Abstracts tagged "clinical trial"

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…
Abstract Number: 0593 • ACR Convergence 2024
Value of the Routine Assessment of Patient Index Data 3 in Assessing Disease Severity and Treatment Effect in Patients with Early Oligoarticular Psoriatic Arthritis Treated with Apremilast
Alvin F. Wells¹, Arthur Kavanaugh², William Tillett³, Philip S. Helliwell⁴, Marijn Vis⁵, Yuri Klyachkin⁶, Cynthia Deignan⁷, Lichen Teng⁷, Rebecca Wang⁷ and Alexis Ogdie⁸, ¹Rheumatology and Immunotherapy Center, Franklin, WI, ²University of California San Diego, La Jolla, CA, ³Royal National Hospital of Rheumatic Diseases; Department of Life Sciences, Centre for Therapeutic Innovation, University of Bath, Bath, United Kingdom, ⁴Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK, Leeds, United Kingdom, ⁵Erasmus MC, Rotterdam, Netherlands, ⁶Amgen, Lexington, KY, ⁷Amgen Inc., Thousand Oaks, CA, ⁸Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA
Background/Purpose: The Routine Assessment of Patient Index Data 3 (RAPID3) score is a composite of 3 patient-reported outcomes (PROs): Health Assessment Questionnaire (HAQ), pain visual…
Abstract Number: 0747 • ACR Convergence 2024
Clofutriben to Improve the Benefit-Risk Profile of Prednisolone in Patients with Polymyalgia Rheumatica
FRANK HARTMUT DR. BUTTGEREIT¹, Andrea Everding², Ioana Andreica³, Herbert Kellner⁴, Florian Schuch⁵, Tonya K Marmon⁶, Frank S Czerwiec⁷, Ketan Desai⁸ and David A Katz⁹, ¹Charité University Medicine Berlin, Berlin, Germany, ²Hamburger Rheuma Forschungszentrum II, Hamburg, Germany, ³Rheumazentrum Ruhrgebiet, Bochum, Germany, ⁴Schwerpunktpraxis f�r Rheumatologie und Gastroenterologie, Munich, Germany, ⁵PGRN, Erlangen, Germany, ⁶Marmon Biostatistics, Seattle, WA, ⁷Sparrow Pharmaceuticals, Portand, OR, ⁸IMC, Easton, PA, ⁹Sparrow Pharmaceuticals, Portland, OR
Background/Purpose: 11β-hydroxysteroid dehydrogenase type 1 (HSD-1) differentially regulates intracellular glucocorticoid levels in the immune system and glucocorticoid toxicity target organs. Clofutriben is a potent HSD-1…
Abstract Number: 1169 • ACR Convergence 2024
Efficacy of Intravenous Immunoglobulin (Octagam 10%) on Pulmonary Manifestations in Patients with Dermatomyositis: Results from the ProDERM Study
Rohit Aggarwal¹, christina Charles-Schoeman² and Joachim Schessl³, and the ProDERM Investigators, ¹Division of Rheumatology and Clinical Immunology, University of Pittsburgh, Pittsburgh, PA, USA, Pittsburgh, PA, ²UCLA Medical Center, Santa Monica, CA, ³Friedrch-Baur-Institut; Ludwig-Maximilians University of Munich, Munich, Germany
Background/Purpose: Interstitial lung disease (ILD) and other pulmonary manifestations are a major cause of mortality and morbidity in patients with dermatomyositis (DM). The ProDERM study…
Abstract Number: 1427 • ACR Convergence 2024
Observed and Simulated Pharmacokinetics and Pharmacodynamics of Nipocalimab, a Fully Human FcRn Blocking Monoclonal Antibody, in Adults with Sjögren’s Disease: Results from a Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study
Sophia G. Liva¹, fudan Zheng¹, Jocelyn H. Leu², Kathy Sivils³, Keying Ma¹, He Li⁴, Steven Leonardo⁵, Kim Lo¹, Jada Idokogi¹, Kim Campbell¹ and Jonathan J. Hubbard¹, ¹Janssen Research & Development, LLC, a Johnson & Johnson Company, Spring House, PA, ²Janssen Research & Development, LLC, a Johnson & Johnson company, Spring House, PA, PA, ³Johnson & Johnson Innovative Medicine, Edmond, OK, ⁴Janssen Research & Development, LLC, Therapeutics Discovery, Spring House, PA, ⁵Janssen Research & Development, LLC, a Johnson & Johnson Company, Cambridge, MA
