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

NCT06531395 | Terminated Phase 2 FDA Drug

• 2 other identifiers: KPL-404-C2212024-512986-15-00
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 16

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.

Conditions

Sjögrens Disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) at Week 24

  Baseline, Week 24

Secondary Outcomes (16)

• Proportion of Sjögren's Tool for Assessing Response (STAR) Responders (≥ 5 points) at Week 24

  Week 24

• Proportion of STAR Responders (≥ 5 points) Over Time

  Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56

• Change From Baseline in Stimulated Salivary Flow Rate (mL/min) at Week 24

  Baseline, Week 24

• Change From Baseline in Stimulated Salivary Flow Rate (mL/min) Over Time

  Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56

• Change From Baseline in Unstimulated Salivary Flow Rate (mL/min) at Week 24

  Baseline, Week 24

Study Arms (3)

Abiprubart 400mg SC q2wk

EXPERIMENTAL

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.

Drug: Abiprubart

Abiprubart 400mg SC q4wk

EXPERIMENTAL

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.

Drug: Abiprubart; Drug: Placebo

Placebo

PLACEBO COMPARATOR

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.

Drug: Abiprubart; Drug: Placebo

Interventions

Abiprubart DRUG

humanized monoclonal antibody

Also known as: KPL-404

Abiprubart 400mg SC q2wk; Abiprubart 400mg SC q4wk; Placebo

Placebo DRUG

sterile preservative-free solution

Abiprubart 400mg SC q4wk; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kiniksa Pharmaceuticals International, plc: lead
• Kiniksa Pharmaceuticals, GmbH: collaborator

Study Sites (16)

Medvin Clinical Research

Menifee, California, 92586, United States

Location

BioSolutions Clinical Research Center

Poway, California, 92064, United States

Location

Medvin Clinical Research

Whittier, California, 90602, United States

Location

International Medical Research

Daytona Beach, Florida, 32117, United States

Location

Omega Research Debary, LLC

DeBary, Florida, 32713, United States

Location

Greater Chicago Specialty Physicians/ Clinical Investigation Specialists

Schaumburg, Illinois, 60195, United States

Location

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

Skokie, Illinois, 60076, United States

Location

Springfield Clinic Rheumatology

Springfield, Illinois, 62702, United States

Location

Accurate Clinical Research, Inc

Lake Charles, Louisiana, 70605, United States

Location

Accellacare (Salisbury)

Salisbury, North Carolina, 28144, United States

Location

Carolina Arthritis Associates

Wilmington, North Carolina, 28401, United States

Location

Arthritis and Rheumatology Research Institute, PLLC

Allen, Texas, 75013, United States

Location

Arthritis Care of Texas

Corpus Christi, Texas, 78415, United States

Location

Trinity Universal Research Associates, Inc.

Plano, Texas, 75024, United States

Location

Sun Research Institute

San Antonio, Texas, 78215, United States

Location

Arthritis & Osteoporosis Clinic

Waco, Texas, 76710, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 1, 2024
• Study Start: July 17, 2024
• Primary Completion: March 6, 2025
• Study Completion: May 1, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)