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A Phase 3 Study to Evaluate Claseprubart in Adults With Generalized Myasthenia Gravis (EMERGE)

2026年8月28日 更新者：Dianthus Therapeutics

A Phase 3 Global, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Demonstrate the Efficacy, Safety, and Tolerability of Claseprubart (DNTH103) in Patients With Generalized Myasthenia Gravis (EMERGE)

The purpose of this Phase 3 study is to demonstrate the efficacy, safety, and tolerability of claseprubart in participants with generalized myasthenia gravis (gMG).

調査の概要

状態

募集

条件

介入・治療

詳細な説明

The study includes the following periods:

  • Screening (up to 12 weeks)
  • Randomized, blinded, controlled treatment (RCT) period (17 weeks)
  • Extended treatment period (ETP) (104 weeks) (optional) for eligible participants [includes blinded extension period (BEP) and open-label extension (OLE) period]
  • Safety Follow-Up period (40 weeks)

研究の種類

介入

入学 (推定)

195

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • Florida
      • Boca Raton、Florida、アメリカ、33432
        • 募集
        • Cinical Study Site
    • North Carolina
      • Fayetteville、North Carolina、アメリカ、28304
        • まだ募集していません
        • Cinical Study Site
    • Texas
      • Houston、Texas、アメリカ、77009
        • 募集
        • Cinical Study Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  1. Must have given written informed consent before any study-related activities are carried out
  2. Weight range between 40-130 kg at Screening

  3. Diagnosis of gMG by the following tests:

    1. Acetylcholine receptor antibody (AChR Ab) positive, and
    2. One of the following:

    i. History of abnormal neuromuscular transmission test; ii. History of positive anticholinesterase test; iii. Clinical response to acetylcholinesterase inhibitors.

  4. Myasthenia Gravis Foundation of America (MGFA) Class II-IVa
  5. MG-ADL scale score of 6 or more
  6. QMG scale score of 10 or more
  7. Documented vaccinations against encapsulated bacteria in accordance with local requirements and based on vaccine availability
  8. Female participants must be of non-childbearing potential, or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception
  9. Male participants agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception

Exclusion Criteria:

  1. History or presence of significant medical/surgical condition including any acute illness, mental illness, or major surgery considered to be clinically significant or that could have potential impact on safety/efficacy or study procedures
  2. Known complement deficiency
  3. Prior history (at any time) of N. meningitidis infection
  4. Participants with known seropositivity or who test positive for an active viral infection with human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B (HBV; except participants who are seropositive because of HBV vaccination) or hepatitis C virus (HCV) during Screening
  5. Previous treatment with claseprubart (DNTH103) or participation in a clinical trial with claseprubart. [
  6. Any thymic surgery/biopsy within 1 year of Screening
  7. Any known or untreated thymoma.
  8. Any history of thymic carcinoma or thymic malignancy
  9. History of active malignancy within 5 years prior to Screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone

  10. Concurrent or previous use of the following medication within the time periods specified below.

    1. Rituximab or other B-cell targeting therapies (ie, inebilizumab) within 6 months (180 days) prior to randomization (Day 1);
    2. Intravenous immunoglobulin (IVIg) and plasma exchange (PLEX) within 4 weeks (28 days) prior to randomization (Day 1)
  11. Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent
  12. Diagnosis of systemic lupus erythematosus (SLE) or family history (defined as a parent, sibling, or child) of SLE

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：Placebo
Intravenous (IV) infusion of Placebo on Day 1 followed by subcutaneous (SC) injections of Placebo every 2 weeks (Q2W) starting at Week 1 (Day 8).
薬：Placebo
IV infusion on Day 1
組み合わせ製品：Placebo
Prefilled syringe containing placebo for SC administration
実験的：Claseprubart Q2W
IV loading dose of claseprubart on Day 1 followed by SC injections of claseprubart Q2W starting at Week 1 (Day 8).
薬：Claseprubart
IV loading dose on Day 1
他の名前：
  • DNTH103
組み合わせ製品：Claseprubart
Prefilled syringe containing claseprubart for SC administration
実験的：Claseprubart Every 4 weeks (Q4W)
IV loading dose of claseprubart on Day 1 followed by SC injections of claseprubart or Placebo Q2W starting at Week 1 (Day 8), with doses alternating between claseprubart and placebo.
組み合わせ製品：Placebo
Prefilled syringe containing placebo for SC administration
薬：Claseprubart
IV loading dose on Day 1
他の名前：
  • DNTH103
組み合わせ製品：Claseprubart
Prefilled syringe containing claseprubart for SC administration

