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

NCT07783425 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: C45310052026-525743-32-00
• Study Type: interventional
• Target: 1,375
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Atopic Dermatitis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (44)

• 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

Study Arms (6)

Tilrekimig - Initial treatment period

EXPERIMENTAL

Subcutaneous injections given over 20 Weeks.

Drug: Tilrekimig

Dupilumab - Initial treatment period

ACTIVE COMPARATOR

Subcutaneous injections given over 22 Weeks.

Drug: Dupilumab

Placebo - Initial treatment period

PLACEBO COMPARATOR

Subcutaneous injections given over 22 Weeks.

Other: Placebo for Tilrekimig; Other: Placebo for Dupilumab

Tilrekimig - Maintenance Period - Dose A

EXPERIMENTAL

Subcutaneous injections given at Week 24 through Week 48.

Drug: Tilrekimig

Tilrekimig - Maintenance Period - Dose B

EXPERIMENTAL

Subcutaneous injections given at Week 24 through Week 48.

Drug: Tilrekimig

Placebo - Maintenance Period

PLACEBO COMPARATOR

Subcutaneous injections given at Week 24 through Week 48.

Other: Placebo for Tilrekimig; Other: Placebo for Dupilumab

Interventions

Tilrekimig DRUG

Subcutaneous Injections at required timepoints

Also known as: PF-07275315

Tilrekimig - Initial treatment period; Tilrekimig - Maintenance Period - Dose A; Tilrekimig - Maintenance Period - Dose B

Dupilumab DRUG

Subcutaneous Injections at required timepoints based on weight and age.

Also known as: Dupixent

Dupilumab - Initial treatment period

Placebo for Tilrekimig OTHER

Subcutaneous Injections at required timepoints

Also known as: Placebo for PF-07275315

Placebo - Initial treatment period; Placebo - Maintenance Period

Placebo for Dupilumab OTHER

Subcutaneous Injections at required timepoints during initial treatment period.

Placebo - Initial treatment period; Placebo - Maintenance Period

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:

• 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

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

Study Sites (1)

Vital Prospects Clinical Research Institute., PC

Tulsa, Oklahoma, 74136, United States

Location

Related Links

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

MeSH Terms

Conditions

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

Interventions

dupilumab

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 17, 2026
• First Posted: August 24, 2026
• Study Start: August 19, 2026
• Primary Completion (Estimated): August 29, 2028
• Study Completion (Estimated): June 5, 2029
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)