Abstracts tagged "clinical trial"

Abstract Number: 2578 • ACR Convergence 2024
Safety, Biomarker Response, and Efficacy of E6742, a Dual Antagonist of Toll-Like Receptor 7 and 8, in a First-in-Patient, Randomized, Double-Blind, Phase1/2 Study in Systemic Lupus Erythematosus
Yoshiya Tanaka¹, Atsushi Kumanogoh², Tatsuya Atsumi³, Tomonori Ishii⁴, Fumitoshi Tago⁵, Mari Aoki⁵, Shintaro Yamamuro⁵, Keisuke Sakayori⁵, Kentaro Takahashi⁵ and Shizuo Akira⁶, ¹Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan, ²Osaka University, Osaka, Japan, ³Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan, Sapporo, Japan, ⁴Tohoku Medical and Pharmaceutical University / Department of Hematology and Rheumatology, sendai, Japan, ⁵Eisai Company, Ltd., Tokyo, Japan, ⁶Osaka University Immunology Frontier Research Center, Osaka, Japan
Background/Purpose: There is strong evidence for the relationship between Toll-like receptor (TLR)7/8 and systemic lupus erythematosus (SLE) pathophysiology. Dual inhibition of TLR7/8 will modulate innate…
Abstract Number: 0003 • ACR Convergence 2024
CLN-978, a CD19-directed T Cell Engager (TCE), Leads to Rapid and Deep B Cell Depletion and Has Broad Potential for Development in Autoimmune Diseases
Máire F. Quigley¹, Jennifer S. Michaelson¹, Jeffrey Jones¹, Farrukh T. Awan², Geoffrey P. Shouse³, Yue Zhang¹, Todd Shearer¹, Judy Inumerable¹, Irina M. Shapiro¹, Patrick A. Baeuerle¹ and Stephen Wax¹, ¹Cullinan Therapeutics, Inc., Cambridge, ²UT Southwestern Medical Center, Dallas, ³City of Hope Comprehensive Cancer Center, Duarte
Background/Purpose: CD19-directed CAR T cell therapy has been reported to induce profound B cell depletion and deep clinical responses, including drug-free remission, in patients with…
Abstract Number: 0500 • ACR Convergence 2024
An Update on the Integrated Safety Analysis of Filgotinib in Patients with Moderate to Severe Active Rheumatoid Arthritis over a Median of 4.3 Years
Kevin Winthrop¹, Daniel Aletaha², Roberto Caporali³, Yoshiya Tanaka⁴, Tsutomu Takeuchi⁵, Vikas Modgill⁶, Edmund V. Ekoka Omoruyi⁷, Dick de Vries⁸, Katrien Van Beneden⁹, Jacques-Eric Gottenberg¹⁰ and Gerd Burmester¹¹, ¹School of Medicine, Oregon Health and Science University, Portland, OR, ²Department of Medicine III, Division of Rheumatology, Medical University of Vienna, Wien, Austria, ³Department of Clinical Sciences and Community Health, University of Milan, and Department of Rheumatology and Medical Sciences, ASST Gaetano Pini-CTO, Milan, Italy, ⁴Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan, ⁵Department of Internal Medicine, Keio University, Tokyo, Tokyo, Japan, ⁶Medical Safety, Galapagos NV, Mechelen, Belgium, ⁷Biostatistics, Galapagos NV, Mechelen, Belgium, ⁸Clinical Development, Galapagos BV, Leiden, Netherlands, ⁹Medical Affairs, Galapagos NV, Mechelen, Belgium, ¹⁰Rheumatology Department, Strasbourg University Hospital,, Strasbourg, France, ¹¹Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany
Background/Purpose: The oral Janus kinase 1-preferential inhibitor filgotinib (FIL) is approved at doses of 100 mg (FIL100) and 200 mg (FIL200) for the treatment of…
Abstract Number: 0658 • ACR Convergence 2024
