A Phase 3 study of Abatacept in Patients with Primary Sjogrens Syndrome

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sjogrens Syndrome

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223466

Enrollment

172

Registered

2017-02-24

Start date

2017-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sjogrens Syndrome

Interventions

investigational material(s) Generic name etc : Abatacept INN of investigational material : Abatacept Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for I

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects must meet the 2016 ACR/EULAR Classification Criteria for SS (Sjogren's Syndrome), as specified for pSS. Subjects should have pSS that is refractory to symptomatic or local therapy (e.g. NSAIDs) Subjects having an ESSDAI score of at least 5 at screening. Subjects being anti-SS-A/Ro positive at screening. Stimulated salivary flow of at least 0.1 mL/min at screening and randomization in at least 124 subjects (72%)

Exclusion criteria

Exclusion criteria: Subjects who have a systemic autoimmune disease other than Sjogren's syndrome, such as RA, SLE or systemic sclerosis, that can better explain the majority of the symptoms (ie, secondary Sjogren's syndrome). Subjects who have another autoimmune disease or inflammatory condition that could interfere with assessment of response of pSS to therapy (eg, systemic sclerosis, inflammatory bowel disease, gout). Subjects with any other medical condition associated with clinical features overlapping those of pSS or that would interfere with interpretation of results, including but not limited to a history of head and neck radiation treatment, sarcoidosis, amyloidosis, graft-versus-host disease, hepatitis C, acquired immunodeficiency syndrome, and IgG4-related disease. Active life-threatening or organ-threatening complications of SS disease at the time of screening based on investigator evaluation

Design outcomes

Primary

Measure	Time frame
confirmatory The mean change from baseline (Day 1) in ESSDAI at Day 169.	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics pharmacodynamics The mean change from baseline in ESSPRI at Day 169 The mean change from baseline in the stimulated whole salivary flow at Day 169 among subjects with stimulated whole salivary flow of at least 0.1 mL/min at both screening and baseline.	—

Countries

Argentina, Brazil, Canada, Asia except Japan, Czech Republic, Germany, France, Europe, Italy, Mexico, Puerto Rico, Japan, Japan, Korea, US, Australia, North America, Oceania, South America, Sweden

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026