Study Title: A Prospective Dose-Finding Phase II/III Study With Atacicept Given Subcutaneously to Subjects Having Recently Experienced a Flare of Systemic Lupus Erythematosus (SLE)
Category: Lupus
Currently accepting participants?
Not at this time.
Principal Investigator: Stanford Peng
Study Coordinator: Gail Chumbley
Phone: 206-223-6835 Ext.68188
Email: gchumbley@benaroyaresearch.org
What is the A Prospective Dose-Finding Phase II/III Study With Atacicept Given Subcutaneously to Subjects Having Recently Experienced a Flare of Systemic Lupus Erythematosus (SLE) study?
Study Arms (Blinded) 1. Drug: Atacicept 75mg Dose is 75mg given subcutaneously (under the skin), twice a week for 4 weeks, and then once a week for 48 weeks. 2: Atacicept 150mg Dose is 150mg given subcutaneously (under the skin), twice a week for 4 weeks, and then once a week for 48 weeks. 3: Placebo Comparator Placebo comparator is matched volume given subcutaneously (under the skin), twice a week for 4 weeks, and then once a week for 48 weeks.
Who can participate?
3
What do I have to do as a study participant?
The participant then enteres the study and receives blinded study drug for 52 weeks. The subject attends clinic visits after 2 weeks, 4 weeks, and then monthly thereafter for the remainder of the study.
Study Summary:
Atacicept is a recombinant fusion protein that functions to reduce mature B cell numbers and circulating immunoglobulins, and is expected to slow down progression of SLE. This study is intended to evaluate the use of atacicept compared to placebo in reducing the number of flares for people with SLE, and to determine the optimal dosing level.
Detailed Study Description:
Study Design: Blinded
Phase of Study: Phase II / III
Study Type: Interventional
Condition or Study Focus: Systemic Lupus Erythematosis
Intervention Type: Drug
Intervention Name: Atacicept (TACI-Fc-5)
Gender: Male and Female
Age group: Interventional
Sponsor: EMD Serono
Other studies in this category include:
Studies currently accepting study participants:
- A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with Systemic Lupus Erythematosus
- A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE)
Studies currently not accepting study participants: