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Clinical Trials in Japan / NCT07765888
Recruiting Phase 3

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

NCT07765888 · tracked via the Priya Life Science Japan tracker
Sponsor
Pfizer
Phase
Phase 3
Started
2026-08-17
Last updated
2026-10-15

Condition(s) studied

Atopic Dermatitis

Investigational drug(s) / intervention(s)

Tilrekimig →Placebo

Tilrekimig: Subcutaneous Injections at required timepoints

Placebo: Subcutaneous Injections at required timepoints

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 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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Participants 12 years of age or older * Must meet the following AD criteria: 1. Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 12 months prior to Day 1 2. An inadequate response to standard of care treatments {eg, at least medium potency topical corticosteroids (TCS)} consistent with AD treatment guidelines 3. Moderate-to-severe eczema for at least 1 year * Adolescent participants must be up to date on immunizations per local guidance. 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 and Severity Index (EASI)75 responders between tilrekimig versus placebo — Week 16
  • Difference in the proportion of Validated Investigator Global Assessment (vIGA)-AD™ 0/1 responders between tilrekimig versus placebo — Week 16

Trial sites (21)

FacilityCityRegionStatus
Cahaba Dermatology & Skin Health Center Birmingham Alabama Not Yet Recruiting
ORSO Health Scottsdale Arizona Not Yet Recruiting
Kern Research, Inc. Bakersfield California Not Yet Recruiting
Northridge Clinical Trials Northridge California Recruiting
University Clinical Trials, Inc San Diego California Recruiting
Focus Clinical Research West Hills California Not Yet Recruiting
Pediatric Skin Research Miami Florida Recruiting
AllerVie Clinical Research Panama City Florida Recruiting
GCP Research , Global Clinical Professionals St. Petersburg Florida Recruiting
Marietta Dermatology Clinical Research, Inc. Marietta Georgia Recruiting
Aeroallergy Research Laboratories of Savannah, Inc Savannah Georgia Not Yet Recruiting
Red River Research Partners LLC Fargo North Dakota Recruiting
Derm Texas Dallas Texas Recruiting
Stryde Research-Epiphany Dermatology Southlake Texas Not Yet Recruiting
Charme Clinique Matsudo Chiba Not Yet Recruiting
Miyata Dermatology Clinic Matsudo Chiba Not Yet Recruiting
Shibaki Dermatology Clinic Teine-ku Hokkaido Not Yet Recruiting
Aile Home Clinic Nagaoka Nagaoka Niigata Not Yet Recruiting
Dermatology and Ophthalmology Kume Clinic Sakai Osaka Not Yet Recruiting
NTT Medical Center Tokyo Shinagawa Tokyo Not Yet Recruiting
Osaka Metropolitan University Hospital Osaka Japan Not Yet Recruiting

More Pfizer trials in Japan

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Symbiotic-Lung-04: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Extensive-Stage Small Cell Lung Cancer Recruiting
A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer Active, not recruiting
A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata Recruiting
Non Interventional Study to Investigate the Safety and Effectiveness in Patients With Relapsed and Refractory Multiple Myeloma Treated With Elranatamab Under the Actual Use. Active, not recruiting

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 NCT07765888 on ClinicalTrials.gov ↗ ← All trials in Japan