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NCT06531395 | RECRUITING | Sjögrens Disease

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

Kiniksa Pharmaceuticals International, plc

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.

Condition or disease

Sjogren's Disease

Intervention/treatment

Abiprubart

Placebo

Phase

PHASE2

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2024-07-17
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2027-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
A Study to Evaluate the Efficacy and Safety of Abiprubart in Participants with Sjögren's Disease

Location Details

NCT06531395

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Medvin Clinical Research

Menifee, California, United States, 92586

RECRUITING

United States, California

Medvin Clinical Research

Whittier, California, United States, 90602

RECRUITING

United States, Florida

Omega Research Debary, LLC

DeBary, Florida, United States, 32713

RECRUITING

United States, Illinois

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

Skokie, Illinois, United States, 60076

RECRUITING

United States, North Carolina

Carolina Arthritis Associates

Wilmington, North Carolina, United States, 28401

RECRUITING

United States, Texas

Arthritis and Rheumatology Research Institute, PLLC

Allen, Texas, United States, 75013

RECRUITING

United States, Texas

Arthritis Care of Texas

Corpus Christi, Texas, United States, 78415

RECRUITING

United States, Texas

Trinity Universal Research Associates, Inc.

Plano, Texas, United States, 75024

RECRUITING

United States, Texas

Sun Research Institute

Saint Anthony, Texas, United States, 78215