Recruiting
Phase 3

Tilrekimig with Creams

Sponsor:

Pfizer

Code:

NCT07765888

Conditions

Atopic Dermatitis

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Tilrekimig

Placebo

Study Details

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

Study ID

NCT07765888

Start date

Aug 17, 2026

Status verified date

Sep, 2026

Completion date

Jun 2, 2028

Anticipated

Primary completion date

Mar 10, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

375 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tilrekimig

Subcutaneous injections given over 20 weeks

placebo comparator: Placebo

Subcutaneous injections given over 20 weeks

Interventions

Tilrekimig

Subcutaneous Injections at required timepoints

Placebo

Subcutaneous Injections at required timepoints

Primary outcome measure

  • Difference in the proportion of Eczema and Severity Index (EASI)75 responders between tilrekimig versus placebo [ Time Frame: Week 16 ]
  • Difference in the proportion of Validated Investigator Global Assessment (vIGA)-AD™ 0/1 responders between tilrekimig versus placebo [ Time Frame: Week 16 ]

Central Contacts and Locations

Central contacts

Locations

GCP Research , Global Clinical Professionals

Recruiting

St. Petersburg, Florida, United States, 33714

More Information

Sponsor

Pfizer

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pfizer on 2026-09-04.