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

Phase 2 Terminated 52 enrolled National Institute of Allergy and Infectious Diseases (NIAID) Autoimmunity Centers of Excellence · collab Biogen · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2012-07
Primary completion: 2015-01
Completion: 2015-06

Outcome

Missed primary endpoint

Stopped: “Expired experimental study agent, no additional supply available.”

paper The change from baseline to week 24 in the SWSF rate was not significantly different PMID 29604186 ↗

registry Baminercept 100 mg vs Placebo; p = 0.33; ANCOVA NCT01552681 ↗

Publications

Results St Clair EW, Baer AN, Wei C, Noaiseh G, Parke A, Coca A, Utset TO, Genovese MC, Wallace DJ, McNamara J, Boyle K, Keyes-Elstein L, Browning JL, Franchimont N, Smith K, Guthridge JM, Sanz I, James JA; Autoimmunity Centers of Excellence. Clinical Efficacy and Safety of Baminercept, a Lymphotoxin beta Receptor Fusion Protein, in Primary Sjogren's Syndrome: Results From a Phase II Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Rheumatol. 2018 Sep;70(9):1470-1480. doi: 10.1002/art.40513. Epub 2018 Jul 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Baminercept	Protein / enzyme biologic	100 mg	Subcutaneous