Clinical trial NCT06531395: A Study to Evaluate the Efficacy and Safety of Abiprubart in Participants With Sjögren's Disease
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Sjögrens Disease
Lead sponsor: Kiniksa Pharmaceuticals International, plc
Sponsor class: INDUSTRY
Collaborators: name: Kiniksa Pharmaceuticals, GmbH
First posted: 2024-08-01
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change From Baseline in European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) at Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Proportion of Sjögren's Tool for Assessing Response (STAR) Responders (≥ 5 points) at Week 24
timeFrame: Week 24
measure: Proportion of STAR Responders (≥ 5 points) Over Time
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
measure: Change From Baseline in Stimulated Salivary Flow Rate (mL/min) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Stimulated Salivary Flow Rate (mL/min) Over Time
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
measure: Change From Baseline in Unstimulated Salivary Flow Rate (mL/min) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Unstimulated Salivary Flow Rate (mL/min) Over Time
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
measure: Change From Baseline in EULAR Sjögren's Syndrome Disease Patient Reported Index (ESSPRI) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in ESSPRI Over Time
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
measure: Change From Baseline in Schirmer's Test at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Schirmer's Test Over Time
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
measure: Change From Baseline in Clinical EULAR Sjögren's Syndrome Disease Activity Index (clinESSDAI) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in clinESSDAI Over Time
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in FACIT-Fatigue Over Time
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
measure: Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D 5L) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in EQ-5D 5L Over Time
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, 56
Other outcomes:
Locations:
city: Menifee
country: United States
facility: Medvin Clinical Research
state: California
city: Poway
country: United States
facility: BioSolutions Clinical Research Center
state: California
city: Whittier
country: United States
facility: Medvin Clinical Research
state: California
city: Daytona Beach
country: United States
facility: International Medical Research
state: Florida
city: DeBary
country: United States
facility: Omega Research Debary, LLC
state: Florida
city: Schaumburg
country: United States
facility: Greater Chicago Specialty Physicians/ Clinical Investigation Specialists
state: Illinois
city: Skokie
country: United States
facility: Clinic of Robert Hozman, MD/Clinical Investigation Specialists, Inc.
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic Rheumatology
state: Illinois
city: Lake Charles
country: United States
facility: Accurate Clinical Research, Inc
state: Louisiana
city: Salisbury
country: United States
facility: Accellacare (Salisbury)
state: North Carolina
city: Wilmington
country: United States
facility: Carolina Arthritis Associates
state: North Carolina
city: Allen
country: United States
facility: Arthritis and Rheumatology Research Institute, PLLC
state: Texas
city: Corpus Christi
country: United States
facility: Arthritis Care of Texas
state: Texas
city: Plano
country: United States
facility: Trinity Universal Research Associates, Inc.
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Waco
country: United States
facility: Arthritis & Osteoporosis Clinic
state: Texas
Study officials:
References: