| アイテムタイプ |
学術雑誌論文 / Journal Article(1) |
| 公開日 |
2026-01-29 |
| タイトル |
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タイトル |
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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言語 |
en |
| 言語 |
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言語 |
eng |
| 資源タイプ |
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資源タイプ識別子 |
http://purl.org/coar/resource_type/c_6501 |
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資源タイプ |
journal article |
| 著者 |
Endo, Yushiro
Hosogaya, Naoki
Fukushige Yuri
Narita, Sawana
Jacobs, Julie
Reiss, William
Imai, Yuya
Shimizu, Toshimasa
Koga, Tomohiro
Yamamoto, Hiroshi
Sakai, Tomoya
Takagi, Yukinori
Sumi, Misa
Kawakami, Atsushi
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| 抄録 |
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内容記述タイプ |
Abstract |
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内容記述 |
Background: Sjögren’s disease (SjD) is a chronic systemic autoimmune disease characterized by lymphocytic infiltration and progressive destruction of the lacrimal and salivary glands, leading to ocular and oral dryness as hallmark symptoms. Despite low systemic activity, these sicca symptoms significantly impair the quality of life, particularly in patients with severe dryness. Currently, no disease-modifying therapy is approved for SjD. Efgartigimod PH20, the neonatal Fc receptor (FcRn) blocker, has shown promising efficacy and safety in patients with moderate-to-severe systemic SjD. However, its efficacy for dryness in patients with SjD remains unknown. Methods/design: This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, investigator-initiated trial conducted in Japan. Approximately 45 adult patients with SjD and moderate-to-severe dryness will be randomized in a 1:1:1 ratio to receive subcutaneous efgartigimod PH20 at 1,000 mg weekly (QW), 1,000 mg every other week (Q2W), or placebo for 24 weeks. The primary endpoint is the change in EULAR Sjögren’s Syndrome Patient-Reported Index (ESSPRI)-dryness score from baseline to week 24. Key secondary endpoints include changes in ESSPRI-total, ESSPRI-fatigue, Diary of Sjögren’s Symptoms Assessment (DiSSA) scores, and the proportion of responders in ESSPRI and Sjögren’s Tool for Assessing Response (STAR) assessments. After the blinded period, all participants will be offered an open-label extension treatment to assess long-term safety and efficacy. Discussion: This trial specifically targets patients with SjD who have prominent sicca symptoms. By using FcRn blockade to reduce pathogenic IgG autoantibodies, this study aims to explore the potential of efgartigimod PH20 as a novel therapeutic approach for dryness-predominant SjD. The findings are expected to provide future treatment strategies to address the major unmet need regarding dryness-related burden in this patient population. |
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言語 |
en |
| 書誌情報 |
en : Frontiers in Medicine
巻 12,
p. art. no. 1719757,
発行日 2026-01-02
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| 出版者 |
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出版者 |
Frontiers Media SA |
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言語 |
en |
| ISSN |
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収録物識別子タイプ |
EISSN |
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収録物識別子 |
2296-858X |
| DOI |
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関連タイプ |
isIdenticalTo |
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識別子タイプ |
DOI |
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関連識別子 |
https://doi.org/10.3389/fmed.2025.1719757 |
| 権利 |
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権利情報 |
© 2026 Endo, Hosogaya, Fukushige, Narita, Jacobs, Reiss, Imai, Shimizu, Koga, Yamamoto, Sakai, Takagi, Sumi and Kawakami. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
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言語 |
en |
| 著者版フラグ |
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出版タイプ |
VoR |
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出版タイプResource |
http://purl.org/coar/version/c_970fb48d4fbd8a85 |
| 引用 |
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内容記述タイプ |
Other |
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内容記述 |
Frontiers in Medicine, 12, art. no. 1719757; 2026 |
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言語 |
en |
FM12_1719757.pdf (930 KB)
