Abstracts tagged "clinical trial"

Abstract Number: 0662 • ACR Convergence 2025
Efficacy Across Baseline Characteristic Subgroups in Patients With Systemic Lupus Erythematosus Treated With Upadacitinib: Results From SLEek, a Phase 2 Randomized
Marta Mosca¹, Karen H. Costenbader², Amit Saxena³, Michelle Petri⁴, Andrea Rubbert-Roth⁵, Karim Masri⁶, Christopher Saffore⁷, Ling Cheng⁸ and Joan Merrill⁹, ¹University of Pisa, Pisa, Pisa, Italy, ²Harvard Medical School and Brigham and Women's Hospital, Boston, MA, ³Division of Rheumatology, Department of Medicine, NYU Grossman School of Medicine, New York, NY, ⁴Johns Hopkins University School of Medicine, Timonium, MD, ⁵Division of Rheumatology and Immunology, Cantonal Hospital St Gallen, St Gallen, Switzerland, ⁶AbbVie Inc., North Chicago, IL, ⁷AbbVie Inc., waukegan, IL, ⁸AbbVie, North, IL, ⁹Oklahoma Medical Research Foundation, Oklahoma City ⁷³¹⁰⁴, OK
Background/Purpose: Clinical and immunological manifestations of systemic lupus erythematosus (SLE) vary widely across patients, complicating diagnosis and treatment (1,2). Upadacitinib (UPA), an oral selective JAK…
Abstract Number: 0876 • ACR Convergence 2025
Effect of QX002N on Clinical and Radiographic Outcomes in Ankylosing Spondylitis: Results from a Phase III Randomized, Double-blind, Placebo-Controlled Study
Xiaofeng Zeng¹, Shangzhu Zhang², SHENGYUN LIU³, Fengju Li⁴, xuebin wang⁵, LINGYUN SUN⁶, Hongwei Du⁷, Guixiu Shi⁸, yanling li⁹, hongwei zhang¹⁰, Liyun Zhang¹¹, Jian Wu¹², mingxuan zhou¹³, zhanqing gu¹⁴, yi zhao¹⁵, min fang¹⁶, Qingyi Song¹⁷ and ting wang¹⁷, ¹Department of Rheumatology, Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID), Beijing, China (People's Republic), ²Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Beijing, China (People's Republic), ³The First Affiliated Hospital Of Zhengzhou University, zhengzhou, China (People's Republic), ⁴Puyang Olifield General Hospital, puyang, Henan, China (People's Republic), ⁵Binzhou Medical University Hospital, binzhou, Shandong, China (People's Republic), ⁶Nanjing Drum Tower Hospital, NANJING, China (People's Republic), ⁷Jinhua Municipal Central Hospital, Jinhua, China (People's Republic), ⁸The First Affiliated Hospital of Xiamen University, xiamen, Fujian, China (People's Republic), ⁹Hospital of Traditional Chinese Medicine of Zhongshan, 中山, Guangdong, China (People's Republic), ¹⁰The First People's Hospital of Foshan, foshan, Guangdong, China (People's Republic), ¹¹Shanxi Bethune Hosptial, Taiyuan, China (People's Republic), ¹²The First Affiliated Hospital of soochow University, Suzhou, China (People's Republic), ¹³The Second Affiliated Hospital of Fujian Medical University, quanzhou, Fujian, China (People's Republic), ¹⁴The First Hospital of Hebei Medical University, shijiazhuang, Hebei, China (People's Republic), ¹⁵Xuanwu Hospital, Capital Medical University, beijing, Beijing, China (People's Republic), ¹⁶Qyuns Therapeutics Co., Ltd., Shanghai, Shanghai, China (People's Republic), ¹⁷Qyuns Therapeutics CO., Ltd., Shanghai, China (People's Republic)
Background/Purpose: QX002N is a novel high-affinity monoclonal antibody (mAb) that selectively targets IL-17A.In the phase II clinical study, QX002N was well tolerated and rapidly reduced…
Abstract Number: 0498 • ACR Convergence 2025
Pharmacokinetic Similarity of DRL_AB, a Proposed Biosimilar Abatacept (Orencia®): Results from a Randomized, Single Dose, Double-Blind, Parallel Arm, Comparative Pharmacokinetic Study in Healthy Subjects by the Intravenous Route.
