A Phase 2 interventional study of ONO-4915 and Placebo in Sjogren's Disease, sponsored by Ono Pharmaceutical Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Ono Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment
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To evaluate the efficacy and safety of ONO-4915 in patients with primary Sjogren's disease
330 studies on the registry are indexed under Sjogren's Syndrome; 99 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 218 interventional studies indexed under Sjogren's Syndrome.
Browse Sjogren's Syndrome studies →Ono Pharmaceutical Co., Ltd. is the lead sponsor of 49 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: ONO-4915
Drug: Placebo
Subcutaneous administration
Subcutaneous administration
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
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.
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
Time frame: up to week 24
Unstimulated salivary secretion rate
Time frame: up to week 24
Tear secretion rate
Time frame: up to week 24
Adverse events and adverse reactions
Time frame: up to week 32
Number of participants with abnormal laboratory tests (hematology)
Time frame: up to week 32
12-lead electrocardiogram (Heart rate)
Time frame: up to week 24
Number of participants with abnormal Chest X-ray tests
Time frame: up to week 24
Body Weight
Time frame: up to week 32
Number of participants with abnormal laboratory tests (Immunological test)
Time frame: up to week 32
Rate of PD-1/CD19 occupancy
Time frame: up to week 24
Serum CXCL13 concentration
Time frame: up to week 32
T-cell markers (immunophenotyping)
Time frame: up to week 32
Anti-SS-A/Ro antibody titer
Time frame: up to week 32
Plasma ONO-4915 concentration
Time frame: up to week 32
Number of Participants with anti-ONO-4915 antibody
Time frame: up to week 24
Anti-SS-B/La antibody titer
Time frame: up to week 32
Anti-centromere antibody titer
Time frame: up to week 32
Antinuclear antibody titer
Time frame: up to week 32
Concentration of Rheumatoid factor
Time frame: up to week 32
ESSPRI domain scores
Scores for the dryness, pain, and fatigue symptoms comprising the ESSPRI. Higher scores indicate worse symptom severity.
Time frame: up to week 32
ESSPRI responder rate
Time frame: up to week 32
Serum BAFF concentration
Time frame: up to week 32
B-cell markers (immunophenotyping)
Time frame: up to week 32
Number of participants with abnormal laboratory tests (blood biochemistry)
Time frame: up to week 32
Number of participants with abnormal laboratory tests (urinalysis)
Time frame: up to week 32
Number of participants with abnormal laboratory tests (coagulation tests)
Time frame: up to week 32
12-lead electrocardiogram (PR interval)
Time frame: up to week 24
12-lead electrocardiogram (RR interval)
Time frame: up to week 24
12-lead electrocardiogram (QRS duration)
Time frame: up to week 24
12-lead electrocardiogram (QT interval)
Time frame: up to week 24
12-lead electrocardiogram (QTcF Interval)
Time frame: up to week 24
Blood Pressure
Time frame: up to week 32
Pulse Rate
Time frame: up to week 32
Body Temperature
Time frame: up to week 32
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Feb 2029, 28 months later.
Of 26 phase 2 interventional studies under Sjogren's Syndrome, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 43. This study's planned 28 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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