Abstracts tagged "clinical trial"

Abstract Number: 0644 • ACR Convergence 2025
Improvement of Fatigue, Musculoskeletal Pain, and Morning Stiffness in Patients with Systemic Lupus Erythematosus Treated with Dapirolizumab Pegol: 48-Week Results from a Phase 3 Trial
Ioannis Parodis¹, Caroline Gordon², Joan Merrill³, Matthias Schneider⁴, Zahi Touma⁵, Teri Jimenez⁶, Thomas Morel⁷, Mina Nejati⁸, Christian Stach⁹, Christine de La Loge¹⁰ and Laurent arnaud¹¹, ¹Karolinska Institutet and Karolinska University Hospital, Department of Medicine Solna, Division of Rheumatology, Stockholm, Sweden, ²Department of Inflammation and Ageing, College of Medicine and Health, University of Birmingham, Birmingham, United Kingdom, ³Oklahoma Medical Research Foundation, Oklahoma City ⁷³¹⁰⁴, OK, ⁴Clinic of Rheumatology and Hiller Research Unit, Heinrich-Heine-University, Düsseldorf, Germany, ⁵University of Toronto, Toronto, ON, Canada, ⁶UCB, Raleigh, NC, ⁷UCB, Basel, Switzerland, ⁸Biogen, Cambridge, MA, ⁹UCB, Monheim am Rhein, Germany, ¹⁰UCB, Brussels, Belgium, ¹¹Service de rhumatologie, Hôpitaux Universitaires de Strasbourg, INSERM UMR-S ¹¹⁰⁹, Strasbourg, France, Strasbourg, France
Background/Purpose: Fatigue, musculoskeletal pain, and joint stiffness are common manifestations of SLE, presenting considerable treatment challenges, particularly in addressing chronic fatigue. Dapirolizumab pegol (DZP) is…
Abstract Number: 0852 • ACR Convergence 2025
LEVI-04 Significantly Reduces Bone Marrow Lesions and Symptoms in Knee Osteoarthritis: Results from a Phase II RCT
Simon Westbrook¹, Ali Guermazi² and Philip Conaghan³, ¹Levicept Ltd, Sandwich, United Kingdom, ²Boston University, West Roxbury, MA, ³University of Leeds, Leeds, United Kingdom
Background/Purpose: Bone marrow lesions (BMLs), detectable on MRI as areas of ill-defined high signal intensity on fluid-sensitive sequences, are a common feature of osteoarthritis (OA),…
Abstract Number: 0482 • ACR Convergence 2025
R-2487, a Synthetic Biology-Based Oral Immunotherapy, Promotes Treg-Mediated Immune Rebalancing and Reduces Disease Activity in Rheumatoid Arthritis Patients
Christian Furlan Freguia¹, Janet Stephens¹, Sathya Janardhanan¹, Chuck Bourne¹, Kaitlyn Skeie¹, Hudson Lowe¹, David Pascual² and Gary Fanger¹, ¹Rise Therapeutics, Rockville, MD, ²University of Wyoming, Laramie, WY
Background/Purpose: R-2487 is a novel, orally delivered, synthetic biology-based immunotherapy that utilizes Lactococcus lactis as a carrier vehicle to deliver Colonization Factor Antigen I (CFA/I)…
Abstract Number: 1506 • ACR Convergence 2025
Perspectives on Clinical Trial Participation for Novel Advanced Therapies: A Focus Group Study in Systemic Lupus Erythematosus (SLE)
Olivia A. Stein¹, Jennifer Lee¹, Evelyne Vinet², Arielle Mendel³, Christian Pineau⁴, Leanne Mielczarek⁵ and Sasha Bernatsky², ¹Research Institute of the McGill University Health Centre, Montreal, Canada, ²Research Institute of the McGill University Health Centre, Montreal, QC, Canada, ³McGill University Health Centre, Montreal, Canada, ⁴McGill University, Montréal, QC, Canada, ⁵Lupus Canada, Newmarket, Canada
Background/Purpose: Our objective is to identify barriers and facilitators perceived by people with systemic lupus erythematosus (SLE) regarding participation in clinical trials for novel/advanced agents,…
Abstract Number: 2697 • ACR Convergence 2025
A Prospective Randomized Controlled 96-week Study to Evaluate the Efficacy and Safety of Tacrolimus and Glucocorticoid as Continuous Induction-Maintenance Treatment for Class III/IV±V Lupus Nephritis
