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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Tilrekimig; Drug: Dupilumab; Other: Placebo for Tilrekimig; Other: Placebo for Dupilumab

• Study Type: Interventional
• Enrollment (Estimated): 1375
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clinical Research Institute., PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tilrekimig - Initial treatment period; Subcutaneous injections given over 20 Weeks.	Drug: Tilrekimig; Subcutaneous Injections at required timepoints; Other Names: PF-07275315
Active Comparator: Dupilumab - Initial treatment period; Subcutaneous injections given over 22 Weeks.	Drug: Dupilumab; Subcutaneous Injections at required timepoints based on weight and age.; Other Names: Dupixent
Placebo Comparator: Placebo - Initial treatment period; Subcutaneous injections given over 22 Weeks.	Other: Placebo for Tilrekimig; Subcutaneous Injections at required timepoints; Other Names: Placebo for PF-07275315; Other: Placebo for Dupilumab; Subcutaneous Injections at required timepoints during initial treatment period.
Experimental: Tilrekimig - Maintenance Period - Dose A; Subcutaneous injections given at Week 24 through Week 48.	Drug: Tilrekimig; Subcutaneous Injections at required timepoints; Other Names: PF-07275315
Experimental: Tilrekimig - Maintenance Period - Dose B; Subcutaneous injections given at Week 24 through Week 48.	Drug: Tilrekimig; Subcutaneous Injections at required timepoints; Other Names: PF-07275315
Placebo Comparator: Placebo - Maintenance Period; Subcutaneous injections given at Week 24 through Week 48.	Other: Placebo for Tilrekimig; Subcutaneous Injections at required timepoints; Other Names: Placebo for PF-07275315; Other: Placebo for Dupilumab; Subcutaneous Injections at required timepoints during initial treatment period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Difference in the proportion of Peak Pruritis Numerical Rating Score (PP-NRS)4 responders between tilrekimig versus placebo	Week 1 through Week 24
Difference in the proportion of PP-NRS4 responders between tilrekimig versus dupilumab	Week 1 through Week 24
Incidence of treatment emergent adverse events (AEs), Serious adverse events (SAEs), and AEs leading to discontinuation	For each participant from the time the participant provides informed consent, through and including a minimum of 16 weeks after the last administration of the study intervention.
Incidence of clinically significant changes in vital signs and laboratory tests.	For each participant following first administration of the study intervention through the end of study visit (week 64).
Difference in the proportion of Eczema Area and Severity Index (EASI)75 responders between tilrekimig versus placebo.	Weeks 2, 4, 8, 12, 14, 20, and 24
Difference in the proportion of Eczema Area and Severity Index (EASI)75 responders between tilrekimig versus dupilumab.	Weeks 2, 4, 8, 12, 14, 16, 20, and 24
Difference in the proportion of validated Investigator Global Assessment- Atopic Dermatitis (vIGA-AD) 0/1 responders between tilrekimig versus placebo.	Weeks 2, 4, 8, 12, 14, 20, and 24
Difference in the proportion of validated Investigator Global Assessment- Atopic Dermatitis (vIGA-AD) 0/1 responders between tilrekimig versus dupilumab.	Weeks 2, 4, 8, 12, 14, 16, 20, and 24
Difference in the proportion of revised Global Investigator Assessment (rIGA) 0/1 responders between tilrekimig versus placebo.	Weeks 2, 4, 8, 12, 14, 16, 20, and 24
Difference in the proportion of revised Global Investigator Assessment (rIGA) 0/1 responders between tilrekimig versus dupilumab.	Weeks 2, 4, 8, 12, 14, 16, 20, and 24
Difference in the proportion of EASI50, EASI90, and EASI100 responders between tilrekimig versus placebo.	Weeks 2, 4, 8, 12, 14, 16, 20 and 24
Difference in the proportion of EASI50, EASI90, and EASI100 responders between tilrekimig versus dupilumab.	Weeks 2, 4, 8, 12, 14, 16, 20 and 24
Difference in the mean percent CFB in EASI total score between tilrekimig versus placebo.	Weeks 2, 4, 8, 12, 16, 20 and 24
Difference in the mean percent CFB in EASI total score between tilrekimig versus dupilumab.	Weeks 2, 4, 8, 12, 16, 20 and 24
Difference in the mean percent CFB in Body Surface Area (BSA) between tilrekimig versus placebo.	Weeks 2, 4, 8, 12, 16, 20 and 24
Difference in the mean percent CFB in Body Surface Area (BSA) between tilrekimig versus dupilumab.	Weeks 2, 4, 8, 12, 16, 20 and 24
Difference in the proportion of Patient Oriented Eczema Measure (POEM) responders achieving ≥4-point improvement from baseline between tilrekimig versus placebo.	Weeks 8, 16, and 24
Difference in the proportion of POEM responders achieving ≥4-point improvement from baseline between tilrekimig versus dupilumab.	Weeks 8, 16, and 24
