NEW YORK, N.Y. — June 2, 2023 Lupus Therapeutics announced the start of a collaboration to conduct three Phase 3 clinical trials testing an investigational therapeutic ianalumab for systemic lupus erythematosus and lupus nephritis. Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance, will help Novartis Pharmaceuticals Corporation (Novartis) conduct the trials through the Lupus Clinical Investigators Network (LuCIN) at top academic centers throughout North America.
Lupus is a devastating heterogeneous autoimmune disease affecting millions worldwide with symptoms that can range from debilitating fatigue to life-threatening organ damage. Lupus Therapeutics and the Lupus Research Alliance are committed to advancing the identification and accelerating the development of potential new treatments for a community in urgent need of more options.
The three trials will evaluate the effectiveness and safety of ianalumab compared to placebo given as a subcutaneous injection once a month or every three months. All the three trials are already underway and enrolling lupus patients.
“We believe this collaboration between Lupus Therapeutics and Novartis Pharmaceuticals will provide a significant opportunity to accelerate the development of new treatments and therapies for both SLE and lupus nephritis conditions and are hopeful that this collaboration will pave the way for improved patient outcomes,” noted Lupus Therapeutics Executive Vice President Stacie Bell, Ph.D.
Click below to learn more about each trial.
- Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis (SIRIUS-LN) – Enrolling patients
- Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients with Systemic Lupus Erythematosus (SIRIUS-SLE 1) – Enrolling patients
- Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients with Systemic Lupus Erythematosus (SIRIUS-SLE 2) – Enrolling patients
Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. More than 90 percent of people with lupus are women; lupus most often strikes during the childbearing years of 15-45. Black/African Americans, Hispanic Americans, Asians and Native Americans are two to three times at greater risk than Caucasians. In lupus, the immune system, which is designed to protect against infection, creates antibodies that can attack any part of the body including the kidneys, brain, heart, lungs, blood, skin, and joints.
About Lupus Therapeutics
Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance, aims to accelerate the development of curative treatments for all patients living with lupus. Lupus Therapeutics collaborates with academic institutions, biotechnology and pharmaceutical partners through the unprecedented Lupus Clinical Investigators Network (LuCIN) to drive rapid and meaningful progress in the treatment of lupus patients. The organization elevates the patient voice, engages community stakeholders and strives for representation of the diverse lupus community in the clinical research process with the most innovative and renowned experts throughout North America. Visit lupustherapeutics.org for more information.
About the Lupus Research Alliance
The Lupus Research Alliance is the largest non-governmental, non-profit funder of lupus research worldwide. The organization aims to transform treatment by funding the most innovative lupus research, fostering diverse scientific talent, and driving discovery toward better diagnostics, improved treatments and ultimately, cure for lupus. Because the Lupus Research Alliance’s Board of Directors funds all administrative and fundraising costs, 100% of all donations goes to support lupus research programs.
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Margy Meislin, Lupus Research Alliance