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NCT Number: NCT07783425

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 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.

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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

Primary location

Vital Prospects Clinical Research Institute., PC

Tulsa, Oklahoma, 74136, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Tilrekimig

Drug

Subcutaneous Injections at required timepoints

Other names: PF-07275315

Dupilumab

Drug

Subcutaneous Injections at required timepoints based on weight and age.

Other names: Dupixent

Placebo for Tilrekimig

Other

Subcutaneous Injections at required timepoints

Other names: Placebo for PF-07275315

Placebo for Dupilumab

Other

Subcutaneous Injections at required timepoints during initial treatment period.

Primary outcomes

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

    Time frame: Week 16

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

    Time frame: Week 16

Secondary outcomes

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

    Time frame: Week 1 through Week 24

  2. Difference in the proportion of PP-NRS4 responders between tilrekimig versus dupilumab

    Time frame: Week 1 through Week 24

  3. Incidence of treatment emergent adverse events (AEs), Serious adverse events (SAEs), 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.

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

    Time frame: For each participant following first administration of the study intervention through the end of study visit (week 64).

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

    Time frame: Weeks 2, 4, 8, 12, 14, 20, and 24

  6. Difference in the proportion of Eczema Area and Severity Index (EASI)75 responders between tilrekimig versus dupilumab.

    Time frame: Weeks 2, 4, 8, 12, 14, 16, 20, and 24

  7. Difference in the proportion of validated Investigator Global Assessment- Atopic Dermatitis (vIGA-AD) 0/1 responders between tilrekimig versus placebo.

    Time frame: Weeks 2, 4, 8, 12, 14, 20, and 24

  8. Difference in the proportion of validated Investigator Global Assessment- Atopic Dermatitis (vIGA-AD) 0/1 responders between tilrekimig versus dupilumab.

    Time frame: Weeks 2, 4, 8, 12, 14, 16, 20, and 24

  9. Difference in the proportion of revised Global Investigator Assessment (rIGA) 0/1 responders between tilrekimig versus placebo.

    Time frame: Weeks 2, 4, 8, 12, 14, 16, 20, and 24

  10. Difference in the proportion of revised Global Investigator Assessment (rIGA) 0/1 responders between tilrekimig versus dupilumab.

    Time frame: Weeks 2, 4, 8, 12, 14, 16, 20, and 24

  11. Difference in the proportion of EASI50, EASI90, and EASI100 responders between tilrekimig versus placebo.

    Time frame: Weeks 2, 4, 8, 12, 14, 16, 20 and 24

  12. Difference in the proportion of EASI50, EASI90, and EASI100 responders between tilrekimig versus dupilumab.

    Time frame: Weeks 2, 4, 8, 12, 14, 16, 20 and 24

  13. Difference in the mean percent CFB in EASI total score between tilrekimig versus placebo.

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

  14. Difference in the mean percent CFB in EASI total score between tilrekimig versus dupilumab.

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

  15. Difference in the mean percent CFB in Body Surface Area (BSA) between tilrekimig versus placebo.

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

  16. Difference in the mean percent CFB in Body Surface Area (BSA) between tilrekimig versus dupilumab.

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

  17. Difference in the proportion of Patient Oriented Eczema Measure (POEM) responders achieving ≥4-point improvement from baseline between tilrekimig versus placebo.

    Time frame: Weeks 8, 16, and 24

  18. Difference in the proportion of POEM responders achieving ≥4-point improvement from baseline between tilrekimig versus dupilumab.

    Time frame: Weeks 8, 16, and 24

  19. Difference in the proportion of Dermatology Life Quality Index (DLQI) responders achieving ≥4-point improvement from baseline between tilrekimig versus placebo.

    Time frame: Weeks 8, 16, and 24

  20. Difference in the proportion of Dermatology Life Quality Index (DLQI) responders achieving ≥4-point improvement from baseline between tilrekimig versus dupilumab

    Time frame: Weeks 8, 16, and 24

  21. Difference in the proportion of Patient Global Impression of Severity (PGI-S) responders achieving a score of 0 or 1 between tilrekimig versus placebo.

