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

Sponsor
Pfizer
Study ID
NCT07765888
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tilrekimig — DRUG
    Subcutaneous Injections at required timepoints
  • Placebo — OTHER
    Subcutaneous Injections at required timepoints

Study Details

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.

Key Dates

First listed
Aug 14, 2026
Start date
Aug 14, 2026
Status verified
Aug 2026
Primary completion
Feb 29, 2028
Completion
May 23, 2028

Study Design

Enrollment
375 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tilrekimig
    Subcutaneous injections given over 20 weeks
  • Placebo Comparator: Placebo
    Subcutaneous injections given over 20 weeks

Primary Outcome Measure

Difference in the proportion of Eczema and Severity Index (EASI)75 responders between tilrekimig versus placebo [ Time Frame: Week 16 ]

Central Contacts

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Atopic dermatitis / eczema trialsDermatology trialsRheumatology trialsAutoimmune disease trials

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