Abstracts tagged "clinical trial"

Abstract Number: 1134 • ACR Convergence 2024
First-in-Human Evaluation of the Safety, Tolerability and Pharmacokinetics of the T Cell Receptor Signal Modulator AX-158
Christopher VanDeusen¹, Andres Gagete¹, Annelize Koch² and D Scott Batty Jr¹, ¹Artax Biopharma, Inc, Cambridge, MA, ²Simbec-Orion, Merthyr Tydfil, Wales, United Kingdom
Background/Purpose: Nck is a cytosolic protein that binds a domain of the T cell receptor (TCR) following TCR interaction to amplify responses from low affinity…
Abstract Number: 1399 • ACR Convergence 2024
A First-in-Human Clinical Trial Evaluating the Safety and Pharmacokinetics of SOL-116, a Novel Humanized Monoclonal Antibody Targeting Bile Salt-Stimulated Lipase for the Treatment of RA
Karin Franck-Larsson¹, Susanne Lindquist², Agneta Wennerholm³, Johan Kolmert⁴, Maria Wanderoy³ and Olle Hernell², ¹Lipum AB, Uppsala, Sweden, ²Lipum AB; Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden, ³Lipum AB, Stockholm, Sweden, ⁴Lipum AB; Unit of Integrative Metabolomics, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden
Background/Purpose: Bile Salt-Stimulated Lipase (BSSL) is a lipolytic enzyme secreted by the lactating mammary gland and exocrine pancreas. Elevated plasma levels of BSSL have been…
Abstract Number: 1543 • ACR Convergence 2024
Improvements in BILAG Musculoskeletal and Mucocutaneous Domains at Week 48 in a Phase 2 Double-Blind Placebo-Controlled Trial of ABBV-599 (Elsubrutinib + Upadacitinib Combination) and Upadacitinib Monotherapy for Treatment of Moderately to Severely Active Systemic Lupus Erythematosus
Amit Saxena¹, Zahi Touma², Edward Vital³, Eric Morand⁴, Marta Mosca⁵, Kristin D'Silva⁶, Peter Wung⁶, Ling Cheng⁶, Melitza Iglesias-Rodriguez⁶, Shelly Kafka⁶ and Joan Merrill⁷, ¹NYU Grossman School of Medicine, New York, NY, ²University of Toronto, Toronto, ON, Canada, ³Leeds Institute of Rheumatic and Musculoskeletal Medicine, Faculty of Medicine and Health, University of Leeds, Leeds, United Kingdom, Leeds, England, United Kingdom, ⁴School of Clinical Sciences, Monash University, Melbourne, Victoria, Australia, ⁵University of Pisa, Pisa, Italy, ⁶AbbVie Inc., North Chicago, IL, ⁷Oklahoma Medical Research Foundation, Oklahoma City 73104, OK
Background/Purpose: ABBV-599 is a novel combination of elsubrutinib (ELS; a selective Bruton’s tyrosine kinase inhibitor) and upadacitinib (UPA; a selective Janus kinase inhibitor), which targets…
Abstract Number: 1952 • ACR Convergence 2024
Interest in Clinical Trial Participation Among People with Lupus: Results from the Research Accelerated by You (RAY) Registry
Michael Fisher¹, Mimi Kim², Joan Merrill³, Safoah Agyemang¹ and Joy Buie¹, ¹Lupus Foundation of America, Washington, DC, ²Albert Einstein College of Medicine, New York, NY, ³Oklahoma Medical Research Foundation, Oklahoma City 73104, OK
Background/Purpose: With many treatments under study for SLE, a crisis in recruiting sufficient numbers of qualified patients for clinical trials has emerged. Willingness to consider…
Abstract Number: 2113 • ACR Convergence 2024
Discontinuation and Non-publication of Postmenopausal Osteoporosis Clinical Studies: A Cross-sectional Analysis of 345,435 Patients
Mohamed Abdelsalam¹, yasmeen Alabdallat², Yousef Hussein³, Mona Sajed⁴, Maryam Taha⁵, Rawan morse⁶, Wessam Selima⁷ and Ahmed Zabady⁸, ¹Rheumatology, Rehabilitation and Physical medicine department - faculty of medicine -Misr University for science and technology, 6th of October, Al Jizah, Egypt, ²Faculty of medicine - Hashemite university, Zarqa, Jordan, ³Faculty of medicine - Benha university, Benha, Egypt, ⁴Faculty of Pharmacy - Al-Azhar university for girls, Mansoura, Ad Daqahliyah, Egypt, ⁵Faculty of medicine - Ain Shams university, Madinat Nasr, Al Qahirah, Egypt, ⁶Medical Research Group of Egypt, Bur sa'id, Egypt, ⁷Anaesethia & pain management department, Faculty of medicine, Ain Shams University, Cairo, Egypt, ⁸Faculty of science - Damanhour university, Cairo, Egypt
Background/Purpose: Postmenopausal osteoporosis (PMOP) significantly contributes to global fracture rates annually, with its silent progression complicating early detection and intervention. Effective management strategies are crucial,…
Abstract Number: 2430 • ACR Convergence 2024
Dapirolizumab Pegol Impacts Important Immunologic Pathways in Systemic Lupus Erythematosus: Pharmacodynamic Analysis of T Cell and Antigen Presenting Cell Pathways from a Phase 2b Trial
Alex S. Powlesland¹, Ioana Cutcutache¹, Andrew Skelton¹, Anthony Shock¹, Matthew Page¹, Eris Bame², Janine Gaiha-Rohrbach², George Stojan³, Ania Skowera¹, Christian Stach⁴ and Thomas Dörner⁵, ¹UCB Pharma, Slough, United Kingdom, ²Biogen Inc., Cambridge, MA, ³UCB Pharma, Atlanta, GA, ⁴UCB Pharma, Monheim am Rheim, Germany, ⁵Department of Medicine, Rheumatology and Clinical Immunology,Charite Universitätsmedizin Berlin, Germany and DRFZ, Berlin, Berlin, Germany
Background/Purpose: CD40-CD40L interactions play a pivotal role in systemic lupus erythematosus (SLE) pathogenesis by orchestrating a range of immune and inflammatory responses involving B cells,…
Abstract Number: L04 • ACR Convergence 2023
EP-104IAR (Extended-Release Fluticasone Propionate for Injectable Suspension): Topline and Key Secondary Results from a Phase 2 Randomized, Double-blind, Vehicle-Controlled Trial in Subjects with Knee Osteoarthritis
James Helliwell¹, Amanda Malone¹, Mark Kowalski², Asger Reinstrup Bihlet³, Claire Miller⁴, Alejandro Castillo Mondragon⁵, Yanqi Li⁶, Christine Dobek⁷, Vik Peck¹, Mike Wilmink⁸ and Lee Simon⁹, ¹Eupraxia Pharmaceuticals, Victoria, BC, Canada, ²Eupraxia Pharmaceuticals, Winchester, VA, ³NBCD A/S, Soeborg, Denmark, ⁴NBCD A/S, Copenhagen, Denmark, ⁵NBCD, Copenhagen, Denmark, ⁶NBCD A/S, Soborg, Denmark, ⁷Eupraxia Pharmaceuticals, Edmonton, AB, Canada, ⁸OrthoArizona, Phoenix, AZ, ⁹SDG LLC, Cambridge, MA
Background/Purpose: EP-104IAR is being developed to treat OA symptoms. Previous results from non-clinical studies evaluating local joint safety in beagle dogs, in contrast to other…
Abstract Number: L05 • ACR Convergence 2023
DICKENS: A Multicentre Randomised Controlled Trial of Diacerein for Knee Osteoarthritis with Effusion-Synovitis
Guoqi Cai¹, Graeme Jones², Flavia Cicuttini³, Anita Wluka³, Yuanyuan Wang³, Catherine Hill⁴, Helen Keen⁵, Benny Antony², barbara de Graaff², Michael Thompson², Tania Winzenberg², Kathy Buttigieg², Petr Otahal² and Dawn Aitken², ¹School of Public Health, Anhui Medical University, Hefei, China, ²Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia, ³Monash University, Melbourne, Australia, ⁴The Queen Elizabeth Hospital, University of Adelaide, Adelaide, Australia, ⁵Fiona Stanley Hospital, Murdoch, Australia
Background/Purpose: There is an unmet need for treatments of knee OA. Diacerein is recommended for alleviating pain in OA patients for its anti-inflammatory effect by…
Abstract Number: L08 • ACR Convergence 2023
Early Clinical Development of CIT-013, a First in Class NETosis Inhibitor, in a Randomized Phase I Dose Escalation Study in Healthy Volunteers Demonstrating Potent Inhibition of LPS Induced Neutrophil Extracellular Trap Formation
Leonie Middelink¹, Renato Chirivi², Helmuth van Es², Eric Meldrum², Peter van Zandvoort², Tirza Bruurmijn², Matthijs Moerland³ and Patrick Round², ¹Middelinc., Utrecht, Netherlands, ²Citryll BV, Oss, Netherlands, ³CHDR, Leiden, Netherlands
Background/Purpose: Aberrant Neutrophil Extracellular Traps (NETs) production contributes to the pathophysiology of multiple inflammatory and autoimmune diseases such as Rheumatoid arthritis (RA) Hidradenitis suppurativa (HS),…
Abstract Number: L09 • ACR Convergence 2023
