A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects with Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects with Active Cutaneous Lupus Erythematosus with or without Systemic Manifestations
March 02, 2018
Natasha Mesinkovska, MD, PhD
UC Irvine Main Campus
The purpose of the study is to evaluate a new drug for the treatment of systemic lupus erythematosus with active skin manifestations (Part A) and active cutaneous lupus erythematosus with or without systemic manifestations (Part B).
Adults between the ages of 18 and 75 years old who are able to give informed consent and with either systemic lupus erythematosus with active cutaneous lesions (Part A) or active cutaneous lupus erythematosus with or without systemic symptoms (Part B).
Part A will require a maximum of 40 weeks (13 1-hour visits total) and Part B will require a maximum of 32 weeks (11 1-hour visits total).
Your disease symptoms may benefit from the administration of BIIB059, the study drug.
You will be compensated for participation in this study. Personal information about you, including your name, address and social security number, will be released to the UCI Office of Accounting for the purpose of payment. You will be paid for your participation in this research as follows: You will be paid $67 per visit over the course of the study. If you participate in Part A, you will attend a total of 13 visits, with 7 compensated visits (screening, day 1, week 4, week 8, week 12, week 16 and week 24), for a total maximum compensation of $469. If you participate in Part B, you will attend a total of 11 visits, with 6 compensated visits (screening, day 1, week 4, week 8, week 12 and week 16) for a total maximum compensation of $402. If you decide to withdraw from the study or are withdrawn by the research team, you will receive compensation for the visits and/or procedures that you have completed. You will be reimbursed a total of up to $42 per visit for your travel expenses including gas mileage upon receipt of invoice and supporting documentation.
Patty Summerville, clinical research coordinator, UCI Department of Dermatology