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change from Baseline to Week 17 in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score
時間枠：Baseline (Day 1) to Week 17
The MG-ADL score is an 8-item patient reported outcome (PRO) instrument. The MG-ADL targets symptoms of disability across ocular, bulbar, respiratory, and axial symptoms. The item responses are scored from 0 to 3, and the total score of the MG-ADL is the sum of the 8 items and ranges from 0 to 24, with a higher score indicating more disability.
Baseline (Day 1) to Week 17

二次結果の測定

結果測定
メジャーの説明
時間枠
Change from Baseline to Week 17 in Quantitative Myasthenia Gravis (QMG) Scale Score
時間枠：Baseline (Day 1) to Week 17
The QMG is a clinician-reported assessment to evaluate muscle strength. The QMG consists of 13 items that measure endurance or fatiguability, with each item having a possible score that ranges from 0 - 3. The total possible QMG scores range from 0 - 39, with a higher score indicating greater disease burden.
Baseline (Day 1) to Week 17
Change from Baseline to Week 17 in Myasthenia Gravis Composite (MGC) Scale Score
時間枠：Baseline (Day 1) to Week 17
The MGC is a validated assessment tool for measuring clinical status of participants with MG. The range of total MGC score is 0 to 50, with higher scores indicating more severe disease. A clinically meaningful improvement is reflected by a 3-point improvement in MGC score. The MGC assesses 10 important functional areas most frequently affected by MG and the scales are weighted for clinical significance that incorporates patient-reported outcomes.
Baseline (Day 1) to Week 17
Proportion of Participants with Greater Than or Equal to (≥) a 5-point Reduction in MG-ADL Scale Score at Week 17 Compared to Baseline
時間枠：Baseline (Day 1) to Week 17
Baseline (Day 1) to Week 17
Proportion of Participants Who Reach Minimal Symptom Expression (MSE), Defined as MG-ADL 0 or 1 at Week 17, Without Use of Rescue Therapy
時間枠：Baseline (Day 1) to Week 17
Baseline (Day 1) to Week 17
Proportion of Participants with a ≥ 5-point Reduction in QMG Scale Score at Week 17 Compared to Baseline
時間枠：Baseline (Day 1) to Week 17
Baseline (Day 1) to Week 17
Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-Emergent and Treatment-Emergent Serious Adverse Events (SAEs) in the RCT period, BEP, OLE, and Safety Follow-Up
時間枠：Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Number of participants with TEAEs and treatment-emergent SAEs will be reported.
Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Serum Concentrations of Claseprubart
時間枠：Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Blood samples will be collected for measurement of serum concentrations of claseprubart at various timepoints both pre- and post-dose.
Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Change from Baseline in Complement Total Blood Test (CH50) in Serum ex vivo
時間枠：Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Blood samples will be collected to determine changes in CH50 at various timepoints.
Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Incidence of Antidrug Antibody (ADAs) Against Claseprubart in the RCT Period, BEP, OLE, and Safety Follow-Up
時間枠：Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Blood samples will be collected to measure ADA against claseprubart at various timepoints.
Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Titer of ADAs Against Claseprubart in the RCT Period, BEP, OLE, and Safety Follow-Up
時間枠：Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)
Blood samples will be collected to measure ADA against claseprubart at various timepoints.
Baseline (Day 1) through Safety Follow-Up period (up to approximately 161 weeks)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Dianthus Therapeutics

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年6月29日

一次修了 (推定)

2028年12月1日

研究の完了 (推定)

2031年9月1日

試験登録日

最初に提出

2026年5月27日

QC基準を満たした最初の提出物

2026年6月9日

最初の投稿 (実際)

2026年6月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月1日

QC基準を満たした最後の更新が送信されました

2026年8月28日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • DNTH103-MG-301
  • 2026-525298-38-00 (Ctis)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

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