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Baminercept, a Lymphotoxin-Beta Receptor Fusion Protein, for Treatment of Sjögren's Syndrome

NCT01552681 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2019-01-14

Study results available
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Summary

The purpose of the study is to find out if the experimental study agent, baminercept, is effective in treating patients with Sjögren's syndrome. The study will also determine if the study agent can be safely given to patients with Sjögren's syndrome; examine how it affects symptoms of the disease; and attempt to understand how baminercept affects the underlying mechanisms of Sjögren's syndrome and the immune system.

Conditions

  • Primary Sjögren's Syndrome

Interventions

BIOLOGICAL

Baminercept

Subjects randomized to baminercept (2:1) will receive 24 weekly injections of 100 mg administered subcutaneously starting at the Day 0 visit and ending at Week 23.

OTHER

Placebo

Subjects randomized to placebo will receive 24 weekly injections of 100 mg administered subcutaneously starting at the Day 0 visit and ending at Week 23.

Sponsors & Collaborators

  • Autoimmunity Centers of Excellence

    collaborator OTHER

  • Biogen

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • E. William St. Clair, MD · Duke University

  • Judith A. James, MD · Oklahoma Medical Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-01-31
Completion
2015-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01552681 on ClinicalTrials.gov