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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?
Yes - please read the description below and contact the study coordinator if you are interested.
Principal Investigator: Stanford Peng
Study Coordinator: Donald Rodriguez
Phone: 206-223-6835 Ext.68188
Email: donald.rodriguez@vmmc.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?
Who Can Participate
• Men or Women 16 years of age or older with a SLE disease history of at least six months
• Must have recently experienced a flare at screening requiring a change in corticosteroids
• Must show a positive ANA or anti-dsDNA at screening
• Female subjects must be willing to avoid pregnancy
• No active moderate to severe kidney impairment
• No active central nervous system SLE deemed to be severe/progressive
• No previous treatment with rituximab, abatacept, or belimumab
What do I have to do as a study participant?
Participants must come to the clinic for a screening visit within 5 days of experiencing of flare. If he/she qualifiess for the study, the participant is put on steroid regimen that tapers down over a 10 week period and the participant is evaluated for improvement. If sufficient improvement is observed, the participant is kept on a stable dose for another 2 weeks to ensure that the flare does not return.
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:
(No information)
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
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