NCT07783425RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL GROUP, ACTIVE- AND PLACEBO-CONTROLLED PHASE 3 MONOTHERAPY STUDY WITH MAINTENANCE PERIOD TO INVESTIGATE THE EFFICACY AND SAFETY OF TILREKIMIG IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
Source: ClinicalTrials.gov · Last updated 22 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 in adults and adolescents with moderate to severe atopic dermatitis (eczema). Eczema is a condition which can cause dryness, itching, and redness of your skin. The 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. The study treatment period will be 52 weeks. During the 24-week initial treatment period, participants will be randomized to one of three study treatments - tilrekimig, dupilumab, or placebo. Placebo does not have any medicine in it but looks just like the medicine being studied. These treatments will be randomized based on a 2:2:1 ratio. This means out of 1375 participants, about 550 participants will receive tilrekimig, 550 will receive dupilumab, and 275 will receive placebo. This will be followed by a 28-week maintenance period. The last dose of study treatment will be administered at week 48. Some participants will join the long-term extension (LTE) study C4531008 at week 52. A long-term extension study is an additional study that some participants may be able to join after completing the study if they are interested and meet eligibility requirements. It allows researchers to continue collecting information about how well the study medicine works. It also helps them assess 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 dose of study treatment.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1375 (estimated)
- First submitted
- 17 Aug 2026
- Start date
- 24 Aug 2026
- Primary completion date
- 8 Sept 2028
- Lead sponsor
- Pfizer
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07783425
- EU CT number
- 2026-525743-32-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1375
- From 24 Aug 2026 to the primary completion date, 8 Sept 2028
- 32 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
- You are \[12\] years of age or older
- You have had moderate-to-severe eczema for at least 1 year
- Topical medicines for eczema have not worked well for you
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (32)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fukuwa Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Not yet recruiting |
| Nihonbashi Sakura Clinic Coordinator of this site? Confirm its status | Chuo-ku | Japan | Not yet recruiting |
| Osaka Habikino Medical Center Coordinator of this site? Confirm its status | Habikino | Japan | Not yet recruiting |
| Katahira Dermatology Urology Clinic Coordinator of this site? Confirm its status | Kagoshima | Japan | Not yet recruiting |
| Japan Community Healthcare Organization Chukyo Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Not yet recruiting |
| Okayama University Hospital Coordinator of this site? Confirm its status | Okayama | Japan | Not yet recruiting |
| Pansy Skin Clinic Coordinator of this site? Confirm its status | Saitama | Japan | Not yet recruiting |
| Dermatology and Ophthalmology Kume Clinic Coordinator of this site? Confirm its status | Sakai | Japan | Not yet recruiting |
| Izumigaoka Skin Clinic Coordinator of this site? Confirm its status | Sakai | Japan | Not yet recruiting |
| Tachikawa Dermatology Clinic Coordinator of this site? Confirm its status | Tachikawa | Japan | Not yet recruiting |
| Ikebukuro-nishiguchi Fukurou Dermatology Clinic Coordinator of this site? Confirm its status | Toshima-ku | Japan | Not yet recruiting |
| Queen's Square Medical Facilities Queen's Square Medical Center, Dermatology and Allergology Coordinator of this site? Confirm its status | Yokohama | Japan | Not yet recruiting |
| Alexandria Associates in Dermatology Coordinator of this site? Confirm its status | Arlington | United States | Not yet recruiting |
| Treasure Valley Medical Research Coordinator of this site? Confirm its status | Boise | United States | Not yet recruiting |
| Dermatology Trial Associates, Inc. Coordinator of this site? Confirm its status | Bryant | United States | Recruiting |
| Best Skin Research, LLC Coordinator of this site? Confirm its status | Camp Hill | United States | Not yet recruiting |
| Dermatology Treatment and Research Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Derm Texas Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Marvel Clinical Research Coordinator of this site? Confirm its status | Huntington Beach | United States | Recruiting |
| Maryland Laser Skin and Vein Coordinator of this site? Confirm its status | Hunt Valley | United States | Not yet recruiting |
| Dawes Fretzin Clinical Research Group, LLC Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| California Allergy & Asthma Medical Group Coordinator of this site? Confirm its status | Los Angeles | United States | Not yet recruiting |
| Marietta Dermatology Clinical Research, Inc. Coordinator of this site? Confirm its status | Marietta | United States | Recruiting |
| Clinical Neuroscience Solutions, LLC. Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
| Northridge Clinical Trials, LLC Coordinator of this site? Confirm its status | Northridge | United States | Recruiting |
| Clinical Neuroscience Solutions, LLC Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Alliance Dermatology & MOHS Center Coordinator of this site? Confirm its status | Phoenix | United States | Not yet recruiting |
| Stryde Research-Epiphany Dermatology Coordinator of this site? Confirm its status | Southlake | United States | Not yet recruiting |
| Complete Dermatology Coordinator of this site? Confirm its status | Sugar Land | United States | Recruiting |
| Revival Research Institute, LLC Coordinator of this site? Confirm its status | Troy | United States | Not yet recruiting |
| Vital Prospects Clinical Research Institute., PC Coordinator of this site? Confirm its status | Tulsa | United States | Recruiting |
| Respiratory Medicine Research Institute of Michigan, PLC Coordinator of this site? Confirm its status | Ypsilanti | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.