Recruiting
Phase 3

Tilrekimig

Sponsor:

Pfizer

Code:

NCT07783425

Conditions

Atopic Dermatitis

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Tilrekimig

Dupilumab

Placebo for Tilrekimig

Placebo for Dupilumab

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 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

Study ID

NCT07783425

Start date

Aug 24, 2026

Status verified date

Oct, 2026

Completion date

Jun 15, 2029

Anticipated

Primary completion date

Sep 8, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1375 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tilrekimig - Initial treatment period

Subcutaneous injections given over 20 Weeks.

placebo comparator: Placebo - Initial treatment period

Subcutaneous injections given over 22 Weeks.

experimental: Tilrekimig - Maintenance Period - Dose B

Subcutaneous injections given at Week 24 through Week 48.

experimental: Tilrekimig - Maintenance Period - Dose A

Subcutaneous injections given at Week 24 through Week 48.

active comparator: Dupilumab - Initial treatment period

Subcutaneous injections given over 22 Weeks.

placebo comparator: Placebo - Maintenance Period

Subcutaneous injections given at Week 24 through Week 48.

Interventions

Tilrekimig

Subcutaneous Injections at required timepoints

Dupilumab

Subcutaneous Injections at required timepoints based on weight and age.

Placebo for Tilrekimig

Subcutaneous Injections at required timepoints

Placebo for Dupilumab

Subcutaneous Injections at required timepoints during initial treatment period.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Marvel Clinical Research

Recruiting

Huntington Beach, California, United States, 92647

Northridge Clinical Trials, LLC

Recruiting

Northridge, California, United States, 91325

Marietta Dermatology Clinical Research, Inc.

Recruiting

Marietta, Georgia, United States, 30060

Dawes Fretzin Clinical Research Group, LLC

Recruiting

Indianapolis, Indiana, United States, 46250

Vital Prospects Clinical Research Institute., PC

Recruiting

Tulsa, Oklahoma, United States, 74136

Clinical Neuroscience Solutions, LLC.

Recruiting

Memphis, Tennessee, United States, 38119

More Information

Sponsor

Pfizer

Last update posted

Oct 6, 2026

Last verified

Oct, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Pfizer on 2026-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.