers (immunophenotyping)

    Measured: up to week 32

  29. Number of participants with abnormal laboratory tests (blood biochemistry)

    Measured: up to week 32

  30. Number of participants with abnormal laboratory tests (urinalysis)

    Measured: up to week 32

  31. Number of participants with abnormal laboratory tests (coagulation tests)

    Measured: up to week 32

  32. 12-lead electrocardiogram (PR interval)

    Measured: up to week 24

  33. 12-lead electrocardiogram (RR interval)

    Measured: up to week 24

  34. 12-lead electrocardiogram (QRS duration)

    Measured: up to week 24

  35. 12-lead electrocardiogram (QT interval)

    Measured: up to week 24

  36. 12-lead electrocardiogram (QTcF Interval)

    Measured: up to week 24

  37. Blood Pressure

    Measured: up to week 32

  38. Pulse Rate

    Measured: up to week 32

  39. Body Temperature

    Measured: up to week 32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionFeb 2029 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07823790
Sponsor's protocol ID
ONO-4915-02
Status last verified
Sep 2026
First submitted
3 Sep 2026
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ONO-4915 in people with Sjogren's Disease, run by Ono Pharmaceutical Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact North America Clinical Trial Support Desk (+18665877745(Toll-Free), clinical_trial@ono-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the Patients with EULAR Sjogren's Syn drome Patient Reported Index (ESSPRI) score at Week 24 (time frame: up to week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07823790.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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