Abstracts tagged "clinical trial"

Abstract Number: 1404 • ACR Convergence 2024
Modeling Diversity in Systemic Lupus Erythematosus (SLE) Clinical Trials Using Real-world Data (RWD) Sources
Andrew Bevan¹ and Nora Carroll², ¹Integrated Project Solutions, PPD, part of Thermo Fisher Scientific, Cambridge, United Kingdom, ²Cardiovascular and General Medicine, Thermo Fisher Scientific, Athlone, Ireland
Background/Purpose: The FDA places emphasis on studying clinically relevant trial populations but does not address how these might be defined. SLE disproportionately affects women and…
Abstract Number: 1545 • ACR Convergence 2024
Rates of Sustained Complete Renal Response with Long-term Use of Voclosporin in AURORA 2
Ernie Yap¹, Matt Truman², Cynthia Auguste¹, Vanessa Birardi³ and Greg Keenan¹, ¹Aurinia Pharmaceuticals Inc., Edmonton, Canada, ²Aurinia Pharmaceuticals, Victoria, BC, Canada, ³Aurinia Pharmaceuticals Inc., Rockville, MD
Background/Purpose: Unlike in many other disease states, there is no accepted definition for clinical response in lupus nephritis (LN). The Phase 3 AURORA 1 study…
Abstract Number: 1978.5 • ACR Convergence 2024
Post-Hoc Analysis of Clinically Relevant Anti-Vaccine Antibodies in Participants with Rheumatoid Arthritis Treated with Nipocalimab
Faye Yu¹, Eugene Myshkin², Carolina Bobadilla Mendez³, Marta Cossu⁴, Kaiyin Fei⁵, Qingmin Wang⁶, Matthew J. Loza⁶, Dessislava Dimitrova³ and Sheng Gao³, ¹Janssen Research & Development, LLC, a Johnson & Johnson company, Cambridge, MA, USA, MA, MA, ²Janssen Research & Development, LLC, a Johnson & Johnson company, Cambridge, MA, ³Janssen Research & Development, LLC, a Johnson & Johnson company, Spring House, PA, ⁴Janssen Pharmaceutical Research and Development, a Johnson & Johnson company, Leiden, Netherlands, ⁵Janssen Research & Development, LLC, Spring House, PA, ⁶Janssen Research & Development, LLC, a Johnson & Johnson company, Spring House, PA, USA, Spring House, PA

Background/Purpose: Nipocalimab is a fully human, high affinity, aglycosylated, effectorless IgG1 monoclonal antibody designed to selectively block neonatal fragment crystallizable receptor (FcRn), thereby lowering IgG…
Abstract Number: 2144 • ACR Convergence 2024
Impact of Immunogenicity on Clinical Outcomes in Postmenopausal Women with Osteoporosis: Results from a Randomized Controlled Phase 3 Study to Compare CT-P41 (Proposed Denosumab Biosimilar) and Reference Denosumab
Jean-Yves Reginster¹, Stuart L. Silverman², Edward Czerwinski³, Przemyslaw Borowy⁴, Tomasz Budlewski⁵, Joanna Kwiatek⁶, Svitlana Postol⁷, Airi Põder⁸, Jerzy Supronik⁹, SungHyun Kim¹⁰, JeeHye Suh¹⁰, GoEun Yang¹⁰, NooRi Han¹⁰, NaHyun Kim¹⁰ and SeoHee Bae¹⁰, ¹Biochemistry Dept, College of Science, King Saud University, Riyadh, Kingdom of Saudi Arabia, CLARENS, Switzerland, ²OMC clinical research center and Cedars Sinai Medical Center, Beverly Hills, CA, ³Krakowskie Centrum Medyczne, Kraków, Poland, ⁴Krakowskie Centrum Medyczne, Krakow, Poland, ⁵Department of Rheumatology, Medical University of Lodz, Lodz, Poland, ⁶Centrum Medyczne Poznan - PRATIA, Skorzewo, Poland, ⁷Medical Center of Medbud - Clinic LLC, Kyiv, Ukraine, ⁸Clinical Research Centre Ltd, Tartu, Estonia, ⁹Osteo-Medic s.c., Białystok, Poland, ¹⁰Celltrion, Inc., Incheon, Republic of Korea

Background/Purpose: CT-P41 has been developed as a proposed biosimilar of the reference denosumab (DEN), a fully human monoclonal antibody that binds the cytokine receptor activator…
Abstract Number: 2462 • ACR Convergence 2024
