Abstracts tagged "clinical trial"

Abstract Number: 1608 • ACR Convergence 2025
Efficacy of Anti-IL-5/R Therapies on Specific Disease Manifestations of Eosinophilic Granulomatosis with Polyangiitis
Peter Merkel¹, Arnaud Bourdin², Bernhard Hellmich³, Nader Khalidi⁴, David Jackson⁵, David Jayne⁶, Parameswaran Nair⁷, Christian Pagnoux⁸, Ulrich Specks⁹, Benjamin Terrier¹⁰, Lena Börjesson Sjö¹¹, Priya Jain¹², Aadarsh Lal¹³, Sofia Necander¹⁴, Claire Walton¹⁵ and Michael Wechsler¹⁶, ¹University of Pennsylvania, Philadelphia, PA, ²Department of Respiratory Diseases, Montpellier University Hospitals, Arnaud de Villeneuve Hospital, Montpellier, France, ³Klinik für Innere Medizin, Rheumatologie, Pneumologie, Nephrologie und Diabetologie, Medius Kliniken, Akademisches Lehrkrankenhaus der Universität Tübingen, Kirchheim unter Teck, Germany, ⁴Department of Medicine, McMaster University and St. Joseph’s Healthcare, Hamilton, Canada, ⁵Guy’s Severe Asthma Centre, Guy's and St Thomas’ NHS Trust, London, and School of Immunology and Microbial Sciences, King's College London, London, United Kingdom, ⁶University of Cambridge, Cambridge, United Kingdom, ⁷Department of Medicine, McMaster University and St. Joseph’s Healthcare, Hamilton, ON, Canada, ⁸Mount Sinai Hospital, University Health Network, Toronto, and Canadian Vasculitis Research Network (CanVasc), Toronto, ON, Canada, ⁹Mayo Clinic, Rochester, MN, ¹⁰Cochin Hospital, Paris, France, ¹¹Late-stage Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca,, Gothenburg, Sweden, ¹²BioPharmaceuticals Medical, AstraZeneca, Cambridge, United Kingdom, ¹³Respiratory & Immunology, AstraZeneca, Bengaluru, Karnataka, India, ¹⁴Late-stage Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ¹⁵Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, ¹⁶Department of Medicine, National Jewish Health, Denver
Background/Purpose: Results from the 1-year double-blind period and first year of the open-label extension (OLE) of the MANDARA trial (NCT04157348) demonstrated that over 60% of…
Abstract Number: 2081 • ACR Convergence 2025
Radiologic surveillance in the Phase II RCT of LEVI-04, a novel neurotrophin-3 inhibitor, in people with knee osteoarthritis: exclusions at screening
Ali Guermazi¹, Philip Conaghan², C Michael Perkins³, Claire Herholdt⁴, Iwona Bombelka⁵ and Simon Westbrook⁶, ¹Boston University, West Roxbury, MA, ²University of Leeds, Leeds, United Kingdom, ³Levicept, Sandwich, United Kingdom, ⁴Levicept Ltd, Ashtead, United Kingdom, ⁵Levicept, Sandwich, Kent, United Kingdom, ⁶Levicept Ltd, Sandwich, United Kingdom
Background/Purpose: LEVI-04 is a first-in-class fusion protein (p75NTR-Fc) that supplements the endogenous p75NTR binding protein, providing analgesia via inhibition of NT-3 activity. Like p75NTR, LEVI-04…
Abstract Number: 2345 • ACR Convergence 2025
Biological Sex-Related Differences in Radiographic Progression and Relationship with Early Clinical Response: Post Hoc Analysis of a Phase 3, Randomized, Double-Blind, Placebo‑Controlled Study in Biologic-Naive Participants with Active Psoriatic Arthritis Treated with Guselkumab
Dafna D. Gladman¹, Lihi Eder², Carlo Selmi³, Philip J. Mease⁴, Alexis Ogdie⁵, Karissa Lozenski⁶, Mohamed Sharaf⁷, Emmanouil Rampakakis⁸, Laura Pina Vegas⁹ and Laura Coates¹⁰, ¹Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Division of Rheumatology, Toronto, ON, Canada, ²University of Toronto, Toronto, ON, Canada, ³Humanitas University, Milan, Italy, ⁴Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ⁵University of Pennsylvania, Philadelphia, PA, ⁶Johnson & Johnson, Horsham, PA, ⁷Janssen - Johnson & Johnson, Dubai, United Arab Emirates, ⁸JSS Medical Research, Montréal, QC, Canada, ⁹Epidemiology in Dermatology and Evaluation of Therapeutics (EpiDermE), University Paris-Est Créteil Val de Marne, Créteil, France; Rheumatology, Hospital Henri Mondor, AP-HP, Créteil, France, Creteil, France, ¹⁰Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom
Background/Purpose: Previous research has shown that women with psoriatic arthritis (PsA) often have lower rates of clinical response to medication but less severe radiographic joint…