Naveen Reddy¹, Narendra Maharaj¹, Pramod Kumar Reddy¹, Mansi Dhananjaya Jakhade¹, Maria Velinova² and Vendel Kemény³, ¹Biologics, Dr. Reddy’s Laboratories Ltd., Hyderabad, India, Hyderabad, India, ²ICON – Early Development Services Van Swietenlaan ⁶ ⁹⁷²⁸ NZ, Groningen, Netherlands, Groningen, Netherlands, ³ICON Magyarország Kft. Fázis I-es Klinikai Farmakológiai Vizsgálóhely Rottenbiller utca ¹³ ¹⁰⁷⁷, Budapest, Hungary, Budapest, Hungary
Background/Purpose: Dr. Reddy’s-abatacept (DRL_AB) is being developed as a biosimilar to the reference product (RP) (RP-US licensed Orencia®) and the reference medicinal product (RMP) (RMP-EU…
Abstract Number: 0279 • ACR Convergence 2025
Assessment of Baseline IgG4-RD Disease Characteristics and Impact Upon Safety and Efficacy of Inebilizumab: Results from the MITIGATE Study
Yoshiya Tanaka¹, Emma Culver², Arezou Khosroshahi³, Wen Zhang⁴, Kazuichi Okazaki⁵, Matthias Lohr⁶, nicolas schleinitz⁷, Xinxin Dong⁸, melissa rosen⁹, Sue Cheng⁸, Daniel Cimbora⁸ and John Stone¹⁰, ¹University of Occupational and Environmental Health, Japan, Kitakyushu, Japan, ²John Radcliffe Hospital; University of Oxford, Oxford, United Kingdom, ³Emory University, Atlanta, GA, ⁴Peking Union Medical College Hospital, Dong Cheng Qu, China (People's Republic), ⁵Kansai Medical University Kori Hospital, Osaka, Japan, ⁶Karolinska Institutet, Stockholm, Sweden, ⁷Aix Marseille university, AP-HM, Marseille, France, ⁸Amgen, Thousand Oaks, CA, ⁹Amgen Inc., Thousand Oaks, CA, ¹⁰Massachusetts General Hospital , Harvard Medical School, Concord, MA
Background/Purpose: IgG4-related disease (IgG4-RD) is a progressive, systemic, fibroinflammatory disease characterized by unpredictable and recurring flares, leading to organ damage and decreased quality of life.…
Abstract Number: 2559 • ACR Convergence 2025
Increasing Clinical Trial Awareness in Sample of Underrepresented Systemic Lupus Erythematosus Patients
Leslie Ranken¹, Kyle Osborne², Robert Fairman³, Gregory Russell⁴, Sara Ohl² and Jessica Kearney-Bryan⁵, ¹Atrium Health Carolinas Medical Center Wake Forest School of Medicine Charlotte, Charlotte, NC, ²Atrium Health, Charlotte, NC, ³Wellstar Health, Marietta, GA, ⁴Wake Forest School of Medicine, Winston-Salem, NC, ⁵Atrium Health Carolinas Medical Center, Charlotte, NC
Background/Purpose: Underrepresented Systemic Lupus Erythematosus (SLE) patients are greatly underrepresented in SLE clinical trials. We aimed to increase clinical trial awareness with various interventions in…
Abstract Number: 2358 • ACR Convergence 2025
Bimekizumab Demonstrated Early and Sustained Efficacy Regardless of Baseline Characteristics in Patients with Active Psoriatic Arthritis: Pooled Post Hoc Results up to 1-Year from Two Phase 3 Studies
Lihi Eder¹, Philip J. Mease², Iain McInnes³, M. Elaine Husni⁴, Mitsumasa Kishimoto⁵, Barbara Ink⁶, Rajan Bajracharya⁶, Jason Coarse⁷ and Fabian Proft⁸, ¹University of Toronto, Toronto, ON, Canada, ²Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ³University of Glasgow, Glasgow, United Kingdom, ⁴Department of Rheumatic and Immunologic Diseases, Cleveland Clinic, Cleveland, OH, ⁵Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, ⁶UCB, Slough, England, United Kingdom, ⁷UCB, Morrisville, NC, ⁸Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany

Background/Purpose: Bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)‑17F in addition to IL‑17A, has demonstrated clinical efficacy and safety to 3 years…
Abstract Number: 2097 • ACR Convergence 2025
