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Lymphotoxin-Beta Receptor Fusion Protein
Baminercept, a Lymphotoxin-Beta Receptor Fusion Protein, for Treatment of Sjögren's Syndrome
Phase 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48
Summary
This trial is testing baminercept, a new drug, on patients with Sjögren's syndrome. The goal is to see if it can safely reduce symptoms by affecting the immune system's attack on the body's glands.
Eligible Conditions
- Sjögren's Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Screening in Stimulated Whole Salivary Flow at Week 24
Secondary study objectives
Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 24
Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24
Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48
+18 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BaminerceptExperimental Treatment1 Intervention
Subcutaneous injections of 100 mg every week for 24 weeks
Group II: PlaceboPlacebo Group1 Intervention
Subcutaneous injections of matched placebo every week for 24 weeks
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,327 Previous Clinical Trials
5,365,937 Total Patients Enrolled
Autoimmunity Centers of ExcellenceOTHER
22 Previous Clinical Trials
1,352 Total Patients Enrolled
BiogenIndustry Sponsor
646 Previous Clinical Trials
466,640 Total Patients Enrolled
1 Trials studying Sjögren's Syndrome
100 Patients Enrolled for Sjögren's Syndrome
E. William St. Clair, MDStudy ChairDuke University
2 Previous Clinical Trials
32 Total Patients Enrolled
Judith A. James, MDStudy ChairOklahoma Medical Research Foundation