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

NCT07765888 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: C45310072026-526155-65-00
• Study Type: interventional
• Target: 375
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atopic Dermatitis

Keywords

eczema; atopic dermatitis; Immune system diseases; skin diseases, genetic; Dermatitis; Skin Diseases, Eczematous; skin diseases

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (24)

• Difference in the proportion of revised investigator's global assessment (rIGA) 0/1 responders between tilrekimig versus placebo

  Week 16

• Difference in the proportion of Eczema and Severity Index (EASI)90 responders between tilrekimig versus placebo

  Week 16

• Difference in the proportion of Dermatology Life Quality Index (DLQI) responders between tilrekimig versus placebo

  Week 16

• Difference in the proportion of Peak Pruritus Numerical Rating Scale (PP-NRS)4 responders between tilrekimig versus placebo

  Weeks 2, 4, 6, 8, and 16

• Difference in the mean percent change from baseline (CFB) in EASI total score, between tilrekimig versus placebo

  Week 16

Study Arms (2)

Tilrekimig

EXPERIMENTAL

Subcutaneous injections given over 20 weeks

Drug: Tilrekimig

Placebo

PLACEBO COMPARATOR

Subcutaneous injections given over 20 weeks

Other: Placebo

Interventions

Tilrekimig DRUG

Subcutaneous Injections at required timepoints

Also known as: PF-07275315

Tilrekimig

Placebo OTHER

Subcutaneous Injections at required timepoints

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Immune System Diseases; Skin Diseases, Genetic; Dermatitis; Skin Diseases, Eczematous; Skin Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start: August 14, 2026
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): May 23, 2028
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share