Zetomipzomib (KZR-616), a First-in-Class Selective Immunoproteasome Inhibitor, Demonstrated Improvements in SLE/LN Disease Measures and Biomarkers in Patients with Highly Active SLE or Nephrotic Range Proteinuria in the Open-label Phase 1b/2 MISSION Study
Richard Furie¹, Amit Saxena², Samir Parikh³, Richard Leff⁴, Lucas Bohnett⁵, Kathryn Ray⁶, Brian Tuch⁴, Janet Anderl⁴, Jennifer Whang⁴ and Kiruthi Palaniswamy⁷, ¹Northwell Health, Manhasset, NY, ²NYU School of Medicine, New York, NY, ³Ohio State University, Columbus, OH, ⁴Kezar Life Sciences, South San Francisco, CA, ⁵Kezar Life Sciences, El Cajon, ⁶Kezar Life Sciences, Mill Valley, CA, ⁷Kezar Life Sciences, Inc, South San Francisco, CA
Background/Purpose: Zetomipzomib is a selective inhibitor of the immunoproteasome with anti-inflammatory and immunomodulatory potential without evidence of immunosuppression to date. The MISSION study (NCT03393013), a…
Abstract Number: 0792 • ACR Convergence 2024
Radiographic and Pain Outcomes from a Phase 3 Trial (OA-07) Evaluating the Efficacy and Safety of Repeat Lorecivivint Injections over 3 Years in Subjects with Knee OA
Yusuf Yazici¹, Jeyanesh Tambiah², Christopher Swearingen³ and Timothy McAlindon⁴, ¹NYU Grossman School of Medicine, La Jolla, CA, ²Biosplice Therapeutics Inc., San Diego, CA, ³Biosplice Therapeutics, Inc, San Diego, CA, ⁴University of Massachusets, Worchester, MA
Background/Purpose: Knee OA has unmet need for safe and efficacious symptom and disease-modifying treatments. Lorecivivint (LOR), an intra-articular (IA) CLK/DYRK inhibitor thought to modulate inflammatory…
Abstract Number: 1367 • ACR Convergence 2024
Maintained Improvement of Disease Activity and Patient-reported Outcomes (PROs) with Filgotinib in Patients with Rheumatoid Arthritis (RA) in the Real World: Up to 2-year Interim Data from FILOSOPHY
James Galloway¹, Jérôme Avouac², Gerd Burmester³, Roberto Caporali⁴, Thomas P.A. Debray⁵, Katrien Van Beneden⁶, Neil Betteridge⁷, Susana Romero Yuste⁸, Monia Zignani⁵, Patrick Verschueren⁹ and Karen Bevers¹⁰, ¹Centre for Rheumatic Diseases, King's College London, London, United Kingdom, ²Rheumatology A Department, Hôpital Cochin, AP-HP Centre - Université Paris Cité, Paris, France, ³Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ⁴Department of Clinical Sciences and Community Health, University of Milan, and Department of Rheumatology and Medical Sciences, ASST Gaetano Pini-CTO, Milan, Italy, ⁵Alfasigma S.p.A., Bologna, Italy, ⁶Medical Affairs, Galapagos NV, Mechelen, Belgium, ⁷Neil Betteridge Associates, Lonodn, United Kingdom, ⁸Department of Rheumatology, University Hospital Complex of Pontevedra, Pontevedra, Spain, ⁹Department of Rheumatology, University Hospital Leuven and KU Leuven, Leuven, Belgium, ¹⁰Department of Rheumatology, Sint Maartenskliniek, Nijmegen, Netherlands
Background/Purpose: FILOSOPHY (NCT04871919) and PARROTFISH (NCT05323591) are ongoing, prospective, observational Phase 4 studies of filgotinib in patients with RA. This interim analysis evaluated effectiveness and…
Abstract Number: 1472 • ACR Convergence 2024
Achievement of Low Disease Activity/Remission in Guselkumab-Treated Patients with Moderately-Highly Active Psoriatic Arthritis Regardless of Baseline Characteristics: Pooled Post-Hoc Analysis of Two Phase 3/Randomized Studies