Trajectories of psychological symptoms during an 18-month Diet + Exercise intervention in overweight or obese adults with osteoarthritis
Lily Alomari¹, Daniel Beavers², Kate Queen³, Shannon Mihalko⁴, Gary Miller⁴, Elena Losina⁵, Paul DeVita⁶, david Hunter⁷, Jovita Newman⁴, Sara Quandt⁸, Mary Lyles⁸, Sandra Soto³, Joanne Jordan⁹, Leigh Callahan³, Stephen Messier¹⁰ and Becki Cleveland¹¹, ¹Kansas City University, Raleigh, ²Wake forest university, Winston Salem, ³UNC, Chapel Hill, ⁴WFU, Winston Salem, ⁵BWH, Boston, MA, ⁶East Carolina University, Greenville, ⁷Sydney Musculoskeletal Health, University of Sydney, St Leonards, New South Wales, Australia, ⁸WFU, Winston-Salem, ⁹University of North Carolina at Chapel Hill, Chapel Hill, NC, ¹⁰WFU, Winston-Salem, NC, ¹¹University of North Carolina, Chapel Hill, NC
Background/Purpose: Psychological symptoms (PsySx) have been associated with osteoarthritis (OA), and exercise may improve PsySx. We aimed to identify unique trajectories of PsySx over the…
Abstract Number: 1676 • ACR Convergence 2025
Long-Term Safety and Efficacy of Upadacitinib or Adalimumab in Patients With Rheumatoid Arthritis: 7-Year Data From the SELECT-COMPARE Study
Roy Fleischmann¹, Jerzy Swierkot², Patrick Durez³, Louis Bessette⁴, Xianwei Bu⁵, Irina Fish⁵, Andrew Gara⁵, Diane Caballero⁵, Charles Peterfy, MD, PhD⁶, Yoshiya Tanaka⁷ and Eduardo Mysler⁵, ¹Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, ²Wroclaw Medical University, Department of Rheumatology and Internal Medicine, Wroclaw, Poland, ³Cliniques Universitaires Saint-Luc – Université catholique de Louvain (UCLouvain) – Institut de Recherche Expérimentale et Clinique (IREC), Rheumatology, Brussels, Belgium, ⁴Centre de l'Ostéoporose et de Rhumatologie de Québec, Quebec, QC, Canada, ⁵AbbVie Inc., North Chicago, ⁶Spire Sciences, Inc., Boca Raton, FL, ⁷University of Occupational and Environmental Health, Japan, Kitakyushu, Japan
Background/Purpose: We assessed the safety and efficacy of UPA versus ADA from SELECT-COMPARE through 7-years.Methods: Patients with RA and an inadequate response to MTX were…
Abstract Number: 1465 • ACR Convergence 2025
Sustainability of Clinical Response Through 2 Years Among Upadacitinib-Treated Patients With Axial Spondyloarthritis: Data From the SELECT-AXIS 1 and SELECT-AXIS 2 Trials
Victoria Navarro-Compan¹, Philip J. Mease², Lianne S. Gensler³, Martin Rudwaleit⁴, Yael Klionsky⁵, Jayne Stigler⁶, Erin Mancl⁷, Shirley Chen⁸, Jamie Urbanik⁹ and Xenofon Baraliakos¹⁰, ¹Department of Rheumatology, La Paz University Hospital, IdiPaz, Madrid, Spain, ²Department of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, ³Department of Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA, ⁴Bielefeld University, Medical School and University Medical Centre OWL, Klinikum Bielefeld, Department of Rheumatology, Bielefeld, Germany, ⁵Division of Rheumatology, Department of Medicine, Wake Forest School of Medicine, Winston-Salem, NC, ⁶AbbVie, Round Lake, IL, ⁷AbbVie, Chicago, IL, ⁸AbbVie, Somerset, NJ, ⁹AbbVie, Grayslake, IL, ¹⁰Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany
Background/Purpose: Treatment with the oral JAK inhibitor upadacitinib (UPA) has shown efficacy and safety in patients with active axial spondyloarthritis (axSpA), including both radiographic (r-axSpA,…
Abstract Number: 1354 • ACR Convergence 2025
Effect of Ivarmacitinib on Joint Swelling and Tenderness in Patients with Moderate-to-severe Rheumatoid Arthritis: A Post-hoc Study of a Phase III Clinical Trial
