Lupus Interventional Clinical Trials Program

There is an unmet need for treatments that are safe, effective, and long-lasting in managing lupus disease activity. The goal of the Hospital for Special Surgery (HSS) Lupus Interventional Clinical Trials Program is to advance toward the development of innovative therapies and treatments that will improve the quality of life of lupus patients. At the same time, we strive to reduce hospitalizations and prevent complications related to treatment or disease activity. Our goal is to maximize patient wellbeing by helping them return to everyday activities one step at a time. 

We believe that the objectives of advancing lupus care are best achieved through novel, cutting-edge research. In addition to supporting the observational and exploratory research that occurs at HSS (research not involving investigational drugs), the HSS Lupus Clinical Trials Program manages numerous interventional trials for novel therapies.

Within the Lupus and APS Center of Excellence, the HSS Lupus Clinical Trials Program collaborates closely with physicians and social work across the hospital’s rheumatology department. We work closely together with other subspecialties (ie nephrology and oncology) from New York Presbyterian Hospital – Weill Cornell as well as Memorial Sloan Kettering Cancer Center in some of our studies as necessary. Additionally, the HSS Lupus Clinical Trials Program is an active site of The Lupus Clinical Investigators Network (LuCIN) a lupus clinical trials network made up of 57 of the most prestigious academic research medical centers throughout North America, and the Lupus Nephritis Trials Network (LNTN), a worldwide organization that brings researchers together with the shared goal of improving outcomes for patients with lupus nephritis. 

Our team takes pride in the way we conduct clinical trials. We prioritize safety of our patients, and we conduct trials in compliance with federal and institutional regulations.

HSS Lupus Interventional Clinical Trials Program Contacts

Enrolling Trials for Active Lupus Patients

• SUNY SNAC (IRB # 2021-1594)
  • Systemic Lupus Erythematosus (SLE) Treatment with N-acetylcysteine (NAC) (SNAC)
• BMS POETYK (IRB # 2023-0229)
  • A Phase 3 Randomized. Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-2)

Completed, Non-Enrolling Trials

• A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus
• A Novel Phase 2 Double-Blind, Randomized, Controlled Clinical Trial to Evaluate the Efficacy of Centrally Acting, Non-Toxic ACE Inhibition in Cognitive Impairment Associated with SLE
• A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy
• A Multicentre, Randomized, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterize the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus
• Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis: a Randomized, Controlled Phase 2 Open Label Multicenter Study
• Nelfinavir in Systemic Lupus Erythematosus: A Pilot Phase IIa Clinical Trial
• A Phase 3 Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy & Safety of MBS-188667 (Abatacept) or Placebo on a Background of Mycophenolate Mofetil (MMF) & Corticosteroids in Subjects with Active Class III or IV Lupus Nephritis
• A Phase 2B, Dose Ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with SLE
• A Phase 1 Double Blind, Randomized, Single Ascending Dose Study of the Safety and Tolerability of MEDI 570 in SLE
• A Randomized, Double-Blind Controlled, Multicenter Study in SLE Patients Given AKMB-3031 or Placebo For 24 Weeks (Randomized Period) and Followed by an Open Label Extension (OLE) Treatment with AKBM-3031 for the Next 24 Weeks

News

• Steroid Use Higher than Expected in Patients with Lupus
• Fall 2021 Update: 7 Things We Now Know About COVID-19 Vaccines in Rheumatic Disease Patients
• Newly Approved Lupus Drug Based on Discoveries Made in HSS Lab
• New lupus drug with fewer side effects approved by FDA

Publications

Below are selected publications that resulted from our involvement in clinical trials.

• FDA approval for anifrolumab in patients with lupus
• Phase II Randomized Trial of Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis 
• Trial of Anifrolumab in Active Systemic Lupus Erythematosus 
• Safety and pharmacodynamics of rontalizumab in patients with systemic lupus erythematosus: Results of a phase I, placebo-controlled, double-blind, dose-escalation study 
• Safety profile and clinical activity of sifalimumab, a fully human anti-interferon α monoclonal antibody, in systemic lupus erythematosus: a phase I, multicentre, double-blind randomised study
• Correction of omega-3 fatty acid deficiency and improvement in disease activity in patients with systemic lupus erythematosus treated with krill oil concentrate: a multicentre, randomised, double-blind, placebo-controlled trial