LRxL-STAT’s Top Scoring Biologic Ustekinumab: ALR is Working on A Clinical Trial with Janssen

The Alliance for Lupus Research (ALR) is pleased to announce it is working with Janssen Research & Development, LLC (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, on a clinical study to evaluate ustekinumab (Stelara®) for the treatment of systemic lupus erythematosus (SLE, or lupus). Ustekinumab received the highest score in the biologic category of the LRxL-STAT Lupus Drug Repositioning Initiative and will be studied in a Phase 2 lupus clinical study ( that will begin recruiting later this year.

The ALR, in partnership with the Lupus Research Institute and Drs. Peter Lipsky and Amrie Grammer of AMPEL BioSolutions, developed the new LRxL-STAT project ( to repurpose therapies currently approved for other indications and evaluate the effectiveness of such treatments in lupus. After scrutinizing hundreds of potential treatments using the CoLT (Combined Lupus Treatment) scoring system, the ALR and Drs. Lipsky and Grammer identified ustekinumab as a promising biologic candidate. The CoLT scoring system is an evidence-based analysis used on potential lupus therapies that incorporates scientific rationale, pre-clinical/clinical experience, drug properties and safety data. Ustekinumab is approved in the U.S. for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis. The ALR established the Lupus Clinical Investigators Network (LuCIN,, which is comprised of nearly 50 academic lupus centers representing all geographic regions of the U.S., some of whom will participate in the planned clinical trial of ustekinumab, as well as in the evaluation of other potential lupus treatments in close consultation with lupus advocacy organizations.

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