Tilrekimig for moderate to severe eczema in people aged 12 and older
Tests tilrekimig against dupilumab and placebo in people with moderate to severe eczema.
Plain-language title generated from the registry record
Registry title: A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Key facts
- Where
- Montreal, CanadaSee the site
- Phase
- Phase 3
Where in Canada
- Innovaderm Research Inc.Montreal, CanadaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pfizer
- Trial code
- NCT07783425EU 2026-525743-32-00
- Record updated
- 6 November 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Clinically Significant Autoimmune Disease; Significant Infection History or Active Infection; Significant psychiatric illness or suicidality; Known or Suspected Immunodeficiency/Immunosuppression; Clinically significant hepatic, renal, or hematologic abnormalities.