A Potent Inhibitor of PAI-1, MDI-2517, Mitigates Disease Severity in Preclinical Models of Systemic Sclerosis
Enming Su¹, Pei-Suen Tsou¹, Mark Warnock², Natalya Subbotina¹, Kris Mann¹, Sirapa Vichaikul¹, Xianying Xing¹, Enze Xing¹, Olesya Plazyo¹, Rachael Wasikowski¹, Lam C. Tsoi³, Mark Weinberg⁴, Cory D. Emal⁵, Dinesh Khanna¹, John Varga¹, Thomas H. Sisson¹, Johann Gudjonsson¹ and Daniel Lawrence², ¹University of Michigan, Ann Arbor, MI, ²Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, MI, ³Michigan, Dept. of Dermatology, Ann Arbor, MI, ⁴MDI, Ann Arbor, MI, ⁵EMU, Ann Arbor, MI
Background/Purpose: Systemic sclerosis (SSc) is a complex and heterogeneous condition characterized by progressive fibrosis in multiple organs. Currently, there is no known cure for SSc,…
Abstract Number: 0298 • ACR Convergence 2024
RAY121, a Novel Recycling Monoclonal Antibody Against Complement C1s: Safety, Pharmacokinetic and Pharmacodynamic Data from a Phase 1a First in Human Clinical Trial in Healthy Adults
Miwa Haranaka¹, Akinori Yamada², Saki Takahashi², Keisuke Gotanda², Sonoko Nakano-Kanatani², Nana Uemura², Kensuke Ohnishi², Masanobu Nishidate², Ichio Ohnami² and Megumi Kai³, ¹Souseikai Hakata Clinic, Fukuoka, Japan, ²Chugai Pharmaceutical Co., Ltd., Tokyo, Japan, ³Oita University, Oita, Japan
Background/Purpose: Complement C1s is one of the major components of the classical complement pathway (CP), and the abnormal activation of CP is implicated in several…
Abstract Number: 0591 • ACR Convergence 2024
Bimekizumab Maintained Efficacy Responses in Patients with Active Psoriatic Arthritis: Up to 2-Year Results from Two Phase 3 Studies
Jessica A Walsh¹, Joseph F. Merola², Christopher T Ritchlin³, Yoshiya Tanaka⁴, Ennio Giulio Favalli⁵, Dennis McGonagle⁶, Diamant Thaçi⁷, Barbara Ink⁸, Rajan Bajracharya⁸, Jason Coarse⁹ and William Tillett¹⁰, ¹Division of Rheumatology, Salt Lake City Veterans Affairs Health and University of Utah Health, Salt Lake City, UT, ²UT Southwestern Medical Center, Dallas, TX, ³Allergy, Immunology & Rheumatology Division, University of Rochester Medical School, Rochester, NY, ⁴Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan, ⁵ASST Gaetano Pini-CTO, Milan, Lombardia, Italy, ⁶National Institute for Health Research (NIHR) Leeds Biomedical Research Centre (BRC), Leeds Teaching Hospitals, Leeds, UK, Leeds, England, United Kingdom, ⁷Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Schleswig-Holstein, Germany, ⁸UCB Pharma, Slough, United Kingdom, ⁹UCB Pharma, Morrisville, NC, ¹⁰Royal National Hospital of Rheumatic Diseases; Department of Life Sciences, Centre for Therapeutic Innovation, University of Bath, Bath, United Kingdom
Background/Purpose: PsA is a chronic disease, and patients (pts) can experience loss of response with sustained therapy; therefore, assessing long-term maintenance of response in pts…
Abstract Number: 0736 • ACR Convergence 2024
Treatment of IgG4-Related Disease (IgG4-RD) with Elotuzumab, an Inhibitor of SLAM-F7: Report of a Phase 2 Clinical Trial
John Stone¹, Arezou Khosroshahi², Shounak Majumder³, Cory Perugino⁴, Ana Fernandes⁴, Grace McMahon⁴, Isha Jha⁴, John Varghese², Adriana Delgado³, Guy Katz⁴, Zachary Wallace⁵, Shiv Pillai⁴, William Barry⁶, Ashley Pinckney⁷, Ellen Goldmuntz⁸, Beverly Welch⁹ and Kaitlin McShea⁹, ¹Massachusetts General Hospital , Harvard Medical School, Concord, MA, ²Emory University, Atlanta, GA, ³Mayo Clinic, rochester, MN, ⁴Massachusetts General Hospital, Boston, MA, ⁵Massachusetts General Hospital, Newton, MA, ⁶Rho, Durham, NC, ⁷Rho, St Louis Park, NC, ⁸NIAID/ NIH, Washington, DC, ⁹Rho, Washington, DC