Efficacy and Safety of LNK01001 in Chinese Patients with Moderate to Severe Active Rheumatoid Arthritis with an Inadequate Response to Conventional Synthetic DMARDs: 24-week Results from a Phase 2 Trial
Chanyuan Wu¹, Xuebin Wang², Jiankang Hu³, Xiaofei Shi⁴, Xiaoxia Wang⁵, Xuan Zhang⁶, Ju Liu⁷, Hui Rao⁸, Jianhong Zhao⁹, Rong Du¹⁰, Zhenyu Jiang¹¹, Huaxiang liu¹², Lin Liu¹³, Shengyun Liu¹⁴, Changhao Xie¹⁵, Xiangping Liao¹⁶, Lie Dai¹⁷, Zhiduo Hou¹⁸, Jingchun Jin¹⁹, Tianwang Li²⁰, Deqian Meng²¹, Yongfu Wang²², Jian Wu²³, Jieruo Gu²⁴, Wei Wei²⁵, Yu Zhuang²⁶, Kuanting Wang²⁷, Rong Zhang²⁸, Xiao Zhang²⁹, Huaping Wei³⁰, Zhao-Kui Wan³¹, Jun Wang³¹, Michael Vazquez³², Henry Wu³³ and Xiaofeng Zeng¹, ¹Peking Union Medical College Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing, China, ²Binzhou Medical University Hospital, Binzhou, China, ³Pingxiang People's Hospital, Pingxiang, China, ⁴The 1st Affiliated Hospital of He'nan University, Luoyang, China, ⁵Second Hospital of Shanxi Medical University, Taiyuan, China, ⁶Beijing Hospital, Beijing, China, ⁷Jiujiang No. 1 People's Hospital, Jiujiang, China, ⁸Hunan Provincial People's Hospital, Changsha, China, ⁹Jining First People's Hospital, Jining, China, ¹⁰Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China, ¹¹First Affiliated Hospital of Jilin University, Changchun, China, ¹²Qilu Hospital of Shandong University, Jinan, China, ¹³Central Hospital of Xuzhou City, Xuzhou, China, ¹⁴The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China, ¹⁵The First Affiliated Hospital of Bengbu Medical College, Bengbu, China, ¹⁶Chenzhou First People's Hospital, Binzhou, China, ¹⁷Sun Yat-Sen Memorial Hospital, Guangzhou, China, ¹⁸Shantou University Medical College No.1 Affiliated Hospital, Shantou, China, ¹⁹Yanbian University Affiliated Hospital, Yanbian, China, ²⁰guangdong second provincial general hospital, Guangzhou, China, ²¹Huai'an First People's Hospital, Huaian, China, ²²The First Affiliated Hospital of Baotou Medical College, Baotou, China, ²³The First Affiliated Hospital of Soochow University, Suzhou, China, ²⁴The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China, ²⁵Tianjin Medical University General Hospital, Tianjin, China, ²⁶Huizhou Central People's Hospital, Huizhou, China, ²⁷Peking University Shougang Hospital, Beijing, China, ²⁸The First Hospital of China Medial University, Shenyang, China, ²⁹Guangdong Provincial People's Hospital, Guangzhou, China, ³⁰Lynk Pharmaceuticals Co., Ltd., Hangzhou, China, ³¹Lynk Pharma, Hangzhou, China, ³²Lynk Pharma, Saint Louis, MO, ³³Lynk Pharma, Nanjing, China
Background/Purpose: LNK01001 is a selective oral JAK1 inhibitor in clinical development for treating autoimmune and inflammatory diseases, including rheumatoid arthritis (RA). Here, we report the…
Abstract Number: L12 • ACR Convergence 2023
Efficacy and Safety Outcomes of TAK-279, a Selective Oral Tyrosine Kinase 2 (TYK2) Inhibitor, from a Randomized, Double-blind, Placebo-controlled Phase 2b Trial in Patients with Active Psoriatic Arthritis
Alan Kivitz¹, Elena Tomaselli Muensterman², Arthur Kavanaugh³, Désirée van der Heijde⁴, Piotr A. Klimiuk⁵, Guillermo Valenzuela⁶, Eva Dokoupilova⁷, Gabrielle Poirier⁸, Bhaskar Srivastava⁸, Sue Dasen⁸, Xinyan Zhang⁸, Mona Trivedi², Haoling Holly Weng⁹, Ting Hong¹⁰, Peter Pothula¹⁰ and Xenofon Baraliakos¹¹, ¹Altoona Center for Clinical Research, Duncansville, PA, ²Takeda Development Center Americas, Inc., Cambridge, MA, ³Division of Rheumatology, Allergy & Immunology, University of California San Diego Medical School, San Diego, CA, ⁴Department of Rheumatology, Leiden University Medical Center, Meerssen, Netherlands, ⁵Department of Rheumatology and Internal Diseases, Medical University of Bialystok and Inter Clinic Piotr Adrian Klimiuk, Białystok, Poland, ⁶Integral Rheumatology & Immunology Specialists, Plantation, FL, ⁷Department of Pharmaceutical Technology, Faculty of Pharmacy, Masaryk University and MEDICAL PLUS, s.r.o., Brno and Uherské Hradiště, Czech Republic, ⁸Nimbus Discovery, Inc., Boston, MA, ⁹HW MedAdvice LLC, San Diego, CA, ¹⁰Takeda Development Center Americas, Inc., Boston, MA, ¹¹Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Bochum, Germany