    Time frame: Weeks 8, 16, and 24

  22. Difference in the proportion of Patient Global Impression of Severity (PGI-S) responders achieving a score of 0 or 1 between tilrekimig versus dupilumab.

    Time frame: Weeks 8, 16, and 24

  23. Difference in the proportion of Patient Global Impression of Change (PGI-C) responders achieving "Much better" between tilrekimig versus placebo.

    Time frame: Weeks 8, 16, and 24

  24. Difference in the proportion of Patient Global Impression of Change (PGI-C) responders achieving "Much better" between tilrekimig versus dupilumab.

    Time frame: Weeks 8, 16, and 24

  25. Difference in the proportion of Atopic Dermatitis Control Tool (ADCT) responders achieving ≥5-point improvement from baseline between tilrekimig versus placebo.

    Time frame: Weeks 8, 16, and 24

  26. Difference in the proportion of Atopic Dermatitis Control Tool (ADCT) responders achieving ≥5-point improvement from baseline between tilrekimig versus dupilumab.

    Time frame: Weeks 8, 16, and 24

  27. Difference in the mean percent CFB in POEM between tilrekimig versus placebo.

    Time frame: Weeks 8, 16, and 24

  28. Difference in the mean percent CFB in EASI total score between tilrekimig versus dupilumab.

    Time frame: Weeks 8, 16, and 24

  29. Difference in the mean percent CFB in DLQI between tilrekimig versus placebo.

    Time frame: Weeks 8, 16, and 24

  30. Difference in the mean percent CFB in DLQI between tilrekimig versus dupilumab.

    Time frame: Weeks 8, 16, and 24

  31. Difference in the mean percent CFB in Children's Dermatology Life Quality Index (CDLQI) between tilrekimig versus placebo.

    Time frame: Weeks 8, 16, and 24

  32. Difference in the mean percent CFB in CDLQI between tilrekimig versus dupilumab.

    Time frame: Weeks 8, 16, and 24

  33. Difference in the mean percent CFB in PP-NRS weekly average between tilrekimig versus placebo.

    Time frame: Week 1 through week 24

  34. Difference in the mean percent CFB in PP-NRS weekly average between tilrekimig versus dupilumab.

    Time frame: Week 1 through Week 24

  35. Proportion of responders for EASI75, rIGA 0/1, vIGA-AD 0, PP-NRS4, EASI50, EASI90, and EASI100 for tilrekimig doses and placebo.

    Time frame: Weeks 26, 28, 32, 36, 40, 44, 48, 52, and 64

  36. Mean of percent CFB in EASI and BSA for tilrekimig doses and placebo

    Time frame: Weeks 26, 28, 32, 36, 40, 44, 48, 52, and 64

  37. 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).

    Time frame: Week 52

  38. The proportion of POEM responders achieving ≥4-point improvement from baseline for tilrekimig doses and placebo.

    Time frame: Weeks 28, 36, 44, 52, and 64

  39. The proportion of DLQI responders achieving ≥4-point improvement from baseline for tilrekimig doses and placebo.

    Time frame: Weeks 28, 36, 44, 52, and 64

  40. The proportion of PGI-S responders achieving a score of 0 or 1 for tilrekimig doses and placebo.

    Time frame: Weeks 28, 36, 44, 52, and 64

  41. The proportion of PGI-C responders achieving "Much better" for tilrekimig doses and placebo.

    Time frame: Weeks 28, 36, 44, 52, and 64

  42. The proportion of ADCT responders achieving ≥5-point improvement from baseline for tilrekimig doses and placebo.

    Time frame: Weeks 28, 36, 44, 52, and 64

  43. Mean of CFB in POEM, DLQI, and CDLQI for tilrekimig doses and placebo.

    Time frame: Weeks 28, 36, 44, 52, and 64

  44. Mean of CFB in weekly averages of PP=NRS for tilrekimig doses and placebo.

    Time frame: Weeks 26, 28, 32, 36, 40, 44, 48, 52, and 64

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, 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

Acronym: Tilrek

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 24, 2026
Registry last updated
Aug 24, 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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