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A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema (Tilrek)

2026年8月20日 更新者：Pfizer

A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL GROUP, ACTIVE- AND PLACEBO-CONTROLLED PHASE 3 MONOTHERAPY STUDY WITH MAINTENANCE PERIOD TO INVESTIGATE THE EFFICACY AND SAFETY OF TILREKIMIG IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

The purpose of this study is to find out how well tilrekimig works, how safe it is, and how it affects the body in adults and adolescents with moderate to severe atopic dermatitis (eczema). Eczema is a condition which can cause dryness, itching, and redness of your skin.

The study is seeking participants who:

  • Are aged 12 years or older.
  • Were confirmed to have atopic dermatitis (AD) at least 12 months ago.
  • Are not having an effective treatment result from medicines that are applied on skin for AD.
  • Are considered by their doctors to have moderate to severe AD.

The study treatment period will be 52 weeks. During the 24-week initial treatment period, participants will be randomized to one of three study treatments - tilrekimig, dupilumab, or placebo. Placebo does not have any medicine in it but looks just like the medicine being studied. These treatments will be randomized based on a 2:2:1 ratio. This means out of 1375 participants, about 550 participants will receive tilrekimig, 550 will receive dupilumab, and 275 will receive placebo. This will be followed by a 28-week maintenance period. The last dose of study treatment will be administered at week 48.

Some participants will join the long-term extension (LTE) study C4531008 at week 52. A long-term extension study is an additional study that some participants may be able to join after completing the study if they are interested and meet eligibility requirements. It allows researchers to continue collecting information about how well the study medicine works. It also helps them assess how safe it is when used for a longer period of time. Participants who do not join this study will enter a 12-week safety follow-up period. This period ends 16 weeks after their last dose of study treatment.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

1375

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
    • Oklahoma
      • Tulsa、Oklahoma、アメリカ、74136
        • Vital Prospects Clinical Research Institute., PC

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

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Key Inclusion Criteria

  • You are [12] years of age or older
  • You have had moderate-to-severe eczema for at least 1 year
  • Topical medicines for eczema have not worked well for you

Key Exclusion Criteria

  • Clinically Significant Autoimmune Disease
  • Significant Infection History or Active Infection
  • Known or Suspected Immunodeficiency/Immunosuppression
  • Significant psychiatric illness or suicidality
  • Clinically significant hepatic, renal, or hematologic abnormalities

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
実験的：Tilrekimig - Initial treatment period
Subcutaneous injections given over 20 Weeks.
薬：Tilrekimig
Subcutaneous Injections at required timepoints
他の名前：
  • PF-07275315
アクティブコンパレータ：Dupilumab - Initial treatment period
Subcutaneous injections given over 22 Weeks.
薬：Dupilumab
Subcutaneous Injections at required timepoints based on weight and age.
他の名前：
  • デュピクセント
プラセボコンパレーター：Placebo - Initial treatment period
Subcutaneous injections given over 22 Weeks.
他の：Placebo for Tilrekimig
Subcutaneous Injections at required timepoints
他の名前：
  • Placebo for PF-07275315
他の：Placebo for Dupilumab
Subcutaneous Injections at required timepoints during initial treatment period.
実験的：Tilrekimig - Maintenance Period - Dose A
Subcutaneous injections given at Week 24 through Week 48.
薬：Tilrekimig
Subcutaneous Injections at required timepoints
他の名前：
  • PF-07275315
実験的：Tilrekimig - Maintenance Period - Dose B
Subcutaneous injections given at Week 24 through Week 48.
薬：Tilrekimig
Subcutaneous Injections at required timepoints
他の名前：
  • PF-07275315
プラセボコンパレーター：Placebo - Maintenance Period
Subcutaneous injections given at Week 24 through Week 48.
他の：Placebo for Tilrekimig
Subcutaneous Injections at required timepoints
他の名前：
  • Placebo for PF-07275315
他の：Placebo for Dupilumab
Subcutaneous Injections at required timepoints during initial treatment period.

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
時間枠
Difference in the proportion of Eczema Area and Severity Index (EASI)75 responders between tilrekimig versus placebo.
時間枠：Week 16
Week 16
Difference in the proportion of validated Investigator Global Assessment- Atopic Dermatitis (vIGA-AD) 0/1 responders between tilrekimig versus placebo.
時間枠：Week 16
Week 16

