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Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases

2026年5月22日 更新者：Everest Medicines (China) Co.,Ltd.

The Sub-Study 3 of A Phase 1b/2 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases (ES108001)

This is a Phase 1b/2, open-label, multi-center study evaluating the therapeutic potential and safety of the investigational drug EVER001 in adults with FSGS, MCD, or IgAN. EVER001 acts on multiple immune pathways without directly affecting T cells or depleting B cells (both are lymphocytes). The study will be conducted at ~30 centers in China, enrolling 45 participants aged 18-75 years (15 per indication). The IMP is a 100 mg oral capsule, dosed at 200 mg twice daily (2 capsules per dose, 4 daily) for 52 weeks.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

45

段階

  • フェーズ2

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

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100730
        • 募集
        • Peking University First Hospital
        • コンタクト：
    • Hebei
      • Tianjin、Hebei、中国
        • 募集
        • Tianjin Medical University General Hospital
        • コンタクト：

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:

  • Primary FSGS or MCD/IgAN confirmed by renal biopsy
  • eGFR ≥ 45 mL/min/1.73 m²
  • For participants with FSGS or MCD: must have a 24-hour urine protein-to-creatinine ratio (UPCR) > 3.5 g/g and serum albumin < 30 g/L during the screening period
  • For participants in the IgAN group: 24-hour UPCR ≥ 0.8 g/g; ARB or ACEI stable for ≥ 12 weeks prior to Day 1
  • Patients with FSGS or MCD who have not been treated with immunosuppressants or are sensitive to prior immunosuppressant treatment

Exclusion Criteria:

  • Hereditary or secondary FSGS/MCD; collapsing FSGS
  • BMI ≥ 35 kg/m² in participants with FSGS/MCD
  • Evidence of diabetes mellitus or a history of diabetes mellitus
  • Acute or chronic infection requiring treatment
  • Patients infected with HIV, hepatitis C, syphilis, or hepatitis B
  • Patients with current or prior inadequately treated active tuberculosis (TB), latent TB, or evidence of current household contact with active TB
  • At risk of bleeding
  • Baseline 24-hour UPCR > 3 g/g and serum albumin < 30 g/L in participants with IgAN

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：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：EVER001 200mg bid
Participants in this arm receive EVER001 200 mg administered twice daily (bid) orally. This single-arm cohort evaluates the efficacy and safety of EVER001 in subjects with FSGS, MCD, and IgA
薬：EVER001
EVER001 200 mg, oral administration, twice daily (bid), for the treatment of proteinuric glomerular diseases including FSGS , MCD , and IgA

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
Percentage change from baseline in 24-hour urine protein-to-creatinine ratio (UPCR)
時間枠：Week24
Percentage change from baseline in 24-hour UPCR (based on 24-hour urine collection)
Week24
Treatment-emergent adverse events (TEAEs)
時間枠：Throughout the study period, up to Week 56
Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs)
Throughout the study period, up to Week 56
Adverse events of special interest (AESIs)
時間枠：Throughout the study period, up to Week 56
Incidence of adverse events of special interest (AESIs)
Throughout the study period, up to Week 56
Systolic blood pressure change from baseline
時間枠：Throughout the study period, up to Week 56
Measured in mmHg using a calibrated clinical blood pressure monitor
Throughout the study period, up to Week 56
Body weight change from baseline
時間枠：Throughout the study period, up to Week 56
Measured in kilograms (kg) using a calibrated clinical scale
Throughout the study period, up to Week 56
Change from baseline in clinical laboratory safety parameters
時間枠：Throughout the study period, up to Week 56
Change from baseline in routine clinical laboratory safety parameters, measured using standard validated clinical laboratory assays and reported in standard clinical units
Throughout the study period, up to Week 56
Physical examination findings
時間枠：Throughout the study period, up to Week 56
Incidence of new or worsening abnormalities in physical examination findings, assessed at scheduled study visits.
Throughout the study period, up to Week 56
Chest radiography findings
時間枠：Throughout the study period, up to Week 56
Incidence of new or worsening abnormalities in chest radiography findings, assessed at scheduled study visits.
Throughout the study period, up to Week 56
12-lead electrocardiogram (ECG) findings
時間枠：Throughout the study period, up to Week 56
Incidence of new or worsening abnormalities in 12-lead electrocardiogram (ECG) findings, assessed at scheduled study visits.
Throughout the study period, up to Week 56
Pulse rate change from baseline
時間枠：Throughout the study period, up to Week 56
Measured in beats per minute (bpm) using a calibrated vital signs monitor
Throughout the study period, up to Week 56
Diastolic blood pressure change from baseline
時間枠：Throughout the study period, up to Week 56
Measured in mmHg using a calibrated clinical blood pressure monitor
Throughout the study period, up to Week 56
Body temperature change from baseline
時間枠：Throughout the study period, up to Week 56
Measured in degrees Celsius (°C) using a calibrated clinical thermometer
Throughout the study period, up to Week 56