Background/Purpose: Sjögren’s disease (SjD) is a chronic, progressive autoimmune disease characterized by aberrant B lymphocyte activity, elevated IgG production, and the presence of IgG autoantibodies…
Abstract Number: 1596 • ACR Convergence 2024
Efficacy of Eosinophil-Targeting Therapies According to Disease Severity in Patients with Eosinophilic Granulomatosis with Polyangiitis
Bernhard Hellmich¹, Peter Merkel², David Jayne³, Benjamin Terrier⁴, Florence Roufosse⁵, Parameswaran Nair⁶, Nader Khalidi⁶, David J. Jackson⁷, Shunsuke Furuta⁸, Lena Börjesson Sjö⁹, Sofia Necander⁹, Anat Shavit¹⁰, Claire Walton¹¹ and Michael Wechsler¹², ¹Klinik für Innere Medizin, Rheumatologie, Pneumologie, Nephrologie und Diabetologie, Medius Kliniken, Akademisches Lehrkrankenhaus der Universität Tübingen, Kirchheim unter Teck, Germany, ²University of Pennsylvania, Philadelphia, PA, ³University of Cambridge, Cambridge, United Kingdom, ⁴Service de Médecine interne, Hôpital Cochin, AP-HP, Paris, Ile-de-France, France, ⁵Department of Internal Medicine, Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium, ⁶McMaster University and St Joseph’s Healthcare, Hamilton, ON, Canada, ⁷Guy’s Severe Asthma Centre, Guy’s and St Thomas’ NHS Trust; School of Immunology and Microbial Sciences, King’s College London, London, United Kingdom, ⁸Department of Allergy and Clinical Immunology, Chiba University Hospital, Chiba, Japan, ⁹Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden, ¹⁰BioPharmaceuticals Medical, AstraZeneca, Cambridge, United Kingdom, ¹¹Late-Stage Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom, ¹²National Jewish Health, Denver, CO
Background/Purpose: Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare inflammatory disorder characterized by asthma, eosinophilia, and small-to-medium size vessel vasculitis, with individual manifestations widely ranging…
Abstract Number: 2008 • ACR Convergence 2024
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Single Dose of ABP-671 in Participants with Chronic Kidney Disease (CKD)
ullrich schwertschlag¹, william dongfang Shi², rOBERT PERRY³, Kwabena Ayesu⁴, rOY WU⁵, jerry liu⁶, JinSying Lin⁷ and Adam Jin⁸, ¹Atombio Science, PALO ALTO, CA, ²Jiangsu Atom Bioscience,, Suzhou, Jiangsu, China (People's Republic), ³Panax Clin Res, Miami Lakes, FL, ⁴OMEGARLLC, ORLANDO, FL, ⁵Atom Bioscience, SAN FRANCISCO, CA, ⁶atombio, San Diego, CA, ⁷Biostatconsulting, Wuzhong, Suzhou, Jiangsu, China (People's Republic), ⁸atom biosciences, Wuzhong, Suzhou, Jiangsu, China (People's Republic)
Background/Purpose: In this open-label Phase 1 study, 22 participants were enrolled in 3 cohorts, 10 participants with normal kidney function (eGFR ≥90 ml/min/1.73m2 and no…
Abstract Number: 2274 • ACR Convergence 2024
Efficacy and Safety of the Biased Melanocortin Receptor Agonist AP1189/resomelagon in Combination with Methotrexate in DMARD-naïve Rheumatoid Arthritis Patients: The EXPAND Trial
Asger Reinstrup Bihlet¹, Philip G Conaghan², Thomas Boesen³, Mette Arnum Jensen³, Alejandro Castillo Mondragón⁴, Ema Erkocevic Petersen⁴, Cathrine Borgsted Bak⁴ and Thomas EN Jonassen³, ¹NBCD A/S, Soeborg, Denmark, ²Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, ³Synact Pharma ApS, Holte, Denmark, ⁴NBCD A/S, Soborg, Denmark
Background/Purpose: AP1189 is a novel, first-in-class, oral, biased melanocortin (MC)1 and MC3 receptor agonist in development for Rheumatoid Arthritis (RA) treatment. Through multiple actions including…

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