Hongtao Jin, Huifang Guo, Yuxiang Han and Meng Ding, The Second Hospital of Hebei Medical University, Shijiazhuang, China (People's Republic)
Background/Purpose: Joint swelling and tenderness are major symptoms of rheumatoid arthritis (RA). This post-hoc analysis evaluated the effect of ivarmacitinib (SHR0302), a selective Janus kinase…
Abstract Number: 0657 • ACR Convergence 2025
Preliminary Analysis Of Open-Label Dose-Titration Phase Of SLE Treatment With N-Acetylcysteine (SNAC) Shows Evidence For Potential Improvement Of SLEDAI, BILAG, ADHD And Fatigue Scores In Patients With Active SLE
FNU Ruchi¹, Ioana Coman¹, Bryan Blaker¹, Lucero Blaker¹, Joy Park², Jorge Cabezas¹, Dilip Rao¹, +Xiaojing Wang¹, Aparna Godavarthy¹, Marlene Marte Furment³, Sandy Nasr⁴, Sravani Lokineni⁵, Christina Donath⁴, SARA KAHLOWN⁶, Damira Sereda¹, Binod Kc¹, Ilya Ivyanskiy¹, Bhavya Poudyal⁷, Arthur Weinstein⁸, Rosalind Ramsey-Goldman⁹, Michael Weisman¹⁰, Cynthia Aranow¹¹, Mariko Ishimori¹⁰, Kyriakos Kirou¹², Jihad Ben Gabr¹³, Sheetal Rayancha¹⁴, Nancy Olsen¹⁵, Fotios Koumpouras¹⁶, Judith Lin¹⁷, Stephen Faraone¹, Daniel Wallace¹⁸, Michael McDermott¹⁹ and Andras Perl²⁰, ¹SUNY Upstate Medical University, Syracuse, NY, ²Upstate Medical University, Syracuse, NY, ³Medical Affiliates of Cape Cod, Hyannis, MA, ⁴SUNY Upstate University Hospital, Syracuse, NY, ⁵Deaconess Hospital, Evansville, IN, ⁶Suny upstate medical university, Camillus, NY, ⁷SUNY Upstate Medical University, Cicero, NY, ⁸retired from clinical practice, volunteer academic faculty, Claremont, CA, ⁹Northwestern University Feinberg School of Medicine, Chicago, IL, ¹⁰Cedars-Sinai Medical Center, LOS ANGELES, CA, ¹¹Institute of Molecular Medicine, Feinstein Institutes for Medical Research, Manhasset, NY, ¹²Hospital for Special Surgery, New York, NY, ¹³Division of Rheumatology & Clinical Immunology, SUNY Upstate Medical University, Syracuse, NY, ¹⁴SUNY Upstate Medical University, Jamesville, NY, ¹⁵Penn State University/Milton S Hershey, Hershey, PA, ¹⁶Yale School of Medicine, New Haven, CT, ¹⁷Ohio State University Wexner Medical Center, Columbus, OH, ¹⁸Cedars Sinai Medical Center, Studio City, CA, ¹⁹University of Rochester Medical Center, Rochester, NY, ²⁰SUNY, Syracuse, NY
Background/Purpose: Systemic lupus erythematosus (SLE) is an autoimmune disease of unknown etiology with mortality still approaching 10% in 5 years. The major causes of death…
Abstract Number: 0875 • ACR Convergence 2025
Efficacy and Safety of Icotrokinra, a Novel Targeted Oral Peptide (IL-23R-Inhibitor), in Adolescents With Moderate-to-Severe Plaque Psoriasis: Subgroup Analyses From a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (ICONIC-LEAD)
Lawrence Eichenfield¹, Ricardo Galimberti², Adelaide Hebert³, Wen-Hui Wang⁴, Jennifer Soung⁵, Nina Magnolo⁶, John Browning⁷, Angela Moore⁸, Mark Lebwohl⁹, Dagmar Wilsmann-Theis¹⁰, Joseph F Merola¹¹, Georgios Kokolakis¹², Dariusch Mortazawi¹³, Parbeer Grewal¹⁴, Megan Miller¹⁵, Joseph Cafone¹⁶, Shu Li¹⁷, Gigi Jiang¹⁷, Fabio Nunes¹⁷, Cynthia DeKlotz¹⁸ and Amy Paller¹⁹, ¹University of California, San Diego School of Medicine, La Jolla, CA, USA, La Jolla, CA, ²Hosp Italiano de Buenos Aires, Buenos Aires, Argentina, Buenos Aires, Argentina, ³University of Texas Medical School-Houston, Bellaire, TX, USA, Bellaire, TX, ⁴Peking University Third Hospital, Haidian District, Beijing, China, Beijing, China (People's Republic), ⁵Southern California Dermatology, Inc, Santa