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Research & Clinical Trials

Systemic Lupus Erythematosus (SLE) is a heterogeneous disease with multiple clinical manifestations. One drug cannot treat and cure this profound and complex deregulation of the immune system that results in multiple organ manifestations. The better we understand the pathogenesis of the disease, the better we can tailor the tools to treat it.

Researchers at the Lupus Center are now looking into organ and immune system specific measurements and therapies. It has become clear that treatments which work for the kidneys may not work for the joints and what works for one patient may not work for another. While it may not be clear what the best targets are, it is clear that multi-drug therapy – much like the cancer treatment model – is needed to take care of this complicated and tricky disease. The time for personalized therapies and individualized medicine is now.

Patient/Physician Partnership

Living with SLE is a big challenge for patients, mainly due to the unpredictable nature of the disease. While many patients can cope well with lupus and have relatively normal and productive lives, others become their disease. Some patients die because the drugs we use are either inefficient or toxic. Others simply lose a battle of faith, unable to cope with the burden of this devastating disease. They cease to be workers, mothers, daughters, and instead become absorbed in the vicious cycle of disability, depression, and distress. It is important for any member of an multidisciplinary health care team to be fully aware of how lupus may affect a patient, as well as to have an appreciation for the interdependence between the biological dimension of the disease and the psychological sequelae of Lupus.

Active Therapeutic Clinical Trials at the Lupus Center

The future depends on the critical partnership between patients and physician/researchers. Patient participation in clinical trials and research is the only path towards finding a cure for this challenging disease.

A study sponsored by the NIH to evaluate “Ajumelic Acid in SLE: A Pilot Phase IIa Clinical Trial”
Principal Investigator: Anca Askanase
The purpose of this study is to evaluate the efficacy, safety and tolerability of Ajumelic Acid in patients with SLE. Ajumelic Acid is a synthetic cannabinoid derivative of the non-psychoactive THC metabolite11-nor-9-carboxy-THC that shows useful analgesic and anti-inflammatory effects without causing a subjective "high".

A study sponsored by the Lupus Foundation of America to validate a novel and simple outcome measure in SLE, the“LFA-REAL”
Principal Investigator: Anca Askanase

A study sponsored by the Mallinckrodt evaluating “ACTHar in the Treatment of Proliferative Lupus Nephritis”
Principal Investigator: Anca Askanase
The purpose of this study is to evaluate the efficacy and safety of two dosing regimens of ACTHar, used in conjunction with Mycophenolate Mofetil in treating proliferative lupus nephritis.

A study sponsored by Mallinckrodt to assess the efficacy and safety of H.P. Acthar Gel in subjects with persistently active SLE despite moderate dose corticosteroids
Principal Investigator: Anca Askanase
The purpose of this study is to define the efficacy and safety of ACTH in the treatment of subjects with moderate to severe SLE despite steroid treatment.

A study sponsored by Astra-Zeneca to assess the "Efficacy and Safety of Anifrolumabin SLE”
Principal Investigator: Anca Askanase
The purpose of this study is to define the efficacy and safety of an Anti-IFN in the treatment of subjects with SLE.

A study sponsored by Celgene to assess the "Efficacy and Safety of CC-220 in SLE Patients”
Principal Investigator: Anca Askanase
The purpose of this study is to define the efficacy and safety of a cereblon with immune modulatory effects in the treatment of subjects with SLE.

A study sponsored by LuCIN and the Lupus Research Alliance to assess the "Efficacy of RAYOS in Lupus Patients”
Principal Investigator: Anca Askanase
The purpose of this study is to define the efficacy of RAYOS, a delayed-release Prednisone, in the treatment of subjects with SLE.

A study sponsored by Xencor to assess the "Efficacy and Safety of XmAb5871-04 in SLE Patients”
Principal Investigator: Anca Askanase
The purpose of this study is to define the efficacy and safety of an Anti-CD19 antibody in the treatment of subjects experiencing an SLE flare.

A study sponsored by Ablynx to assess the "Efficacy and Safety ALX-0061 in SLE Patients”
Principal Investigator: Anca Askanase
The purpose of this study is to define the efficacy and safety of an Anti-IL6 nanobody in the treatment of subjects with SLE.

A study sponsored by Aurinia to assess the "Efficacy and Safety of Orelvo in SLE Patients with Lupus Nephritis”
Principal Investigator: Anca Askanase
The purpose of this study is to define the efficacy and safety of a calcineurin inhibitor in the treatment of subjects with active lupus nephritis: class III, IV, and V.

A study sponsored by Boheringer-Ingelheim to assess the "Efficacy and Safety of BI 655064 in Lupus Nephritis”
Principal Investigator: Laura Geraldino-Pardilla
The purpose of this study is to define the efficacy and safety of an Anti-CD40 antibody in the treatment of subjects with Lupus Nephritis.

A study sponsored by Roche to assess the "Efficacy and Safety of Obinutuzumab in Lupus Nephritis”
Principal Investigator: Laura Geraldino-Pardilla
The purpose of this study is to define the efficacy and safety of an Anti-CD20 antibody in the treatment of subjects with Lupus Nephritis.