Lupus Interventional Clinical Trials Program

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.

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)
• SHIELD Study (IRB # 2023-0408)

  • A Phase III, Randomized, Double-Blind Placebo-Controlled, Non-Inferiority, Multi-Center Study of the Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease (SHIELD)

Completed, Non-Enrolling Trials

• A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants with Moderately To Severely Active Systemic Lupus Erythematosus
• 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

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