Philip Mease¹, Alice Gottlieb², Iain McInnes³, Natalie J. Shiff⁴, Anthony Todd⁵, Emmanouil Rampakakis⁶, Francois Nantel⁷, Jenna Parrett⁵, Frederic Lavie⁸ and Proton Rahman⁹, ¹Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ²Icahn School of Medicine at Mount Sinai, Department of Dermatology, Seattle, WA, ³University of Glasgow, College of Medical Veterinary and Life Sciences, Glasgow, United Kingdom, ⁴Janssen Scientific Affairs, LLC / University of Saskatchewan, Adjunct, Community Health and Epidemiology, Horsham, PA, ⁵Janssen Scientific Affairs, LLC, Horsham, PA, ⁶McGill University, Department of Pediatrics / Scientific Affairs, JSS Medical Research Inc., Montreal, QC, Canada, ⁷Nantel Medsci Consult, Montreal, QC, Canada, ⁸Janssen Cilag Global Medical Affairs, Immunology Global Medical Affairs, Issy les Moulineaux, France, ⁹Memorial University of Newfoundland, Faculty of Medicine, Division of Rheumatology, St. John's, Canada
Background/Purpose: Guselkumab (GUS), a fully human IL-23p19-subunit inhibitor, has demonstrated multidomain efficacy (swollen/tender joints, psoriasis, enthesitis and dactylitis) in patients (pts) with active PsA in…
Abstract Number: 1734 • ACR Convergence 2024
Safety and Efficacy Data from a Phase I Trial of Umbilical Lining-Derived Stem Cells (ULSC) in Adult Dermatomyositis/Polymyositis
Michael R Bubb`¹, Eileen Handberg¹, Rafael Gonzalez², Blas Betancourt¹, J. Nicole Bostick¹, Sarah Long¹, Keith March¹ and Carl Pepine¹, ¹University of Florida, Gainesville, FL, ²Restem, LLC, Corona, CA
Background/Purpose: Mesenchymal stem/stromal cells are self-renewing, multi-potent stromal cells which act as modulators of immune responses. Umbilical cord-derived mesenchymal stromal cells, a classification of cells…
Abstract Number: 2047 • ACR Convergence 2024
Safety in Patients with Latent Tuberculosis Who Received Concomitant Anti-Tuberculosis Medications: Analysis of 11 Studies of Guselkumab in Psoriatic Disease
Luis Puig¹, Tsen-Fang Tsai², Enrique R. Soriano³, Tina Bhutani⁴, Megan Miller⁵, Alexa P. Kollmeier⁵, Shu Li⁵, Yin You⁵, Melissa Petrick⁵, Hewei Li⁶, Hetal Patel⁷, Frederic Lavie⁸, Melinda Gooderham⁹, Angela Londoño¹⁰, Mark Lebwohl¹¹ and Peter Nash¹², ¹Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain, ²National Taiwan University Hospital, Taipei, Taiwan (Republic of China), ³Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, ⁴University of California San Francisco Medical Center, San Francisco, CA, ⁵Janssen Research & Development, LLC, Spring House, PA/San Diego, CA, ⁶Janssen Pharmaceutical, Hopewell Township, NJ, ⁷Pharmaceutical Companies of Johnson & Johnson, Naperville, IL, ⁸Janssen Cilag Global Medical Affairs, Immunology Global Medical Affairs, Issy les Moulineaux, France, ⁹SKiN Centre for Dermatology and Probity Medical Research, Peterborough, ON, Canada, ¹⁰CES University, Medellín, Colombia, ¹¹Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, ¹²School of Medicine, Griffith University, Sunshine Coast, Queensland, Australia
