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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
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

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Miyata Dermatology Clinic
Coordinator of this site? Confirm its status
MatsudoJapanNot yet recruiting
Charme Clinique
Coordinator of this site? Confirm its status
MatsudoJapanNot yet recruiting
Aile Home Clinic Nagaoka
Coordinator of this site? Confirm its status
NagaokaJapanNot yet recruiting
Osaka Metropolitan University Hospital
Coordinator of this site? Confirm its status
OsakaJapanNot yet recruiting
Dermatology and Ophthalmology Kume Clinic
Coordinator of this site? Confirm its status
SakaiJapanNot yet recruiting
NTT Medical Center Tokyo
Coordinator of this site? Confirm its status
ShinagawaJapanNot yet recruiting
Shibaki Dermatology Clinic
Coordinator of this site? Confirm its status
Teine-kuJapanNot yet recruiting
Kern Research, Inc
Coordinator of this site? Confirm its status
BakersfieldUnited StatesNot yet recruiting
Cahaba Dermatology Skin Health Center
Coordinator of this site? Confirm its status
BirminghamUnited StatesNot yet recruiting
Derm Texas
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
Red River Research Partners, LLC
Coordinator of this site? Confirm its status
FargoUnited StatesRecruiting
Marietta Dermatology Clinical Research, Inc.
Coordinator of this site? Confirm its status
MariettaUnited StatesRecruiting
Pediatric Skin Research
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting
Northridge Clinical Trials
Coordinator of this site? Confirm its status
NorthridgeUnited StatesRecruiting
AllerVie Clinical Research
Coordinator of this site? Confirm its status
Panama CityUnited StatesRecruiting
University Clinical Trials, Inc
Coordinator of this site? Confirm its status
San DiegoUnited StatesRecruiting
Aeroallergy Research Laboratories of Savannah, Inc.
Coordinator of this site? Confirm its status
SavannahUnited StatesNot yet recruiting
Orso Health
Coordinator of this site? Confirm its status
ScottsdaleUnited StatesNot yet recruiting
Stryde Research-Epiphany Dermatology
Coordinator of this site? Confirm its status
SouthlakeUnited StatesNot yet recruiting
GCP Research, Global Clinical professionals
Coordinator of this site? Confirm its status
St. PetersburgUnited StatesRecruiting
Focus Clinical Research
Coordinator of this site? Confirm its status
West HillsUnited StatesNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.