Abstracts tagged "clinical trial"

Abstract Number: 0645 • ACR Convergence 2025
Achievement of Low Disease Activity and Remission in Patients with Systemic Lupus Erythematosus Treated with Dapirolizumab Pegol: 48-Week Results from a Phase 3 Trial
Eric Morand¹, Lucy Carter², Maria Dall'Era³, Michelle Petri⁴, Ed Vital⁵, Teri Jimenez⁶, Janine Gaiha-Rohrbach⁷, Bernard Lauwerys⁸, Annette Nelde⁹, Christian Stach¹⁰ and Ronald van Vollenhoven¹¹, ¹Centre for Inflammatory Diseases, Monash University and Monash Health, Melbourne, Victoria, Australia, ²Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, ³Division of Rheumatology, University of California, San Francisco, CA, ⁴Johns Hopkins University School of Medicine, Timonium, MD, ⁵University of Leeds, Leeds, England, United Kingdom, ⁶UCB, Raleigh, NC, ⁷Biogen, Cambridge, MA, ⁸Systemic and Inflammatory Rheumatic Diseases Section, Institute of Experimental and Clinical Research (IREC), UCLouvain, Brussels, Belgium, ⁹Biogen, Baar, Switzerland, ¹⁰UCB, Monheim am Rhein, Germany, ¹¹Department of Rheumatology, Amsterdam University Medical Centre, Amsterdam, Netherlands
Background/Purpose: Dapirolizumab pegol (DZP) is a novel CD40L inhibitor with broad modulatory effects on SLE immunopathology;1,2 it consists of a polyethylene glycol (PEG)-conjugated antigen-binding fragment…
Abstract Number: 0855 • ACR Convergence 2025
Certolizumab Pegol to Prevent Adverse Pregnancy Outcomes in Patients with Antiphospholipid Syndrome and Lupus Anticoagulant (IMPACT): Results from Ongoing Recruitment of a Prospective, Single-Arm, Open-Label, Phase 2 Trial
Jane Salmon¹, Mimi Kim², Marta Guerra¹, Joseph Worden³, Carl Laskin⁴, Maria DeSancho⁵, Inna Landres⁵, Jason S. Knight⁶, Haley Slosberg¹, Margaret Minett¹ and Ware Branch⁷, ¹Hospital for Special Surgery, New York, NY, ²Albert Einstein College of Medicine, Bronx, NY, ³University of Utah School of Medicine, Salt Lake City, ⁴University of Toronto, Toronto, ON, Canada, ⁵Weill Cornell Medicine, New York, ⁶University of Michigan, Ann Arbor, MI, ⁷University of Utah Health Sciences Center, Salt Lake City, UT
Background/Purpose: The IMPACT trial (NCT03152058) showed that certolizumab appears effective in preventing placenta-mediated adverse pregnancy outcome (APO) in high-risk antiphospholipid syndrome (APS) patients. We have…
Abstract Number: 0484 • ACR Convergence 2025
Comparable Efficacy of FK-Tocilizumab and Reference Tocilizumab in Rheumatoid Arthritis Patients With and Without Prior Biologic Exposure
Ernest Choy¹, Marco Gattorno², Kamila Klama³, Andras Illes⁴, Peter Baker⁵, Maria Romanova Michailidi⁶ and Anna Zubrzycka-Sienkiewicz⁷, ¹Division of Infection and Immunity, CREATE Centre, Cardiff University, Cardiff, United Kingdom, ²IRCCS G. Gaslini, Genova, Genoa, Italy, ³Solumed Clinical Research Center, Poznan, Poland, ⁴Fresenius Kabi SwissBioSim, Eysin, Switzerland, ⁵Fresenius Kabi Biopharma, Eysins, Switzerland, ⁶University of Geneva, Eysins, Switzerland, ⁷Reumatika - Centrum Reumatologii, Warszawa, Poland
Background/Purpose: Biosimilars offer comparable efficacy and safety to their originators, thereby improving patient access to affordable treatments. FK-Tocilizumab (FK-toci) is the first tocilizumab biosimilar approved…
Abstract Number: 0257 • ACR Convergence 2025
Safety of Guselkumab in Inflammatory Bowel Disease Up to 1 Year: Integrated Safety Analysis of Phase 2 and 3 Studies in Crohn’s Disease and Ulcerative Colitis