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage change from baseline in 24-hour UPCR
時間枠：Week 2 and thereafter, up to Week 56
Percentage change from baseline in 24-hour urine protein-to-creatinine ratio (UPCR)
Week 2 and thereafter, up to Week 56
Proportion of participants achieving complete remission (CR)
時間枠：Week 2 and thereafter, up to Week 56
Proportion of participants achieving complete remission (CR) based on predefined criteria
Week 2 and thereafter, up to Week 56
Proportion of IgAN participants with ≥30% reduction in 24-hour UPCR from baseline
時間枠：At Week 24, Week 36, and Week 52
Proportion of participants with IgAN achieving ≥30% reduction in 24-hour urine protein-to-creatinine ratio (UPCR) from baseline, assessed at Week 24, Week 36, and Week 52
At Week 24, Week 36, and Week 52
Change from baseline in estimated glomerular filtration rate (eGFR)
時間枠：Week 2 and thereafter, up to Week 56
Absolute and percentage change from baseline in estimated glomerular filtration rate (eGFR), calculated per the formula specified in the study protocol
Week 2 and thereafter, up to Week 56
eGFR slope from baseline
時間枠：Baseline to Week 52
Slope of change in estimated glomerular filtration rate (eGFR, calculated per the formula specified in the study protocol) from baseline to Week 52
Baseline to Week 52
Percentage change from baseline in serum albumin
時間枠：Week 2 and thereafter, up to Week 56
Percentage change from baseline in serum albumin level
Week 2 and thereafter, up to Week 56
Proportion of participants achieving partial remission (PR)
時間枠：Week 2 and thereafter, up to Week 56
Proportion of participants achieving partial remission (PR) based on predefined study criteria
Week 2 and thereafter, up to Week 56
Proportion of participants achieving CR or PR
時間枠：Week 2 and thereafter, up to Week 56
Proportion of participants achieving complete remission (CR) or partial remission (PR) based on predefined study criteria
Week 2 and thereafter, up to Week 56
Time to achieve CR or PR
時間枠：Baseline to Week 52
Time from baseline to first documented complete remission (CR) or partial remission (PR), based on predefined study criteria
Baseline to Week 52
Proportion of participants with relapse (CR/PR, no rescue therapy)
時間枠：From Day1 to Week 52
Proportion of participants who experience relapse among those achieving CR or PR during the study and not receiving rescue therapy
From Day1 to Week 52
Time from CR/PR to relapse
時間枠：From Day1 to Week 52
Time from first documented complete remission (CR) or partial remission (PR) to first documented relapse
From Day1 to Week 52
Cumulative dose of glucocorticoids (GC)
時間枠：Week 16, Week 24, Week 32, Week 40, and Week 52
Cumulative dose of glucocorticoids (GC), measured in prednisone equivalent dose, calculated at the specified study visits
Week 16, Week 24, Week 32, Week 40, and Week 52
Proportion requiring GC increase or additional immunosuppressants
時間枠：Throughout the study period (baseline to Week 56)
Proportion of participants requiring increase in GC dosage and/or initiation of additional immunosuppressants
Throughout the study period (baseline to Week 56)
Proportion of IgAN participants with positive hematuria
時間枠：At baseline, Week 12, Week 24, Week 36, and Week 52
Proportion of participants with IgAN with positive hematuria
At baseline, Week 12, Week 24, Week 36, and Week 52
Resolution of hematuria in IgAN participants
時間枠：At Week 12, Week 24, Week 36, and Week 52
Resolution of hematuria in participants with IgA
At Week 12, Week 24, Week 36, and Week 52
Change from baseline in BTK target occupancy
時間枠：Throughout the study period, up to Week 56
Change from baseline in BTK target occupancy in peripheral blood cells
Throughout the study period, up to Week 56
Plasma EVER001 peak concentration (Cmax)
時間枠：Throughout the study period, up to Week 56
Plasma EVER001 peak concentration (Cmax)
Throughout the study period, up to Week 56
Trough Plasma Concentration (Cmin) of EVER001
時間枠：Throughout the study period, up to Week 56
Plasma EVER001 trough concentration (Cmin)
Throughout the study period, up to Week 56
Time to Reach Peak Concentration (Tmax) of EVER00
時間枠：Throughout the study period, up to Week 56
Time to reach peak concentration (Tmax) of EVER001
Throughout the study period, up to Week 56
Accumulation Ratio (AR) of EVER001
時間枠：Throughout the study period, up to Week 56
Accumulation ratio (AR) of EVER001
Throughout the study period, up to Week 56

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

Everest Medicines (China) Co.,Ltd.

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 (推定)

2026年5月15日

一次修了 (推定)

2028年12月31日

研究の完了 (推定)

2029年3月31日

試験登録日

最初に提出

2026年5月5日

QC基準を満たした最初の提出物

2026年5月22日

最初の投稿 (実際)

2026年5月29日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月29日

QC基準を満たした最後の更新が送信されました

2026年5月22日

最終確認日

2026年4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

  • ES108001-001
  • CTR20260886 (レジストリ識別子：A Study to Evaluate the Efficacy and Safety of EVER001 in Patients with Selected Glomerular Diseases)

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

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

IgA腎症（IgAN）の臨床試験

EVER001の臨床試験

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条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

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