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.
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
Director of Program
Kyriakos Kirou, MD, DSc, FACP
212.606.1728
Investigators
David Fernandez, MD, PhD
212.606.1501
Romy Kallas, MD
kallasr@hss.edu
Sarah Lieber, MD, MS
212.606.1935
Timothy B. Niewold, MD, FACR
646.797.8421
Lauren Ambler Robinson, MD
212.606.1360
Manager, Lupus and APS Center of Excellence
Allyson Peysner
646.714.6036; peysnera@hss.edu
Coordinators
Noel Ermer
212.774.2223; ermern@hss.edu
Christele Felix
646.714.6196; felixc@hss.edu
Natasha Zarrin
212.774.2967; zarrinn@hss.edu
Enrolling Trials for Active Lupus Patients
- Systemic Lupus Erythematosus (SLE) Treatment with N-acetylcysteine (NAC) (SNAC) - SUNY SNAC (IRB # 2021-1594)
- 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) - BMS POETYK (IRB # 2023-0229)
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A Phase III, Randomized, Double-Blind Placebo-Controlled, Non-Inferiority, Multi-Center Study of the Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease (SHIELD) - SHIELD Study (IRB # 2023-0408)
- A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of Ianalumab on Top of Standard-of-Care Therapy in Participants with Active Lupus Nephritis (SIRIUS-LN)
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
Webinars and Videos




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
Lupus and APS Center in the News
- Past ACR President Named a PANLAR Master
- A Cutting-Edge Cancer Therapy Offers Hope for Patients With Lupus
- HSS Study at EULAR 2025 Congress Uses an AI Model to Predict Readmissions of Pregnant Women with Lupus Based on Social Determinants of Health
- My Lupus Symptoms Went Away During Pregnancy—but Returned With a Vengeance Postpartum
- Pregnant mothers with lupus face risks but have better outlooks than ever before, doctor says
- Social Isolation a Common Theme Among Older People With SLE
- Need Help With Lupus Nephritis Management? ACR Has Your Back
- 2024 Lupus Guideline
- Lupus Research Alliance Grants Lupus Innovation Awards to Eleven Talented Researchers to Accelerate Pace of Discovery in Lupus Research
- 9 Essential Questions to Ask About Managing Lupus
- HSS Participates in Promising Phase 3 Lupus Trial of Investigational Therapy DZP
- HSS Presents New Research at the ACR Convergence 2024
- What to Know About How Lupus Affects Weight
- Lupus Research Alliance Announces Inaugural Recipients of Translational Bridge Award
- Lupus research focusing on earlier diagnoses, HSS chief doctor says
- Direct-to-Consumer Rheumatologic Tests Carry Some Benefit but Plenty of Potential Risk
- Making Sense of the Connection Between Vaccines and Lupus Flares
- Challenges of designing and conducting cohort studies and clinical trials in populations of pregnant people
- Understanding lupus processes helps identify ‘important targets’ for intervention
- Steroid Use Higher than Expected in Patients with Lupus
- Interferons in Systemic Lupus Erythematosus
- APOL1 High-Risk Genotype in SLE: A Genes in Context Story
- HSS Presents New Reproductive Health Research at the ACR Convergence 2023
- New Antiphospholipid Syndrome Research Findings Presented at ACR Convergence 2023
- Studying the ‘Dark Matter’ of the Genome May Reveal a Deeper Understanding of Lupus
- What Drives Lupus and What are Potential Treatment Approaches?
- Lupus During Pregnancy Carries Higher Maternal, Fetal Morbidity Risks
- How to Navigate Pregnancy With Lupus
- Nadler Announces Over $24 Million in Funding for Hospitals on Manhattan’s East Side
- Experts share real-world experience prescribing voclosporin, belimumab for lupus nephritis
- HSS Research Institute and The University of Utah Receive NIH Grant to Continue Groundbreaking Study on Pregnant Patients with Antiphospholipid Syndrome Patients with or without Lupus
- Hospital for Special Surgery Research Institute Awarded Two New Grants to Study Potential Causes of Lupus Flares
- Fall 2022’s Awards, Appointments & Announcements in Rheumatology
- HSS Research Uncovers How UV Light Triggers Immune Activation and Disease Flares in Lupus
- Study Finds Chronic-Pain Management, Falls and Limited Access to Care Are Critical Issues Among Medically Underserved
- Cytokines and Rheumatic Diseases
- Participation Doubles After Lupus Support Group at HSS Transitions to Virtual Format During Pandemic
- HSS Presents New Research at the ACR Convergence 2022
- HSS Rheumatologists, Social Worker Honored by American College of Rheumatology
- Lupus, coronary artery disease share genetic risk factors; data may lead to early testing
- CBS Saturday Morning
- In Small Study, CAR-T Therapy Pushes Lupus Into Remission
- Women In Wellness: Dr. Ashira Blazer of Hospital for Special Surgery (HSS) On The Five Lifestyle Tweaks That Will Help Support People’s Journey Towards Better Wellbeing
- Lupus, MS and Other Autoimmune Disorders Raise Heart Risks
- Overcoming the Uncertainties of Living with Chronic Diseases like Lupus
- Preterm delivery nearly twice as common in patients with lupus vs. general population
- Study Underscores Importance of Multidisciplinary Medical Team for Pregnant Women with Lupus
- HSS Presents New Research at the EULAR 2022 Congress
- Q&A: Body image concerns in lupus leave patients feeling ‘betrayed,’ ‘out of control’
- Interview with Eliza Ngan-Dittgen, LANtern® at HSS for Asian American Pacific Islander Heritage Month