Bruce E. Sands¹, Remo Panaccione², Silvio Danese³, Julián Panés⁴, Tadakazu Hisamatsu⁵, Geert D’Haens⁶, Rian Van Rampelbergh⁷, Mobolaji Olurinde⁸, Jacqueline Yee⁸, Karissa Lozenski⁹, Thomas Baker⁸, Shadi Yarandi⁸, Matthew Germinaro⁸, Marion L. Vetter⁸, Hewei Li⁸, Mauricio Rosas Ballina¹⁰, Jessica R. Allegretti¹¹, Anita Afzali¹² and David T. Rubin¹³, ¹Icahn School of Medicine at Mount Sinai, New York, NY, USA, NY, ²University of Calgary, Calgary, AB, Canada, AB, Canada, ³Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy, Milano, Italy, ⁴Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain, Barcelona, Spain, ⁵Kyorin University School of Medicine, Tokyo, Japan, Tokyo, Japan, ⁶Amsterdam University Medical Centers, Amsterdam, The Netherlands, D’Haens, Swaziland, ⁷Johnson & Johnson, Antwerp, Belgium, Antwerp, Belgium, ⁸Johnson & Johnson, Spring House, PA, USA, PA, ⁹Johnson & Johnson, Horsham, PA, ¹⁰Actelion Research & Development, Allschwil, Switzerland, Allschwil, Switzerland, ¹¹Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA, MA, ¹²University of Cincinnati, College of Medicine, Cincinnati, OH, USA, OH, ¹³University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL, USA, IL
Background/Purpose: Guselkumab (GUS), a dual-acting interleukin (IL)-23 inhibitor that potently neutralizes IL-23 and binds to CD64 (a receptor on cells that produce IL-23), is currently…
Abstract Number: 2464 • ACR Convergence 2025
IMC-002 (IMM0306), a First-in-Class Bi-specific Fusion Protein, Demonstrates Improvements in Systemic Lupus Erythematosus (SLE) Disease Activity Measures and Biomarkers in Patients with Moderate to Severe Active SLE in the Open-label Phase 1b/2 Study
Haihong Yao¹, Wenzhi Tian², Qian Zheng², Min Chen², Guoping Jiang³, Zhichun Liu⁴, Yingkun Nie⁵, Rui Wu⁶, Zhaohui Zheng⁷ and Zhanguo Li¹, ¹Peking University People's Hospital, Beijing, China (People's Republic), ²ImmuneCare Biopharmaceuticals (Shanghai) Co.,Ltd, Shanghai, China (People's Republic), ³Jilin Province People's Hospital, Changchun, China (People's Republic), ⁴The Second Affiliated Hospital of Soochow, Suzhou, China (People's Republic), ⁵The Second Affiliated Hospital of Harbin Medical University, Haerbin, China (People's Republic), ⁶The First Affiliated Hospital of Nanchang University, Nanchang, China (People's Republic), ⁷The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China (People's Republic)
Background/Purpose: Deep B cell depletion has been confirmed to be the main mechanism for complete clinical response of SLE patients. We analyzed the peripheral blood…
Abstract Number: 2347 • ACR Convergence 2025
Bimekizumab Treatment Resulted in Patients with Axial Spondyloarthritis Maintaining Their Clinical Responses Over 3 Years: Results from Two Phase 3 Studies and Their Open-Label Extension
Fabian Proft¹, Désirée Van Der Heijde², Sergio Schwartzman³, Vanessa Taieb⁴, Sarah Kavanagh⁵, Gaëlle Varkas⁶, Victoria Navarro-Compan⁷ and Xenofon Baraliakos⁸, ¹Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany, ²Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ³Weill Cornell Medical Center, New York Presbyterian Hospital, and Hospital for Special Surgery, New York, NY, ⁴UCB, Colombes, France, ⁵UCB, Morrisville, NC, ⁶Department of Rheumatology, Ghent University Hospital, Ghent, Belgium, ⁷Department of Rheumatology, La Paz University Hospital, IdiPaz, Madrid, Spain, ⁸Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany
Background/Purpose: Axial spondyloarthritis (axSpA) is a chronic inflammatory disease which requires optimal management.1 In clinical trials, Assessment of SpondyloArthritis international Society ≥40% improvement (ASAS40) is…
Abstract Number: 2082 • ACR Convergence 2025
