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

20. srpna 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

1375

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Spojené státy
    • Oklahoma
      • Tulsa, Oklahoma, Spojené státy, 74136
        • Vital Prospects Clinical Research Institute., PC

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Tilrekimig - Initial treatment period
Subcutaneous injections given over 20 Weeks.
Lék: Tilrekimig
Subcutaneous Injections at required timepoints
Ostatní jména:
  • PF-07275315
Aktivní komparátor: Dupilumab - Initial treatment period
Subcutaneous injections given over 22 Weeks.
Lék: Dupilumab
Subcutaneous Injections at required timepoints based on weight and age.
Ostatní jména:
  • Dupixent
Komparátor placeba: Placebo - Initial treatment period
Subcutaneous injections given over 22 Weeks.
Jiný: Placebo for Tilrekimig
Subcutaneous Injections at required timepoints
Ostatní jména:
  • Placebo for PF-07275315
Jiný: Placebo for Dupilumab
Subcutaneous Injections at required timepoints during initial treatment period.
Experimentální: Tilrekimig - Maintenance Period - Dose A
Subcutaneous injections given at Week 24 through Week 48.
Lék: Tilrekimig
Subcutaneous Injections at required timepoints
Ostatní jména:
  • PF-07275315
Experimentální: Tilrekimig - Maintenance Period - Dose B
Subcutaneous injections given at Week 24 through Week 48.
Lék: Tilrekimig
Subcutaneous Injections at required timepoints
Ostatní jména:
  • PF-07275315
Komparátor placeba: Placebo - Maintenance Period
Subcutaneous injections given at Week 24 through Week 48.
Jiný: Placebo for Tilrekimig
Subcutaneous Injections at required timepoints
Ostatní jména:
  • Placebo for PF-07275315
Jiný: Placebo for Dupilumab
Subcutaneous Injections at required timepoints during initial treatment period.

Co je měření studie?

Primární výstupní opatření

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

Sekundární výstupní opatření

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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Pfizer

Vyšetřovatelé

  • Ředitel studie: Pfizer CT.gov Call Center, Pfizer

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

19. srpna 2026

Primární dokončení (Odhadovaný)

29. srpna 2028

Dokončení studie (Odhadovaný)

5. června 2029

Termíny zápisu do studia

První předloženo

17. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

20. srpna 2026

První zveřejněno (Aktuální)

24. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

24. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

20. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

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

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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