Background/Purpose: Certain psoriatic disease treatments, including TNF-α inhibitors (TNFi), increase risk of latent tuberculosis infection (LTBI) activation.1,2 Current treatment guidelines recommend TB screening before initiating…
Abstract Number: 2348 • ACR Convergence 2024
Bimekizumab Efficacy and Safety Through 4 Years in Moderate to Severe Plaque Psoriasis: Long-Term Results from a Phase 3 Study and Open-Label Extension
Diamant Thaçi¹, Luis Puig², Joseph F. Merola³, Denis Jullien⁴, Antonio Costanzo⁵, Maggie Wang⁶, Delphine Deherder⁷, José M. López Pinto⁸ and Mark Lebwohl⁹, ¹Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Schleswig-Holstein, Germany, ²Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain, ³UT Southwestern Medical Center, Dallas, TX, ⁴Department of Dermatology, Hôpital Edouard Herriot, Hospices Civils de Lyon, University of Lyon, Lyon, France, ⁵Department of Dermatology, Humanitas Clinical and Research Centre, IRCCS, Rozzano, Milan, Italy, ⁶UCB Pharma, Morrisville, NC, ⁷UCB Pharma, Braine-l'Alleud, Belgium, ⁸UCB Pharma, Madrid, Spain, ⁹Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY
Background/Purpose: Clinical improvements through Week 152, with no unexpected safety findings, were previously reported with bimekizumab (BKZ) in the BE SURE phase 3 trial and…
Abstract Number: 2581 • ACR Convergence 2024
Vunakizumab in Patients with Active Psoriatic Arthritis: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study
Hejian Zou¹, Weiguo Wan², Yu Xue¹, Lingyun Sun³, Ning Zhang⁴, Haiying Chen⁵, Xiaofei Shi⁶, Shengyun Liu⁷, Lin Chen⁸, Xinmei Ma⁹, Hua Wei¹⁰, Zhenyu Jiang¹¹, Xiaomei Li¹², Hongtao Fan¹³, Hongbin Li¹⁴, Jingyang Li¹⁵, Rui Wu¹⁶, Guixiu Shi¹⁷, Jing Zhu¹⁸, Xiaodan Kong¹⁹, Yuewu Lu²⁰, Xiaojing Cui²¹, Qianning Zheng²¹, Xiaoyan Bai²² and Guangchao Dong²¹, ¹Department of Rheumatology, Huashan Hospital, Fudan University, Shanghai, China, Shanghai, China (People's Republic), ²Huashan Hospital, Fudan University, Shanghai, China (People's Republic), ³Dept of Rheumatology and Immunology, The Affiliated Drum Tower Hospital of Nanjing Univ Medical School, Nanjing, CN, Nanjing, China (People's Republic), ⁴Shengjing Hospital Affiliated to China Medical University, Shenyang, China (People's Republic), ⁵The Third Hospital of Hebei Medical University, Shijiazhuang, China (People's Republic), ⁶The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China (People's Republic), ⁷The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China (People's Republic), ⁸Jilin Province People's Hospital, Changchun, China (People's Republic), ⁹Zaozhuang Municipal Hospital, Zaozhuang, China (People's Republic), ¹⁰Subei People's Hospital of Jiangsu Province, Yangzhou, China (People's Republic), ¹¹The First Hospital of Jilin University, Changchun, China (People's Republic), ¹²The First Affiliated Hospital of the University of Science and Technology of China, Hefei, China (People's Republic), ¹³The First People's Hospital of Yunnan Province, Kunming, China (People's Republic), ¹⁴Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China (People's Republic), ¹⁵Zhuzhou Central Hospital, Zhuzhou, China (People's Republic), ¹⁶The Tirst Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, China (People's Republic), ¹⁷The First Affilated Hospital of Xiamen University, Xiamen, China (People's Republic), ¹⁸Sichuan Provincial People's Hospital, Chengdu, China (People's Republic), ¹⁹The Second Affiliated Hospital of Dalian Medical University, Dalian, China (People's Republic), ²⁰BeiJing Chao-Yang Hospital, Capital Medical University, Beijing, China, ²¹Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China (People's Republic), ²²Jiangsu Hengrui Pharmaceuticals Co., Ltd., Beijing, China
