臨床研究等提出・公開システム

Date of registration	Sept. 03, 2026
Last modified on	Sept. 03, 2026
Trial ID	jRCT2011260036

Scientific Title	ONO-4915-02: 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
Public Title	A Phase II study in patients with primary Sjogren's disease to evaluate the efficacy and safety of ONO-4915

Contact for Scientific Queries	Name	Terasawa Tetsuji
	Affiliation	Ono Pharmaceutical Co.,LTD.
	Address	8-2 Kyutaromachi, 1-Chome,Chuo-ku, Osaka-shi,Osaka, JAPAN
	Telephone	+81-120-278-120
	E-mail	clinical_trial@ono-pharma.com
Contact for Public Queries	Name	JP Clinical Trial Support Desk
	Affiliation	Ono Pharmaceutical Co.,LTD.
	Address	8-2 Kyutaromachi, 1-Chome,Chuo-ku, Osaka-shi,Osaka, JAPAN
	Telephone	+81-120-278-120
	E-mail	clinical_trial@ono-pharma.com

Recruitment status	Pending

Anticipated date of first enrollment		Oct. 01, 2026
Target sample size		60
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Age (at the time of informed consent): >=18 and <75 years 2. Patients who meet the criteria for primary Sjogrens disease defined by the 2016 ACR/EULAR Classification Criteria for Primary Sjogren's Syndrome 3. Patients with positive anti-SS-A/Ro antibody in the screening period 4. Patients with EULAR Sjogrens Syndrome Patient Reported Index (ESSPRI) score of >=5 and dry symptom score of >=5 in the screening period 5. Patients with stimulated salivary secretion rate of >=0.1 mL/min by the Saxon test in the screening period. 6. Patients diagnosed with primary Sjogren's disease within 10 years
	Exclusion Criteria	1. Patients with other concurrent autoimmune diseases 2. Patients who may overlap with the clinical symptoms of primary Sjogren's disease or interfere with the evaluation of the clinical symptoms 3. Patients with any disease that may interfere with the evaluation of dry symptoms of primary Sjogren's disease 4. Patients with any disease that may interfere with the evaluation of pain of primary Sjogren's disease 5. Patients with severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, psychiatric, cardiac, endocrine, neurologic, or cerebral disease unrelated to the primary disease 6. Patients with current malignancy or history of malignancy within 5 years before the start of screening 7. Patients with active infection
	Age Minimum	18age old over
	Age Maximum	75age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Sjogrens disease
Intervention(s)		"The participants will receive study treatment according to their assigned intervention group as follows: - ONO-4915 group: Subcutaneous administration - Placebo group: Subcutaneous administration"
Primary Outcome(s)		Change from baseline in the ESSPRI score at Week 24
Secondary Outcome(s)		ESSPRI score (score at all evaluation time points, each -symptom score, and responder rate) Subjective symptom score of Sjogren's disease ESSDAI score Joint counts PGA score Stimulated salivary secretion rate Unstimulated salivary secretion rate Tear secretion rate Adverse events and adverse reactions General laboratory tests (hematology, blood biochemistry, urinalysis, and coagulation tests) 12-lead electrocardiogram Chest X-ray Vital signs Immunological test PD-1/CD19 occupancy Serum CXCL13 concentration and serum BAFF concentration T-cell markers, B-cell markers (immunophenotyping) Autoantibody titers (anti-SS-A/Ro antibody, anti-SS-B/La antibody, anti-centromere antibody, antinuclear antibody, and rheumatoid factor) Plasma ONO-4915 concentration Anti-ONO-4915 antibody

Primary Sponsor	Ono Pharmaceutical Co.,LTD.

Name of Certified Review Board	Not approved
Address	Not approved, Hokkaido

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none