Lupus (Active Cutaneous Lupus Erythematosus) - Upland CA

Summary:

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.

A patient may be eligible for Part B of the study if he or she:

·         Is between 18 and 75 years of age

·         Has active CLE that has been histological confirmed (in the past or at screening)

·         Has CLASI-A ≥8 at screening and randomization

·         Has subacute CLE with a CLASI-A erythema score of ≥2 and/or chronic CLE, including DLE, with at least 1 active DLE lesion with a minimum CLASI-A erythema score ≥ and in addition, CLASI-D scarring score ≥1

·         Has active CLE despite use of topical corticosteroid and/or antimalarial for at least 12 weeks prior to screening

·         Does not have active lupus nephritis or moderate-to-severe or chronic kidney disease

·         Is not taking a dose of prednisone (or its equivalent) >15 mg/day if he or she is receiving systemic corticosteroids or is taking any dose of prednisone (or its equivalent) and has been on a stable dose for ≥4 weeks prior to randomization

Qualified Participants May Receive:

·         There will be no cost to you for taking part in the study. You will be provided with study drugs, examinations and care related to the study at no cost to you.

·         If you are in Group B you will get up to $432 if you finish the whole study. If you do not finish the whole study, you will get $54 for each study visit you finish. The study doctor or study staff can tell you more about when you will get paid.

If you qualify to enter the study, you will be assigned to one of two dosing groups (on Day 1 of the Dosing Phase):

·         450 mg BIIB059 given subcutaneously every 4 weeks

·         Placebo given subcutaneously every 4 weeks

You have about a 66% chance of receiving BIIB059, and about a 33% chance of receiving placebo. For every two people assigned to receive BIIB059, one person will be assigned to receive placebo. You will receive the first dose on Day 1 of the Dosing Period. Then there will be an additional “loading dose” at week 2, Then you receive doses at weeks 4 and 8, for a total of 4 doses. You will receive the same study drug each time. Study drug will be given by subcutaneous injection, meaning an injection into or under the skin.