Background/Purpose: Patients with psoriasis often develop psoriatic arthritis (PsA), a chronic systemic inflammatory disease with a severe clinical burden that impairs quality of life. In…
Abstract Number: 0018 • ACR Convergence 2024
Preclinical Analysisof CB-010, an Allogeneic anti-CD19CAR-T Cell Therapywith a PD-1 Knockout, for the Treatment of Patients with Refractory Systemic Lupus Erythematosus (SLE)
Elizabeth Garner, George Kwong, Tristan W Fowler, Heinrich Kufeldt, Brian Kerfs, Julie Kim, Art Aviles, Lynne Alexander, Franco Davi, Chris Holland, Jean-Yves Maziere, Ashraf Garrett, Mara Bryan, Linh Chu, Sarbani Bhaduri, Michele Gerber, Elaine Alambra, Justin Skoble, Tom Kochy, Tonia Nesheiwat, Socorro Portella, Enrique Zudaire and Steven B Kanner, Caribou Biosciences, Berkeley, CA
Background/Purpose: Autologous CD19-directed CAR-T cell therapy has been shown to eradicate aberrant B cells leading to durable clinical responses in SLE patients (Müller 2024; Wang 2024). However, autologous CAR-T cell…
Abstract Number: 0502 • ACR Convergence 2024
Similar Efficacy, PK, Safety, and Immunogenicity of Tocilizumab Biosimilar (CT-P47) and Reference Tocilizumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: Week 52 Results from the Phase III Single Transition Study
Gerd Burmester¹, Jakub Trefler², Artur Racewicz³, Janusz Jaworski⁴, Agnieszka Zielińska⁵, Marek Krogulec⁶, Sławomir Jeka⁷, Rafał Wojciechowski⁸, Katarzyna Kolossa⁹, Anna Dudek¹⁰, Magdalena Krajewska-Włodarczyk¹¹, Paweł Hrycaj¹², Piotr Adrian Klimiuk¹³, SungHyun Kim¹⁴, JeeHye Suh¹⁴, GoEun Yang¹⁴, Yunah Kim¹⁴, YooBin Jung¹⁴, JiWoo Hong¹⁴ and Josef Smolen¹⁵, ¹Department of Rheumatology and Clinical Immunology, Charité – Universitätsmedizin Berlin, Berlin, Germany, ²REUMA RESEARCH, Wrocław, Poland, ³Zdrowie Osteo-Medic, Warszawa, Poland, ⁴Reumatika-Centrum Reumatologii, Warszawa, Poland, ⁵MICS Centrum Medyczne Warszawa, Warszawa, Poland, ⁶NZOZ Lecznica MAK - MED, Nadarzyn, Poland, ⁷MICS Centrum Medyczne, Polska, Poland, ⁸Department of Rheumatology and Systemic Connective Tissue Diseases, University Hospital No. 2, Bydgoszcz, PL, Bydgoszcz, Poland, ⁹MICS Centrum Medyczne Bydgoszcz, Bydgoszcz, Poland, ¹⁰Centrum Medyczne Amed, Warszawa, Poland, ¹¹University of Warmia and Mazury, Clinic of Rheumatology, Olsztyn, Poland, ¹²Prywatna Praktyka Lekarska Prof. dr hab. med. Paweł, Poznań, Poland, ¹³Medical University of Bialystok and Inter Clinic Piotr Adrian Klimiuk, Department of Rheumatology and Internal Diseases, Białystok, Poland, ¹⁴Celltrion, Inc., Incheon, Republic of Korea, ¹⁵Medical University of Vienna, Vienna, Austria
Background/Purpose: The therapeutic equivalence of CT-P47 (a proposed biosimilar to reference tocilizumab [ref-tocilizumab]) was demonstrated in patients with moderate to severe RA through disease activity…
