A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to-Severe Eczema
Recruiting · NCT07765888 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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. * 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 can take part
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 it is running
3 locations listed across 2 US states.
- Northridge Clinical Trials - Northridge, California, United States
- AllerVie Clinical Research - Panama City, Florida, United States
- GCP Research , Global Clinical Professionals - St. Petersburg, Florida, United States