Background/Purpose: CD4+ cytotoxic T lymphocytes (CD4+ CTLs), plasmablasts, and selected other cells of the T and B cell lineages have been identified as cellular linchpins of…
Abstract Number: 1137 • ACR Convergence 2024
Deucravacitinib, an Oral,Selective,Allosteric Tyrosine Kinase 2 Inhibitor, in Patients WithModerate to Severe Scalp Psoriasis: Efficacy and Safety Results of a Phase 3b/4, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial (PSORIATYK SCALP)
Kristina Callis Duffin¹, Christopher E. M. Griffiths², Matthias Hoffmann³, Andrew Blauvelt⁴, Eugene Balagula⁵, Andrew Napoli⁵, Ying-Ming Jou⁵, Rachel Dyme⁵, Virginia Hala⁵, andreas pinter⁶ and Mark Lebwohl⁷, ¹University of Utah, Salt Lake City, ²Dermatology Centre, University of Manchester, Manchester, and King’s College Hospital and King’s College London, London, United Kingdom, ³Private Practice, Witten, Germany, ⁴Oregon Medical Research Center, Portland, OR, ⁵Bristol Myers Squibb, Princeton, ⁶University Hospital of the Goethe University, Frankfurt am Main, Frankfurt, Germany, ⁷Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY
Background/Purpose: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is approved in the US, EU, and other countries for treatment of adults with…
Abstract Number: 1413 • ACR Convergence 2024
Pilot Trial of Ustekinumab for Primary Sjogren’s Syndrome
Ummara Shah¹ and Andrea Coca², ¹University of Rochester, Webster, NY, ²University of Pittsburgh, Pittsburgh, PA
Background/Purpose: Sjogren’s Syndrome (SS) is a chronic autoimmune disease characterized by keratoconjunctivitis sicca and xerostomia. Currently there is no approved systemic treatment for primary SS. …
Abstract Number: 1552 • ACR Convergence 2024
Kinetics of Mucocutaneous and Musculoskeletal Responses to Deucravacitinibin Patients with Active SLE in the Phase 2 PAISLEY Trial
Ronald Van Vollenhoven¹, Joseph Merola², Kathryn H. Dao³, Piotr Leszczynski⁴, Marilyn Pike⁵, Samantha Pomponi⁶, Coburn Hobar⁶, Matthew J. Colombo⁶, Ravi Koti⁶, Subhashis Banerjee⁶, Thomas Wegman⁷ and Eric Morand⁸, ¹Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Centers, Amsterdam, Netherlands, ²UT Southwestern Medical Center, Newton, MA, ³Department of Internal Medicine, Division of Rheumatology, The University of Texas Southwestern Medical Center, Dallas, ⁴Department of Internal Medicine, Poznań University of Medical Sciences, Poznań, Poland, ⁵Rheumatology, MedPharm Consulting, Inc., Raleigh, NC, ⁶Bristol Myers Squibb, Princeton, NJ, ⁷Bristol Myers Squibb, Beaver Falls, PA, ⁸School of Clinical Sciences, Monash University, Melbourne, Victoria, Australia
Background/Purpose: Deucravacitinib is a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor approved in multiple countries for the treatment of moderate to severe plaque…
Abstract Number: 2005 • ACR Convergence 2024
Impact of Anti-drug Antibodies on the Efficacy of SEL-212 in Patients with Chronic Gout Refractory to Conventional Therapy
Puja Khanna¹, Vibeke Strand², Atul Singhal³, Herbert Baraf⁴, Rehan Azeem⁵, Wesley DeHaan⁶, Sheldon Leung⁵, Hugues Santin-Janin⁷, Aletta Falk⁸ and Alan Kivitz⁹, ¹University of Michigan, Ann Arbor, MI, ²Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, ³Southwest Arthritis Research Group, Mesquite, TX, ⁴Center for Rheumatology and Bone Research, Wheaton, MD, ⁵Sobi Inc., Waltham, MA, ⁶Sobi, Inc, Waltham, MA, ⁷Sobi, BETTENDORF (68560), France, ⁸Sobi, Stockholm, Sweden, ⁹Altoona Center for Clinical Research, Duncansville, PA
