NCT07765888RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to-Severe Eczema
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
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 375 (estimated)
- First submitted
- 10 Aug 2026
- Start date
- 17 Aug 2026
- Primary completion date
- 10 Mar 2028
- Lead sponsor
- Pfizer
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07765888
- EU CT number
- 2026-526155-65-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 375
- From 17 Aug 2026 to the primary completion date, 10 Mar 2028
- 21 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Clinically Significant Autoimmune Disease
- Significant Infection History or Active Infection
- Significant psychiatric illness or suicidality
Other
- Known or Suspected Immunodeficiency/Immunosuppression
- Clinically significant hepatic, renal, or hematologic abnormalities
Who the study is looking for
- 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.
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Miyata Dermatology Clinic Coordinator of this site? Confirm its status | Matsudo | Japan | Not yet recruiting |
| Charme Clinique Coordinator of this site? Confirm its status | Matsudo | Japan | Not yet recruiting |
| Aile Home Clinic Nagaoka Coordinator of this site? Confirm its status | Nagaoka | Japan | Not yet recruiting |
| Osaka Metropolitan University Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Not yet recruiting |
| Dermatology and Ophthalmology Kume Clinic Coordinator of this site? Confirm its status | Sakai | Japan | Not yet recruiting |
| NTT Medical Center Tokyo Coordinator of this site? Confirm its status | Shinagawa | Japan | Not yet recruiting |
| Shibaki Dermatology Clinic Coordinator of this site? Confirm its status | Teine-ku | Japan | Not yet recruiting |
| Kern Research, Inc Coordinator of this site? Confirm its status | Bakersfield | United States | Not yet recruiting |
| Cahaba Dermatology Skin Health Center Coordinator of this site? Confirm its status | Birmingham | United States | Not yet recruiting |
| Derm Texas Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Red River Research Partners, LLC Coordinator of this site? Confirm its status | Fargo | United States | Recruiting |
| Marietta Dermatology Clinical Research, Inc. Coordinator of this site? Confirm its status | Marietta | United States | Recruiting |
| Pediatric Skin Research Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Northridge Clinical Trials Coordinator of this site? Confirm its status | Northridge | United States | Recruiting |
| AllerVie Clinical Research Coordinator of this site? Confirm its status | Panama City | United States | Recruiting |
| University Clinical Trials, Inc Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| Aeroallergy Research Laboratories of Savannah, Inc. Coordinator of this site? Confirm its status | Savannah | United States | Not yet recruiting |
| Orso Health Coordinator of this site? Confirm its status | Scottsdale | United States | Not yet recruiting |
| Stryde Research-Epiphany Dermatology Coordinator of this site? Confirm its status | Southlake | United States | Not yet recruiting |
| GCP Research, Global Clinical professionals Coordinator of this site? Confirm its status | St. Petersburg | United States | Recruiting |
| Focus Clinical Research Coordinator of this site? Confirm its status | West Hills | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.