Health TrialsbyHealthPanel

ONO-4915 in Patients With Primary Sjogren's Disease

ConditionSjogren's Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-74
SponsorOno Pharmaceutical Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • ONO-4915

    Drug

    Subcutaneous administration

  • Placebo

    Drug

    Subcutaneous administration

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: ONO-4915Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
up to week 24

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
up to week 32
4

Joint counts

Time frame
up to week 32

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ono Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: