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Clinical Trials in Japan / NCT07783425
Recruiting Phase 3

A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema

NCT07783425 · tracked via the Priya Life Science Japan tracker
Sponsor
Pfizer
Phase
Phase 3
Started
2026-08-24
Last updated
2026-10-06

Condition(s) studied

Atopic Dermatitis

Investigational drug(s) / intervention(s)

Tilrekimig →Dupilumab →Placebo for TilrekimigPlacebo for Dupilumab

Tilrekimig: Subcutaneous Injections at required timepoints

Dupilumab: Subcutaneous Injections at required timepoints based on weight and age.

Placebo for Tilrekimig: Subcutaneous Injections at required timepoints

Placebo for Dupilumab: Subcutaneous Injections at required timepoints during initial treatment period.

Study summary

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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria * 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 Key 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

Primary outcome measure(s)

  • Difference in the proportion of Eczema Area and Severity Index (EASI)75 responders between tilrekimig versus placebo. — Week 16
  • Difference in the proportion of validated Investigator Global Assessment- Atopic Dermatitis (vIGA-AD) 0/1 responders between tilrekimig versus placebo. — Week 16

Trial sites (22)

FacilityCityRegionStatus
Alliance Dermatology & MOHS Center Phoenix Arizona Not Yet Recruiting
Marvel Clinical Research Huntington Beach California Recruiting
Northridge Clinical Trials, LLC Northridge California Recruiting
Marietta Dermatology Clinical Research, Inc. Marietta Georgia Recruiting
Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana Recruiting
Revival Research Institute, LLC Troy Michigan Not Yet Recruiting
Respiratory Medicine Research Institute of Michigan, PLC Ypsilanti Michigan Not Yet Recruiting
Vital Prospects Clinical Research Institute., PC Tulsa Oklahoma Recruiting
Best Skin Research, LLC Camp Hill Pennsylvania Not Yet Recruiting
Clinical Neuroscience Solutions, LLC. Memphis Tennessee Recruiting
Dermatology Treatment and Research Center Dallas Texas Not Yet Recruiting
Complete Dermatology Sugar Land Texas Not Yet Recruiting
Japan Community Healthcare Organization Chukyo Hospital Nagoya Aichi-ken Not Yet Recruiting
Katahira Dermatology Urology Clinic Kagoshima Kagoshima-ken Not Yet Recruiting
Queen's Square Medical Facilities Queen's Square Medical Center, Dermatology and Allergology Yokohama Kanagawa Not Yet Recruiting
Izumigaoka Skin Clinic Sakai Osaka Not Yet Recruiting
Dermatology and Ophthalmology Kume Clinic Sakai Osaka Not Yet Recruiting
Pansy Skin Clinic Saitama Saitama Not Yet Recruiting
Nihonbashi Sakura Clinic Chuo-ku Tokyo Not Yet Recruiting
Fukuwa Clinic Chuo-ku Tokyo Not Yet Recruiting
Tachikawa Dermatology Clinic Tachikawa Tokyo Not Yet Recruiting
Ikebukuro-nishiguchi Fukurou Dermatology Clinic Toshima-ku Tokyo Not Yet Recruiting

On this site

📄 Dupixent (dupilumab) drug profile →

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Other trials for the same condition

A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis Active, not recruiting
A Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis Recruiting
A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Atopic Dermatitis Active, not recruiting
Safety and Efficacy of Upadacitinib in Combination With Topical Corticosteroids in Children From 2 to Less Than 12 Years of Age in Japan With Moderate to Severe Atopic Dermatitis Active, not recruiting
A Study to Evaluate the Effectiveness and Safety of Treatments, Either Alone or in Combination, for the Treatment of Moderate to Severe Atopic Dermatitis Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07783425 on ClinicalTrials.gov ↗ ← All trials in Japan