Pharmacokinetic Profile of MM-II Following a Single Intra-Articular Injection in Patients with Knee Osteoarthritis in a Phase 2b Randomized, Controlled, Dose-Ranging Trial
Thomas Schnitzer¹, Xavier Chevalier², Helene Rovsing³, Edith Lau⁴, Sidsel Boll⁵, Ballari Brahmachari⁶, Richard Chou⁷, Tarini Joshi⁸, Roni Wechsler⁹, Sveta Weiner¹⁰, Mudgal Kothekar¹¹, Asger Bihlet¹² and Philip Conaghan¹³, ¹Northwestern University Feinberg School of Medicine, Chicago, IL, ²Henri Mondor Hospital, University Paris XII UPEC, Créteil, France, ³Sanos Clinic, Gandrup, Denmark, ⁴Hong Kong Center for Clinical Research, Hong Kong, Hong Kong, ⁵Sanos Clinic, Vejle, Denmark, ⁶Sun Pharmaceuticals Industries Ltd., mumbai, Maharashtra, India, ⁷Sun Pharmaceutical Industries, Inc., Princeton, NJ, ⁸Sun Pharmaceutical Industries Limited, Mumbai, India, ⁹Moebius Medical, Tel Aviv, Israel, ¹⁰Sun Pharma Advanced Research Company Limited, Princeton, NJ, ¹¹Sun Pharma Advanced Research Company Limited, Andheri (E), Princeton, NJ, ¹²NBCD A/S, Herlev, Denmark, ¹³University of Leeds, Leeds, United Kingdom
Background/Purpose: MM-II is a first-in-class investigational treatment for knee OA pain that consists of a one-time IA injection of empty liposomes comprised of phospholipids dipalmitoylphosphatidylcholine…
Abstract Number: 1662 • ACR Convergence 2025
Efficacy and Safety of Nerandomilast in Patients with Autoimmune Disease-Related Progressive Pulmonary Fibrosis: Subgroup Analysis of the FIBRONEER-ILD trial
Anna-Maria Hoffmann-Vold¹, Shervin Assassi², Vincent Cottin³, Michael Kreuter⁴, Claudia Valenzuela⁵, Marlies S Wijsenbeek⁶, Hui Gu⁷, Ivana Ritter⁸, Susanne Stowasser⁸, Gerrit Weimann⁸ and Toby M Maher⁹, ¹Oslo University Hospital, Oslo, Norway, ²Division of Rheumatology, UTHealth Houston, Houston, Texas, USA, Houston, TX, ³National Reference Center for Rare Pulmonary Diseases, Louis Pradel Hospital, Hospices Civils de Lyon, Claude Bernard University Lyon ¹, UMR ⁷⁵⁴, ERN-LUNG, Lyon, France, Lyon, France, ⁴Center for Pulmonary Medicine, Department of Pneumology, Mainz University Medical Center and Pulmonary, Critical Care & Sleep Medicine, Marienhaus Clinic Mainz, Mainz, Germany, Heidelberg, Germany, ⁵Pulmonology Department, Hospital Universitario de la Princesa, Universidad Autónoma de Madrid, Madrid, Spain, Madrid, Spain, ⁶Center of Expertise for Interstitial Lung Diseases, Department of Respiratory Medicine, Erasmus MC, University Medical Centre, Rotterdam, The Netherlands, Rotterdam, Netherlands, ⁷Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA, Ridgefield, ⁸Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, Ingelheim am Rhein, Germany, ⁹Department of Pulmonary, Critical Care and Sleep Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA and Section of Inflammation, Repair and Development, National Heart and Lung Institute, Imperial College London, London, UK, Los Angeles
Background/Purpose: Nerandomilast is a preferential inhibitor of phosphodiesterase 4B with antifibrotic and immunomodulatory properties. The Phase III FIBRONEER-ILD trial in patients with progressive pulmonary fibrosis…
Abstract Number: 1455 • ACR Convergence 2025
Sonelokimab in Patients With Active Psoriatic Arthritis Who Are Naive to Biologic DMARDs: Phase 2 ARGO Analysis and Phase 3 IZAR-1 Study Design
