375 Participants NeededMy employer runs this trial

Tilrekimig for Eczema

Recruiting at 2 trial locations
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: Pfizer
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for people aged 12 and older who have had moderate-to-severe eczema (atopic dermatitis) for at least a year, and whose skin hasn't improved enough with standard creams or ointments. Adolescents must be up to date on their vaccines.

Inclusion Criteria

I am 12 years old or older.
I did not improve after using standard treatments, including medium-strength steroid creams.
I am up to date on all required vaccines for my age.
See 2 more

Exclusion Criteria

I have a history of serious infections or currently have an active infection.
I have a serious autoimmune disease.
Significant psychiatric illness or suicidality
See 2 more

What Are the Treatments Tested in This Trial?

Interventions

  • Tilrekimig

Trial Overview

The study compares tilrekimig (an investigational medicine) to a placebo in people with moderate-to-severe eczema. Participants are randomly assigned to receive either tilrekimig or placebo along with usual medicated creams for 24 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: TilrekimigExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University