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Efficacy and safety of efgartigimod PH20 SC for Sjögren's disease-associated dryness: study protocol for an investigator-initiated, multicenter, phase 2, randomized, double-blind, placebo-controlled trial (OASIS study).

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Title: Efficacy and safety of efgartigimod PH20 SC for Sjögren's disease-associated dryness: study protocol for an investigator-initiated, multicenter, phase 2, randomized, double-blind, placebo-controlled trial (OASIS study).
Authors: Endo Y; Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Medical Sciences, Nagasaki, Japan.; Clinical Research Center, Nagasaki University Hospital, Nagasaki, Japan., Hosogaya N; Clinical Research Center, Nagasaki University Hospital, Nagasaki, Japan., Fukushige Y; Clinical Research Center, Nagasaki University Hospital, Nagasaki, Japan.; Department of Hospital Pharmacy, Nagasaki University Hospital, Nagasaki, Japan., Narita S; Clinical Research Center, Nagasaki University Hospital, Nagasaki, Japan., Jacobs J; Argenx, Ghent, Belgium., Reiss W; Argenx, Ghent, Belgium., Imai Y; Argenx, Ghent, Belgium., Shimizu T; Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Medical Sciences, Nagasaki, Japan., Koga T; Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Medical Sciences, Nagasaki, Japan., Yamamoto H; Clinical Research Center, Nagasaki University Hospital, Nagasaki, Japan., Sakai T; Department of Integrated Science and Technology, Graduate School of Integrated Science and Technology, Nagasaki University, Nagasaki, Japan., Takagi Y; Department of Radiology and Biomedical Informatics, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan., Sumi M; Department of Radiology and Biomedical Informatics, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan., Kawakami A; Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Medical Sciences, Nagasaki, Japan.
Source: Frontiers in medicine [Front Med (Lausanne)] 2026 Jan 02; Vol. 12, pp. 1719757. Date of Electronic Publication: 2026 Jan 02 (Print Publication: 2025).
Publication Type: Journal Article
Journal Info: Publisher: Frontiers Media S.A Country of Publication: Switzerland NLM ID: 101648047 Publication Model: eCollection Cited Medium: Print ISSN: 2296-858X (Print) Linking ISSN: 2296858X NLM ISO Abbreviation: Front Med (Lausanne) Subsets: PubMed not MEDLINE
Database: MEDLINE Ultimate
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  Data: Efficacy and safety of efgartigimod PH20 SC for Sjögren's disease-associated dryness: study protocol for an investigator-initiated, multicenter, phase 2, randomized, double-blind, placebo-controlled trial (OASIS study).
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  Data: <searchLink fieldCode="AU" term="%22Endo+Y%22">Endo Y</searchLink>; Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Medical Sciences, Nagasaki, Japan.; Clinical Research Center, Nagasaki University Hospital, Nagasaki, Japan.<br /><searchLink fieldCode="AU" term="%22Hosogaya+N%22">Hosogaya N</searchLink>; Clinical Research Center, Nagasaki University Hospital, Nagasaki, Japan.<br /><searchLink fieldCode="AU" term="%22Fukushige+Y%22">Fukushige Y</searchLink>; Clinical Research Center, Nagasaki University Hospital, Nagasaki, Japan.; Department of Hospital Pharmacy, Nagasaki University Hospital, Nagasaki, Japan.<br /><searchLink fieldCode="AU" term="%22Narita+S%22">Narita S</searchLink>; Clinical Research Center, Nagasaki University Hospital, Nagasaki, Japan.<br /><searchLink fieldCode="AU" term="%22Jacobs+J%22">Jacobs J</searchLink>; Argenx, Ghent, Belgium.<br /><searchLink fieldCode="AU" term="%22Reiss+W%22">Reiss W</searchLink>; Argenx, Ghent, Belgium.<br /><searchLink fieldCode="AU" term="%22Imai+Y%22">Imai Y</searchLink>; Argenx, Ghent, Belgium.<br /><searchLink fieldCode="AU" term="%22Shimizu+T%22">Shimizu T</searchLink>; Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Medical Sciences, Nagasaki, Japan.<br /><searchLink fieldCode="AU" term="%22Koga+T%22">Koga T</searchLink>; Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Medical Sciences, Nagasaki, Japan.<br /><searchLink fieldCode="AU" term="%22Yamamoto+H%22">Yamamoto H</searchLink>; Clinical Research Center, Nagasaki University Hospital, Nagasaki, Japan.<br /><searchLink fieldCode="AU" term="%22Sakai+T%22">Sakai T</searchLink>; Department of Integrated Science and Technology, Graduate School of Integrated Science and Technology, Nagasaki University, Nagasaki, Japan.<br /><searchLink fieldCode="AU" term="%22Takagi+Y%22">Takagi Y</searchLink>; Department of Radiology and Biomedical Informatics, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.<br /><searchLink fieldCode="AU" term="%22Sumi+M%22">Sumi M</searchLink>; Department of Radiology and Biomedical Informatics, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.<br /><searchLink fieldCode="AU" term="%22Kawakami+A%22">Kawakami A</searchLink>; Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Medical Sciences, Nagasaki, Japan.
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  Data: <searchLink fieldCode="JN" term="%22101648047%22">Frontiers in medicine</searchLink> [Front Med (Lausanne)] 2026 Jan 02; Vol. 12, pp. 1719757. <i>Date of Electronic Publication: </i>2026 Jan 02 (<i>Print Publication: </i>2025).
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