Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

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

torstai 20. elokuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Ei vielä rekrytointia

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

1375

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Lapsi
  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Nelinkertaistaa

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Tilrekimig - Initial treatment period
Subcutaneous injections given over 20 Weeks.
Lääke: Tilrekimig
Subcutaneous Injections at required timepoints
Muut nimet:
  • PF-07275315
Active Comparator: Dupilumab - Initial treatment period
Subcutaneous injections given over 22 Weeks.
Lääke: Dupilumab
Subcutaneous Injections at required timepoints based on weight and age.
Muut nimet:
  • Dupixent
Placebo Comparator: Placebo - Initial treatment period
Subcutaneous injections given over 22 Weeks.
Muut: Placebo for Tilrekimig
Subcutaneous Injections at required timepoints
Muut nimet:
  • Placebo for PF-07275315
Muut: Placebo for Dupilumab
Subcutaneous Injections at required timepoints during initial treatment period.
Kokeellinen: Tilrekimig - Maintenance Period - Dose A
Subcutaneous injections given at Week 24 through Week 48.
Lääke: Tilrekimig
Subcutaneous Injections at required timepoints
Muut nimet:
  • PF-07275315
Kokeellinen: Tilrekimig - Maintenance Period - Dose B
Subcutaneous injections given at Week 24 through Week 48.
Lääke: Tilrekimig
Subcutaneous Injections at required timepoints
Muut nimet:
  • PF-07275315
Placebo Comparator: Placebo - Maintenance Period
Subcutaneous injections given at Week 24 through Week 48.
Muut: Placebo for Tilrekimig
Subcutaneous Injections at required timepoints
Muut nimet:
  • Placebo for PF-07275315
Muut: Placebo for Dupilumab
Subcutaneous Injections at required timepoints during initial treatment period.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

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

Toissijaiset tulostoimenpiteet

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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Pfizer

Tutkijat

  • Opintojohtaja: Pfizer CT.gov Call Center, Pfizer

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Arvioitu)

Keskiviikko 19. elokuuta 2026

Ensisijainen valmistuminen (Arvioitu)

Tiistai 29. elokuuta 2028

Opintojen valmistuminen (Arvioitu)

Tiistai 5. kesäkuuta 2029

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Maanantai 17. elokuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Torstai 20. elokuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Maanantai 24. elokuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Maanantai 24. elokuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Torstai 20. elokuuta 2026

Viimeksi vahvistettu

Lauantai 1. elokuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

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

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

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.

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Joo

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Tilaa