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

Last updated: March 26, 2025
Sponsor: Kiniksa Pharmaceuticals International, plc
Overall Status: Active - Not Recruiting

Phase

2

Condition

Dermatomyositis (Connective Tissue Disease)

Sjogren's Syndrome

Treatment

Placebo

Abiprubart

Clinical Study ID

NCT06531395
KPL-404-C221
2024-512986-15-00
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has a diagnosis of Sjögren's Disease according to 2016 American College orRheumatology (ACR)-EULAR Classification Criteria.

  • Has ESSDAI value ≥ 5, counting only the biological, hematological, articular,cutaneous, glandular, lymphadenopathy, and constitutional organ domains atScreening.

  • Is seropositive at Screening for anti-Sjögren's-syndrome-related antigen Aautoantibodies (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) withinthe range of 18-40 kg/m2.

Exclusion

Exclusion Criteria:

  • Prior exposure to any other anti-CD40/CD154 agent.

  • Diagnosis of Sjögren's Disease overlap syndromes where another autoimmune rheumaticdisease constitutes the principal illness, including fibromyalgia with currentlyactive, 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 torandomization.

  • Has started, stopped or adjusted dose/regimen of medications for treatment of, orknown to cause dry mouth/eyes within the 30 days prior to screening or isanticipating change to these treatment regimens during the study.

  • Has history of immunodeficiency (e.g., immune disorders or disorders that result indecreased immunity), including human immunodeficiency virus (HIV).

  • History of thromboembolic event or a significant risk of future thromboembolicevents.

  • Has a known high risk of infection; Has a history of chronic or recurrent infectiousdisease; Has any known or suspected active infection, or has had a serious infectionrequiring hospitalization, or has been treated with IV/IM antibiotics for aninfection within 8 weeks prior to first dose of study drug or treatment with oralantibiotics for an infection within 2 weeks prior to first dose of study drug.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
July 17, 2024
Estimated Completion Date:
May 31, 2025

Study 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.

Connect with a study center

  • Medvin Clinical Research

    Menifee, California 92586
    United States

    Site Not Available

  • BioSolutions Clinical Research Center

    Poway, California 92064
    United States

    Site Not Available

  • Medvin Clinical Research

    Whittier, California 90602
    United States

    Site Not Available

  • International Medical Research

    Daytona Beach, Florida 32117
    United States

    Site Not Available

  • Omega Research Debary, LLC

    DeBary, Florida 32713
    United States

    Site Not Available

  • Greater Chicago Specialty Physicians/ Clinical Investigation Specialists

    Schaumburg, Illinois 60195
    United States

    Site Not Available

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

    Skokie, Illinois 60076
    United States

    Site Not Available

  • Springfield Clinic Rheumatology

    Springfield, Illinois 62702
    United States

    Site Not Available

  • Accurate Clinical Research, Inc

    Lake Charles, Louisiana 70605
    United States

    Site Not Available

  • Accellacare (Salisbury)

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Carolina Arthritis Associates

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Arthritis and Rheumatology Research Institute, PLLC

    Allen, Texas 75013
    United States

    Site Not Available

  • Arthritis Care of Texas

    Corpus Christi, Texas 78415
    United States

    Site Not Available

  • Trinity Universal Research Associates, Inc.

    Plano, Texas 75024
    United States

    Site Not Available

  • Sun Research Institute

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Arthritis & Osteoporosis Clinic

    Waco, Texas 76710
    United States

    Site Not Available

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