Philip J. Mease¹, Laure Gossec², Atul Deodhar³, Xenofon Baraliakos⁴, Frank Behrens⁵, Joseph F Merola⁶, Lihi Eder⁷, Ana-Maria Orbai⁸, Andreas Ramming⁹, Iain McInnes¹⁰, Alexis Ogdie¹¹, Dennis McGonagle¹², Christopher Ritchlin¹³, Nuala Brennan¹⁴, Ben Porter-Brown¹⁴, Eva Cullen¹⁴, Matthew R. Thomas¹⁴, Marius Albulescu¹⁴, Alex Godwood¹⁴, Kristian Reich¹⁵ and Laura Coates¹⁶, ¹Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ²Sorbonne Universite and Pitie-Salpetriere Hospital, Paris, France, ³Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ⁴Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany, ⁵Rheumatology, Immunology - Inflammation Medicine, University Hospital Goethe-University & Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt am Main, Germany, ⁶Department of Dermatology and Department of Medicine, UT Southwestern Medical Center, Dallas, TX, ⁷University of Toronto, Toronto, ON, Canada, ⁸Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, ⁹Department of Internal Medicine ³, Rheumatology & Immunology, Friedrich-Alexander-University (FAU) & Universitätsklinikum Erlangen, Erlangen, Germany, ¹⁰University of Glasgow, Glasgow, United Kingdom, ¹¹University of Pennsylvania, Philadelphia, PA, ¹²Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), University of Leeds, Leeds, United Kingdom, ¹³University of Rochester Medical Center, Canandaigua, NY, ¹⁴MoonLake Immunotherapeutics AG, Zug, Switzerland, ¹⁵MoonLake Immunotherapeutics AG and Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany, Zug, Switzerland, ¹⁶Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom
Background/Purpose: Sonelokimab (SLK), a novel Nanobody that binds to both IL-17A and IL-17F with similarly high affinity, is designed to target difficult-to-reach sites of inflammation…
Abstract Number: 1157 • ACR Convergence 2025
Safety and Tolerability of a Recombinant Zoster Vaccine in Patients with Inflammatory Rheumatic Musculoskeletal Diseases: A Prospective Longitudinal Study over 12 Months
Ella Steiner¹, Ioana Andreica², Stefanie Reale³, Gianna Chierego⁴, Philipp Köhler⁵, Sonja Zapke⁴, Benjamin Wilde⁶, David Kiefer⁷, Philipp Sewerin², Hilal Kavruk⁵, Dimitra Karagkiozidou⁵, Panagiotis Ermeidis⁵, Barbara Guminski⁵, Andreas Kribben⁶, Jürgen Braun⁸, Xenofon Baraliakos⁹ and Uta Kiltz⁹, ¹Rheumazentrum Ruhrgebiet Herne, Herne, Nordrhein-Westfalen, Germany, ²Rheumazentrum Ruhrgebiet Herne; Ruhr-Universität Bochum, Germany, Herne, Germany, ³Rheumazentrum Ruhrgebiet, Herne, Nordrhein-Westfalen, Germany, ⁴Rheumazentrum Ruhrgebiet, Herne, Germany, ⁵Rheumazentrum Ruhrgebiet Herne, Herne, Germany, ⁶University Hospital, Nephrology, Essen, Essen, Germany, ⁷Private practice of rheumatology, Hattingen, Germany, ⁸Ruhr-University, Bochum, Germany; and Rheumatologische Versorgungszentrum (RVZ) Steglitz, Berlin, Germany, ⁹Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany
Background/Purpose: Herpes zoster (HZ) is common among older adults, with a lifetime risk of 25%. The risk is particularly increased in individuals with immunosuppression such…
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: 2463 • ACR Convergence 2025
Allogenic anti- CD19 CAR-T cells induce remission in refractory systemic lupus erythematosus
Chunnei Yang¹, Chuanyin Sun², Binghe Tan³, Chao Hu¹, Liyan Wan², Changling Xie³, Qian Tan³, Mingyao Liu³, Jin Lin², Bing Du³ and Hongyan Tong¹, ¹Department of Hematology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China (People's Republic), ²Department of Rheumatology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China (People's Republic), ³BRL Medicine Inc., Shanghai, Shanghai, China (People's Republic)
Background/Purpose: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease associated with significant morbidity and mortality. The treatment approach for SLE primarily involves immunomodulation and…

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