Difference in the proportion of Dermatology Life Quality Index (DLQI) responders achieving ≥4-point improvement from baseline between tilrekimig versus placebo.	Weeks 8, 16, and 24
Difference in the proportion of Dermatology Life Quality Index (DLQI) responders achieving ≥4-point improvement from baseline between tilrekimig versus dupilumab	Weeks 8, 16, and 24
Difference in the proportion of Patient Global Impression of Severity (PGI-S) responders achieving a score of 0 or 1 between tilrekimig versus placebo.	Weeks 8, 16, and 24
Difference in the proportion of Patient Global Impression of Severity (PGI-S) responders achieving a score of 0 or 1 between tilrekimig versus dupilumab.	Weeks 8, 16, and 24
Difference in the proportion of Patient Global Impression of Change (PGI-C) responders achieving "Much better" between tilrekimig versus placebo.	Weeks 8, 16, and 24
Difference in the proportion of Patient Global Impression of Change (PGI-C) responders achieving "Much better" between tilrekimig versus dupilumab.	Weeks 8, 16, and 24
Difference in the proportion of Atopic Dermatitis Control Tool (ADCT) responders achieving ≥5-point improvement from baseline between tilrekimig versus placebo.	Weeks 8, 16, and 24
Difference in the proportion of Atopic Dermatitis Control Tool (ADCT) responders achieving ≥5-point improvement from baseline between tilrekimig versus dupilumab.	Weeks 8, 16, and 24
Difference in the mean percent CFB in POEM between tilrekimig versus placebo.	Weeks 8, 16, and 24
Difference in the mean percent CFB in EASI total score between tilrekimig versus dupilumab.	Weeks 8, 16, and 24
Difference in the mean percent CFB in DLQI between tilrekimig versus placebo.	Weeks 8, 16, and 24
Difference in the mean percent CFB in DLQI between tilrekimig versus dupilumab.	Weeks 8, 16, and 24
Difference in the mean percent CFB in Children's Dermatology Life Quality Index (CDLQI) between tilrekimig versus placebo.	Weeks 8, 16, and 24
Difference in the mean percent CFB in CDLQI between tilrekimig versus dupilumab.	Weeks 8, 16, and 24
Difference in the mean percent CFB in PP-NRS weekly average between tilrekimig versus placebo.	Week 1 through week 24
Difference in the mean percent CFB in PP-NRS weekly average between tilrekimig versus dupilumab.	Week 1 through Week 24
Proportion of responders for EASI75, rIGA 0/1, vIGA-AD 0, PP-NRS4, EASI50, EASI90, and EASI100 for tilrekimig doses and placebo.	Weeks 26, 28, 32, 36, 40, 44, 48, 52, and 64
Mean of percent CFB in EASI and BSA for tilrekimig doses and placebo	Weeks 26, 28, 32, 36, 40, 44, 48, 52, and 64
Proportion of maintaining response at Week 52 (defined as meeting ≥50% improvement from baseline in EASI and vIGA-AD <3) for participants who responded to tilrekimig (defined as achieving either EASI75 or vIGA-ADTM 0/1 at Week 24).	Week 52
The proportion of POEM responders achieving ≥4-point improvement from baseline for tilrekimig doses and placebo.	Weeks 28, 36, 44, 52, and 64
The proportion of DLQI responders achieving ≥4-point improvement from baseline for tilrekimig doses and placebo.	Weeks 28, 36, 44, 52, and 64
The proportion of PGI-S responders achieving a score of 0 or 1 for tilrekimig doses and placebo.	Weeks 28, 36, 44, 52, and 64
The proportion of PGI-C responders achieving "Much better" for tilrekimig doses and placebo.	Weeks 28, 36, 44, 52, and 64
The proportion of ADCT responders achieving ≥5-point improvement from baseline for tilrekimig doses and placebo.	Weeks 28, 36, 44, 52, and 64
Mean of CFB in POEM, DLQI, and CDLQI for tilrekimig doses and placebo.	Weeks 28, 36, 44, 52, and 64
Mean of CFB in weekly averages of PP=NRS for tilrekimig doses and placebo.	Weeks 26, 28, 32, 36, 40, 44, 48, 52, and 64

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Estimated): August 19, 2026
• Primary Completion (Estimated): August 29, 2028
• Study Completion (Estimated): June 5, 2029

Study Registration Dates

• First Submitted: August 17, 2026
• First Submitted That Met QC Criteria: August 20, 2026
• First Posted (Actual): August 24, 2026

Study Record Updates

• Last Update Posted (Actual): August 24, 2026
• Last Update Submitted That Met QC Criteria: August 20, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: atopic dermatitis; eczema; skin diseases; Dermatitis; Skin Diseases, Eczematous; Immune system diseases; skin diseases, genetic
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hypersensitivity, Immediate; Hypersensitivity; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Immune System Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; dupilumab
• Other Study ID Numbers: C4531005; 2026-525743-32-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No