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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
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

Full criteria on ClinicalTrials.gov

Sites (32)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Fukuwa Clinic
Coordinator of this site? Confirm its status
Chuo-kuJapanNot yet recruiting
Nihonbashi Sakura Clinic
Coordinator of this site? Confirm its status
Chuo-kuJapanNot yet recruiting
Osaka Habikino Medical Center
Coordinator of this site? Confirm its status
HabikinoJapanNot yet recruiting
Katahira Dermatology Urology Clinic
Coordinator of this site? Confirm its status
KagoshimaJapanNot yet recruiting
Japan Community Healthcare Organization Chukyo Hospital
Coordinator of this site? Confirm its status
NagoyaJapanNot yet recruiting
Okayama University Hospital
Coordinator of this site? Confirm its status
OkayamaJapanNot yet recruiting
Pansy Skin Clinic
Coordinator of this site? Confirm its status
SaitamaJapanNot yet recruiting
Dermatology and Ophthalmology Kume Clinic
Coordinator of this site? Confirm its status
SakaiJapanNot yet recruiting
Izumigaoka Skin Clinic
Coordinator of this site? Confirm its status
SakaiJapanNot yet recruiting
Tachikawa Dermatology Clinic
Coordinator of this site? Confirm its status
TachikawaJapanNot yet recruiting
Ikebukuro-nishiguchi Fukurou Dermatology Clinic
Coordinator of this site? Confirm its status
Toshima-kuJapanNot yet recruiting
Queen's Square Medical Facilities Queen's Square Medical Center, Dermatology and Allergology
Coordinator of this site? Confirm its status
YokohamaJapanNot yet recruiting
Alexandria Associates in Dermatology
Coordinator of this site? Confirm its status
ArlingtonUnited StatesNot yet recruiting
Treasure Valley Medical Research
Coordinator of this site? Confirm its status
BoiseUnited StatesNot yet recruiting
Dermatology Trial Associates, Inc.
Coordinator of this site? Confirm its status
BryantUnited StatesRecruiting
Best Skin Research, LLC
Coordinator of this site? Confirm its status
Camp HillUnited StatesNot yet recruiting
Dermatology Treatment and Research Center
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
Derm Texas
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
Marvel Clinical Research
Coordinator of this site? Confirm its status
Huntington BeachUnited StatesRecruiting
Maryland Laser Skin and Vein
Coordinator of this site? Confirm its status
Hunt ValleyUnited StatesNot yet recruiting
Dawes Fretzin Clinical Research Group, LLC
Coordinator of this site? Confirm its status
IndianapolisUnited StatesRecruiting
California Allergy & Asthma Medical Group
Coordinator of this site? Confirm its status
Los AngelesUnited StatesNot yet recruiting
Marietta Dermatology Clinical Research, Inc.
Coordinator of this site? Confirm its status
MariettaUnited StatesRecruiting
Clinical Neuroscience Solutions, LLC.
Coordinator of this site? Confirm its status
MemphisUnited StatesRecruiting
Northridge Clinical Trials, LLC
Coordinator of this site? Confirm its status
NorthridgeUnited StatesRecruiting
Clinical Neuroscience Solutions, LLC
Coordinator of this site? Confirm its status
OrlandoUnited StatesRecruiting
Alliance Dermatology & MOHS Center
Coordinator of this site? Confirm its status
PhoenixUnited StatesNot yet recruiting
Stryde Research-Epiphany Dermatology
Coordinator of this site? Confirm its status
SouthlakeUnited StatesNot yet recruiting
Complete Dermatology
Coordinator of this site? Confirm its status
Sugar LandUnited StatesRecruiting
Revival Research Institute, LLC
Coordinator of this site? Confirm its status
TroyUnited StatesNot yet recruiting
Vital Prospects Clinical Research Institute., PC
Coordinator of this site? Confirm its status
TulsaUnited StatesRecruiting
Respiratory Medicine Research Institute of Michigan, PLC
Coordinator of this site? Confirm its status
YpsilantiUnited StatesRecruiting

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