Hospital for Special Surgery Logo
phone 1.212.606.1000
Make an Appointment
1.212.606.1000 Make an Appointment

Lupus Interventional Clinical Trials Program

Addressing the unmet need to develop safe, effective, and long-lasting lupus treatments.

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. 

Research Highlight

Lupus Leaders

HSS Participates in Promising Phase 3 Lupus Trial of Investigational Therapy DZP

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
212.606.1977

Sarah Lieber, MD, MS
212.606.1935

Timothy B. Niewold, MD, FACR
646.797.8421

Lauren Ambler Robinson, MD
212.606.1360  

Lisa R. Sammaritano, MD
212.606.1978

Caroline Siegel, MD, MS
212.606.1483

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

Trial/Study
Principal Investigator
IRB #
Safety and Efficacy of ONT0l in Lupus
Timothy B. Niewold, MD, FACR
2024-0364
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 (IRB # 2022-0360)
Kyriakos A. Kirou, MD, DSc, FACP
2022-0360
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)
Kyriakos A. Kirou, MD, DSc, FACP
2023-2124
A Phase III, Randomized, Double-Blind Placebo-Controlled, Non-Inferiority, Multi-Center Study of the Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease (SHIELD)
Caroline H. Siegel, MD, MS
2023-0408
Systemic Lupus Erythematosus (SLE) Treatment with N-acetylcysteine (NAC) (SNAC)
Kyriakos A. Kirou, MD, DSc, FACP
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)
Kyriakos A. Kirou, MD, DSc, FACP
2023-0229

Completed Non-Enrolling Trials

Trial/Study
Principal Investigator
IRB #
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
Kyriakos A. Kirou, MD, DSc, FACP
2020-1776
A Phase 2B, Dose Ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with SLE
Kyriakos A. Kirou, MD, DSc, FACP
11113
Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis: a Randomized, Controlled Phase 2 Open Label Multicenter Study
Kyriakos A. Kirou, MD, DSc, FACP
2015-038
Nelfinavir in Systemic Lupus Erythematosus: A Pilot Phase IIa Clinical Trial
Kyriakos A. Kirou, MD, DSc, FACP
2014-337
A Phase 1 Double Blind, Randomized, Single Ascending Dose Study of the Safety and Tolerability of MEDI 570 in SLE
Kyriakos A. Kirou, MD, DSc, FACP
10117
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
Kyriakos A. Kirou, MD, DSc, FACP
2015-777
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
Kyriakos A. Kirou, MD, DSc, FACP
2020-0197
A Randomized, Double-Blind Controlled, Multicenter Study in SLE Patients Given AKBM-3031or Placebo For 24 Weeks (Randomized Period) and Followed by an Open Label Extension (OLE) Treatment with AKBM-3031 for the Next 24 Weeks
Kyriakos A. Kirou, MD, DSc, FACP
2018-1099
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
Kyriakos A. Kirou, MD, DSc, FACP
2018-0567
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
Kyriakos A. Kirou, MD, DSc, FACP
2020-0226
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...
Kyriakos A. Kirou, MD, DSc, FACP
13126

Webinars and Videos

YouTube video thumbnail
YouTube video thumbnail
YouTube video thumbnail
YouTube video thumbnail

Publications

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

Lupus and APS Center in the News