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NCT Number: NCT07765888

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

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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

Treatment and study plan

Tilrekimig

Drug

Subcutaneous Injections at required timepoints

Other names: PF-07275315

Placebo

Other

Subcutaneous Injections at required timepoints

Primary outcomes

  1. Difference in the proportion of Eczema and Severity Index (EASI)75 responders between tilrekimig versus placebo

    Time frame: Week 16

  2. Difference in the proportion of Validated Investigator Global Assessment (vIGA)-AD™ 0/1 responders between tilrekimig versus placebo

    Time frame: Week 16

Secondary outcomes

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

    Time frame: Week 16

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

    Time frame: Week 16

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

    Time frame: Week 16

    For participants >= 16 yrs of age

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

    Time frame: Weeks 2, 4, 6, 8, and 16

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

    Time frame: Week 16

  6. Incidence of treatment emergent Adverse Events (AE)s, Serious Adverse Events (SAE)s and AEs leading to discontinuation

    Time frame: 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.

  7. Incidence of clinically significant changes in vital signs, and laboratory tests

    Time frame: 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

  8. Difference in the proportion of EASI75 responders

    Time frame: Weeks 2, 4, 8, 12, 20, 24 and 36

  9. Difference in the proportion of vIGA-AD™ 0/1 response

    Time frame: Weeks 2, 4, 8, 12, 20, 24 and 36

  10. Difference in the proportion of rIGA 0/1 response

    Time frame: Weeks 2, 4, 8, 12, 20, 24 and 36

  11. Difference in the proportion of vIGA-AD™ 0 response defined as achieving a vIGA-AD(™) score of clear (0) (on a 5-point scale)

    Time frame: Weeks 2, 4, 8, 12, 16, 20, 24 and 36

  12. Difference in the proportion of PP-NRS4 response at every week except those included as key secondary endpoints

    Time frame: Week 1 through Week 24 (except Weeks 2, 4, 6, 8, and 16), plus Week 36

  13. Difference in the proportion of EASI50, EASI90 and EASI100 (≥50%, ≥90% and 100% improvement from baseline in EASI)

    Time frame: Time frame for both EASI50 and EASI100 is Weeks 2, 4, 8, 12, 16, 20, 24, and 36. Time frame for EASI90 is Weeks 2, 4, 8, 12, 20, 24, and 36.

  14. Difference in the percent CFB in EASI total score

    Time frame: Weeks 2, 4, 8, 12, 20, 24 and 36

  15. Difference in the percent CFB in Body Surface Area (BSA)

    Time frame: Weeks 2, 4, 8, 12, 16, 20, 24 and 36

  16. Difference in the proportion of patient Oriented Eczema Measure (POEM) response based on a participant achieving ≥4-point improvement from baseline in POEM

    Time frame: Weeks 4, 8, 16, 24 and 36

  17. Difference in the proportion of DLQI response based on a participant achieving ≥4-point improvement from baseline in DLQI at scheduled time points except that included as a key secondary endpoint for participants 16 years or older

    Time frame: Weeks 4, 8, 24 and 36

  18. Difference in the proportion of patient global impression of disease severity (PGI-S) response based on a participant achieving a score of None or Mild (0 or 1) in PGI-S

    Time frame: Weeks 4, 8, 16, 24 and 36

  19. Difference in the proportion of patient global impression of change in clinical status (PGI-C) response based on a participant achieving "Much Better" in PGI-C

    Time frame: Weeks 4, 8, 16, 24 and 36

  20. Difference in the proportion of responders for Atopic Dermatitis Control Tool (ADCT) response based on a participant achieving ≥5-point improvement from baseline in ADCT

    Time frame: Weeks 4, 8, 16, 24 and 36

  21. Difference in the mean CFB in POEM

    Time frame: Weeks 4, 8, 16, 24 and 36

  22. Difference in the mean CFB in DLQI at scheduled time points for participants 16 years or older

    Time frame: Weeks 4, 8, 16, 24 and 36

  23. Difference in the mean CFB in Children's Dermatology Life Quality Index (CDLQI) at scheduled time points for participants 12 to <16 years of age

    Time frame: Weeks 4, 8, 16, 24 and 36

  24. Difference in the mean CFB in weekly averages of PP-NRS

    Time frame: Week 1 through Week 24, plus Week 36

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED PHASE 3 COMBINATION THERAPY STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TILREKIMIG IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE OR OLDER WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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