Sandra Navarra¹, Desmond Yat-Hin Yap², Zhaohui Ni³, Yingyos Avihingsanon⁴, Soo Kun Lim⁵, Na Jiang³, Wei Chen⁶, Chao Li⁷, Helen Zhi⁸, Chenzhu Zhang⁹, Catherine Chan², Susan Yung², Tsutomu Takeuchi¹⁰ and Tak Mao Daniel Chan², ¹University of Santo Tomas, Manila, Philippines, ²Department of Medicine, The University of Hong Kong, Hong Kong SAR, Hong Kong, ³Renji Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China (People's Republic), ⁴King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, Thailand, ⁵Department of Medicine, University Malaya Medical Centre, Kuala Lumpur, Malaysia, ⁶Department of Nephrology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China (People's Republic), ⁷Department of Nephrology, Peking Union Medical College Hospital, Beijing, China (People's Republic), ⁸School of Public Health, The University of Hong Kong, Hong Kong SAR, Hong Kong, ⁹Department of Medicine, University of Hong Kong-Shenzhen Hospital, Shenzhen, China (People's Republic), ¹⁰Saitama Medical University and Keio University, Tokyo, Japan
Background/Purpose: Tacrolimus (TAC) and glucocorticoid as continuous induction-maintenance therapy for lupus nephritis (LN) has never been investigated. We conducted a prospective randomized open-label multicenter study…
Abstract Number: 2458 • ACR Convergence 2025
Obecabtagene autoleucel (obe-cel), a CD19-targeting Autologous Chimeric Antigen Receptor T-cell Therapy (CAR T) with a fast off-rate binding domain, in Patients (pts) with Severe, Refractory Systemic Lupus Erythematosus (srSLE): Preliminary Results from the Phase I CARLYSLE Study
Maria Leandro¹, Ruth Pepper², Ben Parker³, Eleni Tholouli⁴, David Jayne⁵, Ben Uttenthal⁶, Josefina Cortés-Hernández⁷, Pere Barba⁷, José Andrés Román Ivorra⁸, Yanqing Hu⁹, Wolfram Brugger¹⁰, Silvia Basilico¹¹, Davide Germano¹¹ and Claire Roddie¹, ¹University College London and University College London Hospital, London, United Kingdom, ²University College London, University College London Hospital and Royal Free Hospital NHS Trust, London, United Kingdom, ³NIHR Manchester CRF, Manchester Royal Infirmary, Manchester, United Kingdom, ⁴Manchester Royal Infirmary, Manchester, United Kingdom, ⁵University of Cambridge, Cambridge, United Kingdom, ⁶Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom, ⁷Hospital Universitari Vall d’Hebron-Universitat Autónoma de Barcelona, Barcelona, Spain, ⁸Hospital Universitari i Politècnic La Fe, Valencia, Spain, ⁹Autolus Therapeutics, Rockville, MD, ¹⁰Autolus Therapeutics, Munich, Germany, ¹¹Autolus Therapeutics, Basel, Switzerland
Background/Purpose: Pts with srSLE have limited remaining treatment options and represent a population with an unmet need. CD19 CAR Ts have potential for deep depletion…
Abstract Number: 2341 • ACR Convergence 2025
Bimekizumab Treatment Resulted in Long-Term Sustained Reductions in Disease Impact Assessed by the Psoriatic Arthritis Impact of Disease (PsAID)-12 Questionnaire in Patients with Active Psoriatic Arthritis: Up to 3-Year Results from Two Phase 3 Studies
Ana-Maria Orbai¹, Dafna D. Gladman², Laura Coates³, Maarten de Wit⁴, Barbara Ink⁵, Rajan Bajracharya⁵, Patrick Healy⁶, Jérémy Lambert⁷ and Laure Gossec⁸, ¹Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, ²Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Division of Rheumatology, Toronto, ON, Canada, ³Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom, ⁴Patient Research Partner, Stichting Tools, Amsterdam, Netherlands, ⁵UCB, Slough, England, United Kingdom, ⁶UCB, Morrisville, NC, ⁷UCB, Colombes, France, ⁸Sorbonne Universite and Pitie-Salpetriere Hospital, Paris, France
Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. The PsA Impact of Disease-12 (PsAID-12) questionnaire is…
Abstract Number: 2035 • ACR Convergence 2025
Interim Phase 1 Results for SPY002, a Novel Half-Life Extended Monoclonal Antibody Targeting TL1A, Suggest A Potential for Q3M or Q6M Maintenance Dosing for Rheumatologic Disease
Joshua Friedman¹, JD Lu², Bing Wang², Kinjal Hew², Preeyam Patel², Michael Kennedy², Mark Rose², Curtis Sheldon², Rachel McLean², Emily Svejnoha², MiRa Huyghe¹, Brian Connolly² and Deanna Nguyen², ¹Spyre Therapeutics, Waltham, MA, ²Spyre Therapeutics, Waltham
Background/Purpose: TL1A is an inflammatory cytokine and a member of the TNF superfamily. Target cells that express DR3 and respond to TL1A include T cells,…
Abstract Number: 1594 • ACR Convergence 2025
Two-Year Efficacy of Anti-Interleukin-5/Receptor Therapies According to Anti-Neutrophil Cytoplasmic Antibodies Status in Patients with Eosinophilic Granulomatosis with Polyangiitis
Benjamin Terrier¹, David Jayne², Bernhard Hellmich³, Nancy Agmon-Levin⁴, Parameswaran Nair⁵, Lena Börjesson Sjö⁶, Priya Jain⁷, Aadarsh Lal⁸, Sofia Necander⁹, Claire Walton¹⁰, Peter Merkel¹¹ and Michael Wechsler¹², ¹Cochin Hospital, Paris, France, ²University of Cambridge, Cambridge, United Kingdom, ³Klinik für Innere Medizin, Rheumatologie, Pneumologie, Nephrologie und Diabetologie, Medius Kliniken, Akademisches Lehrkrankenhaus der Universität Tübingen, Kirchheim unter Teck, Germany, ⁴Clinical Immunology, Angioedema and Allergy, Sheba Medical Center, Ramat Gan, Israel, ⁵Department of Medicine, McMaster University and St. Joseph’s Healthcare, Hamilton, ON, Canada, ⁶Late-stage Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca,, Gothenburg, Sweden, ⁷BioPharmaceuticals Medical, AstraZeneca, Cambridge, United Kingdom, ⁸Respiratory & Immunology, AstraZeneca, Bengaluru, Karnataka, India, ⁹Late-stage Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ¹⁰Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, ¹¹University of Pennsylvania, Philadelphia, PA, ¹²Department of Medicine, National Jewish Health, Denver
Background/Purpose: The MANDARA trial (NCT04157348) demonstrated that after two years of anti-interleukin-5/receptor (anti-IL-5/R) therapy over 60% of patients with relapsing or refractory eosinophilic granulomatosis with…
Abstract Number: 1451 • ACR Convergence 2025
Bimekizumab was Efficacious Regardless of Age, BMI, CRP, or HLA-B27 Status: 1-Year Results from Two Phase 3 Studies
Marina Magrey¹, Helena Marzo-Ortega², Yuho Kadono³, David Nicholls⁴, Martin Rudwaleit⁵, Atul Deodhar⁶, Gaëlle Varkas⁷, Chetan Prajapati⁸, Sarah Kavanagh⁹ and Victoria Navarro-Compan¹⁰, ¹Case Western Reserve University School of Medicine/University Hospitals Cleveland, Richfield, OH, ²NIHR Leeds Biomedical Research Centre, The Leeds Teaching Hospitals NHS Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), University of Leeds, Leeds, United Kingdom, ³Department of Orthopaedic Surgery, Saitama Medical University, Saitama, ⁴Clinical Trials Unit, University of the Sunshine Coast, Queensland, Australia, ⁵Bielefeld University, Medical School and University Medical Centre OWL, Klinikum Bielefeld, Department of Rheumatology, Bielefeld, Germany, ⁶Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ⁷Department of Rheumatology, Ghent University Hospital, Ghent, Belgium, ⁸UCB, Slough, United Kingdom, ⁹UCB, Morrisville, NC, ¹⁰Department of Rheumatology, La Paz University Hospital, IdiPaz, Madrid, Spain
