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

NCT ID: NCT06531395

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-17
• Study Completion Date: 2025-05-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Abiprubart 400mg SC q2wk

Part A: Loading dose of abiprubart 800 mg subcutaneous (SC) followed by abiprubart 400 mg SC every 2 weeks (q2wk) through Week 22.

Part B: Abiprubart 400 mg SC q2wk: abiprubart 400 mg SC q2wk up to and including Week 46.

Group Type: EXPERIMENTAL

Abiprubart

Intervention Type: DRUG

humanized monoclonal antibody

Abiprubart 400mg SC q4wk

Part A: Loading dose of abiprubart 800 mg SC followed by abiprubart 400 mg SC q2wk through Week 22 which will alternately administer placebo or abiprubart to provide active drug every 4 weeks (q4wk) while maintaining treatment concealment.

Part B: Abiprubart 400 mg SC q4wk: abiprubart 400 mg SC q2wk up to and including Week 46 which will alternately administer placebo or abiprubart to provide active drug q4wk while maintaining treatment concealment.

Group Type: EXPERIMENTAL

Abiprubart

Intervention Type: DRUG

humanized monoclonal antibody

Placebo

Intervention Type: DRUG

sterile preservative-free solution

Placebo

Part A: A matched volume placebo loading dose followed by placebo SC injections q2wk through Week 22.

Part B: Participants assigned to placebo in Part A will transition to active abiprubart treatment, according to randomized assignment, with either abiprubart 400 mg SC q2wk or abiprubart 400 mg SC q4wk.

Group Type: PLACEBO_COMPARATOR

Abiprubart

Intervention Type: DRUG

humanized monoclonal antibody

Placebo

Intervention Type: DRUG

sterile preservative-free solution

Interventions

Abiprubart

humanized monoclonal antibody

Intervention Type: DRUG

Placebo

sterile preservative-free solution

Intervention Type: DRUG

Other Intervention Names

KPL-404

Eligibility Criteria

Inclusion Criteria

• Has a diagnosis of Sjögren's Disease according to 2016 American College or Rheumatology (ACR)-EULAR Classification Criteria.
• Has ESSDAI value ≥ 5, counting only the biological, hematological, articular, cutaneous, glandular, lymphadenopathy, and constitutional organ domains at Screening.
• Is seropositive at Screening for anti-Sjögren's-syndrome-related antigen A autoantibodies (SSA) antibodies tested at a central laboratory.
• Has stimulated whole salivary flow rate at Screening of ≥ 0.05 mL/min
• Weighs at least 40 kg and no more than 150 kg and has a body mass index (BMI) within the range of 18-40 kg/m2.

Exclusion Criteria

• Prior exposure to any other anti-CD40/CD154 agent.
• Diagnosis of Sjögren's Disease overlap syndromes where another autoimmune rheumatic disease constitutes the principal illness, including fibromyalgia with currently active, inadequately controlled symptoms.
• Has received cataract surgery, Lasik, or other ophthalmologic surgery procedure (e.g., lachrymal plug) in the 6 months prior to Screening.
• Injectable corticosteroids (including intra-articular) within 8 weeks prior to randomization.
• Has started, stopped or adjusted dose/regimen of medications for treatment of, or known to cause dry mouth/eyes within the 30 days prior to screening or is anticipating change to these treatment regimens during the study.
• Has history of immunodeficiency (e.g., immune disorders or disorders that result in decreased immunity), including human immunodeficiency virus (HIV).
• History of thromboembolic event or a significant risk of future thromboembolic events.
• Has a known high risk of infection; Has a history of chronic or recurrent infectious disease; Has any known or suspected active infection, or has had a serious infection requiring hospitalization, or has been treated with IV/IM antibiotics for an infection within 8 weeks prior to first dose of study drug or treatment with oral antibiotics for an infection within 2 weeks prior to first dose of study drug.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kiniksa Pharmaceuticals, GmbH

INDUSTRY

Sponsor Role: collaborator

Kiniksa Pharmaceuticals International, plc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medvin Clinical Research

Menifee, California, United States

BioSolutions Clinical Research Center

Poway, California, United States

Medvin Clinical Research

Whittier, California, United States

International Medical Research

Daytona Beach, Florida, United States

Omega Research Debary, LLC

DeBary, Florida, United States

Greater Chicago Specialty Physicians/ Clinical Investigation Specialists

Schaumburg, Illinois, United States

Clinic of Robert Hozman, MD/Clinical Investigation Specialists, Inc.

Skokie, Illinois, United States

Springfield Clinic Rheumatology

Springfield, Illinois, United States

Accurate Clinical Research, Inc

Lake Charles, Louisiana, United States

Accellacare (Salisbury)

Salisbury, North Carolina, United States

Carolina Arthritis Associates

Wilmington, North Carolina, United States

Arthritis and Rheumatology Research Institute, PLLC

Allen, Texas, United States

Arthritis Care of Texas

Corpus Christi, Texas, United States

Trinity Universal Research Associates, Inc.

Plano, Texas, United States

Sun Research Institute

San Antonio, Texas, United States

Arthritis & Osteoporosis Clinic

Waco, Texas, United States

Countries

United States

Other Identifiers

2024-512986-15-00

Identifier Type: CTIS

Identifier Source: secondary_id

KPL-404-C221

Identifier Type: -

Identifier Source: org_study_id