Abstracts tagged "clinical trial"

Abstract Number: 0290 • ACR Convergence 2024
Deucravacitinib Long-term Efficacy Through 4 Years in Week 16 Placebo Crossover Patients in the Phase 3 POETYK PSO-1, PSO-2, and LTE Program
Mark Lebwohl¹, Richard Warren², Shinichi Imafuku³, Jerry Bagel⁴, April W. Armstrong⁵, Thierry Passeron⁶, Subhashis Banerjee⁷, Renata M. Kisa⁸, Matthew J. Colombo⁷, Thomas Scharnitz⁸, Kim Hoyt⁸, Diamant Thaçi⁹ and Andrew Blauvelt¹⁰, ¹Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, ²Dermatology Centre, Northern Care Alliance NHS Foundation Trust and NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom, ³Fukuoka University Hospital Faculty of Medicine, Fukuoka, Japan, ⁴Psoriasis Treatment Center of New Jersey, East Windsor, ⁵University of California Los Angeles, Los Angeles, ⁶Université Côte d’Azur, University Hospital of Nice, Nice, France, ⁷Bristol Myers Squibb, Princeton, NJ, ⁸Bristol Myers Squibb, Princeton, ⁹Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Schleswig-Holstein, Germany, ¹⁰Oregon Medical Research Center, Portland, OR
Background/Purpose: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate…
Abstract Number: 0588 • ACR Convergence 2024
Sex-Related Differences in Baseline Patient and Disease Characteristics: Post Hoc Analyses of Three Phase 3, Randomized, Double-blind, Placebo-Controlled Studies in Patients with Active Psoriatic Arthritis
Laura Coates¹, Carlo Selmi², Philip Mease³, Alexis Ogdie⁴, Francois Nantel⁵, Frederic Lavie⁶, Mohamed Sharaf⁷, Oyediran Adelakun⁸, Emmanouil Rampakakis⁹, Laura Pina Vegas¹⁰ and Lihi Eder¹¹, ¹University of Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, United Kingdom, ²Department of Biomedical Sciences, Humanitas University, Rozzano, Italy, ³Swedish Medical Center/Providence St. Joseph Health; University of Washington School of Medicine, Seattle, WA, ⁴Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ⁵Nantel MedSci Consult, Montreal, QC, Canada, ⁶Janssen Cilag Global Medical Affairs, Immunology Global Medical Affairs, Issy les Moulineaux, France, ⁷Johnson & Johnson, Middle East FZ LLC, Dubai, UAE, Dubai, United Arab Emirates, ⁸Janssen Research & Development, LLC, Titusville, NJ, ⁹McGill University, Department of Pediatrics / Scientific Affairs, JSS Medical Research Inc., Montreal, QC, Canada, ¹⁰Leiden University Medical Center, Leiden, Netherlands, ¹¹University of Toronto, Women’s College Hospital and Department of Medicine, Toronto, ON, Canada
Background/Purpose: Although PsA occurs in males and females at similar rates, clinical manifestations and outcomes differ between sexes. Findings from real-world evidence (RWE) studies have…
Abstract Number: 0703 • ACR Convergence 2024
Preliminary Results from the RECONNOITER Trial, a Phase 2 Study of AISA 021 in the Treatment of Secondary Raynaud’s, Primarily Due to Systemic Sclerosis
Andrew Sternlicht¹, Michael Shanahan², Erin Morton², Meredith Todd³, Ivana Hunt², Zoey Reed², amanda weragoda⁴, Lashika Weerakoon² and Elizabeth Briggs², ¹Tufts University Medical Center and Aisa Pharma, Inc., Boston, MA, ²Flinders Medical Centre, Adelaide, Australia, ³Aisa Pharma Pty Ltd., East Lindfield, New South Wales, Australia, ⁴F, Adelaide, Australia
Background/Purpose: While 95% of Systemic Sclerosis (SSc) patients have Raynaud’s phenomenon(RP) and many patients rate it as the most bothersome and severe symptom of their…
Abstract Number: 1135 • ACR Convergence 2024
Deucravacitinib in Plaque Psoriasis: 4-Year Efficacy Results by Prior Biologic Treatment in the Phase 3 POETYK PSO-1, PSO-2, and Long-Term ExtensionTrials
Richard Warren¹, April W. Armstrong², Shinichi Imafuku³, Akimichi Morita⁴, Carle Paul⁵, Matthias Augustin⁶, Thierry Passeron⁷, Leon Kircik⁸, Eleni Vritzali⁸, Thomas Scharnitz⁹, Georgene Schroeder⁹, Subhashis Banerjee¹⁰ and Bruce Strober¹¹, ¹Dermatology Centre, Northern Care Alliance NHS Foundation Trust and NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom, ²University of California Los Angeles, Los Angeles, ³Fukuoka University Hospital Faculty of Medicine, Fukuoka, Japan, ⁴Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan, ⁵Toulouse University and CHU, Toulouse, France, ⁶Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany, ⁷Université Côte d’Azur, University Hospital of Nice, Nice, France, ⁸Icahn School of Medicine at Mount Sinai, New York, NY, ⁹Bristol Myers Squibb, Princeton, ¹⁰Bristol Myers Squibb, Princeton, NJ, ¹¹Department of Dermatology, Yale University, New Haven, and Central Connecticut Dermatology Research, Cromwell, CT
Background/Purpose: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate…
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…

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