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

StatusRecruiting
PhasePhase 3
SponsorPfizer
Started

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Record History

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  1. Notable Primary endpoints: details revised at 1 of 2 entries
    • Trial sites expanded: 3 → 21 locations
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 6 of 24 entries
  2. Notable Recruitment openedv2 Show 5 more changesShow less
    • Trial sites expanded: 0 → 3 locations
    • Interventions modified
    • Primary completion date: Feb 29, 2028 to Mar 10, 2028
    • Study completion date: May 23, 2028 to Jun 2, 2028
    • Start date changed from estimate of Aug 14, 2026 to Aug 17, 2026
  3. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
438 trials monitored
See 32 trials at risk
The purpose of this study is to find out how well tilrekimig works, how safe it is, and how it affects the body when used together with medicated creams or ointments in adults and adolescents with moderate to severe atopic dermatitis (eczema). Eczema (also called atopic dermatitis) is a common skin condition that makes the skin dry, itchy, red, and irritated. * This 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. Participants in this study will randomly receive either tilrekimig or placebo at a 2:1 ratio. A placebo does not have any medicine in it but looks just like the medicine being studied. The study treatment period will be 24 weeks. The last dose of study treatment will be administered at week 20. Some participants will join the long-term extension study C4531008 at week 24. A long-term extension study is an additional study that participants may be able to join after completing the main study. It allows researchers to continue collecting information about how well the study medicine works and 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 study treatment dose.
Trial Details
NCT Number NCT07765888
Lead Sponsor Pfizer
Conditions
(from sponsor)
Atopic Dermatitis
Related terms Dermatitis, Dermatitis, Atopic, Eczema, Immune System Diseases, Skin Diseases, Skin Diseases, Eczematous, Skin Diseases, Genetic
Enrollment 375 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov