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胎児および新生児の同種免疫性血小板減少症（FNAIT）のリスク軽減におけるニポカリマブの研究 (FREESIA-1)

2026年11月2日 更新者：Janssen Research & Development, LLC

リスクのある妊娠における胎児および新生児同種免疫性血小板減少症（FNAIT）のリスク軽減におけるニポカリマブの安全性と有効性を評価する二重盲検ランダム化プラセボ対照研究

The purpose of this study is to evaluate the effectiveness of nipocalimab compared with placebo in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).

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)

39

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

  • イスラエル
      • Ramat Gan、イスラエル、5262000
        • 完了
        • Sheba Medical Center
  • イタリア
      • Milan、イタリア、20122
        • 完了
        • Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico
      • Rome、イタリア、00168
        • 完了
        • Fondazione Policlinico Universitario A Gemelli IRCCS
  • スイス
      • Lausanne、スイス、1011
        • 完了
        • Centre Hospitalier Universitaire Vaudois CHUV
  • スウェーデン
      • Stockholm、スウェーデン、SE-141 86
        • 募集
        • Karolinska Universitetssjukhuset Huddinge
  • スペイン
      • Seville、スペイン、41013
        • 完了
        • Hosp. Virgen Del Rocio
  • スロバキア
      • Košice、スロバキア、04190
        • 完了
        • Univerzitna nemocnica L. Pasteura Kosice
      • Martin、スロバキア、036 01
        • 完了
        • Univerzitná nemocnica Martin
      • Nové Zámky、スロバキア、940 34
        • 完了
        • Fakultna nemocnica s poliklinikou Nove Zamky
  • スロベニア
      • Ljubljana、スロベニア、1000
        • 完了
        • Univerzitetni klinicni center Ljubljana
  • ノルウェー
      • Bergen、ノルウェー、5009
        • 募集
        • Haukeland University Hospital
      • Oslo、ノルウェー、0455
        • 募集
        • Oslo University Hospital HF Ulleval sykehus
      • Tromsø、ノルウェー、9019
        • 募集
        • Universitetssykehuset Nord-Norge HF
      • Trondheim、ノルウェー、7030
        • 募集
        • St. Olavs Hospital
  • ハンガリー
      • Budapest、ハンガリー、1082
        • 募集
        • Semmelweis Egyetem
  • フランス
      • Lille、フランス、59000
        • 完了
        • CHRU Lille
      • Paris、フランス、75012
        • 完了
        • Hopital trousseau- APHP
  • ブラジル
      • Recife、ブラジル、50070-902
        • 完了
        • Instituto de Medicina Integral Professor Fernando Figueira
      • Rio de Janeiro、ブラジル、22281 100
        • 完了
        • IDOR - Regional Rio de Janeiro
      • São Paulo、ブラジル、05403 000
        • 完了
        • Hospital Das Clinicas Da Faculdade De Medicina Da USP
  • ベルギー
      • Leuven、ベルギー、3000
        • 完了
        • Universitair Ziekenhuis Leuven

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

18年～45年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

Inclusion Criteria:

  • Pregnant and an estimated gestational age (GA; based on ultrasound dating) from Week 13 to 18 at randomization
  • Has a history of greater than or equal to (>=) 1 prior pregnancy with fetal and neonatal alloimmune thrombocytopenia (FNAIT) (including neonatal platelet count less than (<) 150×10^9/Liter) with none of them affected by fetal/neonatal intracranial hemorrhage (ICH) or severe hemorrhage based on a clinical review of the medical records
  • Current pregnancy with presence of maternal anti- human platelet antigen (HPA)-1a alloantibody and positive fetal HPA-1a genotype as confirmed by cell-free fetal deoxyribonucleic acid (DNA) in maternal blood
  • Health status considered stable by the investigator based on physical examination, medical history, vital signs, 12-lead Electrocardiogram (ECG), and clinical laboratory tests performed at screening
  • For maternal participant and neonate/infant, willing to forego participation in another clinical study of an investigational therapy until the last follow-up visit

Exclusion Criteria:

  • Currently pregnant with multiple gestations (twins or more)
  • History of severe preeclampsia in a previous pregnancy
  • History of myocardial infarction, unstable ischemic heart disease, or stroke
  • Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients (refer to the Investigator Brochure (IB))
  • Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant

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：ダブル

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：Nipocalimab

Maternal participants will receive nipocalimab Intravenously (IV).
薬：Nipocalimab

Nipocalimab will be administered intravenously.

他の名前：
  • JNJ-80202135
  • JNJ-86507083
プラセボコンパレーター：Placebo

Maternal participants will receive placebo IV.
薬：Placebo

Placebo will be administered intravenously.

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
Fetus/Neonate with Outcome of Death or Adjudicated Severe Bleeding or Platelet Count Less Than (<) 30*10^9/L
時間枠：Up to 1 week post birth

Outcome of fetus/neonate death or adjudicated severe bleeding up to the first week post birth or platelet count <30*10^9/L will be reported.
Up to 1 week post birth

二次結果の測定

結果測定
メジャーの説明
時間枠
Neonate/Fetus With Adjudicated Bleeding
時間枠：Up to 1 Week post birth

Neonate/fetus With adjudicated bleeding will be reported.
Up to 1 Week post birth
Platelet Count at Birth in a Neonate
時間枠：At birth

Platelet count at birth in a neonate will be reported.
At birth
Neonate/Fetus with Outcome of Death
時間枠：Up to 1 Week post birth

Fetus/neonate with outcome of death will be reported.
Up to 1 Week post birth
Platelet Count at Birth <10×10^9/L in a Neonate
時間枠：At birth

Platelet count at birth <10×10^9/L in a neonate will be reported.
At birth
Platelet Count at Birth <30×10^9/ L In a Neonate
時間枠：At birth

Platelet count at birth <30×10^9/L in a neonate will be reported.
At birth
Platelet Count at Birth <50×10^9/L In a Neonate
時間枠：At birth

Platelet count at birth <50×10^9/L in a neonate will be reported.
At birth
Platelet Count at Birth <150×10^9/L In a Neonate
時間枠：At birth

Platelet count at birth <150×10^9/L in a neonate will be reported.
At birth
Nadir Platelet Count of a Neonate Over the First Week Post Birth
時間枠：Upto 1 Week post birth

Nadir platelet count in a neonate will be reported.
Upto 1 Week post birth
Neonate/Fetus Requiring Platelet Transfusion(s)
時間枠：Up to 1 Week post birth

Neonate(s) who require at least one platelet transfusion(s) will be reported.
Up to 1 Week post birth
Number of Platelet Transfusion(s) in Neonate/Fetus
時間枠：Up to 1 Week post birth

Number of Platelet transfusion(s) per neonate will be reported.
Up to 1 Week post birth
Number of Donor Exposures for Platelet Transfusion(s) in Neonate/Fetus
時間枠：Up to 1 Week post birth

Number of donor exposures for neonates who received platelet transfusion(s) will be reported.
Up to 1 Week post birth
Neonate/Fetus With Adjudicated Severe Bleeding
時間枠：Up to 1 week post birth

Neonate/Fetus With adjudicated severe bleeding will be reported.
Up to 1 week post birth
Neonates With Postnatal Intravenous Immunoglobulin (IVIG) for The Treatment of Thrombocytopenia
時間枠：Up to 1 Week post birth

Neonates with IVIG for the treatment of thrombocytopenia will be reported.
Up to 1 Week post birth
Maternal Participants With Treatment-Emergent Adverse Event (TEAE)
時間枠：From randomization up to 24 weeks postpartum

Maternal participants with a TEAE will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
From randomization up to 24 weeks postpartum
Maternal Participants With Serious Adverse Event (SAE)
時間枠：From randomization up to 24 weeks postpartum

Maternal participants with SAE will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. SAE is any untoward medical occurrence that at any dose that results in death, is life-threatening, requires inpatient hospitalization/prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is medically important.
From randomization up to 24 weeks postpartum
Maternal Participants With Adverse Event of Special Interest (AESI)
時間枠：From randomization up to 24 weeks postpartum

Maternal participants with an AESI will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. AESIs are considered as infections that are severe, hypoalbuminemia, deep vein thrombosis and/or pulmonary embolism, and clinically significant bleeding.
From randomization up to 24 weeks postpartum
Maternal Participants with TEAE Leading to Discontinuation of Study Intervention
時間枠：Up to Week 104

Maternal participants with TEAE leading to discontinuation of study intervention will be reported.
Up to Week 104
Neonate/Infant with TEAE
時間枠：Up to Week 104

Neonatal/infant participants with a TEAE will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Up to Week 104
Neonate/Infant with SAE
時間枠：Up to Week 104

Neonatal/infant participants with SAE will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. An SAE is any untoward medical occurrence that at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is medically Important.
Up to Week 104
Neonate/Infant with AESI
時間枠：Up to Week 104

Neonatal/infant participants with AESI will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. AESIs are considered as: In infants- clinically significant mortalities in fetus/neonates due to maternal infections, and hypogammaglobulinemia.
Up to Week 104
Fetus/Neonate With TEAE of Bleeding
時間枠：Up to Week 104

Fetus/Neonate with TEAE of Bleeding will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. Treatment-emergent AEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Up to Week 104
Neonate With TEAE of Infection
時間枠：Up to Week 104

Neonate with TEAE of Infection will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. Treatment-emergent AEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Up to Week 104
Infant Development as Measured by Bayley Scales at Week 52 and Week 104
時間枠：At Week 52 and 104

The Bayley Scales of Infant and Toddler Development include a set of individually administered developmental scales designed to measure current developmental functioning in infants and toddlers up to 42 months of age in the areas of cognition, language, motor skills, social-emotional, and adaptive behavior, with age adjusted for prematurity. The cognition, language, motor skills scales are directly administered to the infant, while social-emotional, and adaptive behavior scales are caregiver questionnaires. The scores are standardized using norm reference samples with representative demographics and age adjusted for prematurity.
At Week 52 and 104
Maternal Participants With Antibodies to Nipocalimab Including Neutralizing Antibodies in Maternal Serum During Pregnancy and Postpartum
時間枠：Up to Week 24

Maternal participants with antibodies to nipocalimab including neutralizing antibodies in maternal serum during pregnancy and postpartum will be reported.
Up to Week 24

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

Janssen Research & Development, LLC

捜査官

  • スタディディレクター：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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)

2024年11月11日

一次修了 (推定)

2029年12月5日

研究の完了 (推定)

2029年12月5日

試験登録日

最初に提出

2024年6月4日

QC基準を満たした最初の提出物

2024年6月4日

最初の投稿 (実際)

2024年6月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月3日

QC基準を満たした最後の更新が送信されました

2026年11月2日

最終確認日

2026年11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

  • 80202135FNAIT3001
  • 80202135FNAIT3001 (その他の識別子：Janssen Research & Development, LLC)
  • 2023-504307-88-00 (レジストリ識別子：EUCT number)
  • 2023 (米国 NIH グラント/契約)

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?

はい

IPD プランの説明

The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

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

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。

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