NCT01552681

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

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial of Baminercept, a Lymphotoxin-beta Receptor Fusion Protein, for the Treatment of Primary Sjögren's Syndrome (ASJ02)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Sjögren's syndrome is an autoimmune disorder in which a person's own immune cells attack the body's tear and salivary glands. This disease is the second most common autoimmune disorder, affects close to four million people in the U.S., and has no known cause. About one-third of patients with Sjögren's syndrome have enlarged parotid glands (the largest salivary glands, the glands that make saliva); inflammation of organs such as the lungs and joints may also occur. There is no known effective treatment other than measures that can relieve symptoms. One of the most bothersome symptoms is dryness of the eyes and mouth. Eye drops and saliva stimulants (which help make more saliva) are common treatments. When other organs are affected, symptoms are treated with corticosteroids (prednisone), non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen and naproxen), hydroxychloroquine (Plaquenil®) or other medications that suppress the immune system. These drugs may curb or kill cells of the immune system, but they are not always helpful, do not cure Sjögren's syndrome, and can have many side effects.

Conditions

• Primary Sjögren's Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-01-01
• Completion: 2015-06-01
• First posted: 2012-03-13
• Last updated: 2019-01-14
• Results posted: 2016-03-23

Locations

9 sites across 1 country: United States