Background/Purpose: TYK2 mediates signaling by key cytokines involved in the pathogenesis of immune-mediated inflammatory diseases such as psoriatic arthritis (PsA) and psoriasis (PsO). TAK-279 is…
Abstract Number: L13 • ACR Convergence 2023
An Open-label, Multicenter, Phase 1/2 Study to Assess Safety, Efficacy and Cellular Kinetics of YTB323, a Rapid Manufacturing CAR-T Cell Therapy Targeting CD19 on B Cells, for Severe Refractory Systemic Lupus Erythematosus: Preliminary Results
Josefina Cortés Hernández¹, Pere Barba², Mònica Linares Alberich³, Ozana Fischer⁴, Beata Kovacs⁴, Thomas Calzascia⁴, David Pearson⁴, Ana-Laura Jordán Garrote⁵, Tiina Kirsilä⁴, Richard Siegel⁴, Tamas Shisha⁴, Giulio Cavalli⁴ and Peter Gergely⁴, ¹Vall d'Hebron Institute of Research (VHIR) and Hospital Universitari Vall d'Hebron, Universitat Autonoma de Barcelona, Barcelona, Catalonia, Spain, ²Vall d'Hebron Institute of Oncology and Hospital Universitari Vall d'Hebron, Universitat Autonoma de Barcelona, Barcelona, Catalonia, Spain, ³Banc de Sang i Teixits, Hospital Universitari Vall d'Hebron, Barcelona, Catalonia, Spain, ⁴Novartis Biomedical Research, Basel, Basel-Stadt, Switzerland, ⁵Novartis Farmacéutica, Barcelona, Catalonia, Spain
Background/Purpose: Systemic lupus erythematosus (SLE) is characterized by pathogenic autoreactive B cells producing autoantibodies against multiple self-antigens. Recently, a series of clinical cases suggested that…
Abstract Number: L17 • ACR Convergence 2023
Safety, Tolerability, and Exploratory Efficacy of Afimetoran, a TLR7/8 Inhibitor, in Patients with Cutaneous Lupus Erythematosus: A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study
Fareeda Hosein¹, Stanislav Ignatenko², Kristina Chadwick¹, Lin Zhu¹, Frédéric Baribaud¹, Thanh Bach¹, Hazem Karabeber¹, Michelle Dawes¹, Leon Carayannopoulos¹ and Gopal Krishna¹, ¹Bristol Myers Squibb, Princeton, NJ, ²Charité Research Organisation GmbH, Berlin, Germany
Background/Purpose: Over 50 years have passed since the last therapy was approved for cutaneous lupus erythematosus (CLE).1 Parenteral administration, off-label use, or toxicity with long-term…
Abstract Number: L20 • ACR Convergence 2023
Telitacicept, a Human Recombinant Fusion Protein Targeting and Neutralizing B Lymphocyte Stimulator (BlyS) and a Proliferation-Inducing Ligand (APRIL), in Rheumatoid Arthritis (RA) Patients with an Inadequate Response to Methotrexate (MTX): A Randomized, Double-Blind, Phase 3 Study
Li Wang¹, Dong Xu², Jianmin Fang³, Qing Zuraw⁴ and Fengchun Zhang¹, ¹Peking Union Medical College Hospital, Beijing, China, ²Peking Union Medical College Hospital, Dong Cheng District, China, ³RemeGen Co, Ltd., Yantai, China, ⁴RemeGen Biosciences, Inc., San Francisco, CA
Background/Purpose: Telitacicept is a recombinant fusion protein targeting and neutralizing BLyS and APRIL. This phase 3, randomized, double-blind study evaluated the efficacy and safety of…
Abstract Number: 0271 • ACR Convergence 2023
Successful Treatment of Refractory IgG4-Related Disease with Tofacitinib: Experiences from 7 Patients
Huaqun Zhu, Sumei Tang, Yun Li, Feng Sun, Yuzhou Gan and Hua Ye, Peking University People’s Hospital, Beijing, China
Background/Purpose: Our observational cohort study aimed at assessing the effectiveness and safety of the Janus kinase (JAK) inhibitor tofacitinib in refractory IgG4-Related Disease (IgG4-RD).Methods: Seven…

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM CT on October 25. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].