NCT07765888 · Pfizer
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to-Severe Eczema
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Tilrekimig
Subcutaneous Injections at required timepoints
DRUG
Placebo
Subcutaneous Injections at required timepoints
Primary outcome measures
Difference in the proportion of Eczema and Severity Index (EASI)75 responders between tilrekimig versus placebo
Time frame: Week 16
Difference in the proportion of Validated Investigator Global Assessment (vIGA)-AD™ 0/1 responders between tilrekimig versus placebo
Time frame: Week 16
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants 12 years of age or older
- Must meet the following AD criteria:
- Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 12 months prior to Day 1
- An inadequate response to standard of care treatments {eg, at least medium potency topical corticosteroids (TCS)} consistent with AD treatment guidelines
- 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
Where
- Northridge, California
- Panama City, Florida
- St. Petersburg, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 4, 2026 · Source of record for eligibility and locations