Abstract Number: 0659 • ACR Convergence 2024
Obinutuzumab Benefits Patients with Active Lupus Nephritis Irrespective of Baseline Proteinuria Severity: A Post Hoc Analysis of a Phase II Trial
Richard Furie¹, Jorge A. Ross Terres², Elsa Martins³, Imran Hassan⁴, Thomas Schindler³, Jay Garg⁵, William F. Pendergraft III⁶, Ana Malvar⁷ and Brad Rovin⁸, ¹Northwell Health, Manhasset, NY, ²Genentech, Inc,, San Francisco, ³F. Hoffmann-La Roche Ltd, Basel, Switzerland, ⁴Hoffmann-La Roche Ltd, Mississauga, Canada, ⁵Genentech, Inc., South San Francisco, CA, ⁶Genentech, Inc., Chapel Hill, NC, ⁷Organización Médica de Investigación, Buenos Aires, Argentina, ⁸The Ohio State University, Columbus, OH
Background/Purpose: Lupus nephritis (LN) is the most common severe organ-threatening manifestation of systemic lupus erythematosus (SLE). The randomized, placebo-controlled, Phase II NOBILITY trial (NCT02550652) demonstrated…
Abstract Number: 0823 • ACR Convergence 2024
A Randomized, Double-Blind, Placebo-Controlled Trial of Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis with Polyangiitis
Carol Langford¹, Nader Khalidi², Jason Springer³, Marcia Friedman⁴, Bernhard Hellmich⁵, Christian Pagnoux⁶, Natasha Dehghan⁷, Ora Singer⁸, Curry Koening⁹, Yih Chang Lin¹⁰, Paul Monach¹¹, Larry Moreland¹², Aurore Fifi-Mah¹³, Oliver Flossmann¹⁴, Lindsy Forbess¹⁵, Peter Lanyon¹⁶, Eamonn Molloy¹⁷, Ulrich Specks¹⁸, Robert Spiera¹⁹, Elaine Yacyshyn²⁰, Carol McAlear²¹, Cristina Burroughs¹⁰, Rachel Jones²², Rennie Rhee²¹, Rula A. Hajj-Ali²³, Kenneth Warrington¹⁸, David Cuthbertson¹⁰, Jeffrey Krischer¹⁰, David Jayne²² and Peter Merkel²¹, and the Vasculitis Clinical Research Consortium and the European Vasculitis Society, ¹Cleveland Clinic, Moreland Hills, OH, ²McMaster University, Hamilton, ON, Canada, ³Vanderbilt University Medical Center, Franklin, TN, ⁴Oregon Health and Science University, Portland, OR, ⁵Medius Kliniken, Kirchheim unter Teck, Germany, ⁶Mount Sinai Hospital, Toronto, ON, Canada, ⁷University of British Columbia - Vancouver, Vancouver, BC, Canada, ⁸University of Michigan, Huntington Woods, MI, ⁹University of Texas Dell Medical School, Austin, TX, ¹⁰University of South Florida, Tampa, FL, ¹¹VA Boston Healthcare System, Boston, MA, ¹²University of Colorado, Denver, CO, ¹³University of Calgary, Calgary, AB, Canada, ¹⁴Royal Berkshire Hospital, Reading, United Kingdom, ¹⁵Cedars-Sinai Medical Center, Los Angeles, CA, ¹⁶University of Nottingham, Nottingham, United Kingdom, ¹⁷St Vincent's University Hospital, Dublin, Ireland, ¹⁸Mayo Clinic, Rochester, MN, ¹⁹Scleroderma, Vasculitis, and Myositis Center, Hospital for Special Surgery, Weill Cornell Medical College, New York, NY, ²⁰University of Alberta, Edmonton, AB, Canada, ²¹University of Pennsylvania, Philadelphia, PA, ²²University of Cambridge, Cambridge, United Kingdom, ²³Cleveland Clinic, Cleveland, OH
Background/Purpose: Granulomatosis with polyangiitis (GPA) is a small-vessel vasculitis associated with frequent relapses. Following encouraging results from an open-label study, a randomized, double-blind, placebo-controlled trial…

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