Background/Purpose: SEL-212 is a once-monthly, investigational, two-component infusion therapy consisting of pegadricase (SEL-037, a pegylated uricase) and immune-tolerizing nanoparticles containing sirolimus (SEL-110), for the treatment…
Abstract Number: 2252 • ACR Convergence 2024
Long-term Efficacy of Filgotinib Monotherapy and Combination Therapy: Interim Results from a Post Hoc Analysis of the FINCH 4 Study
Maya H. Buch¹, Patrick Verschueren², Roberto Caporali³, Thomas Huizinga⁴, Edmund V. Ekoka Omoruyi⁵, Dick de Vries⁶, Jeffrey Ritsema⁷, Francesco De Leonardis⁸ and Daniel Aletaha⁹, ¹Division of Musculoskeletal & Dermatological Sciences, University of Manchester, and NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom, ²Department of Rheumatology, University Hospital Leuven and KU Leuven, Leuven, Belgium, 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 Rheumatology, Leiden University, Leiden, Netherlands, ⁵Biostatistics, Galapagos NV, Mechelen, Belgium, ⁶Clinical Development, Galapagos BV, Leiden, Netherlands, ⁷Medical Affairs, Galapagos BV, Leiden, Netherlands, ⁸Medical Affairs, Galapagos GmbH, Basel, Switzerland, ⁹Department of Medicine III, Division of Rheumatology, Medical University of Vienna, Wien, Austria
Background/Purpose: Filgotinib (FIL) is a preferential Janus kinase 1 inhibitor for the treatment of moderate to severe RA. FINCH 4 (NCT03025308) is an ongoing, open-label,…
Abstract Number: 2478 • ACR Convergence 2024
Avacopan versus a Prednisone Taper in Patients with ANCA-Associated Vasculitis Without Kidney Involvement in a Phase 3 Trial
Christian Pagnoux¹, Antoine Neel², Sarah Bray³, Rachel E. Gurlin⁴, Darcy Trimpe⁵, David Jayne⁶ and Peter Merkel⁷, and ADVOCATE Study Group, ¹Mount Sinai Hospital, Toronto, ON, Canada, ²Department of Internal Medicine, CHU Nantes, Nantes, France, ³Amgen Ltd, Cambridge, United Kingdom, ⁴Amgen Inc., Mountain View, CA, ⁵Amgen Inc., Thousand Oaks, CA, ⁶University of Cambridge, Cambridge, United Kingdom, ⁷University of Pennsylvania, Philadelphia, PA
Background/Purpose: Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) are subtypes of ANCA-associated vasculitis that frequently involve the kidneys. However, a subset of patients with…
Abstract Number: 0303 • ACR Convergence 2024
Phase 2b, Long-term Extension, Dose-ranging Study of Oral JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis: FRONTIER-2
Laura K. Ferris¹, Jerry Bagel², Yu-Huei Huang³, Andrew E. Pink⁴, Stephen K. Tyring⁵, Georgios Kokolakis⁶, Amy M. DeLozier⁷, Daniel Kakaley⁸, Shu Li⁹, Yaung-Kaung Shen¹⁰, Takayuki Ota⁷ and Robert Bissonnette¹¹, ¹University of Pittsburgh, Pittsburgh, PA, ²Psoriasis Treatment Center of Central NJ, East Windsor, NJ, ³Chang Gung Memorial Hospital and Chang Gung University, Linkou, Taoyuan City, Taiwan (Republic of China), ⁴NHS Foundation Trust Great Maze Pond, London, United Kingdom, ⁵Center for Clinical Studies, Webster, TX, ⁶Psoriasis Research and Treatment Center, Department of Dermatology, Venereology and Allergology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany, ⁷Janssen Research & Development, LLC, San Diego, CA, ⁸Janssen Scientific Affairs, LLC, Horsham, PA, ⁹Janssen Research & Development, LLC, Spring House, PA/San Diego, CA, ¹⁰Janssen Research & Development, LLC, Spring House, PA, ¹¹Innovaderm Research, Montreal, QC, Canada
Background/Purpose: JNJ-77242113, a targeted oral peptide, inhibits IL-23 signaling by binding the IL-23 receptor. At all doses, JNJ-77242113 showed superior efficacy at Week 16 versus…

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