Background/Purpose: Bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)‑17F in addition to IL-17A, has shown efficacy to Week (Wk) 52 in patients…
Abstract Number: 1123 • ACR Convergence 2025
Nanoencapsulated Sirolimus plus Pegadricase (NASP) Demonstrates Long Term Efficacy and Safety in Patients with Uncontrolled Gout: Results from the 24-week Double-blind Extension of the Phase 3 DISSOLVE I Study
Alan Kivitz¹, Atul Singhal², Anand Patel³, Rehan Azeem⁴, Ben Peace⁵, Bhavisha Desai⁶ and Herbert Baraf⁷, ¹Altoona Center for Clinical Research, Duncansville, PA, ²SouthWest Arthritis Research Group, Mesquite, TX, ³Conquest Research, Winter Park, FL, USA, Winter Park, FL, ⁴Global MACD, Sobi Inc., Waltham, MA, ⁵Statistical Science, Sobi, Stockholm, Sweden, ⁶Sobi, Glastonbury, CT, ⁷The Center for Rheumatology and Bone Research, Rheumatology, Wheaton, Maryland, USA; Division of Rheumatology, The George Washington University, Washington, DC
Background/Purpose: Uncontrolled gout (UG) occurs when serum uric acid (sUA) levels remain persistently elevated despite use of oral urate-lowering therapies and can result in progressively…
Abstract Number: 0641 • ACR Convergence 2025
Safety and efficacy of autologous CD19-CAR T-cell therapy in patients with autoimmune disease – data from the CASTLE Phase I/II basket study
Melanie Hagen¹, Andreas Wirsching¹, Fabian Müller², Soraya Kharboutli³, Christina Bergmann¹, Sebastian Böltz¹, Jule Taubmann⁴, Carlo Tur¹, Laura Bucci¹, Simon Völkl³, Michael Aigner³, Sascha Kretschmann³, Louis Schuster⁴, Koray Tascilar⁴, Silvia Spoerl³, Ingrid Vasova³, Panagiotis Garantziotis¹, Daniel Aletaha⁵, Hans-Peter Kiener⁶, gerlando Natalello⁷, Franco Locatelli⁸, Maria Antonietta D'Agostino⁹, Aline Bozec¹, Linda Hanssens¹⁰, Dirk De Vries¹⁰, Ricardo Grieshaber-Bouyer¹¹, Andreas Mackensen¹² and Georg Schett¹³, ¹Department of Medicine ³ - Rheumatology and Immunology, Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg and Uniklinikum Erlangen, Erlangen, Germany, ²University Hospital of Erlangen, Erlangen, Germany, ³Department of Medicine ⁵ - Hematology and Oncology, Friedrich-Alexander-Universität Erlangen-Nürnberg and University Hospital Erlangen, Erlangen, Germany, ⁴Department of Medicine ³ - Rheumatology and Immunology, Friedrich-Alexander-Universität Erlangen-Nürnberg and University Hospital Erlangen, Erlangen, Germany, ⁵Medical University Vienna, Wien, Austria, ⁶Medical University of Vienna, Vienna, Austria, Vienna, Austria, ⁷Division of Rheumatology and Clinical Immunology - Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy, ⁸IRCCS Ospedale Pediatrico Bambino Gesù, Rome, Italy, Rome, Italy, ⁹Catholic University of the Sacred Heart, Rome, Rome, Italy, ¹⁰Miltenyi Biomedicine, Bergisch Gladbach, Bergisch Gladbach, Germany, ¹¹University Hospital Erlangen, Erlangen, Germany, ¹²Department of Medicine ⁵ - Hematology and Oncology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) and Uniklinikum Erlangen, Erlangen, Germany, ¹³Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Germany, Erlangen, Germany
Background/Purpose: Engineered T cells expressing a chimeric antigen receptor (CAR) binding CD19 are powerful tools to deplete B-cells, representing an attractive therapy for severe autoimmune…
Abstract Number: 0843 • ACR Convergence 2025
Efficacy and Safety of BMS-986353, a CD19-Directed Chimeric Antigen Receptor T Cell Therapy Manufactured Using a Next-Generation Process: Updated Data From a Phase 1 Trial in Patients With Systemic Sclerosis