二次結果の測定

結果測定
時間枠
Difference in the proportion of Peak Pruritis Numerical Rating Score (PP-NRS)4 responders between tilrekimig versus placebo
時間枠：Week 1 through Week 24
Week 1 through Week 24
Difference in the proportion of PP-NRS4 responders between tilrekimig versus dupilumab
時間枠：Week 1 through Week 24
Week 1 through Week 24
Incidence of treatment emergent adverse events (AEs), Serious adverse events (SAEs), and AEs leading to discontinuation
時間枠：For each participant from the time the participant provides informed consent, through and including a minimum of 16 weeks after the last administration of the study intervention.
For each participant from the time the participant provides informed consent, through and including a minimum of 16 weeks after the last administration of the study intervention.
Incidence of clinically significant changes in vital signs and laboratory tests.
時間枠：For each participant following first administration of the study intervention through the end of study visit (week 64).
For each participant following first administration of the study intervention through the end of study visit (week 64).
Difference in the proportion of Eczema Area and Severity Index (EASI)75 responders between tilrekimig versus placebo.
時間枠：Weeks 2, 4, 8, 12, 14, 20, and 24
Weeks 2, 4, 8, 12, 14, 20, and 24
Difference in the proportion of Eczema Area and Severity Index (EASI)75 responders between tilrekimig versus dupilumab.
時間枠：Weeks 2, 4, 8, 12, 14, 16, 20, and 24
Weeks 2, 4, 8, 12, 14, 16, 20, and 24
Difference in the proportion of validated Investigator Global Assessment- Atopic Dermatitis (vIGA-AD) 0/1 responders between tilrekimig versus placebo.
時間枠：Weeks 2, 4, 8, 12, 14, 20, and 24
Weeks 2, 4, 8, 12, 14, 20, and 24
Difference in the proportion of validated Investigator Global Assessment- Atopic Dermatitis (vIGA-AD) 0/1 responders between tilrekimig versus dupilumab.
時間枠：Weeks 2, 4, 8, 12, 14, 16, 20, and 24
Weeks 2, 4, 8, 12, 14, 16, 20, and 24
Difference in the proportion of revised Global Investigator Assessment (rIGA) 0/1 responders between tilrekimig versus placebo.
時間枠：Weeks 2, 4, 8, 12, 14, 16, 20, and 24
Weeks 2, 4, 8, 12, 14, 16, 20, and 24
Difference in the proportion of revised Global Investigator Assessment (rIGA) 0/1 responders between tilrekimig versus dupilumab.
時間枠：Weeks 2, 4, 8, 12, 14, 16, 20, and 24
Weeks 2, 4, 8, 12, 14, 16, 20, and 24
Difference in the proportion of EASI50, EASI90, and EASI100 responders between tilrekimig versus placebo.
時間枠：Weeks 2, 4, 8, 12, 14, 16, 20 and 24
Weeks 2, 4, 8, 12, 14, 16, 20 and 24
Difference in the proportion of EASI50, EASI90, and EASI100 responders between tilrekimig versus dupilumab.
時間枠：Weeks 2, 4, 8, 12, 14, 16, 20 and 24
Weeks 2, 4, 8, 12, 14, 16, 20 and 24
Difference in the mean percent CFB in EASI total score between tilrekimig versus placebo.
時間枠：Weeks 2, 4, 8, 12, 16, 20 and 24
Weeks 2, 4, 8, 12, 16, 20 and 24
Difference in the mean percent CFB in EASI total score between tilrekimig versus dupilumab.
時間枠：Weeks 2, 4, 8, 12, 16, 20 and 24
Weeks 2, 4, 8, 12, 16, 20 and 24
Difference in the mean percent CFB in Body Surface Area (BSA) between tilrekimig versus placebo.
時間枠：Weeks 2, 4, 8, 12, 16, 20 and 24
Weeks 2, 4, 8, 12, 16, 20 and 24
Difference in the mean percent CFB in Body Surface Area (BSA) between tilrekimig versus dupilumab.
時間枠：Weeks 2, 4, 8, 12, 16, 20 and 24
Weeks 2, 4, 8, 12, 16, 20 and 24
Difference in the proportion of Patient Oriented Eczema Measure (POEM) responders achieving ≥4-point improvement from baseline between tilrekimig versus placebo.
時間枠：Weeks 8, 16, and 24
Weeks 8, 16, and 24
Difference in the proportion of POEM responders achieving ≥4-point improvement from baseline between tilrekimig versus dupilumab.
時間枠：Weeks 8, 16, and 24
Weeks 8, 16, and 24
Difference in the proportion of Dermatology Life Quality Index (DLQI) responders achieving ≥4-point improvement from baseline between tilrekimig versus placebo.
時間枠：Weeks 8, 16, and 24
Weeks 8, 16, and 24
Difference in the proportion of Dermatology Life Quality Index (DLQI) responders achieving ≥4-point improvement from baseline between tilrekimig versus dupilumab
時間枠：Weeks 8, 16, and 24
Weeks 8, 16, and 24
Difference in the proportion of Patient Global Impression of Severity (PGI-S) responders achieving a score of 0 or 1 between tilrekimig versus placebo.
時間枠：Weeks 8, 16, and 24
Weeks 8, 16, and 24
Difference in the proportion of Patient Global Impression of Severity (PGI-S) responders achieving a score of 0 or 1 between tilrekimig versus dupilumab.