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…
Abstract Number: 0259 • ACR Convergence 2025
Inhaled pirfenidone as an innovative therapeutic approach to treat autoimmune ILD and other forms of Progressive Pulmonary Fibrosis: Phase 2b Study Design
Kristin Highland¹, Colin Reisner², Allison Trucillo³, Deepthi Nair⁴, Felix Woodhead⁴, Howard Lazarus⁴, Craig Conoscenti⁴ and Martin Kolb⁵, ¹Cleveland Clinic, Shaker Heights, OH, ²DevPro Biopharma, Basking Ridge, NJ, ³Avalyn Pharma, Austin, TX, ⁴Avalyn Pharma, Cambridge, MA, ⁵McMaster University, Hamilton, ON, Canada
Background/Purpose: Progressive Pulmonary Fibrosis (PPF) is an increasingly recognized condition, defined in 2022 to address the progression of pulmonary fibrosis in patients with interstitial lung…
Abstract Number: 0487 • ACR Convergence 2025
Efficacy of sarilumab in patients with rheumatoid arthritis of different disease activity at treatment initiation: a post-hoc analysis of a Phase 3 trial of sarilumab in Japan
Hideto Kameda¹, Toshiya Takahashi², Naoki Soeda² and Yoshiya Tanaka³, ¹Department of Internal Medicine, Toho University, Tokyo, Japan, ²Medical Affairs, Asahi Kasei Pharma Corporation, Tokyo, Japan, ³University of Occupational and Environmental Health, Japan, Kitakyushu, Japan
Background/Purpose: The efficacy and safety of sarilumab (SAR) and methotrexate (MTX) in patients (pts) in Japan with moderate-to-severely active rheumatoid arthritis (RA) and inadequate response…
Abstract Number: 0873 • ACR Convergence 2025
Sex Differences in Proteomic Profiles and the Impact of Deucravacitinib Treatment in Patients with Active Psoriatic Arthritis: A Pooled Phase 3 Analysis
Lihi Eder¹, Shangzhong Li², Philip J. Mease³, Christopher Ritchlin⁴, Walter P Maksymowych⁵, Hendrik Schulze-Koops⁶, Josef Smolen⁷, Oliver FitzGerald⁸, Vinod Chandran⁹, Chun Wu¹⁰ and Jinqi Liu², ¹University of Toronto, Toronto, ON, Canada, ²Bristol Myers Squibb, Princeton, NJ, ³Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ⁴University of Rochester Medical Center, Canandaigua, NY, ⁵Department of Medicine, University of Alberta, Edmonton, AB, Canada, ⁶LMU Hospital, Division for Rheumatology and Clinical Immunology, Munich, Bayern, Germany, ⁷Division of Rheumatology, Department of Medicine ³, Medical University of Vienna, Vienna, Austria, Vienna, Austria, ⁸UCD, Dublin ⁶, Dublin, Ireland, ⁹Division of Rheumatology, Departments of Medicine and Laboratory Medicine and Pathobiology, University of Toronto, and Gladman Krembil Psoriatic Arthritis Research Program, Krembil Research Institute, University Health Network, Toronto, Canada, ¹⁰Bristol Myers Squibb, Princeton
Background/Purpose: PsA affects male and female patients equally; however, variations in manifestations and treatment response exist between sexes. Deucravacitinib is an oral, selective, allosteric tyrosine…
Abstract Number: 0650 • ACR Convergence 2025
Obinutuzumab Demonstrates Steroid-Sparing Effects and Consistent Benefit In Patients with Lupus Nephritis When Using Multiple Primary Endpoint Definitions: A Secondary Analysis of Phase III Trial Results
Brad Rovin¹, Jay Garg², Richard Furie³, Rachel Jones⁴, Amit Saxena⁵, Pasquale Esposito⁶, Elsa Martins⁷, Claire Petry⁷, Nicolas Frey⁷, Bongin Yoo², Imran Hassan⁸, Thomas Schindler⁷, Theodore Omachi⁹, William Pendergraft², Mittermayer Santiago¹⁰, Gustavo Aroca Martínez¹¹ and Ana Malvar¹², ¹The Ohio State University, Columbus, OH, ²Genentech, Inc., South San Francisco, CA, ³Division of Rheumatology, Northwell Health, Great Neck, NY, ⁴Renal Medicine, Cambridge University Hospitals, Cambridge, England, United Kingdom, ⁵Division of Rheumatology, Department of Medicine, NYU Grossman School of Medicine, New York, NY, ⁶Clinica Nefrologica, Dialisi, Trapianto, Department of Internal Medicine, University of Genoa and IRCCS Ospedale Policlinico San Martino, Genova, Italy, ⁷F. Hoffmann-La Roche Ltd, Basel, Switzerland, ⁸Hoffmann-La Roche Ltd, Mississauga, ON, Canada, ⁹Genentech, Inc., South San Francisco, ¹⁰Bahiana School of Medicine and Public Health and UFBA, Federal University of Bahia, and Clínica SER da Bahia, Salvador, Bahia, Brazil, ¹¹Universidad Simón Bolívar, Barranquilla, Colombia y Clínica de la Costa, Barranquilla, Colombia, ¹²Organización Médica de Investigación, Buenos Aires, Argentina
