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

Pfizer

Status and phase: Not yet enrolling; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Tilrekimig; Drug: Dupilumab; Other: Placebo for Dupilumab; Other: Placebo for Tilrekimig

Study type: Interventional

Funder types: Industry

Identifiers

NCT07783425

2026-525743-32-00 (Registry Identifier)

C4531005

Details and patient eligibility

About

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.

Enrollment: 1,375 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,375 participants in 6 patient groups, including a placebo group

Tilrekimig - Initial treatment period

Experimental group

Description:

Subcutaneous injections given over 20 Weeks.

Treatment:

Drug: Tilrekimig

Dupilumab - Initial treatment period

Active Comparator group

Description:

Subcutaneous injections given over 22 Weeks.

Treatment:

Drug: Dupilumab

Placebo - Initial treatment period

Placebo Comparator group

Description:

Subcutaneous injections given over 22 Weeks.

Treatment:

Other: Placebo for Tilrekimig

Other: Placebo for Dupilumab

Tilrekimig - Maintenance Period - Dose A

Experimental group

Description:

Subcutaneous injections given at Week 24 through Week 48.

Treatment:

Drug: Tilrekimig

Tilrekimig - Maintenance Period - Dose B

Experimental group

Description:

Subcutaneous injections given at Week 24 through Week 48.

Treatment:

Drug: Tilrekimig

Placebo - Maintenance Period

Placebo Comparator group

Description:

Subcutaneous injections given at Week 24 through Week 48.

Treatment:

Other: Placebo for Tilrekimig

Other: Placebo for Dupilumab