Dinesh Khanna¹, David Korman², Elana Bernstein³, Neil Kramer⁴, Vikas Majithia⁵, Philip J. Mease⁶, Georg Schett⁷, Jacques Azzi⁸, Richard Nash⁹, Ran Reshef³, Mohammad Cherry¹⁰, Ernesto Ayala⁵, Matthew Schwede¹¹, Monalisa Ghosh¹², Fabian Müller¹³, Alisha Desai¹⁴, San-San Ou¹⁵, Sharmila Das¹⁴, Jerill Thorpe¹⁶, Melissa Harnois¹⁴, Alexis Melton¹⁶, Ashley Koegel¹⁶ and Margrit Wiesendanger⁸, ¹University of Michigan, Ann Arbor, MI, ²Mountain Rheumatology, Denver, CO, ³Columbia University Irving Medical Center, New York, NY, ⁴Overlook Medical Center; Atlantic Medical Group, Atlantic Health System, Summit, NJ, ⁵Mayo Clinic Hospital, Jacksonville, FL, ⁶Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ⁷Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Germany, Erlangen, Germany, ⁸Icahn School of Medicine at Mount Sinai, New York, NY, ⁹Health One Cares, Denver, CO, ¹⁰Atlantic Health System, Morristown, NJ, ¹¹Swedish Cancer Institute, Seattle, WA, ¹²C. S. Mott Children's Hospital University of Michigan Health, Ann Arbor, MI, ¹³University Hospital of Erlangen, Erlangen, Germany, ¹⁴Bristol Myers Squibb, Princeton, NJ, ¹⁵Bristol Myers Squibb, Seattle, WA, ¹⁶Bristol Myers Squibb, Princeton
Background/Purpose: BMS-986353 (CC-97540) is an investigational CD19-directed T-cell therapy expressing the chimeric antigen receptor (CAR) used in globally-approved lisocabtagene maraleucel; it is manufactured via the…
Abstract Number: 0473 • ACR Convergence 2025
A Phase 2b Dose-Ranging Study of Peresolimab for Adults with RA
Jay Tuttle¹, Kirstin Griffing², Mark Genovese², Hyungmin Rha², So Young Park², Pia Yachi¹, Ajay Nirula¹, LANCE PFEIFER², Tami Jo Rayle², Jesus Abraham Simón-Campos³, Clifton Bingham⁴, Kevin Winthrop⁵, Daniel Aletaha⁶, Iain McInnes⁷, Yu Xue⁸, Yoshiya Tanaka⁹, Roy Fleischmann¹⁰, Paul Emery¹¹ and Michael Weinblatt¹², ¹Lilly Biotechnology Center, San Diego, CA, ²Eli Lilly and Company, Indianapolis, IN, ³Köhler & Milstein Research, UADY School of Medicine, Merida, Yucatan, Mexico, ⁴Johns Hopkins University, Baltimore, MD, ⁵Oregon Health & Science University, Portland, OR, ⁶Medical University Vienna, Wien, Austria, ⁷University of Glasgow, Glasgow, United Kingdom, ⁸Huashan Hospital, Fudan University, Shanghai, China (People's Republic), ⁹University of Occupational and Environmental Health, Japan, Kitakyushu, Japan, ¹⁰Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, ¹¹University of Leeds, Leeds, England, United Kingdom, ¹²Brigham and Women's Hospital, Boston, MA
Background/Purpose: Peresolimab, a humanized IgG1 mAb, activates programmed cell death protein 1. In a phase 2a study, peresolimab demonstrated efficacy in participants (pts) with RA…
Abstract Number: 2694 • ACR Convergence 2025
Effect of Deucravacitinib Treatment on Renal Dysfunction–Associated Plasma Biomarkers From a Phase 2 Study in Patients With Systemic Lupus Erythematosus
Amit Saxena¹, Chun Wu², Brad Rovin³, Zahi Touma⁴, Xueer Chen⁵, Ilias Kouris⁶ and Jinqi Liu⁵, ¹Division of Rheumatology, Department of Medicine, NYU Grossman School of Medicine, New York, NY, ²Bristol Myers Squibb, Princeton, ³The Ohio State University, Columbus, OH, ⁴University of Toronto, Toronto, ON, Canada, ⁵Bristol Myers Squibb, Princeton, NJ, ⁶Bristol Myers Squibb, Boudry, Switzerland
Background/Purpose: Plasma biomarkers may play a role in understanding kidney health in patients with lupus, particularly in terms of early detection of lupus nephritis (LN),…

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