TOPAZ-1: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care
The aim of this study is to investigate the effectiveness and safety of an investigational drug (BIIB059) in patients with active systemic lupus erythematosus, who are currently receiving treatment with background lupus standard of care therapy.
Lupus is an autoimmune disease where the body’s immune system attacks itself, resulting in inflammation. Systemic lupus erythematosus (SLE) can affect many different parts of the body, but frequently involves the joints, skin, kidneys and blood cells. Most therapies used to treat SLE are only partially effective and have considerable toxicity.
BIIB059 is a type of antibody developed to target certain cells thought to play a role in the development of lupus. Data from previous trials indicate that BIIB059 has the potential to decrease active lupus disease and control disease activity in SLE by inhibiting the production of some inflammatory mediators.
Participants will be randomly assigned to one of three groups (placebo, BIIB059 225 mg or BIIB059 450 mg) and will receive these as subcutaneous (under the skin) injections every 4 weeks, up to a total of 52 weeks.
This trial is not currently recruiting.
This trial has received ethics approval from the St Vincent’s Hospital Melbourne Human Research Ethics Committee. The sponsor of this trial is Biogen Australia Pty Ltd.
PRINCIPAL INVESTIGATOR: Professor Peter Youssef (Rheumatology, RPAH)
SUB-INVESTIGATOR: Dr Matthew Parker (Rheumatology, RPAH)