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

20. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

1375

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • Oklahoma
      • Tulsa, Oklahoma, Vereinigte Staaten, 74136
        • Vital Prospects Clinical Research Institute., PC

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Tilrekimig - Initial treatment period
Subcutaneous injections given over 20 Weeks.
Arzneimittel: Tilrekimig
Subcutaneous Injections at required timepoints
Andere Namen:
  • PF-07275315
Aktiver Komparator: Dupilumab - Initial treatment period
Subcutaneous injections given over 22 Weeks.
Arzneimittel: Dupilumab
Subcutaneous Injections at required timepoints based on weight and age.
Andere Namen:
  • Doppelt
Placebo-Komparator: Placebo - Initial treatment period
Subcutaneous injections given over 22 Weeks.
Sonstiges: Placebo for Tilrekimig
Subcutaneous Injections at required timepoints
Andere Namen:
  • Placebo for PF-07275315
Sonstiges: Placebo for Dupilumab
Subcutaneous Injections at required timepoints during initial treatment period.
Experimental: Tilrekimig - Maintenance Period - Dose A
Subcutaneous injections given at Week 24 through Week 48.
Arzneimittel: Tilrekimig
Subcutaneous Injections at required timepoints
Andere Namen:
  • PF-07275315
Experimental: Tilrekimig - Maintenance Period - Dose B
Subcutaneous injections given at Week 24 through Week 48.
Arzneimittel: Tilrekimig
Subcutaneous Injections at required timepoints
Andere Namen:
  • PF-07275315
Placebo-Komparator: Placebo - Maintenance Period
Subcutaneous injections given at Week 24 through Week 48.
Sonstiges: Placebo for Tilrekimig
Subcutaneous Injections at required timepoints
Andere Namen:
  • Placebo for PF-07275315
Sonstiges: Placebo for Dupilumab
Subcutaneous Injections at required timepoints during initial treatment period.

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Difference in the proportion of Peak Pruritis Numerical Rating Score (PP-NRS)4 responders between tilrekimig versus placebo
Zeitfenster: Week 1 through Week 24
Week 1 through Week 24
Difference in the proportion of PP-NRS4 responders between tilrekimig versus dupilumab
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: Weeks 8, 16, and 24
Weeks 8, 16, and 24
Difference in the mean percent CFB in POEM between tilrekimig versus placebo.
Zeitfenster: Weeks 8, 16, and 24
Weeks 8, 16, and 24
Difference in the mean percent CFB in EASI total score between tilrekimig versus dupilumab.
Zeitfenster: Weeks 8, 16, and 24
Weeks 8, 16, and 24
Difference in the mean percent CFB in DLQI between tilrekimig versus placebo.
Zeitfenster: Weeks 8, 16, and 24
Weeks 8, 16, and 24
Difference in the mean percent CFB in DLQI between tilrekimig versus dupilumab.
Zeitfenster: 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.
Zeitfenster: Weeks 8, 16, and 24
Weeks 8, 16, and 24
Difference in the mean percent CFB in CDLQI between tilrekimig versus dupilumab.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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).
Zeitfenster: Week 52
Week 52
The proportion of POEM responders achieving ≥4-point improvement from baseline for tilrekimig doses and placebo.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: Weeks 26, 28, 32, 36, 40, 44, 48, 52, and 64
Weeks 26, 28, 32, 36, 40, 44, 48, 52, and 64

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Pfizer

Ermittler

  • Studienleiter: Pfizer CT.gov Call Center, Pfizer

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

19. August 2026

Primärer Abschluss (Geschätzt)

29. August 2028

Studienabschluss (Geschätzt)

5. Juni 2029

Studienanmeldedaten

Zuerst eingereicht

17. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. August 2026

Zuerst gepostet (Tatsächlich)

24. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • C4531005
  • 2026-525743-32-00 (Registrierungskennung: CTIS (EU))

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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