NCT06531395

A Study to Evaluate the Efficacy and Safety of Abiprubart in Participants With Sjögren's Disease

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Abiprubart in Participants With Sjögren's Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Kiniksa Pharmaceuticals International, plc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Primary objective of the study is to evaluate the effect of abiprubart on an established systemic disease activity measure for Sjögren's Disease.

Detailed description

This is a 56-week (24-week randomized double-blind period, 24-week active treatment period, and 8-week safety follow-up period) multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of abiprubart in participants with Sjögren's Disease with moderate or high systemic disease activity according to the European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI). The objectives of the study are to evaluate efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of abiprubart compared with placebo across the estimated therapeutic range using different dosing regimens of abiprubart.

Conditions

• Sjögrens Disease

Interventions

Type	Name	Description
DRUG	Abiprubart	humanized monoclonal antibody
DRUG	Placebo	sterile preservative-free solution

Timeline

• Start date: 2024-07-17
• Primary completion: 2025-03-06
• Completion: 2025-05-01
• First posted: 2024-08-01
• Last updated: 2025-05-21

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study