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). |
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| 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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