Background/Purpose: The Phase III REGENCY study (NCT04221477) demonstrated superiority of obinutuzumab (OBI) over placebo (PBO) in achieving complete renal response (CRR) at Week 76 when…
Abstract Number: 1175 • ACR Convergence 2025
Secukinumab In Patients with Giant Cell Arteritis with Polymyalgia Rheumatica Symptoms: A Post Hoc Analysis of the Phase 2 TitAIN Study
Nils Venhoff¹, Wolfgang Schmidt², Raoul Bergner³, Juergen Rech⁴, Leonore Unger⁵, Stephanie Finzel⁶, Ioana Andreica⁷, David Kofler⁸, Stefan Weiner⁹, Prof. Dr. med. Peter Lamprecht¹⁰, Hendrik Schulze-Koops¹¹, Meryl Mendelson¹², Weibin Bao¹³, Monica Keyport¹⁴, Meron Maricos¹⁵, Valeria Jordan M.¹⁶ and Jens Thiel¹⁷, ¹University of Freiburg, Freiburg, Germany, ²Immanuel Krankenhaus Berlin, Medical Centre for Rheumatology Berlin-Buch; Waldfriede Hospital, Rheumatology, Berlin, Germany, ³Department of Internal Medicine A, Nephrology and Rheumatology, Municipal Hospital Ludwigshafen, Ludwigshafen, Germany, ⁴Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Germany, Erlangen, Germany, ⁵Städtisches Klinikum Dresden, Dresden, Germany, ⁶Universitétsklinikum Freiburg, Freiburg im Breisgau, Germany, ⁷Rheumazentrum Ruhrgebiet Herne; Ruhr-Universität Bochum, Germany, Herne, Germany, ⁸University of Cologne, Cologne, Germany, ⁹Brüderkrankenhaus Trier, Trier, Germany, ¹⁰University of Lübeck, Lübeck, Germany, ¹¹LMU Hospital, Division for Rheumatology and Clinical Immunology, Munich, Bayern, Germany, ¹²Novartis Pharmaceuticals, Larchmont, NY, ¹³Novartis Pharmaceuticals Corporation, Hanover, NJ, ¹⁴Novartis Pharmaceuticals, Stillwater, MN, ¹⁵Novartis, Nürnberg, Germany, ¹⁶Novartis Pharmaceuticals Corporation, Tenafly, NJ, ¹⁷University Hospital Freiburg, Medical University Graz, Freiburg, Germany
Background/Purpose: GCA and PMR are closely related, immune-mediated chronic inflammatory diseases often occurring concurrently in individuals over 50.1,2 While glucocorticoids (GC) are the mainstay of…
Abstract Number: 1458 • ACR Convergence 2025
Clinical Efficacy of Bimekizumab Treatment up to 2 Years Across Patients with Psoriatic Arthritis and Varying Baseline Joint Involvement: Results from a Post Hoc Analysis of Two Pooled Phase 3 Studies
Philip J. Mease¹, Laure Gossec², Hideto Kameda³, David Nicholls⁴, Proton Rahman⁵, Barbara Ink⁶, Rajan Bajracharya⁶, Patrick Healy⁷ and Laura Coates⁸, ¹Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ²Sorbonne Universite and Pitie-Salpetriere Hospital, Paris, France, ³Department of Internal Medicine, Toho University, Tokyo, Japan, ⁴Clinical Trials Unit, University of the Sunshine Coast, Queensland, Australia, ⁵Division of Rheumatology, Craig L. Dobbin Genetics Research Centre, Discipline of Medicine, Memorial University of Newfoundland, St. John's, Canada, ⁶UCB, Slough, England, United Kingdom, ⁷UCB, Morrisville, NC, ⁸Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, England, United Kingdom
Background/Purpose: Patients (pts) in PsA clinical trials often have greater joint involvement than in the clinical setting due to trial inclusion criteria,1 thus it is…
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: 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: 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: 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: 0261 • ACR Convergence 2025
Randomized Confirmatory Basket Trial: Performance Evaluation of a Simulated Application Example in Rare Disease Using Real World Data
Daphne Guinn¹, Linchen He², Yuru Ren¹, Valeriy Korostyshevskiy¹ and Robert Beckman¹, ¹Georgetown University, Washington, ²Novartis, East Hanover
Background/Purpose: Basket trials group together participants who share a common biomarker or disease pathway across several diseases or phenotypes in a single clinical study. Such…

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