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Can an experimental injection ease the dryness and fatigue of Sjogren's?

NCT ID NCT07823790

Symptom relief Sponsor: Ono Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are testing an experimental drug called ONO-4915 in adults with primary Sjogren's disease, a condition that causes dryness, fatigue, and pain. The trial enrolls about 60 people who have moderate to severe symptoms and a positive anti-SS-A/Ro antibody. Participants receive either ONO-4915 or a placebo as an injection under the skin, and neither they nor their doctors know which one they get. The main goal is to see whether ONO-4915 improves a patient-reported symptom score after 24 weeks compared with placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ONO-4915, an experimental drug given as an injection under the skin
What this could lead to
If ONO-4915 works, it could offer a new way to ease the dryness, fatigue, and pain that define primary Sjogren's disease, a condition with few targeted treatment options.
What could go wrong
This is a small Phase II trial of 60 people, so any benefit seen may not hold up in larger studies. The drug may fail to beat placebo, and injected drugs can cause reactions at the injection site or other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 74 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Sjogren syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sjogren's disease

How to take part

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  1. The official record

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