Phase
Condition
Dermatomyositis (Connective Tissue Disease)
Sjogren's Syndrome
Treatment
Placebo
Abiprubart
Clinical Study ID
Ages 18-80 All Genders
Study Summary
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
Study Description
Connect with a study center
Medvin Clinical Research
Menifee, California 92586
United StatesSite Not Available
BioSolutions Clinical Research Center
Poway, California 92064
United StatesSite Not Available
Medvin Clinical Research
Whittier, California 90602
United StatesSite Not Available
International Medical Research
Daytona Beach, Florida 32117
United StatesSite Not Available
Omega Research Debary, LLC
DeBary, Florida 32713
United StatesSite Not Available
Greater Chicago Specialty Physicians/ Clinical Investigation Specialists
Schaumburg, Illinois 60195
United StatesSite Not Available
Clinic of Robert Hozman, MD/Clinical Investigation Specialists, Inc.
Skokie, Illinois 60076
United StatesSite Not Available
Springfield Clinic Rheumatology
Springfield, Illinois 62702
United StatesSite Not Available
Accurate Clinical Research, Inc
Lake Charles, Louisiana 70605
United StatesSite Not Available
Accellacare (Salisbury)
Salisbury, North Carolina 28144
United StatesSite Not Available
Carolina Arthritis Associates
Wilmington, North Carolina 28401
United StatesSite Not Available
Arthritis and Rheumatology Research Institute, PLLC
Allen, Texas 75013
United StatesSite Not Available
Arthritis Care of Texas
Corpus Christi, Texas 78415
United StatesSite Not Available
Trinity Universal Research Associates, Inc.
Plano, Texas 75024
United StatesSite Not Available
Sun Research Institute
San Antonio, Texas 78215
United StatesSite Not Available
Arthritis & Osteoporosis Clinic
Waco, Texas 76710
United StatesSite Not Available
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