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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 12 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tilrekimig 		Subcutaneous injections given over 20 weeks
  • Drug: Tilrekimig
    Subcutaneous Injections at required timepoints
    Other names:
    • PF-07275315
Placebo Comparator
Placebo 		Subcutaneous injections given over 20 weeks
  • Drug: Placebo
    Subcutaneous Injections at required timepoints

Recruiting Locations

GCP Research , Global Clinical Professionals
St. Petersburg, Florida 33714

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.