Ana, CA, USA, Santa Ana, ⁶University Hospital Muenster, Muenster, Germany, Muenster, Germany, ⁷Methodist Children's Hospital, San Antonio, TX, USA, San Antonio, TX, ⁸Baylor University Medical Center, Dallas, TX, USA, Dallas, TX, ⁹Icahn School of Medicine at Mount Sinai, New York, NY, ¹⁰University Hospital Bonn, Center for Skin Diseases, Bonn, Germany, Bonn, Germany, ¹¹Department of Dermatology and Department of Medicine, UT Southwestern Medical Center, Dallas, TX, ¹²Charité-Universitätsmedizin Berlin, Berlin, Germany, Berlin, Germany, ¹³Clinical Research Center, Remscheid, Germany, Remscheid, Germany, ¹⁴University of Alberta, Edmonton, Alberta, Canada, Edmonton, AB, Canada, ¹⁵Johnson & Johnson, San Diego, CA, USA, San Diego, CA,, CA, ¹⁶Johnson & Johnson, San Diego, CA, USA, San Diego, CA, CA, ¹⁷Johnson & Johnson, Spring House, PA, USA, Spring House, PA, ¹⁸Johnson & Johnson, San Diego, CA, USA, San Diego, CA, ¹⁹Northwestern University Feinberg School of Medicine, Chicago, IL, USA, Chicago, IL
Background/Purpose: Icotrokinra (ICO), a novel targeted oral peptide, binds the interleukin (IL)-23 receptor to inhibit IL-23 signaling. ICONIC-LEAD (NCT06095115) is the first Phase 3 study…
Abstract Number: 0493 • ACR Convergence 2025
Phase I Trial in Participants with Rheumatoid Arthritis and Healthy Volunteers with CIT-013, a First in Class NETosis Inhibitor
Maarten Kraan¹, Salah Hadi², Leonie Middelink³, Renato Chirivi³, Eric meldrum³, Naomi Klarenbeek⁴ and Patrick Round³, ¹Citryll BV, Den Dolder, Netherlands, ²ICON Netherlands BV, Groningen, Netherlands, ³Citryll BV, Oss, Netherlands, ⁴CHDR, Leiden, Netherlands
Background/Purpose: Aberrant Neutrophil Extracellular Trap (NET) production contributes to the pathophysiology of multiple inflammatory and autoimmune diseases including rheumatoid arthritis (RA). We report data of…
Abstract Number: 0277 • ACR Convergence 2025
A Phase 1, Randomized Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single and Multiple Ascending Doses and Food Effects of BGB-45035, a chimeric degradation activating compound (CDAC), in Healthy Participants
Vaibhav Mundra¹, Cunjing Yu², Roland Morley¹, Yuan Yuan³, Yifan Qin³, Jingjing Schneider¹, Shengnan Chen³, Zhenyuan Zhou³ and Zhen Yao², ¹BeOne Medicines USA, Inc., San Carlos, CA, ²BeOne Medicines (Beijing) Co, Ltd., Beijing, China (People's Republic), ³BeOne Medicines (Shanghai) Co, Ltd., Shanghai, China (People's Republic)
Background/Purpose: Interleukin 1 receptor associated kinase 4 (IRAK4) degradation may modulate toll-like receptor signaling and alleviate symptoms in rheumatoid arthritis and atopic dermatitis.1,2 BGB-45035, an…
Abstract Number: 2466 • ACR Convergence 2025
Efficacy and Safety Results of Zetomipzomib from the PALIZADE Phase 2b Clinical Trial in Patients with Lupus Nephritis
Richard Furie¹, Neel Anand², Shraddha Desai³, Eric Lowe⁴, Tony Muchamuel³, Kiruthi Palaniswamy², Rachel Peterson², Kathryn Ray², Zung To², Jennifer Whang² and Richard Leff⁵, ¹Division of Rheumatology, Northwell Health, Great Neck, NY, ²Kezar Life Sciences, Inc, South San Francisco, CA, ³Kezar Life Sciences, Inc, South San Francisco, ⁴Kezar Life Sciences, South San Francisco, CA, ⁵Richard L Leff MD LLC, Chadds Ford, PA
Background/Purpose: Zetomipzomib (zeto), a selective immunoproteasome inhibitor, has previously shown anti-inflammatory activity in patients (pts) with SLE and LN in the open-label MISSION study. The…

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