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

RecruitingPhase 3

A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED PHASE 3 COMBINATION THERAPY STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TILREKIMIG IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE OR OLDER WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

Who can join

Ages 12 and older · All sexes

Full eligibility criteria

Inclusion Criteria:

* Participants 12 years of age or older
* Must meet the following AD criteria:

  1. Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 12 months prior to Day 1
  2. An inadequate response to standard of care treatments {eg, at least medium potency topical corticosteroids (TCS)} consistent with AD treatment guidelines
  3. Moderate-to-severe eczema for at least 1 year
* Adolescent participants must be up to date on immunizations per local guidance.

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

About the study

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.

What is being tested

Tilrekimig (drug)
Placebo (drug)

Sponsor: Pfizer · Participants: 375 · Started: Aug 17, 2026

Contact the study team

Pfizer CT.gov Call Center · Phone: 1-800-718-1021

Official record on ClinicalTrials.gov — NCT07765888

Locations in the U.S.

California	Northridge Clinical Trials, Northridge (Not yet recruiting)
Florida	AllerVie Clinical Research, Panama City (Not yet recruiting) GCP Research , Global Clinical Professionals, St. Petersburg

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.