時間枠：Weeks 8, 16, and 24
Weeks 8, 16, and 24
Difference in the proportion of Patient Global Impression of Change (PGI-C) responders achieving "Much better" between tilrekimig versus placebo.
時間枠：Weeks 8, 16, and 24
Weeks 8, 16, and 24
Difference in the proportion of Patient Global Impression of Change (PGI-C) responders achieving "Much better" between tilrekimig versus dupilumab.
時間枠：Weeks 8, 16, and 24
Weeks 8, 16, and 24
Difference in the proportion of Atopic Dermatitis Control Tool (ADCT) responders achieving ≥5-point improvement from baseline between tilrekimig versus placebo.
時間枠：Weeks 8, 16, and 24
Weeks 8, 16, and 24
Difference in the proportion of Atopic Dermatitis Control Tool (ADCT) responders achieving ≥5-point improvement from baseline between tilrekimig versus dupilumab.
時間枠：Weeks 8, 16, and 24
Weeks 8, 16, and 24
Difference in the mean percent CFB in POEM between tilrekimig versus placebo.
時間枠：Weeks 8, 16, and 24
Weeks 8, 16, and 24
Difference in the mean percent CFB in EASI total score between tilrekimig versus dupilumab.
時間枠：Weeks 8, 16, and 24
Weeks 8, 16, and 24
Difference in the mean percent CFB in DLQI between tilrekimig versus placebo.
時間枠：Weeks 8, 16, and 24
Weeks 8, 16, and 24
Difference in the mean percent CFB in DLQI between tilrekimig versus dupilumab.
時間枠：Weeks 8, 16, and 24
Weeks 8, 16, and 24
Difference in the mean percent CFB in Children's Dermatology Life Quality Index (CDLQI) between tilrekimig versus placebo.
時間枠：Weeks 8, 16, and 24
Weeks 8, 16, and 24
Difference in the mean percent CFB in CDLQI between tilrekimig versus dupilumab.
時間枠：Weeks 8, 16, and 24
Weeks 8, 16, and 24
Difference in the mean percent CFB in PP-NRS weekly average between tilrekimig versus placebo.
時間枠：Week 1 through week 24
Week 1 through week 24
Difference in the mean percent CFB in PP-NRS weekly average between tilrekimig versus dupilumab.
時間枠：Week 1 through Week 24
Week 1 through Week 24
Proportion of responders for EASI75, rIGA 0/1, vIGA-AD 0, PP-NRS4, EASI50, EASI90, and EASI100 for tilrekimig doses and placebo.
時間枠：Weeks 26, 28, 32, 36, 40, 44, 48, 52, and 64
Weeks 26, 28, 32, 36, 40, 44, 48, 52, and 64
Mean of percent CFB in EASI and BSA for tilrekimig doses and placebo
時間枠：Weeks 26, 28, 32, 36, 40, 44, 48, 52, and 64
Weeks 26, 28, 32, 36, 40, 44, 48, 52, and 64
Proportion of maintaining response at Week 52 (defined as meeting ≥50% improvement from baseline in EASI and vIGA-AD <3) for participants who responded to tilrekimig (defined as achieving either EASI75 or vIGA-ADTM 0/1 at Week 24).
時間枠：Week 52
Week 52
The proportion of POEM responders achieving ≥4-point improvement from baseline for tilrekimig doses and placebo.
時間枠：Weeks 28, 36, 44, 52, and 64
Weeks 28, 36, 44, 52, and 64
The proportion of DLQI responders achieving ≥4-point improvement from baseline for tilrekimig doses and placebo.
時間枠：Weeks 28, 36, 44, 52, and 64
Weeks 28, 36, 44, 52, and 64
The proportion of PGI-S responders achieving a score of 0 or 1 for tilrekimig doses and placebo.
時間枠：Weeks 28, 36, 44, 52, and 64
Weeks 28, 36, 44, 52, and 64
The proportion of PGI-C responders achieving "Much better" for tilrekimig doses and placebo.
時間枠：Weeks 28, 36, 44, 52, and 64
Weeks 28, 36, 44, 52, and 64
The proportion of ADCT responders achieving ≥5-point improvement from baseline for tilrekimig doses and placebo.
時間枠：Weeks 28, 36, 44, 52, and 64
Weeks 28, 36, 44, 52, and 64
Mean of CFB in POEM, DLQI, and CDLQI for tilrekimig doses and placebo.
時間枠：Weeks 28, 36, 44, 52, and 64
Weeks 28, 36, 44, 52, and 64
Mean of CFB in weekly averages of PP=NRS for tilrekimig doses and placebo.
時間枠：Weeks 26, 28, 32, 36, 40, 44, 48, 52, and 64
Weeks 26, 28, 32, 36, 40, 44, 48, 52, and 64

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

Pfizer

捜査官

  • スタディディレクター：Pfizer CT.gov Call Center、Pfizer

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。

便利なリンク

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8月19日

一次修了 (推定)

2028年8月29日

研究の完了 (推定)

2029年6月5日

試験登録日

最初に提出

2026年8月17日

QC基準を満たした最初の提出物

2026年8月20日

最初の投稿 (実際)

2026年8月24日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月24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20日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • C4531005
  • 2026-525743-32-00 (レジストリ識別子：CTIS (EU))

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

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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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